From an update, an analyst weighs in:
>>Analyst Craig West of A.G. Edwards & Sons said it was unclear what concerns the FDA has, but added he is optimistic the drug will eventually be approved by the agency because it has shown efficacy and safety in clinical trials and Amgen has an excellent track record with the agency.
Plenaxis, which has the chemical name abarelix, is part of a class of drugs called gonadotropin releasing hormone (GnRH) antagonists that are designed to suppress the production of testosterone and other hormones at the beginning of therapy.
Testosterone, the male sexual hormone, is believed to stimulate prostate cancer. But West said rival drugs, such as Lupron and Zoladex, can temporarily boost production of the hormone in the early phases of treatment before slowing it in the long term.
Lupron is made by TAP Pharmaceutical Products Inc., a joint venture between Illinois-based Abbott Laboratories Inc.(NYSE:ABT - news) and Takeda Chemical Industries Ltd. of Japan. Zoladex is made by AstraZeneca Plc.
West said the class of drugs has been known to stimulate histamine, the protein that causes allergic reactions like itchy eyes and runny noses -- although he said the side effect was not a problem in clinical trials conducted by Amgen.
``In the worst-case scenario, the FDA may be concerned about safety and effectiveness of the drug and could ask for Amgen to conduct a new trial,'' West said. He added that the FDA might only need more detailed data about trials already conducted.
West said he expected the drug to have $20 million in sales this year and $125 million in 2002, revenue he has now at least temporarily scratched from his earnings forecast for the drug.<<
snip
I had hedged with calls at $22.5. Just bought 'em back. If we get a big dead cat bounce, I might sell another round. It'll be a couple of months before we know much, I'd guess.
Cheers, Tuck |
