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Bristol-Myers Squibb Co.
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Re: Neurodegenerative Disease - Isn't This A Completely New Disease Area For BMY?BMY had an active Neuroscience presence based in CT until a strategic decision was taken to invest more in immuno-oncology after numerous industry-wide disappointments, especially in the Alzheimer'sDisease (AD) arena, such as Bapi discovered by Elan (ELN), partnered with Wyeth (WYE) and Dimebon. BMY passed on investing in ELN based on the potential that the Phase II Bapi AD data in non-APOE4 carriers was an artefact due to an abnormally poor placebo arm. JNJ's Janssen purchased 51% of the AD program and made a substantial investment in ELN equity. Pfizer (PFE) acquired WYE. Unfortunately, the Phase III BAPI trials proved out that there was no benefit with virtually no separation between the experimental and control arms. In fact, one of the co-founders of Biohaven (BHVN) was in charge of BMY's AD clinical trials. PFE acquired BHVN to acquire their CGRP migraine franchise for $148.50 per share. BMY picked up some neurodegenerative partnerships in the acquisitions of Celgene (CELG). Additional relations with Prothena (PRTA) and Evotec were announced in recent years. Biohaven (BHVN) was launched by a team of ex-BMY executives after a strategic decision to close Neuroscience to delve deeper into Immuno-Oncology https://www.pmlive.com/pharma_news/bms_exits_hep_c,_diabetes_and_neuroscience_research_517119 The BHVN founding executive team were all highly experienced BMY neuroscience leaders. One of the key assets licensed by this team was a promising CGRP migraine therapeutic, Rimegepant, which is now approved and marketed as Nurtec launched in 2Q2020 and generating $462M net sales in 2021. Rimegepant and Zavegepant The intellectual property rights related to rimegepant and zavegepant include patents and patent applications in-licensed from BMS, with expiration dates of February 22, 2031 for rimegepant, and October 7, 2031 for zavegepant, not including eligible patent term extensions, and patent applications filed by the Company, which if granted, will have statutory expiration dates from 2039 and later. U.S. Patent 8,314,117 covers the composition of matter of rimegepant, and has an expiration date of February 22, 2031, including patent term adjustment but not including any potential patent term extension. Based on the FDA’s approval of NURTEC ODT (rimegepant sulfate) orally disintegrating tablets on February 27, 2020, a request for Patent Term Extension under 35 U.S.C.156 of the United States Code was filed for U.S. Patent 8,314,117. If the application is granted as filed, the term of U.S. Patent 8,314,117 will be extended to February 27, 2034, not including a potential additional six month period of pediatric exclusivity. U.S. Patent 8,481,546 covers the composition of matter of zavegepant, and has an expiration date of October 7, 2031, including patent term adjustment but not including any potential patent term extension. These and other patents and applications cover rimegepant and zavegepant and their use in treating migraine and other neurological conditions. The BMS license also includes several patent families of related compounds directed to the CGRP receptor. We also have an agreement with Catalent whereby Catalent granted an exclusive license under certain of its patents and technology to use the Zydis ODT technology for development of our rimegepant product. The Company is obligated to make milestone payments to BMS upon the achievement of specified development and commercialization milestones with respect to the development of rimegepant and zavegepant. If the Company receives revenue from sublicensing any of its rights under the agreement, it is also obligated to pay a portion of that revenue to BMS. The Company is also obligated to make tiered royalty payments to BMS based on annual worldwide net sales, with percentages in the low to mid-teens. Under the BMS Agreement, the Company is obligated to use commercially reasonable efforts to develop licensed products and to commercialize at least one licensed product and is solely responsible for all development, regulatory and commercial activities and costs. The Company is also primarily responsible for the filing, prosecution, defense, and maintenance of patent rights licensed under the BMS Agreement. The BMS Agreement will terminate on a licensed product-by-licensed product and country-by-country basis upon the expiration of the royalty term with respect to each licensed product in each country and can also be terminated if certain events occur, e.g., material breach or insolvency. In March 2018, the Company entered into an amendment to the BMS Agreement (the “2018 BMS Amendment”). Under the 2018 BMS Amendment, the Company paid BMS an upfront payment in return for a low single-digit reduction in the royalties payable on net sales of rimegepant and a mid single-digit reduction in the royalties payable on net sales of zavegepant. In August 2020, the Company entered into a further amendment of the BMS Agreement (the “August 2020 BMS Amendment”). Under the August 2020 BMS Amendment, the Company paid BMS an upfront payment in return for a reduction in the royalties payable on net sales of rimegepant and zavegepant in China, with percentages in the low- to mid-single digits. In addition, the Company is obligated to pay milestone payments for each licensed product upon the achievement of commercial milestones in China. The August 2020 BMS Amendment also amended the BMS Agreement to remove sales in China from the commercial milestone payment obligations due on global sales from all territories other than China. In November 2020, the Company entered into a further amendment of the BMS Agreement (the “November 2020 BMS Amendment”). Under the November 2020 BMS Amendment, certain exclusivity provisions under the BMS Agreement were waived which permits the Company to develop certain CGRP compounds licensed by the Company from Heptares Therapeutics Limited (“Heptares”). Under the November 2020 Amendment, if the Company initiates clinical development of a Heptares compound prior to July 8, 2023, the Company is obligated to pay BMS certain fees based on net sales of the Heptares compounds, milestone payments for each Heptares compound upon the achievement of certain development milestones and milestone payments for each Heptares compound upon the achievement of certain commercial milestones. No fees or milestones are due by the Company to BMS for Heptares compounds that begin clinical trials after July 8, 2023. The BMS License Agreement continues to provide the Company with exclusive global development and commercialization rights to rimegepant, zavegepant and related CGRP molecules, as well as related know-how and intellectual property. https://www.pmlive.com/pharma_news/bms_exits_hep_c,_diabetes_and_neuroscience_research_517119 11 November 2013 BMS exits hep C, diabetes and neuroscience drug discoveryWill discontinue 'broad-based discovery work' in the therapy areas
The company will discontinue 'broad-based discovery work' in neuroscience, which has been a particularly difficult area for pharma of late, with a number of late-stage pipeline failures. BMS will also halt such discovery work in hepatitis C and diabetes, but will keep supporting existing or late-stage candidates in two therapy areas. Meanwhile, the plans will see BMS “executing development, regulatory and commercial plans” in diabetes and hepatitis C, while it focuses more wholeheartedly on HIV, hepatitis B, heart failure, oncology, immunoscience and fibrotic disease research. Francis Cuss, BMS' chief scientific officer, said: “We have decided to shift R&D toward a more speciality biopharma model that focuses on the areas of significant unmet medical need, driving near-term growth through our current late-stage portfolio and on ensuring the long-term growth of the company by evolving the disease areas and drug platforms on which we concentrate our research efforts.” Part of these plans will see BMS “evolve the disease areas and drug platforms on which we concentrate our research efforts to drive growth for the company in 2020 and beyond”, the company said. But it pledged to continue to advance its oral anticoagulant Eliquis (apixaban); cancer drugs Sprycel (dasatinib) and Erbitux (cetuximab); Orencia (abatacept) for arthritis; hepatitis B treatment Baraclude (entecavir); and HIV drugs Reyataz (atazanavir sulfate)/Sustiva (efavirenz). BMS also said it would increase investment in immuno-oncology, an area in which it see “significant opportunity” and which has already yielded its antibody treatments Erbitux, Yervoy (ipilimumab) and its anti-PD1 candidate nivolumab. Meanwhile, BMS last year signed an academic immune-oncology research alliance and in 2009 paid $2.4bn for US biotech firm Medarex, which specialises in human antibody-based therapeutics. Diabetes research at BMS Despite promising to keep up with its current diabetes franchise, the change in R&D direction throws into question BMS's billion-dollar diabetes alliance with AZ. This stepped up a gear last year with the $7bn purchase of Amylin, the company behind Byetta and Bydureon, but recently the partners suffered a setback with Onglyza (saxagliptin) and are still waiting for US approval for Forxiga (dapagliflozin). Analysts are already sizing up the sale prospects for BMS' diabetes franchise, with one predicting the company's interests outside the US could be worth $4bn-6bn. The company is not alone in making research cuts, with this year seeing much deeper cuts at AstraZeneca, Merck & Co, Novartis and Shire. But BMS' plans will reportedly hit just a small number of employees, with some 70 to 75 research positions set to be cut by the end of the year, and up to a further 300 facing changes in their roles. |
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Bristol-Myers Squibb (BMS) has called time on R&D in several therapy areas to focus more on priority fields, such as immuno-oncology, and bringing its late-stage pipeline to fruition.
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