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Alexion's Soliris Successful in Phase III Study for NMOSD

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Alexion Pharmaceuticals, Inc. (ALXN - Free Report) announced that the phase III study, PREVENT, on lead drug Soliris was successful.

The Prevention of Relapses and Evaluation of Eculizumab in NMOSD Treatment (PREVENT) trial was a multinational, double-blind, parallel-group time-to-event study that evaluated the efficacy and safety of Soliris compared to placebo for the treatment of patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

The study enrolled 143 adults suffering from NMSOD, who were randomized 2:1 to receive either Soliris or placebo. The primary endpoint was the time to first on-trial relapse as adjudicated by an independent committee comprised of three external experts in neurology/neuro-ophthalmology who were blinded to treatment. 

The study met its primary endpoint. Data showed that treatment with Soliris reduced the risk of NMOSD relapse by 94.2% compared to placebo. Treatment with Soliris reduced the adjudicated on-trial annualized relapse rate compared to placebo, a key secondary endpoint, by 95.5%.

97.9% of patients who received Soliris were free of relapse compared to only 63.2% of patients who received placebo.

The safety profile was consistent with that seen in previous studies. The impressive results reinforce Soliris efficacy in treating NMSOD patients.

Alexion expects to present detailed results from the study at a future medical congress. As there are currently no approved therapies for NMSOD, the company plans to meet regulatory bodies at the earliest and file for approval in the United States, EU and Japan.

Soliris is already approved in the United States and EU for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is also approved in the EU as the first and only treatment of refractory generalized MG (gMG) in adults who are anti-AchR antibody-positive, and in the United States for the treatment of adult patients with gMG who are anti-AchR antibody-positive.

Sales in the first half of 2018 came in at $1.7 billion.  Label expansion into additional indications would give Soliris access to a higher patient population and increase the commercial potential of the drug significantly.

 

Shares of Alexion have gained 7.5% year to date, outperforming the industry’s gain of 1.6%.

Meanwhile, Alexion acquired Sweden-based Wilson Therapeutics for $855 million. The acquisition added a late-stage candidate, WTX101 to Alexion’s pipeline. The candidate is currently in phase III for the treatment of Wilson disease, a rare genetic disorder.

The company is constantly making efforts to develop its pipeline. 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. The FDA has granted a priority review to its biologics license application (BLA) for ALXN1210 for PNH and has set an action date of Feb 18, 2019.

Zacks Rank & Stocks to Consider

Alexion carries a Zacks Rank #4 (Sell). Better-ranked stocks in the healthcare sector include Celgene Corp. (CELG - Free Report) , Ligand Pharmaceuticals Inc. (LGND - Free Report) and Illumina, Inc. (ILMN - Free Report) . While Ligand and Illumina sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%.

Illumina’s earnings estimates have from $4.88 to $5.46 for 2018 and from $5.62 to $6.14 for 2019 in the last 60 days.

Celgene’s earnings estimates have been moved up from $8.74 to $8.76 for 2018 and from $10.59 to $10.65 for 2019 in the last 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.

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