Summary
- Celgene finally gets the FDA on board with its regulatory application for potential approval of ozanimod to treat relapsing forms of multiple sclerosis; PDUFA date set for March 25, 2020.
- The European Medicines Agency has also accepted the application for review of ozanimod for the European Union with a decision expected by the 1st half of 2020.
- It is believed that ozanimod could pull in peak annual sales between $4 to $6 billion.
- A major risk for ozanimod would be a patent dispute, because Novartis owns a patent for S1P modulators in dose titration and that could be a major challenge for Celgene.
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Celgene (CELG) is in good shape in terms of its multiple sclerosis (MS) drug ozanimod. That's because it announced that regulatory applications for the drug was accepted by both the FDA and EMA. This gives the company the potential to obtain approval for both territories. Getting this product filed with regulatory agencies has been a tough road for Celgene, because its first application to file for regulatory approval was refused by the FDA. The company is on the right track now.
