Celgene (NASDAQ:CELG) has submitted a new drug application to the U.S. Food and Drug Administration for pomalidomide, a drug designed for multiple myeloma that does not respond to therapies.
Since the drug is for an unmet need, the company stands to get a priority review. It is also planning to submit a marketing application submission for the same indication with European regulators in the second quarter. Data from a phase 3 trial for the treatment of myelofibrosis is expected at the end of the year.
Additionally, it made a supplemental NDA submission for its protein-based chemotherapy drug Abraxane to the FDA to treat advanced non-small cell lung cancer. Abraxane is currently approved in the United States to treat metastatic breast cancer. Both of the new drug applications were made in the first quarter, according to the company’s quarterly earnings announcement.
Celgene also has a phase 3 trial under way that is using the Abraxane in the treatment of metastatic pancreatic cancer with data expected in the second half of 2012 or the first half of 2013. It has at least six late-stage clinical trials under way across hematology and oncology, which gives the company multiple drug candidates that could be ready for a drug filing with the FDA.
It has also forged a collaboration with Massachusetts-based Epizyme for personalized therapeutics in patients with genetically defined cancer in a deal valued at up to $250 million. The Massachusetts-based therapeutics developer’s products use histone methyltransferase inhibitors, which are associated with the underlying causes of some human diseases. It has two therapies in preclinical development for non-Hodgkin’s lymphoma and leukemia. Celgene gets the non-U.S. rights to the therapies in exchange for a $90 million initial payment and up to $160 million if the therapies meet certain milestones.
Net profits for the company rose 57 percent in the first quarter, largely driven by sales of Revlamid that climbed to $861 million.
