AZ says Calquence is a safer drug than Imbruvica

AstraZeneca’s fast-growing BTK inhibitor Calquence is already challenging class leader Imbruvica from Johnson & Johnson/AbbVie in the treatment of chronic lymphocytic leukaemia (CLL). Now, AZ has new data suggesting its drug is less likely to cause a serious cardiac side effect.

The latest study in AZ’s ELEVATE trial series showed that Calquence (acalabrutinib) matched Imbruvica (ibrutinib) on keeping adults with previously treated, high-risk CLL alive without disease progression.

It also showed that AZ’s drug was significantly less likely to be associated with atrial fibrillation (AF), an irregular heart rate that can increase the risk of stroke, heart failure and other cardiovascular complications.

Two years ago, a study by the Cleveland Clinic in the US suggested that around 9% of patients treated with Imbruvica developed AF within a year of starting the drug, which was in the middle of other reviews suggesting the rate varied from around 4% to 16%. The authors suggested that it could generally be managed safely with drugs like beta blockers.

According to AZ, the ELEVATE-RR trial is the first  phase 3 study to compare two BTK inhibitors head to head in CLL, which is the most common form of leukaemia in adults. So far only the top-line outcome has been released, without any supporting data.

First approved for mantle cell lymphoma (MCL) in 2017, Calquence sales have rocketed since its approval for CLL towards the end of 2019, rising more than 200% to reach $340 million in the first nine months of 2020.

It is however still dwarfed by J&J and AbbVie’s blockbuster, which made around $5.6 billion in 2019 from half a dozen indications, including CLL and MCL. AZ has said is seeing swift growth for its brand in CLL thanks to its “outstanding efficacy and a favourable tolerability profile”.

That allowed the drug to capture around 35% of new patient starts in the US in the third quarter of 2020, according to the drugmaker.

That came ahead of the approval of Calquence for CLL in Europe, which was secured last November, as well registration of the drug in the last few days for relapsed or refractory CLL in Japan, based ono the results of the ASCEND trial.

“With over forty months of follow-up, today’s results confirm that Calquence…displays superior safety in atrial fibrillation without compromising efficacy,” said the company’s head of oncology José Baselga.

“The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence.”

AZ meanwhile is running trials to try to position Calquence as an alternative to Imbruvica in other indications, including diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, and follicular lymphoma.

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ViiV/J&J’s long-acting HIV regimen finally approved in US

The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen.

It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC).

The clinical data supplied by ViiV was enough to support approval, however, and the FDA has finally given the go-ahead for Cabenuva.

Cabenuva is based on ViiV’s long-acting integrase inhibitor cabotegravir and the non-nucleoside reverse transcriptase inhibitor (RTI) Edurant (rilpivirine) developed by J&J’s Janssen pharma unit.

ViiV, which is a joint venture with GlaxoSmithKline as a majority shareholder, with Pfizer and Shionogi holding minority interests, noted that this is the first treatment to offer this less demanding treatment regimen.

The injection is delivered in a clinic and aside from clinical data supporting its safety and efficacy, ViiV said nine out of ten patients preferred the dosing regimen to their previous daily oral therapy in the studies used for approval.

This was based on a survey filled in alongside one of the trials used for approval, where 532 patients completed a single-item question at Week 48.

Results showed 88% preferred Cabenuva compared with 2% who preferred their previous daily oral HIV treatment.

The results were descriptive in nature and are not intended to imply clinical significance, ViiV noted in a statement, adding that only 59 patients chose not to answer the questionnaire.

The approval of Cabenuva is based on the pivotal phase III ATLAS studies that included more than 1,100 patients from 16 countries.

Before treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine (lead-in) was administered for around one month to assess the tolerability of each therapy.

In these studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period.

In both studies, the most common adverse reactions 2% or more of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

Serious adverse events occurred in 4% (24/591) of patients taking Cabenuva, and 3% (17/591) of adverse events led to withdrawal.

 

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One in 11 over-65s unwilling to take COVID-19 shot

One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey.

The findings are concerning given that adults in this group are at highest risk for complications from the disease.

Findings from part of the Heartline clinical study, sponsored by Johnson & Johnson and Apple, have been published online on a preprint server and have yet to be peer-reviewed.

Recruitment to the study began in February last year and it was initially set up to test whether wearable and custom-built mobile apps could enable earlier detection and better treatment of atrial fibrillation in patients aged 65 and older.

Willingness to vaccinate against COVID-19 was assessed through an optional survey through the Johnson & Johnson app between 6th and 20th November last year,

The assessment included questions on beliefs about vaccines in general, beliefs about COVID-19 and the COVID-19 vaccine, and opinions on vaccine dosing and potential side effects.

Shortly after the survey was offered, Pfizer announced first interim analysis results showing the vaccine it developed with BioNTech had an efficacy of around 90% and authors compared answers before and after this event to gauge its impact on opinions.

Of the 7,402 people who responded, 63.6% of participants reported they were very willing to receive a COVID-19 vaccine, 27.8% were somewhat willing, 6.0% were not very willing, and 2.6% were not at all willing.

Overall, authors said that 91.3% were “willing” to be immunised and 8.7% were “unwilling”.

Analysing different demographic groups, the study found participants identifying as Black or African American were least likely to want to take COVID-19 vaccines.

A total of 26.8% of Black or African American participants noted they were not very willing or not at all willing to vaccinate, compared with 8.0% of white participants.

Study author Janeta Nikolovski, director of the World Without Disease Accelerator at Johnson & Johnson’s Janssen pharma unit, told pharmaphorum in an emailed interview that she not surprised about vaccine hesitancy in older age groups.

“Several prior published studies have shown those trends as well,” said Nikolovski, who said further work is being done to understand why older people are more likely to be sceptical about vaccines.

She added: “Among those who said they were unwilling to get vaccinated, the majority stated that they would discuss their decision with their healthcare provider, providing an important opportunity for education.”

Further work is also needed to identify why different demographic groups have differing attitudes to the vaccine.

She added: “We agree that further study is needed and a one-size-fits all approach in communication will not be ideal to address specific concerns.”

Nikolovski is hopeful that as vaccine campaigns are rolled out, attitudes to vaccines could change for the better.

“Given that we found vaccine safety and efficacy to be a strong predictor of willingness to vaccinate, I think as people get vaccinated and share their experience with others, trust will grow.

“We saw an increased vaccine willingness after the trial results were released, suggesting that public willingness to vaccinate may continue to rise as additional positive data are released.”

Conversely, negative news stories about vaccines, including reports about adverse events, may have a negative impact.

“In general however, I believe transparency with research results is important, whatever the results, as it is important to realistically manage expectations, “ she concluded.

Janssen is working on a single shot COVID-19 vaccine, which has shown promise in early trials with phase 3 data possibly due by the end of the month.

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J&J’s Darzalex Faspro is first US therapy for rare blood disorder

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder.

The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its own and as part of multiple combination therapies.

J&J’s Janssen pharma unit got approval for Darzalex Faspro as a multiple myeloma treatment in the US last May and in Europe the following month, lending further momentum to a franchise that looks set to make more than $4 billion in sales in calendar 2020.

AL amyloidosis is a much smaller indication for the drug, but a crucial one medically as patients with the disease currently have limited treatment options and a poor prognosis.

It is caused by a defect in bone marrow cells called plasma cells, causing them to produce abnormal forms of light chain proteins, which enter the bloodstream and form amyloid deposits. Amyloid plaques can then form in multiple organs such as the heart, kidneys and liver, damaging them and in some cases leading to organ failure.

Until now people with AL amyloidosis have had to rely on chemotherapy, with its accompanying side effects, and other drugs to tackle organ failure once damage gets severe.

A stem cell transplant or organ transplant can be an option for some patients and other drugs – notably Takeda’s Ninlaro (ixazomib), which failed a phase 3 trial in 2019 – have struggled to show an impact on the disease.

Darzalex Faspro looks set to transform the prospects for the 30,000 to 45,000 people in the US and Europe AL amyloidosis patients. It has already been submitted for approval in the EU.

In the phase 3 ANDROMEGA trial, adding Darzalex Faspro to a standard chemotherapy regimen of bortezomib, cyclophosphamide and dexamethasone (VCd) and comparing it to VCd alone.

Patients treated with Darzalex Faspro saw a haematologic response rate that was nearly triple that of those treated with VCd alone, at 53% compared to 18%, respectively.

Moreover, J&J’s drug seemed to limit the organ damage, improving measures of heart and kidney function after six months’ treatment and prolonging the time to major organ deterioration.

Isabelle Lousada, founder and chief executive of the Amyloidosis Research Consortium (ARC), hailed the approval as a major step forward for AL amyloidosis patients, but noted that much more has to be done.

“Sadly, most patients with AL amyloidosis are diagnosed more than one year after their initial symptoms present, at a time when they may already be experiencing organ deterioration or failure,” she pointed out.

“I believe this approval will increase awareness of and education around this life-threatening disease and offer new hope for people with AL amyloidosis and their caregivers.”

It’s an added benefit that Darzalex Faspro can be delivered in three to five minutes, while the original IV formulation requires a four- to six-hour infusion, meaning it will be easier to administer.

J&J licensed the daratumumab antibody used in both Darzalex products from Danish biotech Genmab in 2012, while US company Halozyme supplied the subcutaneous delivery technology that underpins Darzalex Faspro.

The AL amyloidosis filing was reviewed under the FDA Real-Time Oncology Review (RTOR) programme, which allows data for certain applications to be reviewed before the applicant formally submits the complete application.

There are some other drugs coming through the development pipeline for AL amyloidosis, notably Alexion and Caelum Biosciences’ CAEL-101, a first-in-class amyloid fibril targeted therapy which started phase 3 testing last September.

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J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.

The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.

Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.

The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.

The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.

J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

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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).

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Top 20 Biopharma M&A of 2020 by Total Deal Value

  • Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years.
  • AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% strengthening its capabilities in immunology, neurology, metabolic cardiovascular, nephrology, and rare disease.
  • This article is based on the 2020 deals data as provided by the DealForma database. Our team at PharmaShots compiled a list of the top 20 acquisitions of 2020 based on total deal value.

Deal Date: Dec 17, 2020

Deal Value: $0.77B 

Novartis acquired Cadent Therapeutics. The acquisition strengthens Novartis’ neuroscience portfolio with the addition of Cadent’s NMDAr program, including CAD-9303, an NMDAr positive allosteric modulator in Phase I for schizophrenia, and MIJ-821, an NMDAr negative allosteric modulator in Phase I for treatment-resistant depression. CAD-9303 and MIJ-821 were licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical-stage SK channel positive allosteric modulator for movement disorders. Cadent Therapeutics received $210M up front and is eligible for up to $560M in milestones.

Deal Date: Aug 11, 2020

Deal Value: $0.87B

Bayer acquired KaNDy Therapeutics with its Phase IIb compound, NT-814, a small molecule for menopause and vasomotor symptoms. The acquisition strengthens Bayer’s drug development portfolio in women’s healthcare. KaNDy Therapeutics received $425M up front and is eligible for up to $450M in R&D milestones and additional undisclosed sales-based milestones.

Deal Date: Aug 25, 2020

Deal Value: $0.93B

ACADIA Pharmaceuticals acquired CerSci Therapeutics with its lead candidate, ACP-044, a Phase I small molecule for acute & chronic pain. The acquisition strengthens ACADIA’s non-opioid pain therapies portfolio. CerSci shareholders received $52.5M up front and are eligible for up to $887M in development and sales-based milestones.

Deal Date: Dec 15, 2020

Deal Value: $1.04B

Eli Lilly acquired Prevail Therapeutics. The acquisition strengthens Eli Lilly’s gene therapies portfolio with Prevail’s clinical and preclinical disease-modifying AAV9 gene therapy assets in neuroscience. Prevail’s pipeline includes PR001 in Phase I/II for Parkinson’s disease and in preclinical studies for neuronopathic Gaucher disease, and PR006 in Phase I/II for frontotemporal dementia with GRN mutations. Prevail shareholders received $880M up front at a purchase price of $22.50 per share which represents a premium of approximately 117% plus 1 non-tradable CVR worth up to $4.00 per share in cash (or an aggregate of approximately $160M), for a deal total of up to $26.50 per share in cash, approximately $1.04B. The CVR is payable upon the first regulatory approval for the commercial sale of a Prevail product in one of the countries, including the US, Japan, UK, Germany, France, Italy, or Spain.

Deal Date: Jan 10, 2020

Deal Value: $1.1B     

Eli Lilly acquired Dermira with its IL-13 inhibitor antibody lebrikizumab, which is in Phase III for moderate-to-severe atopic dermatitis, and its marketed QBREXZA (glycopyrronium) medicated cloth for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). Dermira licensed lebrikizumab from Genentech/Roche, which acquired the compound when it acquired Tanox, the originator. Dermira shareholders received $18.75 per share in cash at a 1-day premium of 2.2% for approximately $1.1B.

Deal Date: Oct 15, 2020

Deal Value: $1.3B

Lilly acquired Disarm Therapeutics. The acquisition strengthens Lilly’s neurology portfolio with the addition of preclinical SARM1 inhibitors, a small molecule for peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm shareholders received $135M up front and are eligible for up to $1.225B in development, regulatory, and commercial milestones if Lilly develops and commercializes new medicines based on Disarm’s approach.

Deal Date: May 5, 2020

Deal Value: $1.3B     

Alexion Pharmaceuticals acquired Portola Pharmaceuticals including its balance sheet and debt of approximately $215M. The acquisition expands Alexion’s hematology, neurology, and critical care portfolio. Portola shareholders received $18 per share in cash at a premium of 130% for a total of $1.38B.

Deal Date: Dec 10, 2020

Deal Value: $1.4B     

Boehringer Ingelheim acquired NBE-Therapeutics. The acquisition strengthens Boehringer Ingelheim’s oncology pipeline with NBE-002, Phase I immunoconjugates for TNBC, lung, and ovarian cancers. NBE-Therapeutics is eligible to receive up to EUR 1.18B ($1.428B).

Deal Date: Dec 10, 2020

Deal Value: $1.7B

Gilead Sciences acquired MYR. The acquisition strengthens Gilead’s infectious disease and liver disease portfolio with the addition of hepcludex, a lipoprotein approved for Hepatitis D in Europe and in Phase III for Hepatitis D, in Phase II for Hepatitis B, in Phase I for dyslipidemia, and in preclinical studies for NASH and primary biliary cholangitis. MYR shareholders received EUR 1.15B ($1.39B) up front and are eligible for up to EUR 300M ($363.7M) in milestones.

Deal Date: Nov 6, 2020

Deal Value: $1.8B     

Novo Nordisk acquired Emisphere Technologies for $1.8B. The acquisition strengthens Novo Nordisk’s biologics segment with the addition of Eligen SNAC drug delivery technology. Additionally, Novo Nordisk will buy out its Eligen SNAC royalty stream obligations with MHR Fund Management, Emisphere’s largest shareholder. Novo Nordisk partnered with Emisphere in 2007 to develop oral biologics by applying Eligen SNAC. Emisphere shareholders received $7.82 per share in cash representing a 15% 1-day premium at approximately $1.35B. Additionally, Novo Nordisk will pay $450M to MHR Fund in connection with its royalty stream obligations.

Deal Date: June 11, 2020

Deal Value: $2.1B

Novo Nordisk acquired Corvidia Therapeutics. The acquisition strengthens Novo Nordisk’s cardiovascular disease portfolio with Phase II ziltivekimab, an antibody for inflammatory cardiovascular risk in CKD patients. Corvidia received $725M up front and is eligible for up to $1.375B in regulatory and sales-based milestones.

Deal Date: Aug 31, 2020

Deal Value: $2.6B

Nestle acquired Aimmune Therapeutics. The acquisition strengthens Nestle’s food allergy portfolio with Palforzia, an approved protein for peanut allergy. Aimmune Therapeutics received $2.6B at $34.50 per share at a 1-day premium of 174%. Nestle previously acquired 25% of the company starting with their 2016 partnership.

Deal Date: Nov 5, 2020

Deal Value: $2.7B     

Merck acquired VelosBio. The acquisition strengthens Merck’s oncology pipeline with the addition of Phase II VLS-101 antibody-drug conjugate targeting ROR1 for hematologic malignancies and solid tumors plus preclinical ADCs and bispecific antibodies. VelosBio shareholders will receive $2.75B.

Deal Date: Aug 17, 2020

Deal Value: $3.6B     

Sanofi acquired Principia Biopharma. The acquisition strengthens Sanofi’s autoimmune and allergic diseases portfolio with tolebrutinib (SAR442168), a small molecule in Phase III for multiple sclerosis and in Phase II for CNS disorders. Principia Biopharma received $3.6B at a purchase price of $100 per share at a premium of 10%. In 2017, Sanofi and Principia partnered on the development and commercialization of SAR442168, which was in Phase IIb for multiple sclerosis. Principia’s lead compound was rilzabrutinib, which was in Phase III for pemphigus.

Deal Date: Oct 26, 2020

Deal Value: $4B

Bayer acquired Asklepios BioPharmaceutical for $4B. The acquisition strengthens Bayer’s cell and gene therapy portfolio with the addition of AskBio’s AAV technology platform, CDMO facilities, and preclinical and clinical compounds for neuromuscular, CNS, cardiovascular, and metabolic diseases. Its leading gene therapy is in Phase I/II for Pompe disease. This also complements Bayer’s 2019 acquisition of BlueRock Therapeutics. Asklepios is eligible to receive 75% of the milestone payments in the next five years.

Deal Date: Mar 2, 2020

Deal Value: $4.9B

Gilead acquired Forty-Seven with its lead product magrolimab, a monoclonal antibody targeting CD47 in Phase Ib for acute myeloid leukemia (AML). The company is also studying myelodysplastic syndrome (MDS) and diffuse large B-cell lymphoma (DLBCL). The acquisition strengthens Gilead’s oncology portfolio. Forty-Seven received $4.9B at $95.50 per share at a premium of 65%.

Deal Date: Aug 19, 2020

Deal Value: $6.5B     

Johnson & Johnson acquired Momenta Pharmaceuticals for $6.5B at $52.50 per share at a premium of 79%. The acquisition strengthens Johnson & Johnson’s portfolio of autoimmune disease therapies with Phase III nipocalimab (M281), an anti-FcRn antibody for warm autoimmune hemolytic anemia, which is also in Phase II for myasthenia gravis among other indications. Momenta’s potential pipeline may have indications in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology, and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation.

Deal Date: Oct 05, 2020

Deal Value: $13.1B 

Bristol Myers Squibb acquired MyoKardia for $13.1B at $225 per share at a 1-day premium of 61%. MyoKardia’s mavacamten, a small molecule in Phase III for obstructive hypertrophic cardiomyopathy (HCM), has an NDA submission expected in Q1 2021 and is in Phase II for Non-obstructive Hypertrophic Cardiomyopathy. MyoKardia also has 2 clinical compounds, danicamtiv (MYK-491) in Phase II for genetic dilated cardiomyopathy, systolic dysfunction, and atrial fibrillation, and MYK-224, a Phase I small molecule for hypertrophic cardiomyopathy.

Deal Date: Sep 13, 2020

Deal Value: $21B

Gilead acquired Immunomedics for $21B at $88.00 per share at a premium of 108%. The acquisition gives Gilead trodelvy, an antibody-drug conjugate approved for mTNBC. Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, which received accelerated approval for mTNBC in the US. Trodelvy is also being studied in Phase III for 3L HR+/HER2- breast cancer and Phase II for bladder cancer, NSCLC, and other solid tumors.

Deal Date: Dec 12, 2020

Deal Value: $39B     

AstraZeneca acquired Alexion for $39B including its drugs Soliris, Ultomiris, and 11 pipeline molecules in 20 different clinical programs. Soliris is an anti-complement component 5 mAb approved for paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder and is in Phase III for Guillain-Barre syndrome. Ultomiris is an approved antibody for Paroxysmal nocturnal hemoglobinuria and Hemolytic uremic syndrome and is in Phase III for generalized Myasthenia gravis, neuromyelitis optica spectrum disorder (NOSMD), hematopoietic stem cell transplant-associated thrombotic microangiopathy, Amyotrophic lateral sclerosis, complement-mediated thrombotic microangiopathy, severe pneumonia or acute respiratory distress syndrome in COVID-19. Alexion’s expertise in the complement cascade beyond C5 and additional modalities, including the pathway of the complement system, will strengthen AstraZeneca’s portfolio including immunology, neurology, metabolic cardiovascular, nephrology, and rare disease. Alexion shareholders received $60 per share in cash and 2.1243 ADS shares of AstraZeneca valued at $175 per share at a premium of 45%, or approximately $39B. Upon completion, Alexion will own 15% of the combined company.

The post Top 20 Biopharma M&A of 2020 by Total Deal Value first appeared on PharmaShots.

U.S. and Pfizer Seal Deal for 100 Million More Vaccine Doses

The company agreed to deliver the additional doses of its coronavirus vaccine by the end of July, helping address a looming shortage.

Pfizer Nears Deal to Provide More Vaccine Doses

The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.

Pfizer Nears Deal to Provide More Vaccine Doses

The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.

Pfizer Nears Deal to Provide More Vaccine Doses

The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.

Pfizer Nears Deal to Provide More Vaccine Doses

The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.

Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA

Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy.

Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form of blood cancer, specifically in heavily treated adults who currently have few therapeutic options.

BMS’ CAR-T idecabtagene vicleucel (ide-cel) is going after the same indication and is due for a verdict from the US regulator on 27 March 2021.

The rolling application allows portions of the dossier to be filed as they become available, shortening the review time, although BMS is still in pole position to bring a multiple myeloma cell therapy to the US market, despite a setback earlier this year when the FDA rejected the filing for the CAR-T, asking for more data.

Cilta-cel’s filing triggers a $75 million payment from J&J to its development partner Legend Biotech under the terms of a deal signed in December 2017. It is J&J’s first application for a cell therapy.

The submission is based on results from phase 1b/2 CARTITUDE-1 study, which showed an overall response rate of 97% with cilta-cel, with 67% of patients achieving a stringent complete response despite having received a median of five prior therapies.

The median duration of response and progression-free survival still have not been reached in the study, suggesting the effect is long-lasting, according to Janssen.

Like other CAR-Ts the therapy isn’t without risk however, and there were 14 deaths reported during the study, including six due to complications related to treatment itself.

With all the caveats about comparing different trials, cilta-cel’s results look a little better than those of ide-cel’s KarMMa study, which had an overall response rate of 73%, including 33% complete responses, among patients who had a median of six prior treatments.

BMS is also developing another BCMA directed CAR-T – orvacabtagene autoleucel (orva-cel) – which generated positive results in the EVOLVE trial this year.

Ide-cel and cilta-cel aren’t the first BCMA-targeted drugs for myeloma, however. GlaxoSmithKline’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) has already been approved in the US and Europe, making almost $11 million in third-quarter sales in its first few weeks on the market.

There are other BCMA drugs coming through the pipeline as well, including a string of bispecific antibody therapies from Regeneron, Amgen, J&J and others that could sidestep the cumbersome and risky treatment and manufacturing process for CAR-T therapies.

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FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

U.S. and Pfizer Are Negotiating Deal for More Vaccine Doses Next Year

The Trump administration is discussing helping the drug maker get the raw materials it would need to produce tens of millions of extra doses of its Covid-19 vaccine in the spring.

ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma

Eli Lilly’s buyout of Loxo Oncology last year has already yielded one approved drug, and it now has a path to market for a second after BTK inhibitor LOXO-305 after reporting promising data at the American Society of Haematology (ASH) meeting.

Updated results from the phase 1/2 BRUIN trial suggest that LOXO-305 could become a go-to therapy in B-cell non-Hodgkin’s lymphoma (NHL) patients whose cancer progresses despite earlier treatment with older BTK drugs.

Lilly’s drug is a non-covalent inhibitor, while already-approved BTK inhibitors like Johnson & Johnson and AbbVie’s Imbruvica (ibrutinib), AstraZeneca’s Calquence (acalabrutinib), and BeiGene’s Brukinsa (zanubrutinib) are covalent inhibitors.

According to its developers, that means it has efficacy in NHL that has developed resistance to first-line BTK drugs, mainly because it binds to its target reversibly. That means it can return to the circulation and continue to bind to BTK, without stimulating the resistance escape mechanism.

Imbruvica has become a mainstay of first-line treatment for NHL and other blood cancers like chronic lymphocytic leukaemia, driving it to sales of more than $6 billion collectively for J&J and AbbVie last year, but resistance can make its benefits short-lived.

It’s estimated that resistance can cause treatment failure of more than 40% of patients treated with first-line Imbruvica after five years, and more than 50% when the drug is used second-line for relapsed or refractory disease.

In BRUIN, LOXO-305 was tested in various types of NHL, including 61 patients with mantle cell lymphoma (MCL) and 19 with Waldenström’s macroglobulinemia (WM) who had previously been treated with a covalent BTK inhibitor.

In MCL, the drug had an overall response rate (ORR) of 52%, even though patients had received on average three prior lines of therapy, with around half of them seeing a complete response to the drug.

Most patients had been treated with a BTK drug, anti-CD20 antibody therapy with rituximab, and/or chemotherapy, with some also receiving Bristol-Myers Squibb/Celgene’s Revlimid (lenalidomide), a bone marrow transplant or CAR-T cell therapies.

Four out of five (83%) of the MCL patients were still responding to LOXO-305 at the data cutoff, after a median of six months of treatment.

For the WM group there was an ORR of 68%, with 13 of 19 patients responding including nine partial responses and four minor responses.

Ten of the 13 are still on the drug and responding after a median of 4.6 months, and there were also encouraging response data with other forms of NHL including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and marginal zone lymphoma (MZL).

Armed with the new data, Lilly has embarked on a bold strategy for LOXO-305 that will try to position it quickly as an alternative to the established drugs, rather than an option after they have failed.

The drugmaker is planning to start a head-to-head phase 3 trial of LOXO-305 versus the investigator’s choice of covalent BTK inhibitor in relapsed-refractory MCL in the first quarter of next year, gambling that its drug will show best-in-class efficacy.

If it eventually does get approved, LOXO-305 would join Lilly’s RET inhibitor Retevmo (selpercatinib, formerly LOXO-292) on the market, becoming the second product from Lilly’s $8 billion acquisition of Loxo in January 2019.

Analysts think LOXO-305 has greater sales potential than Retevmo, given the size of its target market and the fact that the RET inhibitor is in a marketing battle with rival drug Gavreto (pralsetinib) from Roche and Blueprint Medicine.

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J&J files lung cancer bispecific amivantamab for FDA approval

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).

J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.

Janssen has ambitions to expand the use of the drug into the larger EGFR inhibitor market, which at the moment, is led by AstraZeneca’s fast-growing EGFR tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib).

Amivantamab (formerly JNJ-6372) is a bispecific or double-headed antibody, combining an EGFR-binding domain at one end with one targeting mesenchymal epithelial transition (MET) factor, which is a common resistance mechanism that can reduce the activity of EGFR drugs.

That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use.

EGFR mutations are some of the most common mutations in NSCLC, and that has driven sales of Tagrisso – the standard of care for previously-untreated EGFR-positive NSCLC – to more than $3 billion last year.

The Exon 20-mutated population is fairly large in its own right, as these mutations are the third most prevalent primary EGFR mutation. That said, they often go undetected, so J&J will have to develop ways to identify suitable patients if amivantamab is to make headway in the market.

In the summer, the drugmaker signed partnered with Guardant Health to seek regulatory approval of a companion diagnostic for amivantamab that will be used to identify suitable patients.

Along with the marketing approval submission, J&J has also set up an expanded access programme, which would allow patients at need to use the drug while the FDA review is underway.

Patients with exon 20 insertion mutations have a median survival of less than 17 months, around half that of patients with other EGFR mutations.

Amivantamab has been filed for approval based on the phase 1 CHRYSALIS study which showed that the drug shrank tumours in 36% of all patients in the study, and 41% of those previously treated with chemo. The median durations of response were 10 months and seven months, respectively.

CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC.

That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients. Called MARIPOSA, it will compare Tagrisso to lazertinib alone as well as the combination.

Meanwhile, J&J is also exploring the use of amivantamab in patients who have failed TKI therapy and only have chemo as an option.

Both lazertinib and amivantamab – which was developed using technology from Danish biotech Genmab –  have blockbuster sales potential, according to the company.

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Janssen adds Hemera’s AMD gene therapy to pipeline

Johnson & Johnson’s pharma unit Janssen has bought rights to an investigational gene therapy for a severe form age-related macular degeneration from specialist biotech Hemera Biosciences.

Financial details of the deal have not been disclosed and will add Hemera’s gene therapy HMR59 to Janssen’s pipeline of ophthalmology drugs.

The privately-held biotech has developed the gene therapy as a single shot to treat dry age-related macular degeneration, or dry AMD.

In the form of dry AMD known as geographic atrophy, dysregulation of the complement system can lead to the formation of a “membrane attack complex” that causes cells in the retina to die, leading to progressive loss of vision.

HMR59 is designed as a potential one-time treatment administered in an office setting that increases the ability of retina cells to produce a soluble form of CD59, called sCD59, that blocks the formation of the membrane attack complex and limits further damage to the retina.

It uses a modified adeno-associated virus to deliver the genetic material to the back of the eye.

Geographic atrophy affects five million people globally, and is a leading cause of blindness in people over 50 years of age.

The prevalence of geographic atrophy increases as the global population ages, with roughly one in 29 people over age 75 affected, and nearly one in four people over age 90. There are currently no available therapies other than vitamins and low vision aids.

The phase 1 study of HMR59 for patients with geographic atrophy is complete. A second phase 1 study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate long-term safety.

Janssen established its eye disease portfolio in 2018 and is developing expertise and assets across a range of rare and common eye diseases, including achromatopsia and X-linked retinitis pigmentosa, age-related macular degeneration, diabetic retinopathy, and diabetic macular oedema.

Spark Therapeutics, which is now part of Roche, has shown that gene therapies can be converted into marketable ophthalmology drugs, after approval of Luxturna in 2017 for retinal degeneration caused by mutations in the gene RPE65.

 

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Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Shots:

  • In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial in collaboration with the UK NIHR
  • The P-lll ENSEMBLE 2 study will evaluate the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine for the prevention of COVID-19 in ~30,000 patients across the globe. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel
  • The two P-III studies follow positive interim results of P-I/IIa study assessing the safety profile and immunogenicity of both a single-dose/ two-dose vaccination

Click here ­to­ read full press release/ article | Ref: Janssen | Image: Philadelphia Inquirer

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J&J begins trial of two-dose COVID-19 vaccine regimen

Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as a two-dose regimen.

The company’s Janssen pharmaceuticals and vaccines unit has already begun the ENSEMBLE study testing the single-dose vaccine and plans to enrol up to 60,000 participants worldwide.

It has now begun the two-dose regimen trial ENSEMBLE 2 trial, which will run in parallel with the first ENSEMBLE and will recruit up to 30,000 people worldwide.

The company acknowledged that a single-dose vaccine with a good safety profile would have significant benefit but is assessing other dosing regimens as well to see if they work better in the long term.

ENSEMBLE 2 study is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older.

Patients may or may not have stable comorbidities associated with an increased risk for severe COVID-19.

The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.

Janssen is testing the vaccine in countries with high infection rates, such as Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.

In the UK, ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR).

There are 11 vaccines in late stage-development, according to the World Health Organization, including the Pfizer/BioNTech shot, which is more than 90% effective according to top-line clinical trial results announced last week.

BioNTech’s co-founder professor Ugur Sahin told the BBC’s Andrew Marr show that if it is approved by regulators, the vaccine’s impact will significantly kick in over summer, leading to resumption of normal life by next winter.

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With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

Finish line ahead

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

Insights+: COVID-19 Healthcare News Monthly Updates – October 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

Prenetics Acquires Oxsed, Oxford University Spin-out to Scale Rapid COVID-19 Test Globally. Rapid Airport Testing has begun in Heathrow with Trials in Hong Kong International Airport.

Oct 30, 2020 |

OncoSec Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19

Oct 29, 2020 |

Moleculin Announces Additional Collaboration on Drug Candidate Targeting COVID-19

Oct 29, 2020 |

Kintor Pharmaceutical’s COVID-19 Clinical Trials for Proxalutamide to expand Patient Enrolment

Oct 29, 2020 |

Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine

Oct 28, 2020 |

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Oct 28, 2020 |

COVID-19 Immune Response Study Could Lead to More Effective Treatments

Oct 28, 2020 |

JadiCell™ Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double Blind FDA Clinical Trial

Oct 28, 2020 |

Daewoong Pharmaceutical’s COVID-19 Treatment Candidate Also Highly Effective against Influenza Virus

Oct 28, 2020 |

Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19

Oct 28, 2020 |

Ampio Begins Phase 1 Clinical Trial of Inhaled Ampion For COVID-19 Patients With Respiratory Distress

Oct 28, 2020 |

Companies could face difficulties registering cleaners and disinfectants with claims of “long-lasting” effectiveness against COVID-19, says TSG Consulting

Oct 27, 2020 |

Daewoong Pharmaceutical’s Long-Acting Niclosamide Shows High Promise Against Upcoming COVID-19 ‘Twindemic’

Oct 27, 2020 |

Quest Diagnostics and Catapult Health Provide Virtual Preventive Care Services for Employers During COVID-19 Pandemic and Beyond

Oct 27, 2020 |

Ampio Presents at Roth Capital Partners 2020 MedTech Innovation Forum Focusing on COVID-19 Clinical Trial Activities

Oct 26, 2020 |

Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19

Oct 26, 2020 |

Truvian Sciences Announces Plans to Make Rapid Antibody Testing More Accessible with Easy Check COVID-19 IgM/IgG™ POC Antibody Test

Oct 26, 2020 |

Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix® COVID-19 Test

Oct 26, 2020 |

SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission

Oct 26, 2020 |

Biophytis Enrolls First Patient in Brazil in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Oct 26, 2020 |

Entos Pharmaceuticals Awarded funding to Conduct Phase I Clinical Trial of COVID-19 DNA Vaccine

Oct 23, 2020 |

FDA Approves First Treatment for COVID-19

Oct 22, 2020 |

Arizona Based Biotech Company Finds Preliminary Success Developing an Intranasal COVID-19 Vaccine Alternative

Oct 22, 2020 |

TrippBio Announces the Completion of Enrollment in a Proof of Concept Clinical Trial Evaluating the Efficacy of TD213 in Treating Patients with Confirmed COVID-19 Infections

Oct 22, 2020 |

Fresenius Medical Care North America Presents New Insights Related to COVID-19 and Dialysis Innovations at Kidney Week 2020

Oct 22, 2020 |

Alight and THINKMD Rapidly Adapt Established Medical Infrastructure in Fight Against COVID-19

Oct 22, 2020 |

Kedrion’s Partner, Kamada Ltd, Signs a Supply Agreement with the Israeli Health Authorities for the Investigational Anti-COVID-19 Plasma-Derived Therapy

Oct 22, 2020 |

Amyris and The Infectious Disease Research Institute Enter into Exclusive License for Novel RNA Vaccine Platform, Beginning with COVID-19 Vaccine

Oct 22, 2020 |

COVID-19 Respiratory Monitoring with MediPines AGM100® in Long-Term Care Facilities

Oct 22, 2020 |

Poseida Therapeutics and TScan Therapeutics Announce Research Collaboration and License Agreement to Explore Developing Allogeneic T Cell Receptor Therapies for the Treatment of COVID-19

Oct 21, 2020 |

Facilitating the ‘Vaccine Era’ of COVID-19 Response: ThermoGenesis to Receive U.S. Patent for Breakthrough Serological Test Reader Technology

Oct 20, 2020 |

CSL’s Broad Response to COVID-19 and Advancements across the Company’s Strategic Scientific Platforms are the Focus of Annual R&D Day

Oct 20, 2020 |

OPKO Health’s BioReference Laboratories Launches Multiplex COVID-19 and Influenza A/B Test

Oct 20, 2020 |

IncellDx to Study Maraviroc, a CCR5 antagonist, in a COVID-19 Phase 2 Clinical Trial

Oct 20, 2020 |

EIB Provides Immunic With up to €24.5 Million to Support Ongoing Development of a Potential COVID-19 Therapy

Oct 20, 2020 |

NHS Hospitals trial ground-breaking new decontamination technology to reduce COVID-19 transmission indoors

Oct 20, 2020 |

Open Orphan/hVIVO Signs Contract with UK Government for the Development of a COVID-19 Human Challenge Study Model

Oct 20, 2020 |

Aridis Pharmaceuticals Reports Positive Preclinical Efficacy Data of a Highly Effective Inhaled Treatment Supporting a Proposed Self-Administered Therapy for COVID-19 Patients

Oct 19, 2020 |

Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell

Oct 19, 2020 |

DxTerity Announces a New At-Home COVID-19 Testing Solution

Oct 19, 2020 |

Aetion Statement on UCSF-Led Study to Inform Drug Development for COVID-19, Future Pandemics

Oct 15, 2020 |

Genalyte Obtains FDA Emergency Use Authorization for Rapid COVID-19 Antibody Test

Oct 15, 2020 |

Beckman Coulter receives BARDA funding to validate Monocyte Distribution Width in the rapid detection of Multisystem Inflammatory Syndrome (MIS-C), a severe COVID-19 complication in Children

Oct 15, 2020 |

Eiger BioPharmaceuticals Announces Positive Results of Investigator Sponsored Randomized Controlled Trial at University of Toronto with Peginterferon Lambda in Outpatients with Mild to Moderate COVID-19

Oct 15, 2020 | Clinical Trial

No Aborted Fetal Material in AVM Biotechnology’s COVID-19 Treatment Drug

Oct 14, 2020 |

New blood test predicts which Covid-19 patients will develop severe infection

Oct 14, 2020 |

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) and Other Acute Respiratory Conditions

Oct 13, 2020 |

Medigen’s COVID-19 Vaccine Combined with Dynavax’s CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October

Oct 13, 2020 |

NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19

Oct 13, 2020 |

University of Milan Study Finds Self-Contained, Rapid ADEXUSDx® COVID-19 Antibody Test has 100% Specificity

Oct 12, 2020 |

Abbott Receives FDA Emergency Use Authorization for its COVID-19 IgM Antibody Blood Test

Oct 12, 2020 |

Review Article, Authored by ZyVersa Therapeutics’ Esteemed Scientific Advisors, Demonstrates the Role of Inflammasomes in the Exacerbated Immune Response Associated with COVID-19 Infection (Just Published in Frontiers in Immunology)

Oct 12, 2020 |

The Covid-19 pandemic is expected to further affect RhoVac’s clinical phase IIb study

Oct 12, 2020 | Clinical Trial

Rigel Announces First Patients Enrolled in NIH/NHLBI-Sponsored Trial of Fostamatinib in Hospitalized COVID-19 Patients in Collaboration with Inova

Oct 9, 2020 | Collaboration

Grifols’ anti-SARS-CoV-2 hyperimmune globulin begins clinical trial in patients with COVID-19

Oct 9, 2020 | Clinical Trial

Exogenesis Surgical Mask Reaches Primary Endpoints in COVID-19 Deactivation Challenge Trials

Oct 9, 2020 | Clinical Trial

First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine

Oct 8, 2020 | Clinical Trial

Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen

Oct 8, 2020 |

Johnson & Johnson Receives European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate

Oct 8, 2020 | Collaboration

Prevea Health Selects Syntellis as Financial Planning Partner to Navigate COVID-19 Market Volatility

Oct 7, 2020 |

Abbott Reports Results of ID NOW™ COVID-19 Interim Clinical Study from 1,003 People to Provide the Facts on Clinical Performance and to Support Public Health

Oct 7, 2020 | Clinical Trial

Centaur Biopharmaceutical Signs Expansion Agreement with Vaxart of Manufacturing for COVID-19 and Other Vaccine Candidates

Oct 7, 2020 | Collaboration

Promising Research Showing New Way To Treat And Stop The Spread Of COVID-19 Using Gene Silencing And Reactivation Of “Innate” Immune System

Oct 6, 2020 |

Karyopharm Presents Results of Selinexor at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19

Oct 6, 2020 | Clinical Trial

CLEAR Collaborates with Quest Diagnostics to Integrate COVID-19 Test Results with “Health Pass” for Safer Environments

Oct 5, 2020 | Collaborates

Hematogenix Unites With 19 Organizations from the Healthcare Community to Form COVID-19 Testing Industry Consortium

Oct 5, 2020 |

Intermountain Healthcare Researchers Develop New Diagnostic Tool to Identify & Treat Patients with COVID-19 at Risk of Severe Illness, Death Due to Inflammatory Disorder

Oct 1, 2020 |

GVN’s Top Virus Experts Meet Together To Identify Most Promising Advances To Battle COVID-19 & Strategies To Prepare For Future Pandemics

Sept 30, 2020 |

The post Insights+: COVID-19 Healthcare News Monthly Updates – October 2020 first appeared on PharmaShots.

Bayer data for kidney disease hope finerenone sets up filings

Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial.

Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the data under wraps other than to say the drug met the dual objectives of reducing renal and cardiovascular events in patients with type 2 diabetes and chronic kidney disease.

Now, the 5,734-patient study has been presented at the Kidney Week 2020 congress and simultaneously published in the New England Journal of Medicine, and the data look solid.

A second ongoing phase 3 trial – called FIGARO-DKD – is concentrating primarily on cardiovascular endpoints but also includes aptietnsd with earlier-stage kidney disease and has a read out due next year.

Bayer is eyeing regulatory filings before the end of 2020 on the back of the FIDELIO-DKD results, which would set up a clash with SGLT2 inhibitors, drugs for diabetes that are also emerging as promising therapies for DKD.

That includes Johnson & Johnson’s Invokana (canagliflozin) – already approved for diabetic kidney disease – as well as AstraZeneca’s Farxiga (dapagliflozin) which showed positive results in the DAPA-CKD trial in both diabetic and non-diabetic subjects just last week.

Finerenone – billed as a first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist – reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy in FIDELIO-DKD.

The drug also cut cardiovascular outcomes – including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke or hospitalisation for heart failure – by 14%.

“Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, which represents an unmet medical need,” said lead investigator Prof George Bakris of University of Chicago Medicine.

“The results with finerenone are highly relevant for these patients who currently have limited options,” he added.

There is also a huge number of them. Diabetes is the leading cause of kidney failure, and there are estimated to be almost 850 million people worldwide with chronic kidney disease (CKD).

If approved, finerenone would enter a market in which J&J is struggling to overturn the lingering impact of black-box warnings over amputation risks with Invokana that were dropped in the summer. The drugmaker sees kidney disease as its route to growth after a couple of years of declining sales, and is promoting the new use strongly.

AZ meanwhile is on a roll with Farxiga, with the new data in CKD building on recent data for the drug in heart failure that is helping to drive sales growth, although patent expirations and the threat of generic competition are looming.

Bayer is also eyeing a heart failure indication for finerenone, and now has a phase 3 trial in heart failure with preserved ejection fractions (HFpEF) in play that if successful would unlock a hitherto untapped market with no approved drugs.

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AZ, J&J COVID-19 vaccine trials okay to restart in US

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.

Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of  its coronavirus candidate JNJ-78436735, which has also suspended after one study subject fell ill.

AZ confirmed the FDA’s move in a statement, saying that regulators in the US, UK, Brazil, South Africa and Japan have now said that trials of the Oxford University-partnered shot are safe to continue.

The FDA took a lot longer to reach its conclusion however, as recruitment into studies restarted just a few days after the halt elsewhere.

AZ chief executive Pascal Soriot said: “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

On 6 September, AZ said it had put trials of AZD1222 on temporary hold because of a potential safety issue involving one patient in the UK, who had become ill after taking the vaccine with what at the time was reported to be transverse myelitis – an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.

“It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” said AZ, which hasn’t confirmed the nature of the adverse reaction.

A report in the Wall Street Journal suggests that the FDA has reviewed two cases of potential neurological side effects in patients receiving AZD1222. One was subsequently found to be in a patient with MS, but the US regulator couldn’t either identify or rule out a clear link to the vaccine in both cases.

A death has also occurred in a patient enrolled onto an AZD1222 study in Brazil, although that has not been linked to the vaccine and is believed to have occurred in a subject who did not receive the shot.

AZ is now expecting to have results from the trials before the end of the year – analysts at Jefferies think it could occur in mid-November – and rolling regulatory  reviews of AZD1222 are already underway in some markets including the EU.

J&J meanwhile said that the independent data safety monitoring committee overseeing the phase 3 ENSEMBLE trial of JNJ-78436735 had found no clear cause behind a “serious medical event” – reported to be a stoke – in one subject that caused the study to be placed on hold earlier this month.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” said the drugmaker in a statement indicating the findings had been shared with the FDA. “There are many possible factors that could have caused the event.”

The suspension of studies for AZD1222 and JNJ-78436735 has put two coronavirus vaccines from BioNTech/Pfizer and Moderna in the lead in the US, with top-line efficacy results due within the next 4-5 weeks, although safety data will take a little longer to come in.

The resumption of the two stalled studies means that AZ and J&J will now not be too far behind.

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EU ramps up supply of COVID-19 vaccine, drugs

The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate.

The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and comes as wealthy nations are scrambling to secure access to the initial supplies of the shots furthest ahead in development.

If the vaccines are approved and the contracts are fulfilled, they would supply more than two shots apiece for each of the EU’s 446 million inhabitants.

In the US, Health and Human Services Secretary Alex Azar suggested this week that the country will have enough doses of vaccine available for every America citizen by March or April next year, with production underway for six shots backed by the US government across more than 23 manufacturing facilities.

The latest agreement involves an undisclosed down payment to J&J, whose vaccine started phase 3 trials in September. It covers an initial order for 200 million doses for EU member states, followed by an option on a second 200 million tranche.

The bloc ordered 400 million doses of AZ and the University of Oxford’s AZ1222 vaccine in August, and followed that up with a contract for 300 million doses of the Sanofi/GSK shot last month.

Just this week, it emerged that AZ has the right to declare an end to the pandemic in July 2021, having previously said it would supply AZD1222 at cost while the outbreak is still ongoing, according to a Financial Times report.

Remdesivir procurement

Meanwhile, the EC has also reached an agreement with Gilead Sciences to secure “rapid and equitable” access to its antiviral drug Veklury (remdesivir) – just as there are reports of shortages emerging around the world.

The joint procurement agreement (JPA) covers the 27 EU member states as well as the UK and European Economic Area (EEA) countries over a six-month period from later this month, and will do away with the need for country-by-country reimbursement negotiations, according to Gilead.

Veklury was granted conditional approval in the EU for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen in July, but by that time a large proportion of the drug’s supply had already been snapped up by the US government.

Gilead said in a statement that a “greatly expanded supply of Veklury is expected to meet European real-time demand and stockpiling needs in October.”

The company says it is on track to produce more than two million treatment courses of Veklury this year, and several million more treatment courses in 2021 if required. It’s ramped up production capacity internally and through a series of agreements with contract manufacturing partners.

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J&J settles 1,000 talc lawsuits for $100m+; report

Johnson & Johnson has agreed to pay more than $100 million to settle over 1,000 lawsuits that allege the company’s Baby Powder talc products caused cancer, according to Bloomberg.

Citing people close to the matter, the news agency said the settlement marks the first time that J&J has opted to settle litigation in bulk, rather than individually.

All told, there are estimated to be more than 19,000 lawsuits claiming injury caused by J&J’s talc products, so the settlement – if confirmed – represents a fraction of the potential liability facing the company.

The Bloomberg report suggests that the hiatus on courtroom proceedings caused by the coronavirus pandemic in the last few months allowed settlement talks to gather pace.

Many of the lawsuits claim that users of Baby Powder developed ovarian cancer or mesothelioma as a result of exposure to minute levels of asbestos in talc, and plaintiffs insist the company knew of the product’s cancer risks by the early 1970s and failed to warn consumers.

J&J refutes that assertion, and insists there is no asbestos in its talc, although it has been at odds on the latter issue with the FDA.

Earlier this year the company said it was planning to phase out its talc-based Baby Powder range in North America, leaving some corn starch-based products on sale, but insisted that decision was taken as a result of declining demand for Baby Powder products.

The drop in sales came from changing consumer habits, misinformation about talc’s safety, and “a constant barrage of litigation advertising”, it said at the time. Liability law specialists said the phase-out was a key step in resolving the talc litigation as it sets a cut-off point for future lawsuits.

J&J hasn’t commented on the Bloomberg article other than to say that “in certain circumstances, we do choose to settle lawsuits, which is done without an admission of liability and in no way changes our position regarding the safety of our products.”

The company has been fighting litigation over talc for years, with wins and losses, but the standout result was a $4.7 billion damages award to plaintiffs in a Missouri lawsuit a couple of years ago, that was reduced to $2.1 billion on appeal and is still in play.

Before COVID-19 lockdowns, a jury in a New Jersey trial awarded $750 million in punitive damages against J&J, although that was immediately slashed to $187 million by the judge as that was the maximum penalty allowed under state law.

In its latest quarterly report J&J said it had spent $600 million on litigation in the first half of 2020, primarily associated with talc lawsuits. A fresh trial involving a factory worker who claims his mesothelioma was caused by J&J’s talc products is due to start in California later this month.

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Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Pharmaceutical Marketing

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals

As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx for its tarnished reputation?

The Pharma industry has long been at the center of a firestorm, cited consistently as one of the most disliked and distrusted industries in the Gallup poll. It’s not surprising given the media coverage of CEO and company financial disclosures, patent trials, illegal activities, and questionable practices, legal settlements, price gouging, product recalls, and, most recently, its role in the devastating opioid epidemic. While the public’s high distrust and disdain are directed at “greedy” Pharma, prescription drug spending accounts for between 10-12% of total US healthcare costs, and now, in our time of greatest need, we turn to this industry to help us confront COVID-19. This pandemic has brought the committed, community-focused side of Pharma to the forefront, with its rapid and relentless pursuit to deliver the best science to solve this crisis.

Pharmaceuticals Collaborating for COVID’s Rx

There are brilliant and talented people in dozens of companies, both established manufacturers and small start-ups, working tirelessly to find a solution. Early efforts developed and produced testing assays to help the healthcare community identify and confirm the virus. The expanded focus now pursues proven treatments and vaccines. We see unexpected partnerships and creativity abound in the race to find answers that will address the crippling impact on public health and disrupt the economy and supply chains. Thomas Cueni, who leads the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, notes, “the industry, which is traditionally fiercely competitive, has come together.”

For example, rivals like Sanofi and GSK are working to bring their innovative technologies together for a vaccine, with Astra-Zeneca and Oxford University signing a global development and distribution agreement for a CO-19 vaccine, Takeda and CoVIg-19 Alliance investing in plasma therapies, Regeneron and Sanofi conducting clinical trials for their jointly marketed Rheumatoid Arthritis drug Kevzara, and Pfizer and BioNTech are collaborating on an mRNA vaccine. There is an impressive number of ongoing trials to evaluate existing drugs for other diseases, including Gilead’s Remdesivir which now has FDA authorization for emergency use, and Gilead Sciences is applying for full authorization in the U.S., specialty biotech companies like Moderna and Novavax have also entered the race and are fast-tracked for their vaccine candidates.

Pharma’s Investments & Innovations during COVID-19

Beyond drug treatment and vaccine development, the industry has also brought new ingenuity and investment to fight COVID-19 and support the healthcare system; Johnson & Johnson is pledging $300M over ten years to help front-line workers, Astra-Zeneca donating 9M face masks to protect healthcare workers around the world, companies deploying their 3D printing capabilities to manufacture PPE and equipment, and Consumer Product companies producing hand sanitizers.

This industry, its brilliant researchers, and dedicated employees are unwavering in their mission to be a part of the solution by investing in unknowns despite the risk, diverting focus from other commercially available/development assets, and pioneering scientific innovation to confront COVID-19. With the sheer number of companies in this race, we stand the best chance of finding solutions and having the scale to keep up with the alarming projections of cases. It also helps to foster competition and encourage fair pricing. Despite Pharma‘s commitment to the cause, there continue to be critics who attribute Pharma’s efforts to capitalizing on a crisis and solely focused on profit. For those who feel Pharma should not make a profit from the deep investment, at this moment, it’s difficult to put a price on overcoming this enemy.

Pharma Marcom & PR during COVID

With the knowledge that consumers look to brands and companies that demonstrate social responsibility, philanthropic and community support, other industry leaders and I agree that there is an opportunity for Pharma to begin to evolve from some of the negative perceptions and elevate recognition of its essential role in moving us from “StayatHome” to “StayHealthy.” We are beginning to see public opinion improve throughout this pandemic, according to a recent Harris poll. From a marketing and public relations standpoint, I’m hopeful the Pharmaceutical Research and Manufacturers of America (PhRMA) will take this moment to elevate public awareness and highlight the level of corporate commitment and investment behind the scenes of this pandemic.

This is not self-serving. This is about scientific innovation, leadership during crisis, corporate responsibility, and saving lives. The industry should continue to demonstrate its thought leadership during this time through scientific publications and serving as an expert voice. As consumers increasingly search for information about the virus, vaccines, and treatment, Pharma needs to ensure the public has access to credible, scientifically-grounded content across media channels. Given the sequelae from this pandemic, there is also a tremendous need to address mental health and wellbeing. With the significant investment and access to mental health solutions and services, Pharma can also answer this call.

Pharma Marketing & Healthcare Marketing | COVID & Beyond

As advertising and communication experts, now is the time to step up and be even truer and more innovative pharmaceutical marketing agency partners. While our pharma, medical and healthcare clients are redirecting their efforts toward COVID-19, our own industry must be even more proactive and creative. Let’s bring pharmaceuticals strategically inventive marketing communication ideas and messaging programs to keep their brands and marketing more relevant during the COVID pandemic. Let’s help pharmas more effectively reach their increasingly “remote” customers and patients. Let’s drive better search rankings by developing more useful and authoritative content to educate online-engaged healthcare audiences. Let’s explore corporate campaigns and grass-roots programs to draw medical and pharmaceutical enterprises closer to their patient communities and genuinely bolster reputations. As experts in social media, let’s help Pharma be consistently compliant and proactively trustworthy participants in conversations concerning diseases & conditions. Let’s elevate the pharma industry’s core values currently on display through successfully inventive creativity and discerning innovation. As partners, let’s work tirelessly to create and focus insightful spotlights on the heroic efforts of our client-partners — healthcare and medical innovators dedicated to making “life-changing” differences within today’s life-changing public health crisis.

COVID and Healthcare Marketing — related articles: [Podcast] Hospital Crisis Management and Healthcare PR in the Age of COVID-19 | 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic | Healthcare Marketing: Pause, Pivot, or Push for Success?

 

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J&J to buy Momenta Pharmaceuticals for $6.5B

The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.

J&J pays $6.5bn for Momenta and its inflammatory disease hopeful

Johnson & Johnson is to buy Momenta Pharmaceuticals for $6.5 billion, adding potential inflammatory diseases blockbuster nipocalimab to the pipeline at its Janssen pharmaceuticals unit.

J&J thinks that Momenta’s lead drug nipocalimab could be a kind of Swiss army knife drug that could be used across a range of inflammatory diseases including maternal-foetal disorders, neuro-inflammatory disorders, rheumatology, and autoimmune haematology.

The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks.

Johnson & Johnson’s own Remicade (infliximab) was also a blockbuster several times over thanks to approvals in a range of inflammatory diseases including Crohn’s, rheumatoid arthritis and psoriasis.

But like the rest of this first generation of antibody-based drugs, Remicade has been hit by cheaper competition from biosimilars and the hunt is on for newer drugs that outperform standard therapy in terms of safety and efficacy.

Whether nipocalimab achieves the astronomical figures seen from Humira and Remicade remains to be seen – but the price J&J has paid shows the big pharma thinks it has considerable potential.

Momenta is best known for producing a generic version of Teva’s multiple sclerosis drug Copaxone (glatiramer), but nipocalimab is the company’s lead pipeline asset and the main rationale behind the acquisition.

Nipocalimab works against the neonatal Fc Receptor, a protein that can cause pathogenic antibodies to linger in the body and is thought to play a role in inflammatory diseases.

Diseases driven by the body’s own antibodies include myasthenia gravis, haemolytic diseases of the foetus, newborn, warm autoimmune haemolytic anaemia and a host of other conditions.

Around 2.5% of the population, around 195 million people worldwide, suffer from some form of autoantibody-driven disease, many of which are orphan and rare diseases.

Janssen thinks that individual indications could exceed $1 billion, as it looks to outgrow the pharma market in the long term.

The company said that while the deal is focused on nipocalimab, Momenta’s other approved drugs and pipeline assets will be assessed as more data becomes available.

Nipocalimab has recently received a rare paediatric disease designation from the FDA and the transaction will include full global rights to nipocalimab.

The transaction valuing Momenta at $52.50 per share is expected to close in the second half of 2020, subject to clearance by US antitrust regulators.

The costs are expected to increase J&J’s R&D spend, shaving off around $0.1-$0.15 from earnings per share in 2021.

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Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

Shots:

  • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Canva

UK signs coronavirus vaccine deals with J&J and Novavax

The UK is to buy millions more doses of potential coronavirus vaccines from Johnson & Johnson and Novavax, with the latter expanding its manufacturing operation in the country.

Johnson & Johnson’s Janssen pharmaceuticals unit will supply an initial 30 million doses on a not-for-profit basis for emergency use in the pandemic, with an option for an additional 22 million doses.

Novavax said separately that the UK is buying a further 60 million doses of its vaccine candidate, NVX-CoV2373 for a phase 3 clinical trial.

Both the UK and the US have six COVID-19 vaccine deals between them as governments from across the world race to strike deals with drugmakers for vaccines.

Reuters reported that J&J is also working with the UK government on a phase 3 trial testing a two-dose regimen of its vaccine candidate, running in parallel to a phase 3 trial of its single-dose vaccine.

Novavax is based in the US but is collaborating with Fujifilm Diosynth Biotechnologies on a manufacturing operation in Stockton-on-Tees in the UK in addition to sites in North Carolina and Texas in the US.

The UK site is expected to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for other markets.

Novavax is planning a phase 3 trial in the coming weeks after encouraging results from an early study showing the vaccine produced higher levels of neutralising antibodies than in recovered patients.

The phase 3 trial could provide enough data to support approval before the end of the year, the company has said.

According to the World Health Organization there are now 29 potential vaccines in clinical trials, none of which have yet been proven to work.

The most advanced is from the University of Oxford and AstraZeneca – and the UK has already ordered 100 million doses of this should it prove effective in ongoing phase 3 trials.

The UK government has also ordered 90 million doses of two other COVID-19 vaccines from BioNTech/Pfizer and Valneva.

 

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EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Shots:

  • The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose
  • If approved, the EC expects to facilitate a process for the allocation of the vaccine doses among the member states.
  • The exploratory talks concluded today are intended to result in an Advance Purchase Agreement to be financed with the Emergency Support Instrument, which has funds for vaccines with different profiles and produced by different companies

Click here to­ read full press release/ article | Ref: European Commission | Image: USA Today

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots:

  • The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA
  • The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global access of the vaccines
  • J&J expects to meet its goal to supply 1B doses globally through the course of 2021, provided the vaccine is safe and effective. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use

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

Related News: Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium




J&J in $1B supply pact with federal government for one-shot Covid-19 vaccine

Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Shots:

  • J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs
  • Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected initiation of P-III study in Sept’2020. The P-I/IIa study will evaluate the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in ~1,000 healthy adults aged 18-55yrs. and 65+ yrs.
  • Additionally, the company is planning to initiate P-III clinical trial program, will evaluate both one/two-dose regimens of Ad26.COV2.S initiate in parallel studies while the P-IIa study in the Netherlands, Spain, and Germany and a P-I study in Japan in underway

Click here ­to­ read full press release/ article | Ref: Johnson & Johnson | Image: StraitTimes




Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they not limited to only these indications and are rapidly increasing with the increasing medical needs. The drugs are developed targeting with the motive to cure, vaccinate, and alleviate the symptoms.

We have compiled a list of global top 20 drugs blockbuster prescription drugs based on their sales for last year i.e. 2019. The top position was maintained by AbbVie’s blockbuster drug Humira with $19.16B another drug grasped the second position headed by Merck’s Keytruda with $11.08B following the third was occupied by BMS’s Revlimid with $9.37B while ended at the low end by Gilead’s Truvada.

If you have any questions or see something we might have missed? Please reach out to Senior Editor, Shiwani Sharma by email.

Product – Truvada

First Approved – US (Aug 02, 2004), EU (Feb 20, 2005)

Indications Approved – HIV-1

Company – Gilead Sciences

Total Revenue – $2.81B

Truvada is a combination of tenofovir disiproxil fumarate (tenofovir DF) and emtricitabine used for HIV treatment and pre-exposure prophylaxis for PrEP (pre-exposure prophylaxis) that can help reduce the risk of getting HIV-1 through sex. On July 23, 2019, Gilead presented new findings on the profile of Descoy for potential use as HIV Pre-exposure Prophylaxis compared with Truvada. Descovy and Truvada are only 2 FDA-approved pills for PrEP.

Product Neulasta    

First Approved US (Jan 31, 2002), EU (Aug 22, 2002)

Indications Approved – Febrile Neutropenia

Company Amgen

Total Revenue $3.22B

Neulasta is a PEGylated form of the recombinant human granulocyte colony-stimulating factor analogue filgrastim. Neulasta has been steadily losing market share due to the launch of multiple biosimilars and the utilization of Neulasta’s OnPro on-body injector (the dominant player at > 55%) has been relatively steady.

Product Victoza                                                                                             Company Novo Nordisk

First Approved US (Jan 25, 2010), EU (Jun 30, 2009)                       Total Revenue $3.29B

Indications Approved – Glycemic control in type 2 diabetes mellitus patients, Reduce adverse cardiovascular events in adults with type 2 diabetes mellitus

Victoza or liraglutide belongs to a class of drugs called glucagon-like peptide-1 agonists (GLP-1). Recently Novo Nordisk’s patent on Victoza is been reviewed as Mylan has claimed that its invalid because it covers an obvious invention. Mylan has challenged the Victoza patent with an aim to launch the low-cost copy of the drug.

Product Lyrica                                                                                                Company Pfizer

First Approved US (Dec 30, 2004), EU (Jul 05, 2004)                       Total Revenue $3.32 B

Indications Approved – Neuropathic pain associated with diabetic peripheral neuropathy, Postherpetic neuralgia                

Lyrica is an anticonvulsant or an anti-seizure drug that can treat a range of conditions, including epilepsy, fibromyalgia, and nerve pain. The recent update on May 28, 2019, Pfizer announced that its epilepsy drug Lyrica (pregabalin), failed to meet the primary endpoint in P-III study, assessing it as adjunctive therapy in epilepsy patients (aged 5 to 65 years) with primary generalized tonic-clonic (“PGTC”) seizures.

Product Imbruvica                                                                                       Company Johnson & Johnson

First Approved US (Nov 13, 2013), EU (Nov 21, 2014)                    Total Revenue $3.41B

Indications Approved – Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia

Imbruvica is an oral therapy which inhibits Bruton’s tyrosine kinase (BTK) and has received its 10 FDA approval. In Apr 2020, US FDA approved Imbruvica (ibrutinib) plus Rituximab for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) 

Product Genvoya                                                                                         Company – Gilead Sciences

First Approved – US (Nov 05, 2015), EU (Nov 19, 2015)                    Total Revenue $3.93 B

Indications Approved – HIV-1

Genvoya is a combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide targeting HIV. In Aug 2018, The CNDA approved Gilead’s Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for treating HIV Infection.

Product – Remicade                                                                                       Company – Johnson & Johnson

First Approved US (Aug 24, 1998), EU (Aug 13, 1999)                     Total Revenue $4.38B

Indications Approved – Crohn’s Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis, Pediatric Ulcerative Colitis, Pediatric Crohn’s Disease

Remicade or infliximab is a tumour necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody. In June 2019, Janssen’s Remicade was issued a Civil Investigative Demand to Johnson & Johnson by FTC for investigating whether its contracting practices violate federal antitrust.

Product – Ibrance                                                                                            Company – Pfizer

First Approved US (Feb 03, 2015), EU (Nov 09, 2016)                    Total Revenue $4.96B

Indications Approved – HER2 Negative Advanced Breast Cancer

Ibrance PO is CDKs 4 and 6 inhibitors indicated for HR+, HER2- advance or mBC and has been prescribed up xto 160,000 patients with approval in 85 countries worldwide. On May 29, 2020, the Data Monitoring Committee (DMC) of the collaborative P-III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial failed in the primary endpoint of invasive disease-free survival (iDFS). Eli Lilly’s Verzenio has been chasing Ibrance in the metastatic setting since it hit the market and it now its ahead of Ibrance which recently took a big blow.

Product – Enbrel                                                                                              Company – Amgen

First Approved US (Nov 02, 1998), EU (Feb 02, 2000)                    Total Revenue $5.22B

Indications Approved – Rheumatoid Arthritis, Polyarticular-Course Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Enbrel is a TNF inhibitor drug that treats autoimmune diseases by interfering with tumour necrosis factor by acting as a TNF inhibitor. Enbrel was the drug of choice for multiple autoimmune indications. On Jul 01, 2020, the US Court of Appeals for the Federal Circuit held in Amgen’s favour on the validity of 2 patents that describe and claim Enbrel’s methods.

Product – Prevnar 13                                                                                       Company – Pfizer

First Approved US (Feb 24, 2010), EU (Dec 12, 2009)                     Total Revenue $5.84B

Indications Approved – S. Pneumoniae Infection

Prevnar 13 or Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumonia strains. In June 2020, Pfizer started four P-III clinical trials for investigational vaccines including Prevnar 13.

Product – Herceptin                                                                                       Company – Roche

First Approved – US (Sep 25, 1998), EU (Aug 28, 2000)                      Total Revenue – $6.23 B

Indications Approved – Metastatic Breast Cancer, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma  

Herceptin or trastuzumab is a mAb that binds to HER2 receptors on the surface of HER2-positive tumor cells, blocking them from receiving growth signals and flagging them for destruction by the immune system. It is on the WHO’s List of Essential Medicines, the safest and most effective medicines needed in a health system. On 29 June 2020, Roche got the approval of Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin with hyaluronidase, administered by SC injection in combination with IV chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two mAbs that can be administered by a single SC injection.

Product – Stelara                                                                                             Company – Johnson & Johnson

First Approved – US (Sep 25, 2009), EU (Jan 15, 2009)                       Total Revenue – $6.36B

Indications Approved – Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis

Stelara or ustekinumab is a mAb with a novel mechanism of action that targets the p40 subunit of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). In Apr 2020, Johnson & Johnson received NICE’s positive Final Appraisal Document (FAD) recommending Stelara (ustekinumab) for the treatment of ulcerative colitis.

Product – Rituxan                                                                                             Company – Roche

First Approved – US (Nov 26, 1997), EU (Jun 02, 1998)                      Total Revenue – $6.69B

Indications Approved – Non-Hodgkin’s lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Pemphigus Vulgaris

Rituxan or rituximab is a mAb used to target cancer cells with CD20 markers in patients. In Sep 2019, The US FDA approved Roche’s Rituxan (rituximab) in combination with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) disorders.

Product – Opdivo                                                                                             Company – Bristol-Myers Squibb

First Approved – US (Dec 22, 2014), EU (Jun 19, 2015)                      Total Revenue – $7.20B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer,Melanoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Mismatch Repair Deficient Metastatic Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma

Opdivo or nivolumab is a PD-1 immune checkpoint inhibitor targeted for cancer cells and is approved in 65 countries including the US, EU, Japan & China. In Jun 2020, the US FDA granted approval for Opdivo (nivolumab) following the P-III ATTRACTION-3 study results evaluate it in comparison with taxane CT (docetaxel/paclitaxel) to treat patients with unresectable advanced, recurrent or ESCC, refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT.

Product – Avastin                                                                                             Company – Roche

First Approved – US (Feb 26, 2004), EU (Jan 12, 2005)                       Total Revenue – $7.30B

Indications Approved Metastatic Carcinoma, Metastatic Colorectal Cancer, Non–Small Cell Lung Cancer, Glioblastoma, Metastatic Renal Cell Carcinoma, Metastatic Cervical Cancer, Primary Peritoneal Cancer, Hepatocellular Carcinoma

Avastin or bevacizumab is a tumour-starving (anti-angiogenic) therapy targeted for preventing tumour growth. In Jun 2020, Roche received the US FDA’s approval for a combination of Avastin (bevacizumab) + Tecentriq (atezolizumab) to treat patients with Unresectable Or Metastatic Hepatocellular Carcinoma (HCC) who have not received prior systemic therapy, which lead to a novel immunotherapy approval for the indication. The approval followed the P-III IMbrave150 study results assessing the combination.

Product – Eylea                                                                                                 Company – Regeneron Pharmaceuticals

First Approved – US (Nov 18, 2011), EU (Nov 21, 2012)                     Total Revenue – $7.54B

Indications Approved – Age-Related Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy

Eylea or aflibercept is one form of anti-VEGF therapy administered by injection into the eye. Recently, Bayer launched Eylea (aflibercept) pre-filled syringe in all 27 states of the EU including the UK, Iceland, Norway, and Liechtenstein in Apr 2020. In May 2019, Regeneron’s Eylea injection received the US FDA’s approval to treat all stages of Diabetic Retinopathy (DR) further reducing the risk of blindness.

Product – Eliquis                                                                                               Company – Bristol Myers Squibb  

First Approved – US (Dec 28, 2012), EU (May 18, 2011)                    Total Revenue – $7.92B

Indications Approved – Stroke, Systemic Embolism, Deep Vein Thrombosis, Pulmonary Embolism, Recurrence of DVT and PE

Eliquis or apixaban is an anticoagulant that reduces blood clotting. Eliquis stood on the fourth-highest selling product with $7.92B in 2019. In late 2019, the US FDA approved BMS’ Eliquis tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Product – Revlimid                                                                                          Company – Bristol-Myers Squibb

First Approved – US (Dec 27, 2005), EU (Jun 14, 2007)                      Total Revenue – $9.37B

Indications Approved – Anemia, Multiple Myeloma, Myelodysplastic Syndromes, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

Revlimid or lenalidomide is a thalidomide analogue candidate which reported WW sales of $9.37B. In Feb 2020, BMS’ Revlimid received the National Institute for Health and Care Excellence (NICE) approved it targeting to treat previously treated follicular lymphoma in combination with MabThera (rituximab).

Product – Keytruda                                                                                         Company – Merck & Co

First Approved – US (Sep 04, 2014), EU (Jul 17, 2015)                        Total Revenue – $11.08B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Head, and Neck Squamous Cell Cancer, Hodgkin Lymphoma, Mediastinal Large B-Cell Lymphoma, Urothelial Carcinoma, Deficient Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma, Tumor Mutational Burden-High Cancer, Cutaneous Squamous Cell Carcinoma

Keytruda or pembrolizumab is a mAb serving as an anti-PD-1 therapy for the tumour cells blocking the interaction between PD-1 and its ligands, PD-L1, and PD-L2. It initially received FDA accelerated approval for refractory, advanced melanoma in September 2014. Subsequently, it has received approval for the treatment of many other oncologic conditions, and many more are currently in clinical development.

Keytruda acquired the second position in the WW sales list of 2019. In Jul 2020, the US FDA granted Priority Review to Merck’s Keytruda for its sBLA to treat patients with 2L+ Relapsed or Refractory Classical Hodgkin Lymphoma (cHL). The designation follows P-III KEYNOTE-204 study results and the expected PDUFA date as Oct 30, 2020. In Jun 2020, Merck’s Keytruda receives the US FDA’s approval to treat patients with 1L Unresectable or Metastatic MSI-H or dMMr Colorectal Cancer.

Product Name – Humira                                                                                Company Name – AbbVie

First Approved – US (Dec 31, 2002), EU (Aug 09, 2003)                     Total Revenue – $19.16B

Indications Approved – Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Humira (adalimumab) is a mAb blocking TNF-a protein targeted for the inflammatory response of immune-mediated diseases. Humira has recorded the highest selling product sales with a generated revenue of $19.16B in 2019. Humira continues to be the leader of the commercial drug market and keeping its first position with the crown of the most lucrative drug in the history of the pharmaceutical market. In Jun 2020, AbbVie reported results of ABBV-3373, an ADC comprising novel glucocorticoid receptor modulator (GRM) vs Humira in patients with Moderate to Severe Rheumatoid Arthritis and resulted in similar profile with the original product.