Celgene Submits MS Drug for Approval in Europe, FDA Filing on Track

Xconomy New York — 

An experimental multiple sclerosis treatment identified as a key asset in Bristol-Myers Squibb’s proposed acquisition of Celgene has been filed for regulatory approval in Europe.

Celgene (NASDAQ: CELG) submitted its application to the European Medicines Agency for ozanimod, a drug developed to treat a form of MS characterized by relapses, or periodic flare-ups, of neurological attacks. Financial analysts project the pill will become a blockbuster seller if approved, and it’s one of the “Big 5” late-stage pipeline assets that Bristol (NYSE: BMY) cited in justifying its proposed $74 billion acquisition of the Summit, NJ, drug maker. That deal is facing scrutiny from some investors who say the Celgene buyout is not in the best interest of Bristol shareholders.

Ozanimod, which Celgene added to its pipeline in 2015 through its $7.2 billion acquisition of Receptos, was developed to treat inflammatory diseases. In MS, the immune system attacks myelin, the protective sheath that covers nerves. This damage disrupts the ability of the brain to communicate with the rest of the body. Celgene says ozanimod causes lymphoid tissues to retain lymphocytes, a type of immune cell. The exact way that ozanimod addresses MS is not known, but Celgene says it may involve reducing the movement of these immune cells into the central nervous system. The drug is also being tested as a treatment for ulcerative colitis and Crohn’s disease.

Celgene’s filing in Europe comes more than a year after ozanimod hit a setback at the FDA. Last year, the FDA refused to review the drug, saying that there were deficiencies in Celgene’s application. The company now says it is on track to resubmit the drug to the FDA by the end of this month.

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