Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: chirodoc who wrote (548)	12/18/1997 6:30:00 PM
From: Cymeed	Read Replies (2) \| Respond to of 887

Question for the Thread: Who will be the losers if DepoCyt is approved ? Insurance company ? (They have to pay more for the longer survival of patients) Other drug companies ?

To: chirodoc who wrote (548)	12/18/1997 7:47:00 PM
From: Andrew H	Respond to of 887

Chirodoc and others, my condolences in regard to this bad news. From the educated opinions I had read on the thread, I had assumed there was no question of approval, so I was extrememly surprised by the news. As an observer who has no position in the company, I have several thoughts about the company and its products. Something is wrong and the stock price tomorrow will reflect it. I would look for a close in the 6-8 area, considering what happened to NRGN. Some of the problems I see are these: 1. worst--the company's leading product has effectively been crushed. DEPO can try more trials but chances are this drug is finished. 2. while the company's technology may still be effective, the high side effect profile and arachnoiditis clouds this issue, so ivestors will be wondering. 3. one must question if the company has been forthright to its investors in presenting the results of the trials. 61 people is a small sample size for a P3. Why were so many investors so sure of efficacy when the FDA saw none? Why did the company apply for approval with such a severe side effect profile and apparent lack of efficacy. Was this not evident in earlier trials. I believe that questions like these will be likely to cause a loss of confidence in the company over and above the failure of the lead product. I hope DEPO management has good answers to these questions. News release below: BETHESDA, Md, Dec 18 (Reuters) - A U.S. Food and Drug Administration advisory panel voted against recommending approval of Chiron Corp's new drug for neoplastic meningitis, saying it found no evidence it worked better than current therapy. The drug, which would have been marketed as Depocyte, was developed by San Diego-based DepoTech(Nasdaq:DEPO - news). The panel voted 7 to 3, with one abstention, that DepoTech's one trial, a 61 patient study, was not enough for approval. ''I don't see anything in this trial that provides any evidence of clinical benefit,'' said Richard Simon of the National Cancer Institute. The panel recommendation seemed to come as a suprise to most analysts, who had expected the vote to be positive. Depocyte, known generically as cytarabine, was tested against neoplastic meningitis, a cancer of the lining of the brain and spinal cord that results from other cancers --in this case from solid tumors. The disease is usually fatal within three months. An FDA reviewer said there was no real difference found in the number of patients who responded to Depocyte or the standard drug tested in the trial, methotrexate. Eight of 31 depocyte patients and 6 of 30 methotrexate patients had no worsening of disease, the reviewer said. ''Depocyte has activity that is not statistically different from methotraxate in patients with solid tumors,'' said FDA reviewer Steve Hirschfeld. The drug, a sustained release injectable, is more convenient than current therapy -- given twice a month instead of twice a week. But it also is known to have more side-effects including headache, backache, fever and neck rigidity leading to a syndrome called chemical arachnoiditis in 69 percent of Depocyte patients. Though the steroid dexamethasome has been found to help lessen symptoms, panelist Sandra Swain questioned using a drug with such toxicity in terminal patients. ''I would not want to have a headache the last three months of my life,'' she said. ''The data say it's approximately equivalent (to methotraxate) but more toxic,'' said Derek Ragavan, a panelist from the Roswell Park Cancer Institute in Buffalo New York. DepoTech is also seeking FDA approval of the drug for neoplastic meningitis resulting from leukemia and lymphoma. Pharmacia and Upjohn(NYSE:PNU - news; PNU.ST) would market DepoCyte outside the United States, Canada and Europe, the company said.