Celgene said Monday it has again sent the FDA an application for approval of ozanimod, an experimental multiple sclerosis drug it added to its pipeline in 2015 as part of its $7.2 billion acquisition of San Diego’s Receptos.
Just over a year ago, the FDA refused to review Celgene’s application for ozanimod, citing a lack of sufficient information in the submission. The FDA’s response then came in the form of a “refusal to file” letter. That’s not as grave as a “complete response letter,” or what the FDA sends out when it, in essence, rejects an application for a new drug. It was, however, a serious setback for Celgene, which had snapped up ozanimod as part of an effort to diversify its product line.
Celgene, based in Summit, NJ, is aiming for an approval to treat people with a form of MS in which neurological symptoms periodically flare up. Known as relapsing-remitting MS, it’s the most common form of the condition. Celgene is also pursuing ozanimod approval in Europe; it filed an application there earlier this month. Nearly 1 million adults in the U.S. and more than 2.3 million people worldwide have multiple sclerosis, according to the National MS Society.
Beyond MS, Celgene is testing ozanimod as a treatment for ulcerative colitis, a form of inflammatory bowel disease, and for Crohn’s disease. The company expects to finish enrollment in its Phase 3 ulcerative colitis trial this summer, and data are expected by year’s end.
To tout the rationale behind Bristol-Myers Squibb’s massive $74 million bid for their company, Celgene officials have said they anticipate U.S. approval of five late-stage drug candidates, including ozanimod, in 2019 and 2020. The proposed transaction has met resistance from some Bristol shareholders who don’t believe the deal is in their best interest. Shareholders are slated to vote April 12.
Under the terms of the deal announced in January, Celgene shareholders would receive a Bristol share and $50 per Celgene share, plus tradeable options tied to the approval of three of those late-stage drugs—including ozanimod—that could result in more payments.
In 2018 Celgene reported unadjusted net income of about $4 billion in 2018, about 38 percent above 2017, and total revenue of about $15.3 billion, about 18 percent more than the year prior, according to its full-year financials.