Chemex Pharmaceuticals Inc. has announced it will have todelay by a year or more its filing for FDA marketing approvalfor a canker sore treatment that will require additional PhaseII testing.
The Fort Lee, N.J., company (NASDAQ:CHMX) in Marchcompleted Phase II trials of its Amlexanox anti-inflammatoryagent for treatment for apthous ulcers, or canker sores.
Amlexanox was shown to be safe and effective in Phase I andII trials. But the placebo in Phase II was statistically aseffective as Amlexanox when it was used alone, said LenStigliano, vice president of finance. This will necessitateadditional Phase II studies to determine the optimumconcentration and treatment regimen for Amlexanox.
According to Stigliano, the placebo may have acted as a barrierthat covered the canker sore and allowed it to heal faster. Ifthe placebo proves to have some value, it would be developedas an over-the-counter product, he said.
The additional time in the clinic will delay by a year or morethe filing of a new drug application, originally scheduled for thesecond quarter of 1993, he said.
Chemex was given North American dermatological rights toAmlexanox by Takeda of Japan, and rights to the rest of theworld are pending, Stigliano said. The product, an anti-allergic,5-lipoxygenase inhibitor, is marketed in Japan for asthma.
Chemex also said it has filed to begin Phase I trials of its EPCK1topical, non-steroidal anti-inflammatory agent as a treatmentfor contact dermatitis.
EPCK1 links vitamin C, which has anti-inflammatory properties,with vitamin E, which prolongs its life in the skin, saidStigliano. Senju Pharmaceuticals of Japan granted an exclusiveworldwide dermatological license for EPCK1 to a joint venturethat includes Chemex and Block Drug Co. Inc. of Jersey City, N.J.
Under the joint venture agreement, Chemex contributed rightsto several dermatological compounds and will do all of theresearch. Block paid a $2 million initial fee and will do allmanufacturing, marketing and distributing. Chemex willcontribute $7 million and Block will contribute $10 million forresearch and development. Each company will receive half ofthe profits.
Chemex's alliance with Block will help it market Amlexanox if itis approved because Block "has the biggest dental sales force inthe country, and about 60 percent of canker sore sufferers goto their dentist for treatment," Stigliano said.
Chemex shares closed at $2.44, down 13 cents.
-- Kris Herbst BioWorld Washington Bureau
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