Plenaxis was approved in Nov 2003 to control testosterone flareups from LHRH agonist therapy, but the conditions of its approval were so stringent and required so much rigorous physician education that the indication was severely limited. Not to mention it was difficult for physicians to be reimbursed for their efforts. I think in its 18 months on the market it didn't even come close to $10 million in sales.
I was in the stock and sold the day after approval...I was thinking at the time that it might to $30 to 50 million in its second year. PRCS only wishes it could have been that successful.
drugs like lupron give a testosterone surge which is the opposite effect that you want to give a person with prostate cancer
the problem was that in rare occasions (a couple of people in the trials got a life threatening infection. I don't know what kind of infection though.
The company doesn't know what caused the infection so there was no way to figure out who shouldn't get the drug. The risk benefit was then a rare chance to die versus avoiding the testosterone surge.