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Alexion (ALXN) Files for Label Expansion of Soliris in U.S., EU

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Alexion Pharmaceuticals, Inc. announced that it has filed regulatory applications with the FDA as well as the European Medicines Agency (EMA) seeking approval for a label expansion of Soliris. The company is looking to get Soliris approved for the treatment of refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor antibody-positive.

Shares of Alexion have outperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year. Specifically, the stock has lost 11.1% during this period, while the industry witnessed a decline of 11.6%.

The EMA has validated the application, thereby marking the initiation of the review process.

We note that Soliris is currently approved in the U.S., the EU, Japan and other countries for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

The latest development on the regulatory front is encouraging. According to the press release issued by the company, refractory gMG is an ultra-rare segment of MG – a complement-mediated neuromuscular disease. Most gMG patients continue to suffer from this debilitating condition despite treatment with existing MG therapies.

Considering the lack of approved therapies for refractory gMG, there is significant unmet need for treatments for this disease. We note that Soliris enjoys Orphan Drug status in the U.S., the EU, and Japan for the treatment of MG.

Alexion has faced significant setbacks in its attempts to expand Soliris’ label. Last month, Soliris failed to meet the primary endpoint in a phase II/III study – PROTECT. The drug was being evaluated for the prevention of delayed graft function in adult recipients of a deceased-donor kidney transplant, who are at increased risk of the disease (Read more: Alexion Soliris Fails in Phase II/III Delayed Graft Function Study).

Soliris is the company’s key growth driver. The drug registered sales of $2.1 billion in the first nine months of 2016. Soliris is expected to bring in revenues in the range of $2.835–$2.875 billion in 2016. Label expansion into additional indications would give Soliris access to a higher patient population and increase the commercial potential of the drug significantly.

Alexion Pharmaceuticals, Inc. Price and Consensus

Zacks Rank & Stocks to Consider

Alexion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in this industry include Kite Pharma, Inc. , Epizyme, Inc. and Orexigen Therapeutics, Inc. . While Orexigen sports a Zacks Rank #1 (Strong Buy), Kite and Epizyme carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Kite’s loss estimates narrowed 2.1% and 0.2% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise twice in the four trailing quarters with an average beat of 7.89%.

Epizyme’s loss estimates narrowed 3% and 2.4% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise in each of the four trailing quarters, with an average beat of 14.03%. Its share price gained approximately 17% in the past one year.

Orexigen’s loss estimates for 2016 and 2017 have narrowed 8.5% and 52.4%, respectively, over the last 60 days.

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