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Alexion's (ALXN) Soliris Label Expansion Approved in Japan

Zacks Equity Research

Alexion Pharmaceuticals, Inc. (ALXN announced that the label expansion of its lead drug Soliris (eculizumab) has been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. The drug’s label is approved for the treatment of patients with generalized myasthenia gravis (gMG) who anti-acetylcholine receptor (AChR) antibody-positive and display symptoms that are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris is the first and only complement inhibitor approved in Japan as a treatment for these patients.

The approval was based on the phase III REGAIN study and its ongoing open-label extension study. In the study, Soliris showed treatment benefits for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms.

Alexion’s shares have underperformed the industry year to date. The stock has declined 2.5%, against the industry’s growth of 3.6%.

We note that Soliris is approved for two severe and ultra-rare disorders resulting from chronic uncontrolled activation of the complement component of the immune system – paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

In October, the FDA also approved Soliris as a treatment for adult patients with generalized gMG who are anti-AchR antibody-positive. In August, the drug received approval from the European Commission for the same indication.

Additionally, a phase III study (PREVENT) on Soliris in patients with relapsing neuromyelitis optica spectrum disorder is ongoing with data expected in 2018. Label expansion into additional indications would give Soliris access to a higher patient population and increase the commercial potential of the drug significantly.

We note that Soliris has received Orphan Drug Designation (“ODD”) for the treatment of patients with MG in the United States and European Union, and for the treatment of patients with refractory gMG in Japan.

 

Alexion Pharmaceuticals, Inc. Price

 

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Zacks Rank & Stocks to Consider

Alexion carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space include Sucampo Pharmaceuticals SCMP, Achillion Pharmaceuticals, Inc. ACHN and Corcept Therapeutics Incorporated CORT. While Sucampo sports a Zacks Rank #1 (Strong Buy), Achillion andCorcept carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, in the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 32.8%, year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018, in the last 60 days. The company recorded positive earnings surprises in two of the trailing four quarters, with an average beat of 4.51%.

Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents for 2018 in the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 158.8% year to date.

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