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Alexion (ALXN) Files for Soliris' Label Expansion in Japan

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Alexion Pharmaceuticals, Inc. announced that it has submitted an application to Japan’s Ministry of Labour and Welfare (MHLW) for the label expansion for Soliris to treat patients with refractory generalized myasthenia gravis (gMG), who are anti-acetylcholine receptor (AChR) antibody-positive.

The submission was supported by data from the phase III REGAIN study. Recently, the FDA accepted the supplemental Biologics License Application (sBLA) filed for Soliris for the same indication. The FDA has also set a Prescription Drug User Fee Act (PDUFA) date of Oct 23. Additionally, the company also submitted marketing application to European Medicines Agency (EMA) for the indication.

Alexion’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry in the last one year. The stock declined 1.9% compared to the industry’s gain of 5.5%.

Soliris enjoys Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and the EU. In fact, it is already approved in the U.S., the EU and Japan along with other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) for the reduction of hemolysis. Also, this drug is approved for atypical hemolytic uremic syndrome (aHUS).

We note that Soliris is the key drug for Alexion. However, as Soliris accounts for majority of revenues for Alexion, the company relies on the drug heavily for growth. Moreover, the drug is witnessing access challenges in Latin America. And its quarter-to-quarter revenues growth is expected to be impacted by the enrolment ramp-up of trials on ALXN1210 (in $70 million–$110 million range).

Meanwhile, the company is currently evaluating ALXN1210 (a longer-acting anti-C5 antibody that inhibits terminal complement) in phase III studies for both PNH and aHUS. Patients are also being dosed in a phase III trial, which compares ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH.

Further, the company is also initiating a phase III PNH switch study on ALXN1210, which compares the candidate administered intravenously every eight weeks to patients currently treated with Soliris. Enrolment in both the studies is expected to be completed in 2017.

Currently, recruitment is ongoing in a phase III trial on ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrolment is expected to be complete in 2017. Moreover, Alexion anticipates initiation of a phase III trial on ALXN1210 in pediatric patients with aHUS, in the second quarter of 2017.

Zacks Rank & Stocks to Consider

Alexion currently carries a Zacks Rank #4 (Sell). Some other better-ranked stocks in the health care sector include Heska Corporation , Retrophin, Inc. and Addus HomeCare Corporation (ADUS - Free Report) . While Heska and Retrophin carry a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 34.8% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.  

Addus HomeCare earnings estimates increased from $1.38 to $1.41 for 2017, over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 10.14%.

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