* 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 |
