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Tuesday January 28 1:03 PM EST
ImmuLogic( Immulogic Pharmaceutical Corp )sees ragweed drug approval in '98
By Leslie Gevirtz
WALTHAM, Mass., Jan 28 (Reuter) - The head of ImmuLogic Pharmaceutical Corp told analysts on Tuesday that after another successful trial of the biotech firm's ragweed product he expects U.S. Food and Drug Adminstration approval in 1998.
Acting President and Chief Executive Officer Dr. Joseph Marr said the 1996 placebo-controlled, double-blind trial involving 500 people "validates the technology, validates the science" of the Allervax product line.
Another Phase II/III trial of Allervax Ragweed that will mimic the 1996 trial as much as possible is expected to be conducted this summer and fall, Marr said. With those results in hand, he said he expects FDA approval in 1998 and "to bring this product on line in 1999."
The FDA has not yet seen the 1996 trial results, he said.
The 1996 trial's result "enhances our opportunities for partnership...it validates the technology and that should make us more attractive to companies looking down stream two, three, four years," he said, adding the Waltham-based firm will be meeting with firms late in February.
ImmuLogic, whose previous partnership with Marion Merrell Dow Inc ended last spring after that firm's merger with Hoechst AG HFAG.F , is now actively looking for a partner for its Allervax line "of a moderate size with enough of a cash flow and a good sales force," Marr said.
In the Allervax ragweed trial, patients who were given eight doses of 250 micrograms each administered over a two-and-a-half week period appeared to have the most success and relief from ragweed symptoms, Marr said. The formal results have not yet been presented to the FDA.
Those who received the 250 microgram dose injections experienced 31 percent fewer symptoms than those who received no drugs and 17 percent fewer symptoms than those who were in the placebo group and believed they were getting the drug, Marr said.
The treatment also cut down on patients' use of medication during the six-to-eight week ragweed season. Those on the 250 microgram dose reported their use of antihistamines during the fall season was cut in half in comparison with those who did not receive any treatment. In comparison with those in the placebo group, antihistamine use was down 39 percent.
Marr said ImmuLogic will spend $20 million on trials for the company's ragweed and cat allegry products as well as its multiple sclerosis treatment and cocaine addiction vaccine during the coming year. The company has enough cash on hand to fund the expenses and does not expect to go back to the market this year, he said.
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