Denmark's Genmab is rolling right along with breakthrough-designated daratumumab for double refractory multiple myeloma, hitting a milestone in Phase II development and triggering a $22 million payout from collaborator Johnson & Johnson.
Novartis' in-development multiple myeloma candidate LBH589 hit its primary endpoint of staving off cancer progression in a late-stage study, the company said, stoking hopes the Swiss drugmaker can take first place among a new class of treatments.
The National Institute for Health and Care Excellence nixed Johnson & Johnson's Velcade as too expensive in comparison with the current standard therapies--at least as far as the current data can show.
The money will be used, in part, to pay for a mid-stage study of MOR208, its anti-CD19 antibody for chronic lymphocytic leukemia as well as new studies of MOR202, an anti-CD38 antibody currently in a Phase I/IIa clinical trial in multiple myeloma.
Multiple myeloma, one of the most common types of blood cancer, has been linked to a gene that's responsible for regulating the aging process in the human body.
Celgene has received the stamp of approval from the European Commission for its oral medication pomalidomide, in combination with the steroid dexamethasone, for the treatment of relapsed and refractory multiple myeloma in patients who have received previous therapies.
Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.
Known for its audacious deals with biotech startups, Celgene forked over $100 million to gain an exclusive option to buy Acetylon Pharmaceuticals. Boston-based Acetylon's most advanced drug candidate is in a Phase Ib clinical trial for multiple myeloma, a blood cancer of strategic importance to Celgene.
Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.
Later this year, the Multiple Myeloma Research Foundation and genomic software startup GenoSpace plan to launch a massive data project, called the CoMMpass study, which will follow 1,000 multiple myeloma patients over a 5-year period to help scientists understand the molecular changes underpinning the progression of the disease.