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, 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 (NASDAQ: DNDN) should be raising the white flag and looking for marketing assistance.
Fighting cancer from within
Dendreon'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 now is the explosion of competition in advanced prostate cancer treatments in both the U.S. and in Europe, where Dendreon 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 (MDVN +0.00%) and Astella Pharma'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.
In addition to these hot new medications are Johnson & Johnson's (JNJ +0.29%) Zytiga and Sanofi's (SNY 0.51%) Jevtana. In December, the FDA expanded Zytiga's indications to treat late-stage prostate cancer before chemotherapy. In trials, it helped add better than five months to the median overall survival relative to the placebo. Sanofi's Jevtana -- which ironically also got FDA approval three months early in 2010 -- was approved in combination with prednisone and extended overall survival by nearly three months.
It isn't difficult to see why Provenge is having a hard time gaining any market share, when the competition is mounting and the cost of its immunotherapy treatment is higher than all of its peers. This is why Dendreon needs to swallow its pride and seek out a marketing partner now.
Dendreon's likely partner
While it's purely speculation on my part, I believe the most likely marketing partner would be one of Europe's premier cancer-fighting companies, Roche (RHHBY 0.90%).
To begin with, Roche was unsuccessful in its attempt in to get Avastin approved to treat prostate cancer some years back. Not only did it fail to meet its primary endpoint of improving overall survival in combination with prednisone, but some of the adverse effects were also fatal. Forging a marketing partnership with Dendreon would allow Roche an opportunity to make a difference in one of the very few cancer types it doesn't currently have a foothold in.
Another intriguing aspect is that Roche currently has a PD-1 inhibitor in very early studies known as MPDL3280A that it plans to detail further at the American Society of Clinical Oncology meeting later this week. This inhibitor is an immunotherapy drug that, like Provenge, teaches the body's immune system to help it fight solid tumors better. Helping Dendreon market Provenge could be another way for Roche to beef up its immunotherapy portfolio.
Stay tuned as tomorrow I'll reveal my third and final biotech company that would benefit greatly from finding a marketing partner.
