Celgene Presents Efficacy & Safety Phase II Ozanimod Data
Celgene Corporation's CELG wholly owned subsidiary, Celgene International Sàrl, announced data from the 96-week blinded extension period (for a total of up to 120 weeks of exposure on treatment) of the phase II study (RADIANCE) on an experimental oral, selective S1P 1 and 5 receptor modulator, ozanimod, in patients suffering from relapsing multiple sclerosis (RMS). Results were presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
The randomized, double-blind, placebo controlled study evaluated the efficacy, safety and tolerability of two orally administered doses (0.5 mg and 1 mg) of ozanimod compared to placebo in patients with RMS, which was followed by a 2-year blinded extension period where all patients received ozanimod. Data showed that ozanimod demonstrated continued efficacy over 96 weeks on MRI and clinical measures of MS disease activity. In addition, no new safety or tolerability concerns were identified during the ongoing blinded extension.
Safety and efficacy results from the blinded extension are encouraging. Per Celgene’s press release, multiple sclerosis affects 400,000 people in the U.S. and about 2.5 million people across the world. Approximately 85% of people are initially diagnosed with RMS in comparison with 10–15% with progressive forms of the disease.
We note that ozanimod is currently being evaluated in a couple of pivotal phase III studies – RADIANCE and SUNBEAM – for the treatment of patients with RMS. Data from both studies are anticipated in the first half of 2017. Apart from RMS, Celgene is evaluating ozanimod in a phase III study – TRUE NORTH – for the treatment of patients with moderate-to-severe ulcerative colitis. Data from the study is expected in 2018.
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We remind investors that ozanimod became a part of Celgene’s pipeline following the Aug 2015 Receptos acquisition. Once approved, Celgene expects the candidate to generate peak annual sales of $4–$6 billion. The company also expects the candidate to accelerate growth from 2019 and be a significant growth driver beyond 2020, subject to approval.
Note that the acquisition of Receptos also added RPC4046 (an anti-interleukin-13 antibody) to Celgene's pipeline. RPC4046 is currently in phase II development for eosinophilic esophagitis, an allergic/immune-mediated orphan disease.
Celgene is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Geron Corporation GERN and ANI Pharmaceuticals, Inc. ANIP. All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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