SCHERING's SECOND PENEM (SCH 34343) IS ON SIX-MONTH HOLD
Executive Summary
SCHERING's SECOND PENEM (SCH 34343) IS ON SIX-MONTH HOLD in early clinical testing as the result of "certain recent toxicological findings in animals," Schering-Plough Exec VP Richard Kogan reported during a June 20 session with the Health Care Analysts of New York. Kogan described the antibiotic as "a product clearly superior to all known agents in treating anerobic infections." SCH 34343 entered Phase I trials in May 1984, and reportedly had progressed into Phase II studies before the halt. Kogan told the analysts that Schering is still expecting to file an NDA "in the second half of 1986." Kogan explained the delay: "As of now, we believe this will be a six-month delay. The initial oral penem was dropped from clinical trials in 1983." Closest to the market among the new Schering Rx products is the sedative/hypnotic, quazepam. The NDA for quazepam could be approved late in 1985 or early next year, the firm says. The company describes quazepam as avoiding rebound insomnia and yielding a "more natural sleep cycle"