I received a lot of email about Dendreon ( DNDN) and the decision by Medicare to open a coverage assessment for Provenge, including this email from Yang O. "Hi Adam, I have been a fan of your articles for many years now. Thank you foryour earnest analysis of biotech companies. You saved me from losing too much onjunk science. On your take about Dendreon:"Firstly, one of the concerns is the fact that Medicare might limit the coverage of Provenge. I wonder about that, as the indication that Provenge is approved for is the last hope for prostate cancer patients that have failed all therapies. How is Medicare going to further limit the usage of Provenge? If Provenge is for first-line prostate cancer, then there might be scope of decreasing its first-line usage."Secondly, I read that most prostate cancer doctors are hoping to prescribe Provenge at an earlier prostate cancer stage with the hope of ensuring better response. Could the enquiries to Medicare for earlier usage of Provenge be the cause of Medicare's coverageanalysis?" Before I get to the meat of Yang's question, let me correct a misperception. The FDA approved Provenge for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer. That's a mouthful, but described more simply, doctors will use Provenge to treat patients with prostate cancer that no longer responds to hormone therapy -- before the use of chemotherapy drugs like Taxotere and the newly approved Jevtana. Provenge will not be used, therefore, in patients who have failed all other therapies, as Yang states. It will be used well before that, which is a big reason why estimates of Provenge's peak commercial potential are measured in billions of dollars. If Medicare decides to limit or restrict Provenge coverage, the agency will likely only do so by requiring doctors to adhere strictly to the drug's label when choosing patients for Provenge treatment. This would dampen doctors' ability to treat prostate cancer patients with earlier stages of the disease; it would also remove from treatment consideration patients with "symptomatic" disease, generally defined as patients who require narcotics to treat pain associated with the spread of prostate cancer to bone.
Abe emails, "Any thoughts on ImmunoGen ( IMGN - Get Report) on the Roche FDA filing?" Roche announced Wednesday that Trastuzumab-DM1 (T-DM1) was filed for FDA approval as a treatment for women with Her-2 positive breast cancer previously treated with multiple therapies. T-DM1, for those not aware, combines Roche's already-approved breast cancer monoclonal antibody Herceptin linked to a toxic chemotherapy payload developed by ImmunoGen. Roche had previously stated its intent to file T-DM1 with the FDA in the middle of the year, so Wednesday's submission hits that target. I don't know the exact filing date, but assume it was sometime this week, which means that the FDA approval decision should come during the week of January 3, 2011. That represents a six-month FDA review cycle, fairly standard for cancer drugs. I've long been a fan of ImmunoGen, but at around $9 a share, ImmunoGen's value bakes in T-DM1's approval, give or take a buck or so for a pop on the approval announcement. (I do think T-DM1 will be approved, although don't be surprised or freaked out to see the FDA schedule an advisory committee meeting before that happens.)
Alex S. writes, " I have quick questions on the upcoming advisory meeting for Vivus (VVUS - Get Report). Do you anticipate the outcome of the meeting to have an impact on Arena Pharmaceuticals (ARNA - Get Report) and Orexigen Therapeutics (OREX)? Do you think the three
Dave D. comments on my story poking holes in MELA Sciences and its skin cancer detection device MELAFind. "I'm not familiar with MELA Sciences, but it looks like you think the capitalraising could suggest problems with approval. Do companies know if there are issues with the upcoming advisory committee reviews? Or is it more that they know their approval submissions are iffy? Is there constant communication (questions from the FDA) during the process that might give the company as idea of where it stands, or is a submit and wait process? Thanks!" Yes, I do think the timing of MELA's financing raises concerns/questions about management's confidence for the FDA approval of MelaFind. Beyond the stock sale, I believe the data generated from MELA's pivotal study of MELAFind also raises doubts about the chances for approval. I laid out the bear thesis on MELA last week.
|More on Biotech 13 Drugs Facing FDA Approval Decisions|