Biogen/Ionis Spinraza Granted Marketing Authorization In EU

Biogen Inc. (NASDAQ:BIIB) announced granting of marketing authorization to its marketed drug Spinraza (nusinersen) by European Commission under the accelerated assessment program for treating patients with 5q spinal muscular atrophy (SMA). This is the first approved treatment in the European Union (EU) for SMA.

In Dec 2016, the FDA officially permitted Spinraza under Priority Review for treating both pediatric and adult patients with SMA. This in fact makes it the first and only treatment to be approved in the U.S. for SMA, thus allowing the product to tap a market with high potential.

Shares of Biogen have underperformed the Zacks classified Medical-Biomedical/Genetics industry so far this year. The stock has lost 11% during the period, while the broader industry witnessed an increase of 1%.



The FDA approval was supported by positive results from two phase III studies - CHERISH and ENDEAR in patients with SMA. Notably, Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals (NASDAQ:IONS) , a leader in antisense therapeutics. Based on the marketing authorization of Spinraza in the EU, Ionis is entitled to receive a $50 million milestone payment and also eligible to earn tiered royalties on global sales of the drug up to a percentage in mid-teens.

It is better to remind investors that Biogen has also filed for approval of Spinraza in Japan, Canada, Australia, Switzerland and Brazil. The company also plans to initiate additional filings in other countries in 2017.

SMA is estimated to affect about 30,000–35,000 patients in the U.S., the EU and Japan. In the U.S., one in every 50 individuals or approximately six million people carries the gene mutation causing SMA. Hence the huge market opportunity to cater to the unmet needs of patients affected with the disease worldwide.

Zacks Rank & Key Picks

Biogen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) and Bayer (DE:BAYGN) AG (OTC:BAYRY) . Each of this stock flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.

Bayer’s earnings per share estimates increased from $8.36 to $8.85 for 2017 and from $8.88 to $9.53 for 2018, over last 30 days. The company posted positive earnings surprises in three of four trailing quarters with an average beat of 10.25%.

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