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MARSAM HAS 30 ANDAS PENDING AT FDA

Executive Summary

MARSAM HAS 30 ANDAS PENDING AT FDA, company President Marvin Samson told analysts at an Alex. Brown & Sons healthcare conference in Baltimore May 11. "Presently, we have about 30 applications pending," Samson said, "and we have about 18 other products under development." Samson noted, however, that Marsam has received no ANDA approvals this year. He attributed the delay to the ongoing grand jury and congressional investigations into charges of favoritism in the FDA generic drug division: "One thing that is probably hurting the industry right now is the general slow down in Rockville. Because of the investigations, because of what's going on right now. We thought we'd have by this time maybe eight or nine approvals this year. We haven't received one this year." Despite the setback in generic approvals so far in 1989, the company has received a growing number of ANDA approvals over the past few years. "In 1986 we received one FDA approval. In 1987 we received two [and] in 1988 we received 14," Samson explained. In a discussion of the company's niche market strategy, Samson said: "Many people thought we were crazy for building a penicillin plant because penicillins" are 40 years old. "But in the penicillin injectable business," he continued, "there are no other generic companies." On the company's outlook for 1989, the Marsam exec commented: "I'm fairly confident that we will be profitable this year." He reported first quarter sales of $884,000. "We're really on the right track, Samson noted. "We're shooting for a 10% net, but it is very, very hard to judge right now." Bolar and Agvar each hold a 25% equity position in the company. When Marsam went public in February 1987, Squibb bought warrants in Marsam at $17.25 per share, or 115% of the initial public offering price of $15.00. The warrants, which would give Squibb 10% ownership of Marsam, are exercisable for two years after Feb 1, 1989. In a recent filing with SEC, Squibb said it does not intend to exercise the warrants unless the market price is higher than the exercise price. Marsam closed at 18-1/2 on May 26.
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