Celgene Corp. (NASDAQ: CELG) Reported Positive Late Stage Results from Trial of Ozanimod

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Blog Coverage: Celgene Reported Positive Late Stage Results from Trial of Ozanimod in Patients with Relapsing Multiple Sclerosis

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Active Wall St. blog coverage looks at the headline from Celgene Corp. (NASDAQ: CELG) as the Company announced on May 22, 2017, that the phase III RADIANCE trial, evaluating the efficacy and safety of Ozanimod in patients with relapsing multiple sclerosis (RMS), met its primary goal of reducing annualized relapse rate (ARR) compared to Biogen Inc.’s Avonex treatment. Register with us now for your free membership and blog access at:

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One of Celgene’s competitors within the Biotechnology space, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), announced on May 04, 2017, its financial results for Q1 2017 and provided a business update. AWS will be initiating a research report on Regeneron Pharmaceuticals in the coming days.

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Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1), and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis, and Crohn’s disease. Ozanimod became part of Celgene’s portfolio from its $7.2 billion acquisition of Receptos Inc. in 2015.

RADIANCE Trial Details

RADIANCE is a pivotal, phase III multicenter, randomized, double-blind, double-dummy, active-controlled trial. RADIANCE evaluated two doses (0.5 mg and 1 mg) of oral Ozanimod, with patients treated for 24 months. The study enrolled 1,313 RMS patients across 147 sites in 21 countries.

In the trial, both Ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex®.

The overall safety and tolerability profile was consistent with results from the recently completed phase III SUNBEAM RMS trial which evaluated the efficacy, safety, and tolerability of two doses of oral Ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over a 24 month treatment period. The study included 1,346 RMS patients across 152 sites in 20 countries, and previously reported phase II trials.

Further analyses of the RADIANCE trial are ongoing. In February 2017, Celgene announced positive top-line results from the second active comparator phase III, SUNBEAM, in RMS. The Company stated that detailed results from the RADIANCE and SUNBEAM trials will be presented at an upcoming medical congress. A New Drug Application submission to the US Food and Drug Administration, based on the combined SUNBEAM and RADIANCE trials for RMS, is expected by the end of 2017.

“We are excited by the results seen to-date across both pivotal trials, which further validated ozanimod’s promising benefit-risk profile relative to current therapies,” said Terrie Curran, President of Celgene Inflammation and Immunology, “We plan to begin submitting global registration dossiers by the end of the year to bring this oral therapy to patients with relapsing multiple sclerosis.”

Multiple Sclerosis

Multiple sclerosis is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. RMS is characterized by clearly defined attacks of worsening neurologic function. As per the press release, approximately 85% of people are initially diagnosed with RMS compared with 10%-15% with progressive forms of the disease.

Stock Performance

On Tuesday, May 23, 2017, Celgene’s shares climbed 1.38%, finishing the day at $117.31. A total volume of 4.40 million shares have exchanged hands. For the last twelve months, the stock has surged 16.13%. Furthermore, since the start of the year, shares of the Company have gained 1.35%. Shares of the company have a PE ratio of 44.18 and have a market cap of $91.97 billion.

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