ByJames Etheridge

BioWorld International Correspondent

PARIS - BioChem Pharma, of Laval, Quebec, has signed a worldwide development, production and marketing agreement with SmithKline Beecham plc, of London, for an influenza vaccine using the nasal delivery system of the French company Biovector Therapeutics.

Under the agreement, which confirms a letter of intent concluded between the two companies in June, SmithKline Beecham Biologicals, of Rixensart, Belgium, will manufacture the vaccine for all countries except Canada, and will market it in all regions of the world outside North America. BioChem will manufacture and market the product in Canada, while the two companies will be jointly responsible for its marketing and distribution in the U.S.

Phase I trials of a BioChem trivalent vaccine using the Biovector Light nasal delivery system were successfully completed in October, validating Biovector's delivery technology, and Phase II trials are planned for 1999. However, Biovector's communications manager, Nathalie Galsomies, told BioWorld International that fresh Phase I trials might have to be conducted to test a new form of the vaccine using antigens produced from cellular strains, since the trials conducted this year used antigens cultured on eggs in the traditional way. Antigens cultured on cells are of higher quality and can be produced more rapidly, so they are more suited to responding to emergencies such as an influenza epidemic.

First Product Not Due Until 2003

According to Galsomies, the first product arising from the collaboration among Biovector, BioChem and Smith Kline will not reach the market before 2003 or 2005. Under the development agreement signed between Biovector and BioChem in April, the two companies are co-developing six vaccines utilizing the French company's delivery systems.

The other pathologies being targeted by Biovector are cancer, certain infectious diseases, meningitis, hemophilia and AIDS. Two therapeutic vaccines for cancer are due to enter Phase I trials in 1999. One, for the treatment of lymphoma, is to be conducted in the U.S. by an American company under license from Biovector, while the other will be carried out at the Institut Gustave Roussy, in Villejuif, near Paris, Europe's leading cancer clinic. Biovector has four other products in preclinical development: a preventive vaccine for meningitis; an anti-cytomegalovirus vaccine to treat immunodeficiency in transplant patients and AIDS, pneumonia and hepatitis sufferers; second-generation, DNA-based vaccines against influenza and AIDS; and gene-delivery systems for the treatment of hemophilia. n