PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results.

Some analysts have intimated that given the small size of the study at just over 270 patients, rival amyloid drug developers Biogen and Eisai could claim the biggest benefit from the data in positive sentiment ahead of an FDA decision later this year.

Goldman Sachs analyst Terence Flynn said the result was a “positive surprise” after Lilly revealed top-line data from the TRAILBLAZER-ALZ study showing that donanemab slowed cognitive decline by a third in people with early Alzheimer’s and completely resolved the amyloid beta plaques that are a hallmark of the disease.

Flynn also said the data was an “incremental positive” for Biogen, whose Eisai-partnered aducanumab is already filed for approval and awaiting an FDA decision by 7 March, as it lends further weight to the amyloid beta hypothesis of Alzheimer’s.

Biogen is nearest to market with aducanumab but a positive verdict from the US regulator is far from assured. In November, an FDA advisory committee voted ten to one against approval, saying the clinical data backing the drug was inconclusive, but that came on the back of a positive assessment by the FDA’s own reviewer.

Wolfe analyst Tim Anderson said in a research note issued ahead of the donanemab readout that the FDA could be influenced by the donanemab data and – if positive – that would raise the chances of a greenlight for aducanumab.

There’s an alternative view however that donanemab’s data might actually harm aducanumab’s prospects. Analysts at Jefferies told Barron’s this week that the FDA may have been minded to approve Biogen and Eisai’s drug because there were no other late-stage candidates in play, but Lilly’s drug could change that perception.

Donanemab is unlike most other amyloid-targeting drugs – including aducanumab – because it targets a pyroglutamated form of amyloid beta called N3pG that is found only in amyloid plaques and according to some research can stimulate misfolding of proteins.

Lilly’s hypothesis – as yet unproven – is that clearing those plaques has a direct association with cognitive benefits.

Lilly says TRAILBLAZER-ALZ met its primary endpoint, slowing decline on the Integrated Alzheimer’s Disease Rating Scale in the donanemab group by 32% compared to placebo, with trends towards improvement on secondary endpoints that didn’t hit statistical significance.

On safety, around 27% of the treatment arm showed ARIA-E – an inflammatory reactions also seen with other amyloid-targeting antibodies – but there’s little other data available yet.

Lilly started a 500-patient phase 2 trial called TRAILBLAZER-ALZ-2 last June that it suggests could serve as a confirmatory pivotal study and potentially support regulatory filings – dramatically shortening the development timeline for the drug. That’s due to read out in next year or later.

The post Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? appeared first on .

Amgen’s Enbrel heads ICER list of unjustified US price rises

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence.

The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for all but one the list price increase was at least double the US rate of inflation in that year.

Amgen’s venerable TNF inhibitor Enbrel (etanercept) for arthritis and other inflammatory conditions topped the list of offenders in terms of the added cost to the healthcare system, which ICER – the Institute for Clinical and Economic Review – estimated to be $403 million.

Enbrel’s list price rose 5.4%, but the net price was up almost 9% once adjusted for other factors, which could include rebates, wholesale fees and other variables like patient assistance programmes.

Second place was Johnson & Johnson’s schizophrenia treatment Invega Sustenna/Invega Trinza (paliperidone), with a 6.8% increase in the list price – and 10.7% net – which added $203 million to US drug spending.

The biggest price increases were seen with Salix’ irritable bowel syndrome therapy Xifaxan (rifaximin) – up 8.4% and 13.3% respectively – which added $173 million to the national spend.

The rest of the seven were: Bristol-Myers Squibb’s arthritis drug Orencia (abatacept) at a cost of $145 million; Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate) at $118 million; AbbVie’s TNF drug Humira (adalimumab) at $66 million; and UCB’s Vimpat (lacosamide) for epilepsy which swelled spending by $58 million.

“Several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago,” said ICER’s chief medical officer David Rind.

The increases came against a backdrop of relatively modest price increases overall in 2019, a time when the US administration had recently published a series of proposals to tackle high prescription drug prices, although many of those failed to come to fruition.

It’s worth noting that the scale of the increase identified in the latest report is considerably lower than was seen in ICER’s last edition in 2019. That also identified seven hefty price hikes for products – including Humira and Tecfidera – but cumulatively they all added a massive $4.8 billion to the US drugs bill.

According to a 2019 report by the OECD group of industrialised nations, the US spends roughly twice the average amount spent by other member countries on pharmaceuticals per head.

Three drugs also saw sizeable price increases, but ICER says those may have been justified by new clinical evidence – although the organisation notes it hasn’t run a full cost-effectiveness analysis.

The three were Novartis’ heart failure therapy Entresto (sacubitril/valsartan), Takeda’s Entyvio (vedolizumab) for ulcerative colitis and Astellas’ prostate cancer therapy Xtandi (enzalutamide).

The post Amgen’s Enbrel heads ICER list of unjustified US price rises appeared first on .

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology.

While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in 2018, it is difficult to get this class of drug distributed through the brain and spinal cord.

But with new technology based on branched silencing RNA licensed from the University of Massachusetts Medical School, Atalanta says it could change this.

Co-founded by Craig Mello, who won the Nobel Prize for Physiology or Medicine in 2006 for his work on RNAi, the company says the technology could be used to treat central nervous system diseases such as Huntington’s, Alzheimer’s and Parkinson’s.

Atalanta has actually been working since 2018 with co-founders Anastasia Khvorova, a UMass biochemist and Neil Aronin, a professor from University of Massachusetts Medical School, providing early leadership.

The company hired Alicia Secor as CEO in summer of 2019, who has previously been CEO of Juniper Pharmaceuticals and serves on the boards of neurology and rare diseases firms GW Pharmaceuticals and Orchard Therapeutics.

Atalanta starts life with two different strategic collaborations with its big pharma backers.

The partnership with Biogen will develop RNAi therapeutics for multiple targets, including HTT for the treatment of Huntington’s disease, as well as additional unnamed CNS targets.

Atalanta will be eligible to receive development and milestone payments as well as undisclosed royalties on any resulting products.

The strategic collaboration with Genentech entails the development of RNAi therapeutics for multiple CNS targets for neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

This could also result in development and milestone payments and royalties.

Unprecedented and astounding

In an interview with pharmaphorum Secor said that the technology comes from a discovery in Khvorova’s lab, which showed the technology allowed potent silencing of Huntington’s for six months in mice.

In 2019 results were published in Nature Biotechnology of the research findings, which were described by Secor as “unprecedented and astounding”.

The founders formed the company with backing from investor F-Prime Capital and has just launched its Series A round with Roche’s Genentech unit and Biogen the first to invest.

Secor said: “In my 30 years I have never seen this level of interest.”

The technology could be used in several indications, according to chief scientific officer and RNAi expert Aimee Jackson.

“There is distribution to multiple regions and deep brain structures and enhanced potency and duration of action,” she said.

With the backing the company already has, Secor said the plan is to focus on preclinical development without needing to worry about funding for the time being.

Quizzed about the possibility of an IPO or buyout from a big pharma company, Secor said the focus is very much on developing the technology.

She told pharmaphorum: “Our long-term vision is to be discovery research and commercialisation platform and product company for a very long time.

“We have a long cash runway to do some building,” she added.

Female leadership

Secor also noted the strong role that women have played in founding and running the company, noting that the name Atalanta refers to the famous female character from Greek mythology.

It also reflects the contribution from Khorova as the founder of the company.

There’s also a connection with Greek mythology from the name of the protein that is targeted by the RNAi drug in Huntington’s – Argonaute 2.

In many versions of Jason’s quest for the Golden Fleece, Atalanta served as the only woman on the crew of the Argo.

Secor noted the recent appointments of Emma Walmsley and Reshma Kewalramani as CEOs at GlaxoSmithKline and Vertex, respectively.

She told pharmaphorum: “I wanted to keep the name to remind us we were named after a woman.

“I think there is a big movement around diversity and inclusion its an opportunity to break through those glass ceilings women should be feeling empowered to take leadership roles.

“It creates a whole lot of opportunities for women. This is a good time for women and I am excited to see more women step into leadership roles.”

 

 

The post RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups appeared first on .

Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Shots:

  • Biogen and Apple collaborated to evaluate the role of Apple Watch and iPhone in monitoring cognitive performance and screening for the decline in cognitive health including mild cognitive impairment (MCI)
  • The study will initiate in late 2021 and will enroll participants including young and aging adults with a range of cognitive performance
  • The study focuses to identify digital biomarkers to aid monitor cognitive performance and health including potentially detecting mild cognitive impairment, an early indicator of certain forms of dementia such as AD

Click here ­to­ read full press release/ article | Ref: Biogen | Image: MyHealthyApp

The post Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies

Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD   

Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD

PerkinElmer to Acquire Oxford Immunotec for ~$591M

Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19

Hologic to Acquire Biotheranostics for ~$230M

Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology

Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities,  Vaccines, Treatments, Diagnostics

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies

Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy

 Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test    

Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis

Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD

Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones

Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology

Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development

 Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013

aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)

 Hologic to Acquire Somatex for ~$64 M   

Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D  

Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D

Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms

Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms

Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil

 Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea     

Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea

AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19

Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Shots:

  • ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations
  • ViGeneron will optimize and validate in vitro therapeutic candidates for undisclosed target to treat inherited eye disease while Biogen has the right to add an additional reserved target within two years after the effective date
  • The companies will work together on the in vivo POC and will use ViGeneron’s vgAAV technology to efficiently transduce target cells via intravitreal injections

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Fierce Biotech

The post Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment

AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy

Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

Published: Dec 21, 2020 | Tags: Autoleucel (cilta-cel), BLA, Initiates, Janssen, Multiple Myeloma, Rolling, Submission, Us FDA

Voyager Therapeutics Provides Update on NBIB-1817(VY-AADC) Program to Treat Parkinson Disease

Published: Dec 22, 2020 | Tags: (VY-AADC), NBIB-1817, Parkinson Disease, Provides, Update, Voyager Therapeutics

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

Published: Dec 22, 2020 | Tags: (daratumumab), DARZALEX, Health Canada Approval, Janssen, Multiple Myeloma, receives, Treatment

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Published: Dec 22, 2020 | Tags: Asthma, AstraZeneca, Corticosteroid, Dependent, Oral, P-III, patients, reports, results, Severe, SOURCE, Tezepelumab, Trial

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Published: Dec 21, 2020 | Tags: (BNT162b2), BioNTech, Comirnaty, Conditional Marketing Authorization, COVID-19, EC, Pfizer, receives

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Published: Dec 21, 2020 | Tags: (peginterferon beta-1a), Biogen, European Commission, Marketing Authorization, Plegridy, receives, Relapsing-Remitting MS

Servier to Acquire Agios’ Oncology Business for ~$2B

Published: Dec 21, 2020 | Tags: $2B, Agios, Agreement, business, Its, Oncology, Royalties, Sell, Servier, Signs

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Published: Dec 21, 2020 | Tags: Diabetic, Edema, Faricimab, Global, Macular, P-III, reports, results, Roche, Studies, Two

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Dec 21, 2020 | Tags: (osimertinib), approval, AstraZeneca, Early-Stage, EGFR-mutated Lung Cancer, receives, Tagrisso, US FDA’s

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Published: Dec 18, 2020 | Tags: Against, COVID-19, EUA, Moderna, mRNA-1273, receives, US, Us FDA

Ultragenyx Signs a License Agreement with Mereo for Setrusumab in Osteogenesis Imperfecta

Published: Dec 17, 2020 | Tags: Agreement, Imperfecta, Mereo BioPharma, Osteogenesis, Setrusumab, Signs, Ultragenyx

ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV

Published: Dec 21, 2020 | Tags: EC Marketing Authorization, Edurant Receives, HIV-1 Infection, Rekambys, ViiV Healthcare, Vocabria (cabotegravir)

Philips to Acquire BioTelemetry for ~$2.8B

Published: Dec 18, 2020 | Tags: Acquires, BioTelemetry, Philips

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Published: Dec 18, 2020 | Tags: Agreement, Candidates, Develop, Drug, Engager, Immuno, Janux Therapeutics, Merck, Novel, Oncology, Signs, T Cell, technology, Using

GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

Published: Dec 21, 2020 | Tags: Digestive System, Global License Agreement, GPR35, GSK, Immune Disorders, Signs, Sosei Heptares

Related News: PharmaShots Weekly Snapshots (Dec 14-18, 2020)

The post PharmaShots Weekly Snapshots (Dec 21-23, 2020) first appeared on PharmaShots.

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Shots:

  • The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers
  • Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were comparable in participants who were dosed with IM followed by SC, compared to SC followed by IM
  • The approval expands the offerings to the individuals with RMS, providing treatment option combining safety & efficacy to optimize the treatment experience with a reduction in injection site reactions

Click here ­to­ read full press release/ article | Ref: Biogen  | Image: The New York Times

The post Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Shots:

  • The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment
  • The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline as measured by MMSE, ADAS-Cog 13 & ADCS-ADL-MCI. MHLW will review the application through the standard review process
  • Aducanumab is an investigational mAb that is under the US FDA’s PR with an anticipated PDUFA date as Mar 7, 2021 and is also under review with the EMA

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Barron’s

The post Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease first appeared on PharmaShots.

Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 03, 2020

Product: CT-P17 (biosimilar, adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

  • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
  • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
  • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

Published: Nov 09, 2020

Product: Biosimilar

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

  • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
  • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
  • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

  • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
  • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
  • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

  • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

  • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
  • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
  • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
  • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
  • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
  • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
  • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

  • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
  • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
  • The draft guidance is to be published in the Federal Register on Nov 20, 2020

Alvotech Reported the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
  • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
  • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

  • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
  • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
  • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

  • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
  • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
  • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

  • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
  • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
  • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020

The post Insights+ Key Biosimilars Events of November 2020 first appeared on PharmaShots.

Eisai forges CNS alliance with UK’s Wren Therapeutics

Japanese drugmaker Eisai has teamed up with UK biotech Wren Therapeutics on an R&D programme seeking drugs for neurodegenerative disorders.

The two companies will focus their efforts on alpha-synuclein, a pathway that has been implicated in disorders such as dementia with Lewy bodies (DLB) and Parkinson’s disease (PD).

DLB and PD are both so-called synucleinopathies, diseases that are characterised by mutations in the SNCA gene coding for alpha-synuclein, leading to the production of misfolded, toxic forms of the protein that clump together and are thought to damage nerve cells.

Wren – a spinout from the universities of Cambridge in the UK and Lund in Sweden – has developed a drug discovery platform that can be used to screen small-molecule drugs to see if they can bind to misfolded proteins and correct their structure, preventing them from aggregating.

It’s a similar concept to interfering with the aggregation of beta-amyloid to form neurotoxic plaques in diseases like Alzheimer’s disease – another of Wren’s research targets.

Under the terms of the agreement, Cambridge-based Wren’s “network kinetics” platform will be deployed alongside Eisai’s drug discovery expertise in neurodegenerative disorders.

Eisai has a long heritage in this area, having been involved in the development of well-established Alzheimer’s drug Aricept (donepezil) and various other drugs for epilepsy, with a late-stage pipeline that includes Biogen-partnered anti-amyloid drug aducanumab, currently under review by the FDA.

“Synucleinopathies such as dementia with Lewy bodies and Parkinson’s disease represent a significant unmet medical need due to the lack of any effective disease-modifying treatments,” said Dr Teiji Kimura, who heads up drug discovery in Eisai’s neurology division.

“The accumulation of alpha-synuclein oligomers with protein misfolding is an important hallmark of these diseases,” he added.

Last summer, Wren raised 23 million in first-round financing to advance its internal R&D in the area of protein-misfolding diseases.

Other companies are also targeting alpha-synuclein, although Eisai and Wren are unusual in that they are seeking small-molecule candidates. Rivals include Roche and Prothera, which have an antibody in late-stage testing, as well as AstraZeneca/Takeda, Biogen, Lundbeck, AbbVie/BioArctic and Denali.

Roche licensed the antibody – called prasinezumab – from Prothera in a $600 million deal that dates back several years. Earlier this year however, the programme had a setback when a phase 2 trial in PD missed the mark.

The partners said the data showed some signs of efficacy, and prasinezumab is now heading for a phase 2b trial as an add-on therapy to standard levodopa therapy in PD.

Biogen has an antibody candidate called cinpanemab (BIIB054) in the phase 2 SPARK trial, due to generate results next year, while Lundbeck started a phase 1 trial in 2018 of Lu AF82422, another antibody, that could read out before year-end.

AZ and Takeda started a first phase 1 trial of their MEDI 1341 antibody in 2017, adding a second earlier this year that is due to run until 2022, while AbbVie’s ABBV-0805 cleared a phase 1 trial but seems to have been sidelined for strategic reasons.

Denali’s project is earlier in development. Its preclinical candidate ATV:aSyn is a bispecific antibody designed to penetrate the central nervous system more effectively, with one end targeting alpha-synuclein and another targeting a transporter in the blood-brain barrier.

The post Eisai forges CNS alliance with UK’s Wren Therapeutics appeared first on .

Biogen bulks up pipeline with Sage drugs in $3bn deal

With the prospects for its Alzheimer’s drug aducanumab still up in the air, Biogen has moved to shore up its late-stage pipeline with a $3 billion licensing deal with Sage that adds drugs for depression and neurological disorders.

The licensing agreement gives Biogen rights to Sage’s zuranolone (SAGE-217) for psychiatric disorders including depression, and SAGE-324 for essential tremor and other neurological diseases, which both target the GABAA receptor pathway.

In return Sage gets $1.525 billion upfront – $875 million in cash and a $650 million equity investment – as well as potential milestones of $1.6 billion if both drugs meet their development and commercial targets.

The deal comes as both companies are facing a challenging period. Biogen has invested heavily in its Alzheimer’s candidate aducanumab, but an FDA advisory committee was unimpressed with the company’s rehashed data for the anti-amyloid drug and voted that it didn’t support efficacy.

The FDA may still approve the drug – its reviewer had called some elements of the data persuasive in a briefing document – but even if it does getting payers to stump up for a drug with shaky data could be a challenge, despite the lack of Alzheimer’s therapies.

Meanwhile, Biogen has suffered recent setbacks including the failures of multiple sclerosis candidate opicinumab and a gene therapy for spinal muscular atrophy (SMA) – at a time when its big selling SMA drug Spinraza (nusinersen) is facing increased competitive pressure.

At the same time, Sage has struggled to make headway with its only approved therapy – Zulresso (brexanolone) for postpartum depression (PPD), which has been held back by a cumbersome dosing schedule that requires a 60-hour inpatient infusion.

Zulresso was launched last year but sales in the recent third quarter were just $1.6 million, around the same level as the same period of 2019.

With zuranolone, Biogen gets shared US and exclusive ex-US rights (excluding Japan, Taiwan and South Korea) to a potential first-in-class, once-daily oral drug with a breakthrough designation from the FDA as a treatment for major depressive disorder (MDD).

It has positive results from two pivotal trials – a phase 2 trial in MDD and phase 3 study in PPD – although a second phase 3 PPD trial (MOUNTAIN) failed to meet its primary objective. Biogen and Sage say there will be data readouts from other phase 3 trials in MDD and PPD next year.

The partners are going after three indications for the drug, namely PPD, as a rapid response therapy for MDD, and “as needed” treatment of acute MDD, and down the line will also look at its potential in bipolar disorder and generalised anxiety disorder.

A key characteristic is a rapid onset of action, which could free patients from the need to take antidepressants chronically and “may enhance quality of life and patient adherence”, according to Biogen.

SAGE-324 meanwhile is in phase 2 for essential tremor, a neurological disorder that causes involuntary and rhythmic shaking, and is being explored for other indications like epilepsy and Parkinson’s disease. Biogen gets shared US rights to the drug under the deal, as well as ex-US rights.

Essential tremor is estimated to affect over six million patients in the US, while 17 million Americans have symptoms of depression every year, and those numbers have led analysts to predict potential blockbuster sales for both zuranolone and SAGE-324 if approved.

Shares in Sage dipped after the announcement, with Jefferies analyst Andrew Tsai suggesting that might be because of disappointment that Sage hadn’t held out for potentially more favourable deal terms if zuranolone hits the mark in trials due to read out in 2021.

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

But it has been a source of controversy – it works by attacking the rogue blood vessels that build up in the retina that are the root cause of wet AMD, something that Roche’s Avastin (bevacizumab) cancer drug can do in an off-label use at a fraction of the price.

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

Samsung Bioepis and Biogen are among a gang of biosimilar developers who want to change this situation and the FDA has just accepted a filing for their potential contender known as SB11.

The European Medicines Agency already began its review of SB11 last month and if approved it will be added to a portfolio of other drugs already marketed by Samsung Bioepis.

Samsung Bioepis, a joint venture between the Korean tech firm and Biogen, last year struck a new marketing agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, Europe, Japan and Australia.

Other potential Lucentis biosimilars could come from Hospira and Pfizer or Formycon/Bioeq, who have potential biosimilars nearing the end of clinical development.

Biosimilars are near-copies of complex biologic drugs grown in cells, that have been rigorously analysed and tested in trials showing that they have the same safety and efficacy profile as the originator drug.

Because the approval process is more complicated and the products themselves are expensive to produce, biosimilars are not sold at the rock-bottom prices of generics.

But they are still sold at a considerable discount compared with the originators and could save billions of dollars in healthcare costs in the coming years.

 

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Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Shots:

  • EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI
  • In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, EU, Japan, and Australia
  • Ranibizumab is an anti-VEGF therapy for retinal vascular disorders, which is a leading cause of blindness in the US

Click here ­to­ read full press release/ article | Ref: Samsung Bioepis | Image: Samsung Bioepis

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PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

Bridging the gap between pharma and the NHS in MS

Janette Curlis is a Multiple Sclerosis Nurse Advisor (MSNA) at Biogen, helping to support the company’s Multiple Sclerosis (MS) field teams and developing patient and Healthcare Professional (HCP) materials.

We spoke to her about being a bridge between pharma and the NHS and the challenges that are facing Multiple Sclerosis Nurses (MSNs) and patients today.

Janette, what does your day-to-day work involve as a MSNA?

I work within the medical department at Biogen covering the UK and Ireland where my role is wide and multifaceted. As well as supporting our field teams, I develop nurse and patient materials, education and projects.

As a MSNA, my role has naturally evolved to accommodate how I support the nurses that I work with. I listen to and identify the gaps in their education and work cross functionally to develop training and education that will support their needs – at the same time being mindful not to increase their workload.

“As the demands of the job have changed, perhaps it is time to review the role and skill mix needed within MS teams. MS support nurses and MS admin coordinators would free the MSNs to concentrate on more complex needs of their patients”

The Disease Modifying Therapy (DMT) landscape alone requires education, information and planning to ensure the patient has the right treatment at the right time and the best experience.

The role of an MSN has changed over the years and has become more complex – what would you say are the main challenges MSNs face today and what are some of the wider challenges in MS care now?

The role is multipurpose, challenging and ever changing along with the National Health Service (NHS) in the UK and the Health Service Executive (HSE) in Ireland.

MSNs are time-poor. As the role has developed there are several new challenges they face. With around 14 disease modifying therapies now available, the MSNs of today require a different skill set to previous years.

There is a lack of consistency when it comes to provision of dedicated admin support to the MSNs. The increasing workload has put pressure onto nurses to fit everything into their working week, whilst maintaining quality time with their patients.

As the demands of the job have changed, perhaps it is time to review the role and skill mix needed within the teams. MS support nurses and MS admin coordinators would free the MSN to concentrate on more complex needs of their patients.

Looking at the wider challenges, it’s difficult to separate them out individually. They are wide ranging, and, not unlike the NHS, a lack of investment in developing services that reflect the change in delivery that’s needed today and for the future is a major factor.

What I find is that there are inefficiencies in the systems causing delays and duplication of work, and with no time to address these issues we see delays on areas such as time to treat and referrals.

How is the NHS addressing these challenges, and how does Biogen support that work?

With limited resource around service improvement in the NHS, Biogen have a team of Neurology Business Managers who work with MS services across the UK and can identify where improvements can be made. I can then support the nurses by assisting where appropriate.

How do you support Biogen in helping to address these challenges?

Moving forward we are building on the programme we delivered in 2019; the nurse advisor team ran numerous bespoke events and individual teaching sessions.

We continue to support the MS Trust Mental Health Campaign and I am working with the team to look at how we can support both MSNs and people with MS.

What are the key areas you’re looking to focus on to help improve value and engagement in MS?

All new MSNs appreciate onboarding is difficult. I have a specific half-day training programme to enable the nurses to have a firm grounding in MS. I also hold follow up sessions for MSNs which include immunology, DMTs, and MRI.

Nurses often ask why I left my hospital position of MSN, and whether I miss the patients. My reply is always that I never left MS nursing; I still work on behalf of the patients, just in a different way!

About the interviewee

Janette CurlisJanette Curlis is a MSNA working at Biogen. She has worked in Neurology since 1991 and specifically as an MSN since 1997. Janette was one of the few MSNs pre risk sharing scheme recruitment. She worked in clinical research in MS studies as well as her role as MSN up until leaving the NHS in 2011. She worked with almost all of the now licensed therapies in trial phase. Janette moved to the pharmaceutical industry to take up a new role as nurse advisor for Novartis in 2011 and joined Biogen in 2014.

Biogen-50773

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FDA panel unimpressed with data for Alzheimer’s drug aducanumab

The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking.

The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved to be a fractious affair, with both the companies’ data – and some of the FDA’s interpretation of it – under fire by panellists.

After hours of debate, the verdict from the experts was pretty unequivocal – 10 panellists voted against the main study supporting the drug, with just one saying they were uncertain about the data. Not one was convinced that the clinical trial results proved that the drug was effective.

The resounding rejection of the clinical data submitted in support of the marketing application for aducanumab came after the FDA published briefing documents that indicated the agency’s clinical reviewer was in favour of approval, calling the results “persuasive” despite a fairly damning assessment by the agency’s statistical expert in an appendix.

Aducanumab is vying to become the first Alzheimer’s drug designed to tackle an underlying cause of the disease, and the first new treatment for the neurodegenerative disease in almost two decades.

The FDA has been working closely with Biogen on the application and could still decide to approve the drug despite its experts’ reservations. That said, the balance of the votes makes that outcome unlikely – despite impassioned testimony during the virtual meeting by patient organizations.

The agency is due to make a decision by 7 March, and a review is also underway at the European Medicines Agency (EMA). Analysts have predicted it could become a multibillion-dollar blockbuster if approved, although at the moment that looks unlikely without another clinical trial.

An approval could also be seen as vindication for the hypothesis that tackling the amyloid plaques that are seen in the brains of people with the disease helps to slow the onset of symptoms. Many people had given up on the hypothesis after dozens of failed studies involving anti-amyloid drugs.

Biogen ran two identically-designed phase 3 studies of aducanumab – EMERGE (Study 302) and ENGAGE (Study 301) – to try to demonstrate that the anti-amyloid antibody could slow down the loss of cognitive function in people with mild cognitive impairment due to Alzheimer’s.

Last year, it called a halt to the studies after a futility analysis found it unlikely that aducanumab would show an effect on cognitive decline, but a few months later said that EMERGE was positive after all, and would form the basis of a marketing application with a phase 1b extension study – called PRIME – used as supportive evidence.

After a positive discussion of the results from Billy Dunn, acting director of the FDA’s office of neuroscience, the panel voted on three aspects of the data set.

In the first, they came down 8 to 1, with 2 uncertain, that the EMERGE trial could not be viewed on its own as providing strong evidence supporting aducanumab’s efficacy without taking into account the negative ENGAGE data.

They then voted 7 against and 4 uncertain on a question asking whether PRIME provide supportive evidence of the effectiveness of aducanumab in Alzheimer’s, before rejecting the premise that EMERGE could serve as primary evidence supporting the efficacy of the antibody.

Overall, the conclusion was that a negative interpretation of the data is just as likely as the positive one put forward by the trial sponsors, with one suggesting Biogen had shot first, and painted a bullseye later.

Biogen issued a short statement after the meeting in which CEO Michel Vounatsos said: “We appreciated the opportunity to share our data with the advisory committee, and we will continue to work with the FDA as it completes its review of our application.”

Trading in the biotech’s stock was halted ahead of the advisory committee meeting, but looks likely to be under considerable pressure when it resumes as it has been fluctuating wildly in reflection of the fortunes of aducanumab.

Biogen has a lot riding on aducanumab, as its pipeline has suffered recent setbacks including the failure of multiple sclerosis candidate opicinumab and a gene therapy for spinal muscular atrophy (SMA) at a time when big selling SMA drug Spinraza (nusinersen) is facing increased competition.

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The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Shots:

  • The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab
  • The committee voted 5-0 and 6 uncertain on showing PD effect of aducanumab on AD pathophysiology. Finally, the committee voted 0-10 & 1 for exploratory analyses of Study 301 & 302, along with study 103 and evidence of a PD effect on AD pathophysiology
  • Following the committee’s opinion, the US FDA is expected to make a decision on approval of aducanumab’s BLA by Mar 7, 2021

Click here ­to­ read full press release/ article | Ref: Biogen | Image: The Conversation

The post The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease first appeared on PharmaShots.

Insights+ Key Biosimilars Events of October 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of October, Henlius signed two agreements for its biosimilar products and presented results of HLX03 (biosimilar, adalimumab) whereas Samsung Bioepis and Biogen announced EMA filing acceptance of SB11 (biosimilar, ranibizumab). Our team at PharmaShots has summarized 09 key events of the biosimilar space of Oct 2020.

1. Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 01, 2020

Product: HLX02 (biosimilar, trastuzumab)

  • Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones
  • Accord to get an exclusive license to develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA’s biosimilar guidelines
  • In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC’s and the NMPA approval sin July & Aug’2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

2. Medicure Signed Agreement with Reliance Life Sciences for Marketing Rights of a Cardiovascular Biosimilar

Published: Oct 05, 2020

Product: Biosimilar

  • Medicure is responsible for the regulatory approval process for the product
  • The agreement grants an exclusive right to Medicure to market & sell the product in the US, Canada & the EU
  • The product fits well with Medicure’s mission of being a significant CV company focused on the US market

3. Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11 (biosimilar, ranibizumab)

Published: Oct 07, 2020

Product: SB11 (biosimilar, ranibizumab)

  • EMA has accepted to review the MAA for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen
  • In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates: SB11 (ranibizumab) and SB15 (aflibercept) in the US, Canada, Europe, Japan, and Australia
  • Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness

4. Innovent and Lilly’s Halpryza (biosimilar, rituximab) Received NMPA’s Approval in China

Published: Oct 12, 2020

Product: Halpryza (biosimilar, rituximab)

  • NMPA has approved Halpryza for patients with DLBCL, FL, and CLL in China. The biosimilar is the fourth mAb approved in China following the approval of Tyvyt (biosimilar, sintilimab), Byvasda (biosimilar, bevacizumab) and Sulinno (biosimilar, adalimumab)
  • The clinical efficacy and safety of rituximab in CD20 +ve NHL have been confirmed in multiple large-scale clinical trials. Rituximab has received its FDA’s approval in 1997 for NHL, CLL, RA, GPA, MPA and PV
  • The approval of Halpryza will bring a new option to Chinese Lymphoma patients, help them to improve QoL & prolong their survival. Halprryza is rituximab injection and a recombinant human/murine chimeric mAb targeting CD20 antigen on the surface of B lymphocytes and mediates CDC and ADCC

5. Henlius Signed a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 19, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the cumulative net sales along with 10% royalties on net sales of the therapy
  • Henlius will be responsible for the pre/ clinical development of HLX04, whereas Essex is responsible for regulatory filings and commercialization of HLX04 globally and will be responsible for 80% of all costs and expenses concerning the development of HLX04. Additionally, Essex has a right to grant a sublicense to third parties, for which Henlius will receive 20% of the related sublicensing revenue
  • Henlius is developing HLX04 for ophthalmic diseases, wAMD & DR. Henlius and Essex plan to conduct global clinical trials of HLX04 in China, Australia, EU & the US, & will apply MAA in different countries across the globe

6. NeuClone Reported Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 21, 2020

Product: NeuLara (biosimilar, ustekinumab)

  • The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study
  • Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs, CI (90%) of the GMR within the pre-specified (80%-125%) acceptance limits for all 3 pairwise comparisons. Additionally, the safety, immunogenicity and tolerability profiles were similar in all three treatment arms
  • NeuLara is a biosimilar referencing Stelara, being developed to treat patients with PsO, PsA, CD and UC. The biosimilar is being co-developed by NeuClone and its strategic manufacturing partner, Serum Institute of India

7. Samsung Bioepis Reported Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Published: Oct 27, 2020

Product: Renflexis (biosimilar, infliximab)

  • The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020
  • One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis in patients with IBD identified from the VAHS database and demonstrated an 83% continuation rate over 1yr. with similar continuation rate in patients who underwent a single & double switch from reference infliximab
  • The second study focused on the real-world utilization pattern of infliximab products for IBD, within the context of VANF policy. The study found that Renflexis became the preferred infliximab product on VANF in Sept’2018 which was faster than the adoption of the previous biosimilar (infliximab-dyyb), listed on VANF in May’2017

8. SomaLogic Collaborated with the US FDA to Advance Biosimilar Development

Published: Oct 29, 2020

Product: Biosimilar

  • SomaLogic collaborate with the FDA to identify circulating pharmacodynamic biomarkers and analytical approaches that could be used to demonstrate bio-similarity of a biosimilar to a reference FDA-approved biologic drug
  • The collaboration will utilize the SomaLogic proteomic technology for the identification of circulating pharmacodynamic biomarkers for therapeutic biologics
  • SomaLogic’s SomaScan platform makes 5,000 protein measurements simultaneously in small samples of blood, to compare changes in circulating proteins following treatment with FDA-approved biologics and could reduce the need for costly and lengthy comparative clinical studies

9. Henlius Presented Results of HLX03 (biosimilar, adalimumab) in P-lll Study for Plaque Psoriasis at EADV 2020

Published: Oct 29, 2020

Product: HLX03 (biosimilar, adalimumab)

  • The P-III HLX03-Ps03 study involves comparing the efficacy, safety, and immunogenicity assessing of HLX03 (80mg, qd) with reference adalimumab in 262 Chinese patients in the ratio of (1:1) with moderate to severe plaque psoriasis
  • Result: On 1EPs % improvement of PASIwk16 (83.48% vs 82.02%), least-square mean difference (1.46%), no significant differences between the treatment groups in 2EPs that include PASI 75, PGA reaching clearance, and change in DLQI
  • HLX03 is an adalimumab biosimilar to be used for the treatment of autoimmune diseases including psoriasis, RA & AS

Related Post: Insights+ Key Biosimilars Events of September 2020

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China’s Green Valley prepares US trial of Alzheimer’s drug inspired by algae

As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease.

For almost two decades there has been no progress with new therapies for Alzheimers – the last new drug approved by the FDA was Forest’s Namenda (memantine) in 2003 and this only helps to relieve symptoms rather than tackling the root cause of the condition.

Since then the story of Alzheimer’s research has been one of expensive failures as experimental drugs, mainly targeting the amyloid plaques found in the brains of people with the disease, failed to stop or slow cognitive decline in clinical trials.

As Biogen hopes to change the narrative with aducanumab and a new analysis of a phase 3 trial initially written off as a failure, Shanghai Green Valley Pharmaceutical is beginning US trials of a radically different approach to treating the disease.

Green Valley’s drug known as GV-971 is a type of sugar extracted from brown algae and does not work directly on the brain at all: it tackles imbalances in the gut’s bacteria population that researchers believe may cause the brain inflammation leading to Alzheimer’s or Parkinson’s disease.

Last year China’s National Medical Products Administration (NMPA) became the first national regulator to approve the drug and the FDA gave the nod for US trials to begin earlier this year.

According to Bloomberg the first patient has been enrolled in a trial that the company hopes will show the cognitive improvements seen in the China-based trial that convinced the NMPA to approve GV-971.

The latest trial has been delayed because of the coronavirus pandemic but will enrol up to 2,046 people across China, the US and Europe, with the first 600 expected to sign up in the next six months.

Bloomberg noted that Green Valley needs the trials to win over sceptics who have questioned the authenticity of the data used by the NMPA for approval.

There is also confusion about why Green Valley has succeeded where the big western pharma companies have failed.

Whether Biogen gets the vote on Friday that could convince the FDA to approve aducanumab, or Green Valley succeeds with its trial, the prize for a drug that sets new standards in Alzheimer’s is huge.

A new Alzheimer’s drug would open up a market worth up to $30 billion in the US alone according to a Sanford C Bernstein & Co analysis cited by Bloomberg.

It’s unlikely that big pharma will be put off research, even if Biogen and Green Valley’s drugs are added to the ever-growing list of trial failures.

 

 

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Trials and tribulations in Biogen’s Alzheimer’s drug reviews

Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough to support approval.

The EMA has just kicked off its review of the anti-amyloid therapy, following in the footsteps of the FDA in the US which has been looking at the drug since August, but a new analysis of the mixed phase 3 data for aducanumab argues that an additional trial should be carried out.

The paper in the journal Alzheimer’s & Dementia, led by Mayo Clinic neurologist David Knopman, says that efficacy of aducanumab “as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes.”

Meanwhile, the paper also notes that Knopman has been excluded from an FDA advisory committee meeting due to discuss the data on Friday, ahead of a decision on the marketing application due in March.

The expert – who was an investigator in the phase 3 trials of Biogen’s drug – told Reuters he was recused from the panel because of his involvement in conducting clinical trials of aducanumab.

Aducanumab – which Biogen is developing with Japanese drugmaker Eisai – was all but abandoned in 2019 after the partners decided that two phase 3 trials of the drug were unlikely to show an effect on cognitive decline in Alzheimer’s.

Shares in Biogen were hit hard, as investors lost hope that aducanumab might be rescue the almost defunct amyloid hypothesis of Alzheimer’s disease, which holds that blocking the formation of amyloid plaques in the brain could delay the onset of dementia.

Just a few months later however they said a fresh look at the results of the EMERGE and ENGAGE studies had revealed that the initial futility analysis was “incorrect.” In fact, the drug reduced clinical decline in patients with early, a chance was put down to more exposure to a higher dose in additional patient follow-up.

Some patients showed statistically significant improvements on symptoms like memory, orientation, and language, as well as being able to carry out day-to-day tasks more easily.

There’s a lot riding on the FDA and EMA reviews. If approved, aducanumab will become the first therapy to reduce the clinical decline of Alzheimer’s and to change the course of the disease, says Biogen. It would also be the first amyloid-targeting drug to reach the market, after dozens of others have failed in clinical development.

Meanwhile, aducanumab is the big hope in Biogen’s late-stage pipeline, which otherwise is looking fairly thin, at a time when the biotech is facing the loss of patent protection for its blockbuster multiple sclerosis therapy Tecfidera (dimethyl fumarate).

Knopman and fellow authors argue in the Alzheimer’s & Dementia paper that Biogen’s interpretation of data in the two trials might not be correct.

They write that they have found alternative explanations for the apparent drug benefits unrelated to the treatment, and say that while there is evidence that aducanumab was working on amyloid and other biomarkers like tau protein as expected, “no evidence was presented to correlate biomarker changes to cognitive benefits.”

They also say there were differences in the placebo responses between the two studies, which could have contributed to the divergent results.

“Our analysis supports the conduct of a third, definitive phase 3 trial with high‐dose aducanumab [that is] optimally designed and adequately powered to prove efficacy,” they conclude.

The FDA has not commented on the reasons for Knopman’s exclusion from the advisory committee meeting publicly, but in these cases there is usually a conflict of interest.

Along with his involvement in EMERGE and ENGAGE, Knopman also serves on a data safety monitoring board for a tau drug for Alzheimer’s developed by Biogen, and is an investigator in a trial sponsored by Eli Lilly and the University of Southern California.

He also performs unpaid consultancy work for Samus Therapeutics, Third Rock, Roche, and Alzeca Biosciences, according to the paper’s conflict of interest statement.

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Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

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Biogen teams up with gene-editing startup Scribe on ALS programme

Scribe Therapeutics, a start-up focusing on gene-editing using CRISPR/Cas9, has burst onto the biotech scene with a $415 million deal with Biogen.

Jennifer Doudna

Scribe – which counts new Nobel Prize for chemistry winner Jennifer Doudna among its founders – is getting $15 million upfront from Biogen for an alliance focusing on the development of a CRISPR-based therapy for neurodegenerative disease including amyotrophic lateral sclerosis (ALS).

It’s also just completed a $20 million first-round financing backed by tech venture capital firm Andreessen Horowitz.

The Alameda, California-based biotech says its gene-editing platform can overcome the limitations of other CRISPR techniques, and also sidesteps the intellectual property infringement issues that have plagued the first wave of companies operating in this area.

Its main platform – called X-editing – can generate CRISPR drugs with improved activity, specificity and deliverability compared to rivals, according to the start-up’s website. One element of its platform is that it has molecules that can modify nucleic acids only when triggered by external stimuli.

It will also use a variation of CRISPR/Cas9 known as CRISPR/Casx which is smaller, making it easier to deliver using viral vectors for example, and more efficient at modifying genes in the body.

Benjamin Oakes

Doudna is serving as scientific advisor to Scribe, and its chief executive is Benjamin Oakes, who has been working on genome editing for most of his scientific career, starting out looking at a rival technology to CRISPR called zinc finger nucleases before working in Doudna’s lab at the University of California, Berkeley.

“Scribe has designed, engineered and tested thousands of evolved CRISPR enzymes to build an advanced platform for creating breakthrough in vivo treatments,” said Oakes.

At the moment, most CRISPR-based medicines rely on the modification of cells outside the body, that are then used as therapies. Further back in development are drugs that will be administered to edit genes within the body, but the first of these candidates are now in clinical trials.

Biogen’s early buy-in to Scribe is a big endorsement of the company’s approach, although details of the collaboration remain sketchy, other than to say the first programme will be “genetically-driven ALS.”

ALS – also known as Lou Gehrig’s disease – is the most common form of motor neurone disease (MND) and results in the slow death of motor neurons that control muscle function.

The disease can be either sporadic or inherited, with several genes implicated in the latter case, and there is currently no cure although drugs are available that can reduce the rate of decline.

Biogen’s agreement includes options on two programmes, but there is no word yet on what disease that follow-up project may target.

The big biotech meanwhile has an antisense drug in trials for a subtype of inherited ALS, licensed from Ionis Pharma, in phase 3 clinical trials.

Last year, it reported interim data from a phase 1/2  trial of that drug – called tofersen – suggesting it could slow down the functional decline in patients with SOD1-mutated ALS.

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Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

Shots:

  • EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen
  • In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates: SB11 (ranibizumab) and SB15 (aflibercept) in the US, Canada, Europe, Japan, and Australia
  • Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness

Click here ­to­ read full press release/ article | Ref: BIOGEN | Image: The Investor

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Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting

The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.

Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam).

Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec).

But Spinraza costs $750,000 in the first year of treatment and about half that price annually from then on.

Zolgensma costs about $2.1m for a single shot of the gene therapy, making it the most expensive drug in the world by many people’s reckoning, although the manufacturer argues this is justified given the costs of treating the condition in later life.

Roche has decided to price Evrysdi according to its weight, costing up to $340,000 per year, with the cost being under $100,000 annually for some younger patients.

While this is not cheap by anybody’s reckoning, Roche hopes that the less intimidating price tag, plus the patient-friendly oral administration method will give it a competitive edge.

The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

Roche noted that Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA.

Infants achieved the ability to sit without support for at least five seconds, a key motor milestone not normally seen in the natural course of the disease.

Evrysdi also improved survival without permanent ventilation at 12 and 23 months, compared to natural history.

A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.

Evrysdi is designed to treat SMA by increasing production of the survival of the motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Evrysdi will be available in the US within two weeks for direct delivery to patients’ homes through Accredo Health Group, an Express Scripts specialty pharmacy.

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Biogen’s shares surge again as FDA hurries Alzheimer’s drug review

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review.

The FDA reserves these quick reviews for drugs that have the potential to improve care standards for serious diseases.

There have been no new drugs approved for Alzheimer’s since 2003 and those that are on the market are only able to treat the symptoms.

Biogen aims to change this with aducanumab, after clinical trial data showed the drug helped to slow onset at a higher dose in two clinical trials that had initially been written off as failures earlier last year.

The FDA has set a decision date for March 27 next year, and Biogen said that the regulator could make a ruling before then.

Biogen said that the FDA is planning to hold an advisory board meeting, which will make a non-binding vote about whether to approve the drug.

The meeting will discuss data from Biogen’s re-analysis of the EMERGE and ENGAGE trials, which last October concluded the drug reduced clinical decline in patients with early AD.

At the time the announcement was a complete shock as the trials had been deemed failures following an analysis last spring.

The renaissance was due to greater exposure to a higher dose of the anti-amyloid antibody in a larger data set, which was not available to the independent committee that initially concluded the trials were unlikely to slow cognitive decline.

Biogen’s share price, which fluctuated wildly to reflect its fortunes with aducanumab, was up more than 10% after the news broke on Friday.

This builds on gains last month when Biogen completed its filing based on the reanalysed study data.

An approval could also be seen as vindication for the hypothesis that tackling the amyloid plaques that are seen in the brains of people with the disease helps to slow the onset of symptoms.

Many people had given up on the hypothesis after a string of trial failures over the last decade or so.

The other main method of action being investigated is targeting the tau protein tangles that are seen in brain cells of people with Alzheimer’s.

At the end of last month Roche signed a deal worth up to $2 billion with Belgium’s UCB to develop its anti-tau antibody UCB0107.

 

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Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

Biogen signs $2.1 billion Parkinson’s disease deal with Denali

Biogen has bought a licence to co-develop and co-market potential Parkinson’s disease drugs with US biotech Denali, in a deal worth more than $2.1 billion.

Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s disease.

Biogen and Denali will co-market the lead LRRK2 product in the US and China, and Biogen will commercialise in all other markets.

A molecule codenamed DNL151, currently in phase 1 development, has been selected to progress into late stage clinical studies that are expected to begin in 2021.

Mutations in the LRRK2 gene can cause Parkinson’s disease. LRRK2 regulates lysosomes, which play a vital role in cell function by breaking down excess or worn-out cell parts, and can also destroy invading viruses and bacteria.

Function of lysosomes is impaired in Parkinson’s disease and may contribute to the neurodegeneration that causes the symptoms of the disease.

Inhibition of LRRK2 activity may slow the progression of Parkinson’s disease in patients with and without known genetic risks based on restoration of lysosomal function.

As well as the LRRK2 drug Biogen will also receive an exclusive option to license two preclinical programmes from Denali’s drug transport platform, which aims to improve brain uptake of biotherapeutics.

Denali’s TV platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins and oligonucleotides across the blood-brain barrier after intravenous administration.

Biogen will have right of first negotiation on two additional transport vehicle (TV) enabled therapeutics, currently at a preclinical stage, should Denali decide to seek a partner.

Biogen will make an upfront payment to Denali of $560 million and make a $465 million equity investment in Denali from the purchase of 13.3 million newly issued shares of Denali common stock at approximately $34.94 per share, representing 11.2% of Denali’s outstanding stock.

Should the LRRK2 program achieve certain development and commercial milestones, Denali will be eligible to receive up to $1.125 billion in potential milestone payments.

People who have Parkinson’s disease experience numerous symptoms, including tremors, slow movement, muscle stiffness and impaired balance.

As these symptoms become progressively worse, patients have difficulty walking, talking or completing other simple tasks.

Parkinson’s disease is the second most common neurodegenerative disease and there are no approved therapies capable of slowing progression.

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Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Shots:

  • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s Pro-forma outstanding stock along with $1.125B as milestones.
  • The two companies will codevelop Denali’s LRRK2 inhibitor for PD and co-commercialize it in the US and China while Biogen has the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
  • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late-stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid-beta + right of first negotiation for two additional unnamed TV platform programs

Click here ­to­ read full press release/ article | Ref: Biogen | Image: PharmaShots




Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis’ gene therapy Zolgensma, combining the two ultra-expensive therapies to treat the rare muscle-wasting disease.

In the US, a single shot of Zolgensma (onasemnogene abeparvovec) costs $2.1 million, while Spinraza (nusinersen) costs $750,000 in its first year.

Biogen said it aims to begin a phase IV study as in a long-term follow-up study of Novartis’ drug it has been reported that some patients have been subsequently treated with Spinraza.

The phase IV RESPOND study aims to test efficacy and safety of Spinraza with a suboptimal clinical response to Zolgensma.

So far four out of 10 patients in a long-term study of Zolgensma have been subsequently treated with Spinraza, Biogen said.

Based on the planned study design, RESPOND will be a two-year, open-label study to evaluate the efficacy and safety of Spinraza in SMA patients previously treated with Zolgensma to further inform treatment decisions.

Efficacy will be assessed by change from baseline on motor function measures and additional clinical outcomes such as swallowing and caregiver burden.

Neurofilament levels, an exploratory endpoint, will also be evaluated as a marker of biological disease activity.

The primary study group aims to include 40 infants aged nine months or younger at the time of the first dose of Spinraza, who have two copies of SMN and are likely to develop type 1 disease and received Zolgensma at six months old or younger.

A second study group will include 20 children and will generate data in patients with a broader age range, up to three years old at the time of the first Spinraza dose.

After a screening period, participants will receive the approved 12 mg dose of Spinraza, which is four loading doses followed by maintenance doses every four months, over the two-year study period.

If approved by regulators the company aims to begin enroling patients in the first quarter of next year.

While Zolgensma is a gene therapy that aims to correct the genetic defect that causes the disease, Spinraza works by increasing the amount of full-length SMS protein that is critical to maintaining motor neurons.

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Biogen to launch Phase IV study of spinal muscular atrophy drug in post-gene therapy patients

The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.

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The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.