Celgene got good marks for a phase three trial for its MS drug. (Kris Tripplaar/Sipa USA/Newscom)
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No. 2 biotech Celgene (CELG) could bolster sales by $800 million on Receptos’ ozanimod in multiple sclerosis, Credit Suisse analyst Alethia Young said Friday after Celgene unveiled strong phase three trial results for the drug.
Ozanimod was acquired in Celgene’s $7 billion purchase of Receptos in 2015. In a late-stage trial, the drug showed statistically significant and clinically meaningful benefits in reducing annualized relapse rates at 1-milligram and 0.5-mg doses compared with Biogen‘s (BIIB) rival drug Anovex.
The drug also hit on secondary endpoints, including a reduction in gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12, according to Celgene’s news release. Indications about its safety were similar to results shown in phase two, Celgene said.
Specific data will be released at an “upcoming international scientific meeting,” Celgene said — potentially the American Academy of Neurology annual meeting in May, RBC analyst Michael Yee said in a research report.
IBD’S TAKE: Celgene CEO Mark Alles defended pharmaceuticals and biotechs in the drug-pricing debate, saying innovation requires incentive. And be sure to head to IBD’s Biotech & Pharma Stock page for the latest headlines from the sector.
The safety profile for ozanimod will be particularly important in differentiating it from rivals. Biogen’s Tecfidera and Novartis‘ (NVS) Gilenya also hit on T2 legions, but Gilenya’s label includes safety information on bradycardia and liver toxicity, Yee said.
It’s possible Celgene could have similar safety data on its label regarding bradycardia, he said.
“How much this impacts the sales of the drug is unclear given Gilenya is going generic (in 2019) and first-dose monitoring is a bit of a hassle,” he wrote. Ultimately, Celgene’s bigger opportunity for ozanimod is in ulcerative colitis where it is slated to be the only pill so far.
Credit Suisse’s Young says she’s most focused on Celgene’s MS data in the first half of this year, UC data in 2018 and GED-301 in Crohn’s disease in 2019. These readouts will give Wall Street confidence in Celgene’s ability to replace Revlimid’s patent losses, she said.
In the stock market today, Celgene stock rose 2.1% to 121.11. Shares popped above their 50-day moving average on Wednesday after trading at or below that mark for the past month. Shares of Biogen fell 0.41% Friday, to 288.94.
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