As we’ve learned over the past few years, getting a drug approved by the Food and Drug Administration is just half the battle in the biotech sector. Too many biotech companies have relied on the past to dictate the present and have simply assumed that a drug approval would equal success. As we’ve witnessed firsthand, that’s not been the case.
Yesterday I pointed out the failure of KV Pharmaceuticals, whose pre-term-birth drug Makena was priced nearly 100 times higher than the previous combination of drugs given to treat pre-term birth. Just a year later, KV Pharmaceuticals was forced to declare bankruptcy.
This is why, over a three-day period, I’m looking at biotech companies that could really use a helping hand to get their lead drug off the ground. Yesterday, I examined VIVUS, Inc. (NASDAQ:VVUS), looking at how its chronic weight-management drug Qsymia has failed to take off, and why now is the time to find a marketing partner.
Today, I’d like to add a familiar name to the list and discuss why Dendreon Corporation (NASDAQ:DNDN) should be raising the white flag and looking for marketing assistance.
Fighting cancer from within
Dendreon Corporation (NASDAQ:DNDN)’s lead drug is Provenge, an immunotherapy treatment for metastatic castration-resistant prostate cancer. The treatment involves harvesting white blood cells from a prostate cancer patient, introducing them to a protein that activates them to recognize and attack this protein (i.e., the same protein expressed by prostate cancer), and then reinjecting then back into the patient to fight their cancer. In trials, Provenge improved median overall survival to 25.8 months compared to just 21.7 months for the placebo.
With results like that, you’d think it would practically be selling itself. However, a hefty $93,000 price tag, and physician concerns that they won’t be reimbursed, compounded with insurers’ slowness to latch onto the treatment, has caused sales to languish badly.
Perhaps the biggest problem for Dendreon Corporation (NASDAQ:DNDN) now is the explosion of competition in advanced prostate cancer treatments in both the U.S. and in Europe, where Dendreon Corporation (NASDAQ:DNDN) is currently running a trial for Provenge.
A slew of competitors
We’ve had two treatments recently approved by the FDA a full three months ahead of their PDUFA date: Medivation Inc (NASDAQ:MDVN) and Astellas Pharma Inc ‘s Xtandi, and Bayer and Algeta‘s Xofigo. Xtandi improved median overall survival to 18.4 months, compared with just 13.6 months for the placebo in trials while Xofigo’s median overall survival tallied 14 months, compared with 11.2 months for the control arm.