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Executive Summary

PRAXIS BIOLOGICS' FRANKLIN TOP, MD, WILL BE ACTING CHIEF EXEC, effective Jan. 1, while the company looks for a permanent successor to Praxis' founder David Smith, MD. Smith, who holds nearly 50% of Praxis stock, will continue to serve as chairman of the Rochester, N.Y.-based vaccine manufacturer. He also has held the titles of president and CEO since the founding of Praxis Biologics in 1983. Top joined Praxis in October as senior VP-clinical research and medical and regulatory affairs and he will continue to be responsible for those duties. However, along with the temporary day-to-day leadership of the company, Top also assumes the new title of executive VP. Before joining Praxis, he was director of the Walter Reed Army Institute of Research in Washington, D.C. Praxis said it has begun a search for a permanent successor to Smith as president and chief executive officer. Like other start-up biopharmaceutical firms -- such as Genentech, Cetus, and Biogen -- Praxis is seeking a operations manager while it makes the transition from an R&D firm to a more integrated business. "This is a natural evolution for a young company like Praxis," Smith explained. "We successfully brought one major product to the market, and several other products and technologies are developed to the point where they form the basis of new marketing relationships." Smith said he is going to "give greater time to negotiating license agreements and securing marketing partners" in the U.S. and abroad. Praxis Biologics' Haemophilus b influenza polysaccharide vaccine, introduced in the U.S. in 1985 as b-CAPSA-1, was the first of its kind to be marketed in the U.S. Distributed by Bristol-Myers' Mead Johnson subsidiary, the vaccine generated first year sales of approximately $40 mil. However, an influx of similar competitive products and the decline in the eligible pool of 2-to-5 year olds not vaccinated after the initial launch have had an adverse impact on Praxis' 1987 results. In addition, Praxis announced in October that Bristol-Myers was withdrawing R&D funding for one of three vaccines being developed at Praxis for Bristol. Largely as a result of Bristol-Myers' decision, Praxis reported a net loss of $520,000 in the third quarter (ended Sept. 30) on a 56% decline in revenues to $1.9 mil. Bristol-Myers continues to fund development of a vaccine for respiratory syncytial virus and a conjugate Haemophilus b influenza vaccine and to hold a large equity position (10.6%) in the vaccine manufacturer. Praxis submitted a PLA for the conjugate vaccine in January 1987. However, Connaught's conjugate Hib vaccine will apparently have a head start; FDA approved the product on Dec. 22.

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