Today, Celgene submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ozanimod for adults with relapsing forms of multiple sclerosis (RMS).
Ozanimod, an anti-inflammatory drug molecule.
With the Bristol-Myers Squibb shareholder meeting coming up to finalize the vote on acquiring Celgene, opposition from several major investors is heating up. But during all that, Celgene continues with business as usual. Today, Celgene submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ozanimod for adults with relapsing forms of multiple sclerosis (RMS).
Bristol-Myers made its bid in January to acquire Celgene for $74 billion. Several big investors, including Starboard Value LP and Wellington Management Company LLP, have protested the deal. What has followed is a tit-for-tat sales pitch with Bristol-Myers Squibb and Celgene urging their shareholders to approve, while the opposition urges others to reject the deal.
BMS and Celgene argue that the deal will create the number one oncology franchise for solid and hematologic cancers. The combined pipeline will include the blockbuster checkpoint inhibitor Opdivo, in addition to Yervoy, and Celgene’s drugs, Revlimid and Pomalyst. There is also a healthy cardiovascular pipeline led by Eliquis and a pipeline of inflammatory drugs including Orencia and Otezla.
Celgene’s chief executive officer Giovanni Caforio, at Cowen and Company’s 39th Annual Health Care Conference, said the deal would create a strong company well-positioned for long-term and sustainable growth.
The primary concern on the part of the major shareholders is the feeling that Celgene’s pipeline isn’t as strong as it should be in light of a pending patent loss for Revlimid. Last year, Revlimid brought in almost $10 billion, but is expected to lose about 60 percent of its earning power over the next seven years. The opposition groups argue there’s nothing in Celgene’s pipeline likely to replace that loss.
The shareholder meeting is set for April 12.
Celgene, for its part, continues its activities as one of the more innovative pharma companies. Two weeks previously, it submitted a Marketing Authorization Application (MMA) to the European Medicines Agency (EMA) for the same drug and indication.
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 and 5. The NDA was built on results from the SUNBEAM and RADIANCE Part B Phase III, multicenter, randomized, double-blind, double-dummy, active-control trials.
SUNBEAN evaluated the efficacy, safety and tolerability of two doses of oral ozanimod against weekly intramuscular interferon beta-1a (Avonex) for at least a year. It enrolled 1,346 patients with RMS across 152 sites in 20 countries. The primary endpoint was annualized relapse rates (ARR).
RADIANCE Part B also looked at two doses of oral ozanimod against weekly intramuscular Avonex over a two-year period. That study included 1,320 people with RMS across 150 sites in 21 countries. The primary endpoint was ARR over 24 months.
The drug is also in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn’s disease.
“New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” stated Jay Backstrom, Celgene’s chief medical officer. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in 2020.”
