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Biogen Halts Tysabri Development in Stroke as Study Fails


Biogen Inc. BIIB announced that its multiple sclerosis (MS) product, Tysabri (natalizumab) failed to meet the primary and secondary endpoints in a phase IIb study, evaluating the medicine for another indication – acute ischemic stroke (AIS).

Tysabri is presently approved to treat multiple sclerosis and Crohn's disease. The drug recorded sales of $1.97 billion in 2017.

Top-line results from the phase IIb dose-ranging ACTION 2 study showed that treatment with natalizumab did not lead to improvement in clinical outcomes – patients’ independence and ability to perform daily tasks – compared to placebo in patients with AIS. Ischemic stroke is a condition in which sudden loss of blood circulation in the brain leads to loss of neurologic function. Biogen has decided not to pursue development of natalizumab in AIS.

Shares declined slightly on Wednesday in response to the news. Biogen’s shares have risen 21.6% in the past year, better than the industry’s rise of 1.1% in the same time frame.

However, Biogen believes that this failure will not affect its pipeline efforts for acute neurological conditions including stroke. Biogen is developing BIIB093 for the treatment of large hemispheric stroke (LHI), a severe form of stroke with no available therapy. It had acquired BIIB093 from Remedy Pharmaceuticals in May last year. A phase III study on the candidate is expected to be initiated in mid-2018.

On the fourth-quarter conference call held last month, Biogen said that since the launch of Roche’s RHHBY MS drug, Ocrevus, it has witnessed a decrease in the number of patient starts and an increase in discontinuation of Tysabri in the United States. Moreover, treatments like Novartis’ Gilenya and Sanofi’s SNY Aubagio pose competitive threat to Tysabri.

Had Tysabri been successfully developed for the stroke indication, it would have improved the drug’s prospects in a competitive market.

As competition in the MS market intensifies, Biogen is looking to diversify to Alzheimer’s disease (AD) and other neurodegenerative disorders area. In 2017, Biogen added seven new clinical stage programs to its neuroscience pipeline through advancing internal pipeline candidates as well as through external deals.

Biogen’s AD pipeline comprises candidates with different mechanisms of action including anti-tau candidate (BIIB092)), anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program.

Biogen and Ionis Pharmaceuticals, Inc.’s IONS spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen) is the first and only treatment to be approved in the United States for SMA. The drug has performed beyond expectations so far witnessing strong patient uptake in the United States and internationally

Biogen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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