LONDON, UK / ACCESSWIRE / June 08, 2018 / If you want access to our free research report on Alkermes PLC (NASDAQ: ALKS), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ALKS as the Company's latest news hit the wire. On June 06, 2018, the Company announced that it has received a $50 million payment from Biogen, Inc. (NASDAQ: BIIB), following the latter's review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098 (formerly known as ALKS 8700), which is an oral fumarate in Phase-3 development for the treatment of relapsing forms of multiple sclerosis (MS). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Alkermes to file NDA for BIIB098 to FDA in Q4 2018
Richard Pops, Chief Executive Officer (CEO) at Alkermes, stated that the clinical data generated from this program underscore the potential value of BIIB098 for patients with MS. Pops added that Alkermes' focus remains on completing the registration requirements and preparing the new drug application (NDA) for BIIB098 for submission to the US Food and Drug Administration (FDA) in the fourth quarter of the fiscal year 2018, as the Company advances this important potential new therapeutic option for patients with MS.
Terms of the License and Collaboration Agreement
- Biogen has an exclusive, worldwide license to commercialize BIIB098 and will pay Alkermes a mid-teens percentage royalty on worldwide net sales.
- Alkermes may also receive a $150 million milestone payment from Biogen upon the FDA's approval, on or before December 31, 2021, of the NDA for BIIB098.
Alkermes Plans to Seek Approval of BIIB098 Under the 505(b)(2) Regulatory Pathway
BIIB098 is currently in Phase-3 development for relapsing forms of MS. Alkermes plans to seek approval of BIIB098 under the 505(b)(2) regulatory pathway, referencing Biogen's TECFIDERA® (dimethyl fumarate). Alkermes' registration package for BIIB098 will include pharmacokinetic bridging studies to establish bioequivalence to dimethyl fumarate and data from a two-year safety study known as EVOLVE-MS-1, an open-label, two-year Phase-3 safety study of BIIB098 for the treatment of relapsing forms of MS.
Biogen and Alkermes Collaboration Deal for Development and Commercialization of ALKS 8700 for MS Treatment
In November 2017, both Companies inked a global license and collaboration agreement to develop and commercialize ALKS 8700 for the treatment of relapsing forms of MS. As per the agreement terms, Biogen received an exclusive, worldwide license to commercialize ALKS 8700 and paid Alkermes a mid-teens royalty on worldwide net sales of ALKS 8700. Biogen reimbursed Alkermes for 50% of the 2017 ALKS 8700 development costs, and Alkermes also received an upfront payment of $28 million representing Biogen's share of development expenses already incurred in 2017.
About Multiple Sclerosis (MS)
MS is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems. Specific symptoms can include double vision, blindness in one eye, muscle weakness, trouble with sensation, or trouble with coordination. MS takes several forms, with new symptoms either occurring in isolated attacks or building up over time.
BIIB098 (diroximel fumarate) is an oral, novel fumarate candidate in development for the treatment of relapsing forms of MS. BIIB098 is designed to rapidly and efficiently convert to monomethyl fumarate (MMF) in the body and to potentially offer differentiated features compared to dimethyl fumarate.
About Alkermes PLC
Founded in 1987 and headquartered in Dublin, Ireland, Alkermes is a fully-integrated, global biopharmaceutical organization developing innovative medicines for the treatment of central nervous system (CNS) diseases. The Company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, and MS.
About Biogen Inc.
Headquartered in Cambridge, Massachusetts, Biogen is a biotechnology Company developing, marketing, and manufacturing therapies for people living with serious neurological, autoimmune, and rare diseases.
Stock Performance Snapshot
June 07, 2018 - At Thursday's closing bell, Alkermes' stock slightly fell 0.02%, ending the trading session at $48.30.
Volume traded for the day: 580.12 thousand shares.
Stock performance in the last month – up 9.30%
After yesterday's close, Alkermes' market cap was at $7.43 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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