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

To: John McCarthy who wrote (621)	12/20/1997 8:40:00 AM
From: Lee	Respond to of 887

* An analyst said DEPO will bounce back to $6 or 7 in short term. * DepoTech is also testing two other compounds, DepoMorphine in Phase II trials for pain and DepoAmikacin, expected to begin a Phase II trial early next year as an anti-bacterial agent. In detail: Friday December 19, 1:44 pm Eastern Time DepoTech collapses on Depocyt drug setback NEW YORK, Dec 19 (Reuters) - Shares of DepoTech Corp collapsed Friday, a day after a federal advisory panel unexpectedly voted against recommending approval of the drug-delivery company's lead product, Depocyt, an experimental treatment for neoplastic meningitis. Shares plunged 9-3/8 to 3-5/8, or 72 percent, in morning trade. ''The extent of the fall is a little drastic,'' said Mary Ann Gray, a drug analyst at SBC Warburg Dillon Read, who cut DepoTech to outperform from buy on the heels of the decision by the panel of the U.S. Food and Drug Administration. ''The extent of the fall is a little drastic,'' said Mary Ann Gray, a drug analyst at SBC Warburg Dillon Read, who cut DepoTech to outperform from buy on the heels of the decision by the panel of the U.S. Food and Drug Administration. The panel late Thursday said it found DepoCyt showed worse side effects with no indication of greater efficacy than the generic drug methotrexate, which is the current therapy for treating neoplastic meningitis. The disease is a cancer of the lining of the brain and spinal cord that results from other cancers. The panel said the San Diego company's one trial of 61 patients with solid tumors was not persuasive. Eight of 31 DepoCyt patients and six of 30 methotrexate patients had no worsening of disease, one FDA reviewer said, a statistically insignificant difference. -- POSSIBLE LOST DATA -- \000 "There's still a chance DepoCyt will be approved," Gray said, adding the company continues to test it in patients whose meningitis arose from solid tumors and in Phase III trials with patients whose meningitis arose from lymphoma and leukemia. ''I think launch of the drug will probably be delayed a year,'' she said, with additional data on solid-tumor patients and on lymphoma patients expected to arrive in the second half of 1998 and be added to the FDA marketing application. Gray said she believed the stock would bounce to ''about $6 or $7 (a share) in the short-term and then stay there until mid-1998 when we see new data.'' Gray said it was difficult to demonstrate efficacy in the solid-tumor group because it consisted of a relatively small number of patients with just months to live. ''In fact, the FDA agreed ahead of time it was not necessary to prove statistical significance in the group because they were really sick and there aren't enough patients with the condition to have a very large trial,'' Gray said. She added the FDA panel indicated it would be easier to evaluate the drug in less-sick patients whose meningitis arose from lymphoma and leukemia, and that good results with them would buttress support for the solid tumor indication. Shares of Chiron Corp (Nasdaq:CHIR - news), the company's U.S. marketing partner for DepoCyt, were off 9/16 to 17-9/16. Its international marketing partner for the drug is Pharmacia & Upjohn (PNU.ST) (NYSE:PNU - news), whose shares were down 5/8 to 35-5/8 on the New York Stock Exchange. DepoTech is also testing two other compounds, DepoMorphine in Phase II trials for pain and DepoAmikacin, expected to begin a Phase II trial early next year as an anti-bacterial agent. The company's proprietary technology, designed for sustained release activity, encapsulates drugs in lipid-based foam particles that allow less frequent injections. I havn't read it on this thread. If it's repeated please forgive me. Regards, Lee

To: John McCarthy who wrote (621)	12/20/1997 10:10:00 AM
From: chirodoc	Read Replies (2) \| Respond to of 887

(UPDATE) DepoTech Shares Plummet After FDA Panel Rejects AntiCancer Drug ..here is the full text of the article .......i think that selling at $4 does not make a lot of sense to me--yes, getting out at 6-7 is a happier scenario. but it may be too late to sell in the short term. .......... the stock will be dead money for a year--but then with the aisan contagion many stocks may be dead money. i am going to hold for a while and try to recoup some more losses.yes, i may need to wait till next summer! .........good luck to all sufferers Dow Jones Online News, Friday, December 19, 1997 at 14:18 EMERYVILLE, Calif. -(Dow Jones)- Shares of drug-delivery concern DepoTech Corp. plunged about 70% Friday after a Food and Drug Administration advisory panel wouldn't recommend approval for the company's cancer drug DepoCyt. DepoTech said it was disappointed by the panel's decision Thursday. The panel said clinical trials weren't sufficient to prove the drug's effectiveness. The company said it will review the results of its studies and trials with the FDA. DepoTech, based in San Diego, developed DepoCyt with Chiron Corp. (CHIR), the world's second-largest biotechnology company. In afternoon trading, Nasdaq-listed shares of DepoTech (DEPO) were down $9.25, or 71%, at $3.813 in heavy trading. Shares of Chiron (CHIR) were down 56.3 cents, or 3.1%, at $17.563. DepoCyt is an injectable sustained-release version of the chemotherapeutic agent cytarabine, which is used to treat patients with neoplastic meningitis resulting from cancerous tumors. The drug is based on DepoTech's proprietary DepoFoam technology. DepoFoam particles - which encapsulate specific drugs - carry drugs into a patient's system through injection. The capsules are nontoxic and biodegradable, and generally well-tolerated by patients. Analysts had predicted U.S. sales of the drug could have reached $100 million, with international sales adding another $50 million annually. "I think it's somewhat of an overreaction," said Mary Ann Gray, analyst at SBC Warburg Dillon Read & Co., of the stock selloff. "Clearly, the FDA panel rulling was a negative, but I think that this by no means calls into question their underlying technology." Despite the negative news and her own lowered earnings estimates and investment rating on the stock, Gray said she thinks DepoCyt will eventually be approved. She projected U.S. approval may take a year or more. Edward Erickson, DepoTech president and chief executive, said that, while the company planned to take steps toward future FDA approval, it was too early to say when that nod might come. Gray predicted the stock would trade well off its highs until DepoTech releases more trial information on DepoCyt and other drugs in its development pipeline. A final decision on DepoCyt will be made by the full FDA. The agency generally follows the recommendation of its advisory panels, although it isn't required to do so. FDA panelist Derrek Raghavan said he was unable to vote in favor of DepoTech's application because the number of those studied in the trial was too small. However, Raghavan said DepoCyt may be an effective second-line therapy for neoplastic meningitis because it appears to be as effective as methotrexate, which is currently widely used. However, DepoCyt appears to be more toxic. Kim Margolin, another FDA panel member, also said the DepoTech's study wasn't large enough for her to form an accurate opinion, and she said the company should have performed some type of confirmatory study. The panel generally agreed that it could revisit the data once DepoTech submits additional clinical data from clinical studies testing DepoCyt in lymphoma and leukemia patients. Copyright (c) 1997 Dow Jones & Company, Inc. All Rights Reserved.

To: John McCarthy who wrote (621)	12/20/1997 6:30:00 PM
From: Andrew H	Respond to of 887

Yeah, biao's post cleared it up for me as well. Its an unfortunate situation, John. I would want to hear more info from the company before I bought this stock even at these low prices. Like were there really communication difficulties between the FDA and the ODAC committee? Why was the company not aware that the patients they considered inevaluable would be considered evaluable by the comittee? Etc. The company should have been fully aware of these things, especially since they had such a small sample size in their treatment group. To me it looks like more than a simple "failure to communicate." It looks like management incompetence. I would hesitate to invest in a company whose management I did not respect at any price.