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OCLASSEN’s FIAU ORAL HEPATITIS B TREATMENT NDA FILING IS EXPECTED IN 1995

Executive Summary

OCLASSEN's FIAU ORAL HEPATITIS B TREATMENT NDA FILING IS EXPECTED IN 1995, the San Rafael, Calif.-based specialty pharmaceutical developer and marketer says. The antiviral FIAU (fialuridine) is in Phase II trials in the U.S. as an oral therapy for hepatitis B. Lilly recently gained development and marketing rights to the drug outside the U.S. Under that licensing agreement, Oclassen retains domestic rights and will copromote the drug with Lilly in the U.S. Lilly will pay all development costs. Oclassen will receive milestone and royalty payments. As part of the licensing agreement with Oclassen, Lilly has obtained a 7% stake in the closely-held company through a $7.5 mil. equity investment at $12 per share. There are an estimated 50,000-100,000 people with chronic active hepatitis B in the U.S. and roughly 3 mil. people are infected worldwide. Worldwide, an estimated 1-2 mil. deaths annually are related to hepatitis B infections, Lilly noted. Asia has a particularly high percentage of cases. FDA recently granted FIAU orphan drug status. Phase II trials of oral fialuridine in HIV-infected patients that were begun last year are currently in follow-up. Dosing in non-HIV-infected subjects is expected to be completed in about one month. Oclassen was granted an exclusive development and marketing license for FIAU by Memorial Sloan-Kettering Cancer Center. If approved, FIAU would be the first oral treatment for hepatitis B infections, both domestically and internationally. The first approved hepatitis B treatment -- Schering-Plough's injectable Intron A -- was cleared by FDA on July 13 as a treatment for chronic hepatitis B infection in adults ("The Pink Sheet" July 20, T&G-2). The deal with Eli Lilly is Oclassen's first outlicensing agreement. Oclassen retains the rights to FIAU for indications other than the treatment of hepatitis B and is looking at a possible application of FIAU as a topical treatment for the symptoms of genital herpes and shingles. Oclassen has a copromotion agreement with Burroughs Wellcome for Oclassen's Condylox (podofilox .5% topical) genital wart treatment ("The Pink Sheet" March 11, 1991, T&G-11). Oclassen also has an ongoing agreement under which Neutrogena will develop and market any OTC dermatologicals that are generated from Oclassen's research. Under the 1991 agreement, Burroughs is detailing Condylox for three years. Oclassen also markets the chlamydia treatment Monodox (doxycycline).
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