4:43 PM
Mar 02, 2018
 |  BioCentury  |  Finance

Rocky road

Buyside views on what Celgene can do to bolster sentiment after ozanimod setback

While a trio of buysiders who spoke with BioCentury believe sentiment toward Celgene Corp. will remain poor in the near term in the wake of a regulatory delay for ozanimod, they believe commercial success from the lead CAR T therapy gained from Juno Therapeutics Inc. and more M&A in the big biotech’s areas of core competency could help pave the road to long-term recovery.

The FDA refusal to file letter for ozanimod Celgene announced on Feb. 27 is the third major setback for the company in the past five months. The multiple sclerosis candidate was expected to be a key near-term revenue driver as the company faces pressure to reduce its reliance on cancer therapy Revlimid lenalidomide, which is slated to lose exclusivity in the mid-2020s.

The news follows announcements in October that the company discontinued development of Phase III Crohn’s disease candidate mongersen and slashed its 2020 guidance by $1-$2 billion, largely due to headwinds for autoimmune drug Otezla apremilast.

Chairman and CEO Mark Alles said on a conference call on Feb. 27 that Celgene is reevaluating the timing of worldwide regulatory submissions for ozanimod including an MAA to EMA, which the company had planned to submit this quarter.

FDA said the non-clinical and clinical pharmacology sections were “insufficient to permit a complete review” of the NDA for the selective modulator of sphingosine 1-phosphate receptor 1 (S1PR1; S1P1; EDG1) and S1PR5, according to Celgene. However, CMO and Head of Global Regulatory Affairs Jay Backstrom said on Tuesday’s call, “There’s nothing to suggest we’ll need to do an additional pivotal study.”

Celgene is down $6.45 to $89.33 since Tuesday and has lost $39.2...

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