$CELG Multiple Sclerosis Drug Reported Positive Phase-III Results

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Blog Coverage Celgene’s Multiple Sclerosis Drug Reported Positive Phase-III Results

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Active Wall St. blog coverage looks at the headline from Celgene Corp. (NASDAQ: CELG) as the Company announced on February 17, 2017, that it took a major step forward toward becoming an important player in the multiple sclerosis treatment market after the Company announced positive results from its phase-III SUNBEAM trial, evaluating the efficacy and safety of its oral drug ozanimod in patients with relapsing multiple sclerosis (RMS). 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, BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported on February 07, 2017, that Jean-Jacques Bienaimé, the Company’s Chairman and Chief Executive Officer, will host a conference call and webcast on Thursday, February 23, at 4:30 p.m. ET to discuss Q4 and full year 2016 financial results and provide a general business update. AWS will be initiating a research report on BioMarin Pharma in the coming days.

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The SUNBEAM Trial

SUNBEAM is a phase-III multicenter, randomized, double-blind, double-dummy, active-controlled study assessing the efficacy, safety, and tolerability of two orally administered doses of ozanimod (0.5 mg and 1 mg) against weekly intramuscular interferon beta-1a (Avonex®) over a minimum of a 12-month treatment period. The randomized phase-III trial enrolled 1,346 RMS patients across 152 sites in 20 countries.

Celgene noted that the top-line results revealed that both the ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Biogen’s Avonex® for the primary endpoint of annualized relapse rate (ARR) in RMS patients. Ozanimod also came top in the secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12. The Company stated that as per its Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA), a pre-specified analysis on the time to onset of disability progression will be conducted using pooled results from both the SUNBEAM and RADIANCE phase-III trials.

Celgene noted that ozanimod’s overall safety and tolerability profile was consistent with results from previously reported phase-II RMS (RADIANCE) and phase-II ulcerative colitis (TOUCHSTONE) trials.

“People living with multiple sclerosis need additional therapies and we are pleased that oral ozanimod showed meaningful improvements across primary and measured secondary endpoints in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “We look forward to data from the confirmatory phase-III RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end.”

About Ozanimod

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. Selective binding with S1PR1 receptors is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained. Ozanimod was acquired by Celgene under its $7 billion purchase of Receptos in 2015.

Selective binding with S1PR5 receptors is believed to activate specific cells within the CNS. This has the potential to enhance remyelination and prevent synaptic defects. Ultimately, neurological damage may be prevented.

Stock Performance

At the closing bell, on Friday, February 17, 2017, following the announcement, Celgene’s stock climbed 2.11%, ending the trading session at $121.16. A total volume of 4.85 million shares were traded at the end of the day, which was higher than the 3-month average volume of 4.28 million shares. In the last month and previous six months, shares of the Company have advanced 6.64% and 8.05%, respectively. Moreover, the stock gained 4.67% since the start of the year. Shares of the company have a PE ratio of 48.74 and have a market cap of $94.13 billion.

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