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AVIRON DEVELOPING LIVE INFLUENZA VACCINE IN NASAL SPRAY FORMULATION

Executive Summary

AVIRON DEVELOPING LIVE INFLUENZA VACCINE IN NASAL SPRAY FORMULATION with the goal of producing a product that is more effective and as safe as the currently available injections. The Burlingame, Calif.-based start-up company is "developing a system for generating live attenuated vaccines every year" and believes the nasal spray formulation may offer better efficacy because it is administered at the point of entry of the virus, the company said. Aviron expects to begin preclinical studies of the influenza vaccine in 1994 and projects human studies will be under way by 1996. Another potential advantage of the nasal spray is that children, who often require two doses of a vaccine, may be more likely to be vaccinated than they are now, the company said. Adults would receive a single dose each year, administered by a physician. Aviron has acquired a patent issued in 1992 to one of its co- founders, Peter Palese, PhD, 11 which protects creation of any genetically engineered virus," a company backgrounder notes. Separately, Aviron hopes to generate near-term revenues by applying its "unique capability to engineer influenza virus" to improve production of the current inactivated vaccine. Although the company does not have any licensing or collaborative agreements, it is in the process of presenting its programs to the major vaccine manufacturers. Aviron raised $15 mil. in a private round of venture financing in September, the company announced Nov. 30. The initial seed funding in July 1992 totaled $2.5 mil. Investors in the latest financing include Institutional Venture Partners, Accel Partners, Abingworth Management Limited, ARCH Venture Fund, BEA Associates, Brinson Partners and Advent International. The company was founded in April 1992 by Chairman and CEO Leighton Read, MD, who also co-founded Affymax. President and Chief Operating Officer Francis Cano, PhD, joined Aviron in 1993 from Lederle Praxis Biologics, where he spent 20 years, most recently as VP and general manager. The three other Aviron co-founders are Palese, chairman of the microbiology department at Mount Sinai School of Medicine; Richard Whitley, NM, University of Alabama School of Medicine professor of pediatrics, microbiology and medicine and chairman of the National Institutes of Health Data Monitoring and Safety Committee for AIDS therapy; and Bernard Roizman, a University of Chicago professor whose primary focus is the molecular biology of herpes simplex viruses. Preclinical studies of a herpes simplex virus-type 2 live vaccine are anticipated to begin in 1994, with human trials slated for 1996. Aviron hopes to create a live vaccine that can be used in all uninfected children and young adults; and additional HSV- 1/HSV-2 bivalent vaccine would be used in all pre-adolescents. The HSV program is based on research by Roizman, who has "recently discovered a protein made by herpes simplex virus which is essential for its replication in nerve cells." When a deletion is engineered into the gene encoding this protein, the virus is attenuated and it cannot produce the recurrent infections which are so troubling, according to the company backgrounder. The three other R&D programs under way are focused on live vaccines for respiratory syncytial virus, cytomegalovirus and varicella zoster virus. Aviron has 35 employees, 14 of whom are PhDs. The company has a 15,000 square foot office and lab complex near San Francisco.

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