Biogen, Inc. BIIB has a strong position in the multiple sclerosis (MS) market with a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy. It is working on strengthening its position further by bringing new treatments. In November 2017, Biogen in-licensed worldwide commercialization rights to Alkermes’ ALKS Vumerity (BIIB098), which the company claims has a potentially differentiated profile to Tecfidera. The NDA for Vumerity is under review in the United States with the FDA decision expected in the fourth quarter of 2019.
As competition in the MS market intensifies, Biogen is trying to diversify its pipeline and aims to be a leader in neuroscience and the adjacent therapeutic area. In 2017 and 2018, Biogen added seven and six new clinical stage programs, respectively, to its neuroscience pipeline by striking external deals.
Meanwhile, Biogen’s spinal muscular atrophy (SMA) treatment, Spinraza has multi-billion dollar potential.The market potential of the disease is huge. The drug has performed beyond expectations, witnessing strong patient uptake in the United States and internationally. It has now become the standard of care in SMA. Biogen has also expanded its collaboration with Ionis to identify new gene therapies for the treatment of SMA as well as a broad range of neurological diseases.
In July, Biogen acquired two programs from AliveGen, targeting the myostatin pathway for potential muscle enhancement across a range of neuromuscular diseases including SMA. In early 2019, Biogen signed a new collaboration with Skyhawk Therapeutics to develop an oral splicing modulator for multiple diseases, including MS and SMA. Biogen is also building a portfolio of best-in-class treatments for stroke and acute neurology.
Biogen plans to strengthen existing efforts in multiple sclerosis and spinal muscular atrophy while continuing to focus research and development efforts in the field of neuroscience. Some promising pipeline candidates include opicinumab (a potential remyelination therapy in MS), BIIB074/vixotrigine (trigeminal neuralgia and small fiber neuropathy), BIIB054 (Parkinson's), BG11/STX-100 (idiopathic pulmonary fibrosis or IPF), dapirolizumab pegol (active systemic lupus erythematosus [SLE], among others. In 2019/2020, important data readouts are expected across clinical programs in MS, Progressive supranuclear palsy (PSP) lupus, epilepsy, Parkinson’s disease and others while multiple launches are expected in the early 2020s.
However, Biogen is heavily reliant on sales of its drugs for MS, which is a highly competitive disease space. The overall trends in the multiple sclerosis market are gradually slowing down. The competitive landscape remains challenging for Biogen’s MS products with newer, competitive entrants. The recent launch of Ocrevus by Roche RHHBY is adversely impacting MS franchise sales, mainly Tysabri.
Meanwhile, potential competition to Spinraza from Novartis’ NVS oral gene therapy for SMA Type 1, Zolgensma, which was approved by the FDA for use in children less than 2 years old in May 2019, is a concern, particularly with the clinical hold placed on Biogen’s own gene therapy program. Meanwhile, Roche and PTC Therapeutics are also evaluating risdiplam in a broad range of patients with SMA, which, if successfully developed and approved, may compete with Spinraza in the future.
Most importantly, though Biogen’s CNS pipeline is attractive, it is a high-risk area, as evident from the recent failure of Alzheimer’s candidate aducanumab and more recently, elenbecestat. In September, Biogen and Eisai discontinued two late-stage studies on elenbecestat. The decision was taken following a safety review conducted by the Data Safety Monitoring Board. The board’s recommendation to discontinue the studies was due to unfavorable risk-benefit ratio.
In March, Biogen/Eisai announced the discontinuation of ENGAGE and EMERGE phase III studies on aducanumab in early AD. A futility analysis conducted by an independent data monitoring committee showed that the studies were unlikely to meet their primary endpoints.
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