The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods
Both the trials met all four co-1EPs demonstrating a significant reduction from baseline in the frequency and severity of moderate to severe VMS to week 4 and week 12
Fezolinetant is an NK3R antagonist targeting NKB binding on the KNDy neuron to moderate neuronal activity in the brain to treat VMS associated with menopause
Click here to read full press release/ article | Ref: Astellas | Image: Nasdaq
Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend.
To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data that made it a rising star at that year’s American Society of Clinical Oncology (ASCO) conference.
But although the response rate data was eye-catching, the FDA could only grant a faster accelerated approval that needed to be confirmed with further data.
That is now available from the trial data announced at this year’s ASCO genitourinary cancer specialist conference (ASCO GU), from a second cohort from the phase 2 EV-201 trial.
The first cohort formed the basis for the accelerated approval and the second cohort from the single-arm trial showed an objective response of 52% and a median duration of response was 10.9 months.
In Seagen’s Q4 results statement, the company said that the new EV-201 data will support a filing for a full licence in the US.
Meanwhile the data from the phase 3 EV-301 data will support filings with regulators outside of the US, Seagen said.
The late stage data showed Padcev significantly improved overall survival compared with chemotherapy in a group of patients previously treated with platinum chemo and and a PD-1/L1 inhibitor.
An interim analysis from EV-301 showed a median overall survival of 12.9 months in patients treated with Padcev compared with nine months in those treated with chemotherapy.
For patients in the Padcev arm of the trial, maculopapular rash, fatigue and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events (TRAEs) occurring in more than 5% of patients.
Median progression-free survival was 5.6 months in the Padcev group compared with 3.7 months in the chemotherapy group.
Overall response rate, the percentage of patients with either complete or partial response, was 40.6% vs. 17.9% of patients in the chemotherapy arm.
Disease control rate – the percentage of patients who have achieved complete response, partial response or had stable disease, was 71.9% for Padcev and 53.4% for chemotherapy.
In an interview with pharmaphorum, Andy Krivoshik, senior vice president and Oncology Therapeutic Area head at Astellas, said the data could be used to confirm a full US licence as well as negotiations with payers.
In the UK, cost-effectiveness body NICE requires overall survival data for regular NHS reimbursement and Krivoshik said the overall survival data could help with discussions with other reimbursement authorities.
He said that the endpoints are “meaningful for payer systems”, because of the implications they have for patients.
Moving forward, Astellas and Seagen will be looking to develop the drug for other cancers with high expression of NECTIN-4, including triple-negative breast cancer, non-small cell lung cancer, head and neck and certain types of gastro-oesophageal cancer.
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination.
Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the Merck KGaA termination of its development and commercialization deal with Pfizer
This article is based on the 2020 biopharma deals data provided by Chris Dokomajilar of DealForma. PharmaShots has compiled a list of the top 20 terminations of 2020 based on total deal value
Sanofi Terminated its 2015 Agreement with Hanmi
In Nov. 2015, Hanmi granted Sanofi exclusive, worldwide rights to its protein/peptide discovery technology, lapscovery to develop and commercialize a late-stage GLP1-RA agonist, efpeglenatide weekly insulin, and a fixed-dose weekly GLP-1-RA/insulin drug combination for the treatment of diabetes. Additionally, Hanmi had an exclusive option to co-commercialize the products in Korea and China. Hanmi received $434.7M up front and was eligible for up to $3.8B in development, regulatory, and sales-based milestones, plus double-digit royalties. In May 2020, Sanofi terminated the agreement and Hanmi regained worldwide rights.
Merck KGaA Terminated its Development and Commercialization Deal with Pfizer
Merck KGaA partnered with Pfizer to jointly develop & commercialize MSB0010718C for multiple types of cancer. The companies would develop the Ab as a single agent and in combination with Pfizer’s and Merck KGaA’s portfolio of approved and investigational oncology therapies. Both companies would collaborate on up to 20 immuno-oncology clinical development programs expected to commence in 2015, including up to 6 trials in P-II or P-III. Pfizer and Merck KGaA also partnered separately to co-promote Pfizer’s Xalkori in the US and other markets. Merck KGaA received $850M up front and was eligible to receive up to $2B in regulatory and sales milestones. Both companies would jointly fund all development and commercialization costs and split profits. On Mar. 19, 2019, Merck & Pfizer discontinued the P-III trial (JAVELIN Ovarian PARP 100) due to clinical trial results to develop avelumab in combination with CT followed by maintenance therapy of avelumab in combination with PARP inhibitor (talazoparib) for LA or metastatic ovarian cancer (Stage III or Stage IV). On Mar. 13, 2020, the companies terminated their P-III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with CRT for LA SCCHN as it failed to hit its 1Eps.
AbbVie (Allergan) Terminated its Development and Commercialization Deal with Assembly Biosciences
In Jan. 2017, Assembly Biosciences granted Allergan exclusive, worldwide rights to co-develop and commercialize ABI-M201 and ABI-M301 for the treatment of ulcerative colitis and Crohn’s disease, plus an additional two drugs for the treatment of Irritable Bowel Syndrome with Diarrhoea, with Constipation (IBS-C), or Mixed (IBS-M). Allergan and Assembly shared development costs until proof-of-concept studies. Assembly received $50M up front and was eligible for up to $2.77B in milestones, plus royalties. In May 2020, AbbVie acquired Allergan and on Jun. 18, 2020, AbbVie, terminated the agreement with Assembly Biosciences.
Eli Lilly Terminated its 2017 Agreement with CureVac
In Oct. 2017, CureVac granted Eli Lilly rights to develop and commercialize its 5 mRNA cancer vaccines using CureVac’s RNActive technology for up to 5 cancer vaccines that target neoantigens across multiple tumor types. Lilly was responsible for target identification, clinical development, and commercialization. CureVac was responsible for mRNA design, formulation, and manufacturing of clinical supplies. CureVac had the option to co-promote vaccines in Germany. CureVac received $50M up front, an equity investment of $51M (€45M), and CureVac would be eligible to receive more than $1.7B in development and sales milestones if all 5 vaccines are successfully developed, plus tiered royalties. In Jun. 2020, Eli Lilly terminated the agreement.
Voyager Terminated its Option and License Deal with AbbVie
In Feb. 2019, Voyager granted AbbVie options to license exclusive, worldwide rights to vectorized antibody-based gene therapies for Parkinson’s and other neurodegenerative diseases. Voyager would perform preclinical development to vectorize antibodies directed against alpha-synuclein designated by AbbVie. AbbVie would select one or more vectorized antibodies to advance into IND-enabling studies and clinical development. Voyager would be responsible for research, IND-enabling, and P-I clinical activities and costs. After completing P-I, AbbVie had an option to license the vectorized alpha-synuclein antibody program for further clinical development and global commercialization for Parkinson’s disease and other synucleinopathies. Voyager received $65M up front and was eligible for up to $245M in preclinical and P-I option payments, up to an additional $728M in development and regulatory milestones for each alpha-synuclein vectorized antibody compound, and up to $500M in total sales milestones, plus tiered royalties. On Aug. 3, 2020, Voyager Therapeutics terminated the agreement with AbbVie.
AstraZeneca Terminated its Development and Commercialization Deal with Allergan
In Oct. 2016, AstraZeneca’s global biologics research and development arm, MedImmune, granted Allergan exclusive, worldwide rights to develop and commercialize MEDI2070. The IL-23 monoclonal antibody was being developed for the treatment of Crohn’s disease and ulcerative colitis and was developed in partnership with Amgen Inc. under a 2012 deal. AstraZeneca received $250M up front and was eligible for up to $1.27B in milestones, plus royalties. AstraZeneca would share one-third of all payments and royalties with Amgen Inc. Amgen would also receive a single-digit inventory royalty on MEDI2070. On Jan. 27, 2020, AstraZeneca and Allergan mutually terminated the agreement, Allergan funded the ongoing study of brazikumab in CD and UC including CDx.
Eli Lilly Terminated its Research Partnership and Option to License Agreement with NextCure
In Nov. 2018, Lilly signed a research partnership with NextCure with an option to license immuno-oncology therapies using NextCure’s FIND-IO platform. Lilly had the exclusive option to license the antibodies resulting from the study. NextCure received $25M up front and Lilly invested $15M in NextCure. If Lilly exercised its option to license the drug, NextCure would be eligible to receive up to $1.4B in milestones, plus royalties. On Jan. 10, 2020, Eli Lilly terminated the agreement with NextCure effective Mar. 3, 2020.
Bridge Biotherapeutics and Boehringer Ingelheim Mutually Terminated their Development and Commercialization Deal
In Jul. 2019, Bridge granted Boehringer exclusive, worldwide rights to develop and commercialize BBT-877 for the treatment of fibrosing interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF). The Bridge received $50.48M up front and was eligible for up to $1.23B in milestones, plus royalties. On Nov. 9, 2020, Bridge Biotherapeutics and Boehringer mutually terminated the agreement.
Voyager Terminated its License Option Deal with AbbVie
In Nov. 2018, Voyager granted AbbVie an option to license the development and commercialization of its vectorized antibodies targeting tau by combining AbbVie’s monoclonal antibody expertise and Voyager’s gene therapy platform and expertise to generate AAV vectors for the treatment of neurodegenerative diseases, including Alzheimer’s disease. Both companies planned to identify 5 antibodies based on Voyager’s gene therapy platform and select 3 antibodies for development. AbbVie had an option to license up to 2 antibodies following the completion of P-I and would be fully responsible for development costs. Voyager received $69M up front, and was eligible for up to $155M in preclinical and P-I option payments, and was eligible for up to $895M in development and regulatory milestones, plus royalties. On Aug. 3, 2020, Voyager terminated the agreement with AbbVie.
Amgen Terminated its 2006 Research Partnership with Cytokinetics
In Dec. 2006, Cytokinetics signed a research partnership with Amgen to develop CK-1827452 for the treatment of heart failure. Amgen had an exclusive option to license the drug candidate worldwide excluding Japan before the completion of a P-IIa study. Cytokinetics was responsible for initial development. Upon exercising its option, Amgen was responsible for all further development costs. Also, the partners developed cardiac myosin as a backup compound. Cytokinetics received $75M up front, including $33M in its common stock at a premium of $6.9M. Upon option exercise, Cytokinetics received a $50M option exercise fee and was eligible for up to $600M in development, regulatory, and sales milestones, plus escalating royalties. Cytokinetics had the option to co-fund the P-III study in exchange for additional royalties. If Cytokinetics decided to co-fund the study, it could co-promote the drug in North America. In 2013, Amgen licensed Japan rights, and in 2016 Amgen sublicensed the rights for Europe and the Commonwealth of Independent States to Servier. On Nov. 23, 2020, Amgen terminated the agreement and Cytokinetics regained worldwide rights for omecamtiv mecarbil and backup compound AMG 594. The termination was effective May 20, 2021. The sublicense agreement between Amgen and Servier would remain effective post-termination.
Roivant Terminated its Development and Commercialization Deal with Poxel
In Feb. 2018, Poxel granted Roivant Sciences and its subsidiary Metavant rights to develop and commercialize its oral therapy, Imeglimin, for T2 Diabetes. Poxel received $35M up front and was eligible for up to $600M in milestones, plus royalties. Roivant invested $15M in Poxel’s common stock by purchasing 1,431,399 ordinary shares at €8.5 per share. Roivant was responsible for worldwide development and commercialization. Poxel planned to contribute $25M to the development and had an option to co-promote the product. In Nov. 2020, Metavant terminated the agreement with Poxel for the development of Imeglimin following a strategic analysis.
Alexion Terminated its Development and Commercialization Deal with Affibody
In Mar. 2019, Affibody granted Alexion rights to develop and commercialize ABY-039 for IgG-mediated autoimmune diseases. Affibody received $25M up front and was eligible for up to $625M in development and sales-based milestones, plus tiered low double-digit royalties. Additionally, Affibody had an option to co-promote the bivalent antibody-mimetic targeting the neonatal Fc receptor (FcRn) in the US. In Feb. 2020, Alexion terminated the agreement following unfavourable early-stage data.
Boehringer Ingelheim Terminated its Development and Commercialization Deal with Zealand
In Jun. 2011, Zealand granted Boehringer Ingelheim exclusive, worldwide rights to develop and commercialize glucagon/GLP-1 dual agonists, including ZP2929, for the treatment of type-2 diabetes and obesity. Zealand received $52.4M up front, including reimbursements cost and $5.6M in research funding, and was eligible for up to $532.2M in development and commercial milestones, plus double-digit royalties. In Mar. 2020, Boehringer Ingelheim terminated the agreement and Zealand regained worldwide rights.
BMS (Celgene) Terminated its Development and Commercialization Deal with Jounce
In Jul. 2019, Jounce granted Celgene exclusive, worldwide rights to develop and commercialize JTX-8064 targeting the LILRB2 receptor on macrophages. Jounce received $50M up front and was eligible for up to $480M in milestones, plus royalties. In Jun. 2020, Bristol Myers Squibb terminated the agreement.
Cytokinetics Terminated its Development and Commercialization Deal with Astellas
In Jun. 2013, Cytokinetics granted Astellas exclusive, worldwide rights to co-develop and commercialize CK-2127107 for skeletal muscle weakness. Cytokinetics had the option to co-promote products in the US and Canada. Cytokinetics received $16M up front, $24M in R&D reimbursement, and was eligible for over $250M in development and sales milestones for collaboration products, including up to $112M for CK-2127107 and up to $200M in sales milestones, plus undisclosed royalties. On Dec. 22, 2014, Cytokinetics restated the agreement and granted Astellas exclusive, worldwide rights to co-develop & commercialize CK-2127107 and other products for SMA and other neuromuscular indications. Cytokinetics was responsible for P-II in patients with SMA and other neuromuscular diseases. Both companies would co-develop and co-commercialize CK-2127107 and other skeletal troponin activators in neuromuscular indications. Cytokinetics had the option to co-fund certain development costs, co-promote & conduct commercial activities for CK-2127107 in non-neuromuscular and neuromuscular indications in the US, Canada, and EU. On Jul. 27, 2016, Cytokinetics extended the agreement and granted Astellas additional rights to develop and commercialize tirasemtiv and CK-2127107 for ALS. Cytokinetics received a $100M option exercise fees and was eligible for additional milestones, plus royalties based on sales of tirasemtiv in Astellas’ countries. Also, Astellas was eligible for royalties based on Cytokinetics’ sales of tirasemtiv in its territory. On Apr. 23, 2020, the companies mutually terminated the agreement, Astellas contributed one-third of the development cost, or ~$12M, in an exchange of royalties in the US, Canada, and the EU for 10 years or reduced royalties until 2034. Also, Astellas returned all inventory and IP related to FRSA compounds and agreed not to engage in any research and development activities on FSRA compounds for 4 years.
Calithera Terminated its Development and Commercialization Deal with Incyte
In Jan. 2017, Calithera granted Incyte worldwide rights to develop and commercialize its arginase inhibitor, CB-1158, for the treatment of hematology and oncology indications. Incyte would fund 70% of the development cost while Calithera would fund 30%. Incyte and Calithera would share profits and losses, with Incyte at 60% and Calithera at 40%, based on U.S. sales. Incyte and Calithera planned to co-detail the drug in the U.S. and Calithera was eligible for up to $483M, including upfront and milestones, plus royalties ex-U.S. In Sep. 2020, Calithera terminated the agreement and regained worldwide rights.
Idorsia Terminated its Option and License Deal with Santhera for Vamorolon
In Nov. 2018, Idorsia granted Santhera an option to sublicense the development and commercialization of vamorolone for the treatment of DMD worldwide, excluding Japan and South Korea. Idorsia received 1M new registered shares of Santhera and an upfront cash payment of $20M. Idorsia became the largest shareholder in Santhera with a 13.3% equity position. The option was exercisable upon receipt of data from the P-IIb VISION-DMD study (VBP15-004). If exercised, Idorsia would receive a one-time payment of $30M and was eligible for regulatory & commercial milestones of up to $80M for the DMD indication and four one-time sales milestone payments of up to $130M in total. Idorsia was also eligible for regulatory milestone payments of up to $205M for three additional indications. On Sep. 2, 2020, Santhera exercised its option to license vamorolone for all indications including DMD, and revised the terms of the agreement. Vamorolone was originally developed by ReveraGen, and Actelion had the option rights. In Jun. 2017, Actelion spun off Idorsia as a separate entity along with vamorolone rights before its merger with Johnson & Johnson. According to the revised terms of the agreement, Idorsia received 366,667 shares in Santhera’s common stock and CHF10M in the form of convertible notes, up to 65% was converted in the form of Santhera common stock and transfer the control rights to its original developer ReveraGen BioPharma. Santhera had replaced Idorsia as party to the ReveraGen agreement.
AMAG Terminated its Development and Commercialization Deal with Palatin Technologies
In Jan. 2017, Palatin Technologies granted AMAG Pharmaceuticals rights to develop and commercialize Rekynda (bremelanotide) for the treatment of female sexual disorders in North America. Palatin received $60M up front, up to $380M in milestones, and $25M in reimbursement payments, plus royalties. In Jul. 2020, AMAG terminated the agreement and Palatin Technologies regained the rights plus $16.3M in termination fees.
Gilead Terminated its Development and Commercialization Deal with Precision BioSciences
In Sep. 2018, Precision granted Gilead rights to develop and commercialize therapies for Hepatitis B Virus targeting HBV cccDNA and integrated HBV DNA present in human hepatocytes using Precision’s ARCUS platform. Precision would focus on the development, formulation, and preclinical studies. Gilead was responsible for clinical studies and commercialization. Precision received research funding and was eligible for up to $445M in milestone payments and royalties. In Sep. 2020, Gilead terminated its agreement with Precision BioSciences.
ReveraGen Terminated its Option and License Deal with Actelion (Idorsia after the spin-off from Actelion)
In Nov. 2016, Actelion signed a research partnership with ReveraGen BioPharma with an option to license vamorolone for the treatment of DMD and other indications. Actelion would co-develop the compound for the next 28 months and would contribute $1M annually. ReveraGen received $10M up front, up to $165M in dev. and reg. milestones for DMD, and up to $190M for an additional three indications, plus tiered double-digit royalties. On Jun. 16, 2017, Actelion was acquired by Johnson & Johnson. Actelion spun off Idorsia as a new company. In 2018, Idorsia maintained the option rights for vamorolone and restructured the agreement. It agreed to contribute the research for an additional year (until mid-2020). ReveraGen initially received $15M to maintain the agreement, a $20M option fee, and would be eligible for up to $75M in milestones for the DMD indication, and three additional sales milestones of up to $120M. Royalties and milestone payments for other indications remain unchanged. In Nov. 2018, Idorsia granted Santhera an option to sublicense the development and commercialization of vamorolone for DMD worldwide, excluding Japan and South Korea. On Sep. 2, 2020, Santhera exercised its option to license vamorolone for all indications including DMD with the control rights transferred to ReveraGen BioPharma.
The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS, mOS (9.3 vs 5.6mos.)
Additionally, Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR designation granted in Jul’2020 and its inclusion in overseas new drugs urgently needed in clinical settings
Xospata is the 1st FLT3 inhibitor approved by the NMPA for patients with r/r AML
Click here to read full press release/ article | Ref: Astellas | Image: Behance
The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency
Click here to read full press release/ article | Ref: PRNewswire | Image: Financial Times
Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability
KaliVir to receive $56M as upfront & other payments supporting the research & preclinical activities of VET2-L2 & is eligible to receive $307M & $271M as development, regulatory & commercialization for VET2-L2 & second product, respectively along with royalties on sales of each licensed product
The alliance integrates KaliVir’s expertise in the development of oncolytic viruses with Astellas’ capabilities in advanced drug development & its global business experience, enabling both parties to develop new immuno-oncology therapies
VET2-L2 (IV) is an oncolytic vaccinia virus that destroys cancer cells & activates anti-cancer immunity through the expression of therapeutic transgenes
Click here to read full press release/ article | Ref: PRNewswire | Image: BioSpectrum Asia
The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue
Immunology Segment Revenue: $0.01B
Founded Year: 1979
Market Cap: ~$0.49B
Total Employees: ~178
Headquarter: New Jersey, United States
Stock Exchange: NASDAQ
AntaresPharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019
Immunology Segment Revenue: $0.24B
Founded Year: 2008
Market Cap: ~$15.70B
Total Employees: ~1,200
Headquarter: Dublin, Ireland
Stock Exchange: NASDAQ
Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”
Immunology Segment Revenue: $0.49B
Founded Year: 1993
Market Cap: ~$2.57B
Total Employees: ~5,047
Headquarter: Shenyang, China
Stock Exchange: HKD
3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.
Immunology Segment Revenue: $0.73B
Founded Year: 1978
Market Cap: ~$42.57B
Total Employees: ~7,400
Headquarter: Massachusetts, United States
Stock Exchange: NASDAQ
Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.
Immunology Segment Revenue: $0.81B
Founded Year: 2000
Market Cap: ~$88.14
Total Employees: ~99,000
Headquarter: Brentford, United Kingdom
Stock Exchange: LON
GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.
Immunology Segment Revenue: $1.11B
Founded Year: 2007
Market Cap: ~$34.6B
Total Employees: ~7,228
Headquarter: Osaka, Japan
Stock Exchange: TYO
Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.
Immunology Segment Revenue: $1.24B
Founded Year: 1891
Market Cap: ~$197.46B
Total Employees: ~71,000
Headquarter: New Jersey, United States
Stock Exchange: NYSE
Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.
Immunology Segment Revenue: $1.68B
Founded Year: 1991
Market Cap: ~$19.38B
Total Employees: ~1,300
Headquarter: Delaware, United States
Stock Exchange: NASDAQ
Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.
Immunology Segment Revenue: $1.79B
Founded Year: 2005
Market Cap: ~ $26.49B
Total Employees: ~15,883
Headquarter: Tokyo, Japan
Stock Exchange: TYO
Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.
Immunology Segment Revenue: $1.79B
Founded Year: 1901
Market Cap: ~$135.16B
Total Employees: ~33,625
Headquarter: Indiana, United States
Stock Exchange: NYSE
Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.
Immunology Segment Revenue: $1.92B
Founded Year: 1928
Market Cap: ~$20.49
Total Employees: ~7,600
Headquarter: Brussels, Belgium
Stock Exchange: EBR
UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.
Immunology Segment Revenue: $2.53B
Founded Year: 1973
Market Cap: ~$122.35B
Total Employees: ~100,000
Headquarter: Paris, France
Stock Exchange: EPA
Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.
Immunology Segment Revenue: $2.97B
Founded Year: 1887
Market Cap: ~$135.30B
Total Employees: ~30,000
Headquarter: New York, United States
Stock Exchange: NYSE
Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.
Immunology Segment Revenue: $3.66B
Founded Year: 1925
Market Cap: ~$52.60B
Total Employees: ~49,578
Headquarter: Osaka, Japan
Stock Exchange: TYO
Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.
Immunology Segment Revenue: $4.22B
Founded Year: 1996
Market Cap: ~$205.93B
Total Employees: ~109,000
Headquarter: Basel, Switzerland
Stock Exchange: SIX Swiss Exchange, NYSE
Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.
Immunology Segment Revenue: $4.73B
Founded Year: 1849
Market Cap: ~$206.05B
Total Employees: ~83,000
Headquarter: New York, United States
Stock Exchange: NYSE
Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.
Immunology Segment Revenue: $5.39B
Founded Year: 1980
Market Cap: ~$134.11B
Total Employees: ~23,400
Headquarter: California, United States
Stock Exchange: NASDAQ
Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.
Immunology Segment Revenue: $8.79B
Founded Year: 1896
Market Cap: ~$281.59B
Total Employees: ~98,000
Headquarter: Basel, Switzerland
Stock Exchange: SWX
Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.
Immunology Segment Revenue: $13.95B
Founded Year: 1887
Market Cap: ~$378.94B
Total Employees: ~132,100
Headquarter: New Jersey, United States
Stock Exchange: NYSE
Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.
Immunology Segment Revenue: $19.57B
Founded Year: 2012
Market Cap: ~$146.29B
Total Employees: ~30,000
Headquarter: Illinois, United States
Stock Exchange: NYSE
AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.
Astellas Pharma is to buy bioelectronic medical devices firm iota Biosciences in a deal worth up to $429m, building on a previous research partnership.
In August last year the companies began a joint research and development agreement based around iota’s bioelectronic devices in several indications.
Bioelectronics is a field that has been investigated by Google’s life sciences division Verily, which co-founded Galvani Bioelectronics with GlaxoSmithKline in 2016.
The partnership focused on harnessing the body’s electrical signals to treat chronic diseases such as asthma, arthritis and gastrointestinal diseases.
Companies including AliveCor and Apple use bioelectronics to measure the heart rate and predict atrial fibrillation.
iota’s technology uses ultrasound as a power source and means of communication. Together with Astellas the pair will develop technology based around tiny millimetre-sized implantable medical devices, the companies said.
Astellas will pay $127.5 million up front to buy the remainder of the iota shares that it does not already own – the Japan-based pharma already has a stake after a US subsidiary invested in iota’s Series A stock offering.
Shareholders in iota could also receive additional payments of up to $176.5 million if pre-determined milestones are met before certain deadlines.
Upon completion iota will become a wholly-owned subsidiary of Astellas, which said it is also committing to spend a total of $125 million over the next five years to fuel iota’s “aggressive expansion”.
iota is a start-up founded in 2017 by Michel Maharbiz and Jose Carmena, who are both experts in the field of bioelectronics.
The company’s technology uses ultrasound to power miniature devices and enable wireless communication, allowing ultra-small, battery-free, wireless implantable medical devices.
Conventional implantable medical devices require batteries for power supply and wires or large electronic circuits to enable communications.
This has made size reduction difficult and has often resulted in highly invasive implant procedures.
iota’s bioelectronic devices can be implanted through a less invasive operative procedure and promise improved effectiveness and reduced physical burden for the patients during and after surgery.
Since striking up the research partnership last year the companies have begun several projects, and clinical trials based on the technology are expected to begin in the next few years.
Astellas said it is still reviewing the financial impacts of the transaction for the fiscal year ending 31st March 2021.
NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acutemyeloid leukaemia.
In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects.
However because of considerable uncertainty about long-term survival after stem cell transplant, NICE said the drug should not be funded as maintenance therapy after a haematopoietic stem cell transplant.
The decision follows first draft guidance in January where NICE rejectedXospata, but has had a rethink after Astellas submitted additional data and cost-effectiveness estimates.
Guidance applies to England and Wales, meaning that around 443 patients will benefit from the drug each year now that final guidance has been issued.
The list price for Xospata is £14,188 per 28-day pack however, the company has made the drug available to the NHS at a confidential discount.
AML is an aggressive and fast-growing blood cancer with a poor prognosis and is often diagnosed after emergency admission to hospital.
Only 16% of women and 15% of men in England survive more than five years with the disease, and those with the FLT3 mutations are more likely to relapse.
Treatment for AML is limited and is managed with salvage chemotherapy, often requiring inpatient care.
But chemotherapy side effects are unpleasant and NICE acknowledged that alternative treatment options that improve survival and quality of life would be welcomed by patients.
Xospata is the first oral monotherapy to be approved in the UK that targets relapsed or refractory FLT3 positive AML.
This means that medication can be taken at home rather than in hospital. Gilteritinib also improves overall survival when compared with chemotherapy. In one study, gilteritinib increased median overall survival from 5.6 months to 9.3 months.
Xospata was approved in this indication by the European Commission in October last year, and by the FDA in 2018.
Daiichi Sankyo has tried to produce a rival FLT3 inhibitor, quizartinib, but this has been rejected by regulators in the US and EU.
