Celgene files ozanimod in Europe as it faces pressure on mega-merger with BMS

By PharmaCompass

2019-03-14

Impressions: 170 Article

In May 2018, Phispers shared with you that Celgene was planning to re-file ozanimod’s new drug application with the FDA in early-2019. Ozanimod is a drug in phase III clinical trials for the treatment of relapsing multiple sclerosis (MS) and ulcerative colitis. In a sudden turn of events, the biotech has submitted ozanimod’s marketing authorization application to the EMA this week, before it plans to knock on FDA’s door.

While the drug received a refuse-to-file letter last February from the US regulators, analysts comparing the drug’s trial data with that of Novartis’ Gilenya (another MS drug) concluded that Celgene would bring the drug onto the market with a similar efficacy profile but better safety features. Ozanimod has been touted as a blockbuster drug even before its launch, with peak sales estimates of US$ 5 billion per year.

For the EMA application, Celgene provided data from the Phase III trials, which offered encouraging comparisons with Biogen’s Avonex in treating patients with relapsing MS.

Celgene’s ozanimod filing to the EMA is crucial as the company prepares itself to battle its blockbuster cancer drug Revlimid’s patent cliff and prove its drug development prowess. Revlimid generated sales of US$ 8.2 billion in 2017, accounting for 63 per cent of Celgene’s overall revenue. Moreover, Celgene also has to contend with pressure from activist investor Starboard Value that is lobbying against its merger with Bristol-Myers Squibb (BMS).

Starboard CEO Jeff Smith highlighted that in the last five years or so, Celgene has failed to bring a single new major drug to market. Meanwhile, reports say that BMS has so far skirted questions on its Plan B if the Celgene deal falls through.

The year-long delay in ozanimod’s filing has, however, had no effect on the biotech CEO’s million-dollar pay cheque — Celgene CEO Mark Alles got a raise of US$ 3 million as his pay packet increased to US$ 16.2 million. Moreover, he is all set to get a US$ 28 million payout after the BMS buy if he decides to leave the company.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

NEWS

DRUGS & DEVELOPMENTS

MARKET INTEL by PharmaCompass