Celgene's ($CELG) blood cancer drug Revlimid is on a roll. Already a blockbuster with $3.77 billion in 2012 sales, Revlimid has snagged an approval from Chinese regulators. And the FDA put the drug up for priority review for a new use in patients with mantle-cell lymphoma.
The market for multiple melanoma drugs has been forecast to grow 60% by 2021, reaching more than $7 billion from about $4.4 billion. That growth will be powered by approvals of new therapies to supplement drugs like Takeda's market leading Velcade and Celgene's Revlimid.
Celgene CEO Bob Hugin is leading a push to rapidly grow the major drugmaker, keeping the company atop lists of go-to partners among biotechs.
Celgene captured the center ring at the J.P. Morgan conference on its opening day Monday. Company CEO Bob Hugin boldly mapped out a 5-year plan to double sales and highlighted upbeat Phase III data on its psoriasis drug apremilast that he believes will set the stage for regulatory approval on both sides of the Atlantic.
The data were "highly statistically significant and clinically meaningful," noted Celgene, which is pushing for an approval to use the drug among treatment-resistant patients. The safety review board recommended that patients in the control arm whose myeloma hadn't progressed should be provided the experimental drug combo.
Celgene has agreed to help fund a study of its blockbuster blood-cancer drug Revlimid in HIV patients. Bionor Pharma, a Norwegian biotech focused on HIV, revealed plans on Monday to test a cocktail consisting of its experimental HIV treatment and Revlimid in Germany.
Onyx Pharmaceuticals has staffed up to launch its newly approved Kyprolis drug for multiple myeloma. The company hired a dedicated marketing team of about 100, Xconomy reports, comprising sales reps, oncology nurses and reimbursement specialists.
A big hurdle popped up in Revlimid's path: Europe's Committee for Medicinal Products for Human Use asked for "more mature" data.
While Onyx unexpectedly found itself facing a friendly group of supporters during its FDA panel session on carfilzomib, Celgene shocked a number of analysts with the news that it is yanking its European application for Revlimid as a treatment for multiple myeloma in newly diagnosed patients after regulators there passed along the word that they would prefer to wait for more "mature" data.
Celgene's bid to expand use of Revlimid as a prostate cancer treatment just hit a major snag. The company stopped a Phase III trial after an independent monitoring committee determined that adding