Biogen's Fampyra Conditional Approval Converted To Standard

Biogen Inc. (NASDAQ:BIIB) announced that the conditional marketing authorization for its drug Fampyra for improvement of walking in multiple sclerosis (MS) patients in the EU has been converted to a standard marketing approval.

As part of the conditional approval received in 2011, Biogen was required to provide additional data on the long-term safety and benefits of Fampyra, especially on the drug’s benefits beyond an improvement in walking speed.

The standard approval was based on positive results of the phase III ENHANCE study, which was conducted to evaluate the long-term safety and efficacy of Fampyra in patients with both relapsing and progressive forms of MS. The study confirmed the clinically meaningful benefits and safety of Fampyra over the long term.

Fampyra is available in the U.S. under the trade name Ampyra where it is marketed by Acorda Therapeutics, Inc. (NASDAQ:ACOR) . Biogen acquired ex-U.S. rights to Fampyra from Acorda in Jul 2009

Biogen has a strong position in the MS market with a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy. Biogen has another MS product, Zinbryta, in its portfolio in partnership with AbbVie, Inc. (NYSE:ABBV) . However, increasing competition and a slowdown in the overall MS market is hurting sales of it MS drugs lately. Importantly, Roche’s Ocrevus (ocrelizumab) was approved for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS) in Mar 2017, which will pose strong competition to Biogen’s MS drugs. However, on Wednesday, Reuters reported that a progressive multifocal leukoencephalopathy (PML) case has been disclosed in a MS patient in Germany who had recently switched to Ocrevus from Tysabri.

Shares of Biogen were up 2% on Wednesday. This year, Biogen’s shares have declined 10.6% so far while the Zacks classified Biomed-Genetics industry has gained 0.3%.

With intensifying competition in the said market, Biogen is trying to diversify its pipeline and aims to be a leader in the neuroscience/neurologic diseases area.

Biogen is looking to strengthen its Alzheimer’s disease (AD) and other neurodegenerative disorders pipeline. Biogen’s AD pipeline comprises candidates with different mechanisms of action including anti-tau (BMS-986168) and anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program. The Dec 2016 FDA approval of Biogen and partner Ionis Pharmaceuticals, Inc.’s (NASDAQ:IONS) spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen), consolidated its position in the neurological disease market with the drug being the first and only treatment to be approved in the U.S. for SMA.

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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