INSTITUT MERIEUX HERPES VACCINE CLINICAL TRIALS

Executive Summary

INSTITUT MERIEUX HERPES VACCINE CLINICAL TRIALS are scheduled to begin in France in the next few months, to be followed by an IND application in the U.S., R&D Director Jacques Armand reported at a Prudential-Bache Capital Funding conference Dec. 13-14 in New York. Institut Merieux' herpes vaccine would be "the first live viral vaccine which is designed through molecular techniques," Armand said, adding: "We hope to start clinical trials in a couple of ... months in France and then draw up INDs in the States." Also, the French vaccine/virology company is collaborating with Stanford University researchers and the Centers for Disease Control to develop a gonococcal vaccine based on a peptide approach. Institut Merieux and its 50.7% owned subsidiary Pasteur Vaccins "together own 35% of the [vaccine and blood derivative] market" outside of North America, Jean-Paul Chausseau, PhD, biological products director at Institut Merieux, told the analysts meeting. However, the company's presence in North America is limited to a 1% share of the vaccine market. "This, of course, is very low," Chausseau explained, "and, in fact, correlates with the market of [the company's] rabies vaccine." Last spring, Merieux attempted to improve its market position in North America through an unfriendly takeover of Canada-based Connaught Biosciences. However, Merieux was forced in late April to withdraw its $32 (Canadian) a share bid for Connaught when the Quebec and Ontario Securities Commission blocked the bid ("The Pink Sheet" May 16, T&G-4). Merieux continues to hold a 13% equity stake in Connaught. Asked how Merieux now planned to expand its North American presence, Secretary General Michel Dubois said the firm has committed "to aggressively register our existing products in the States." He continued: "We think they're good products and we think that we will become a significant partner in the U.S. market in the coming years." Commenting on Merieux's chances of capturing the conjugate Haemophilus influenza vaccine market over Connaught, Merck and Praxis, Armand noted that the Merieux vaccine "is immunogenic after just one shot in 50% of the kids receiving" the vaccine. Armand called the immunogenicity of the Connaught vaccine "mediocre" and the Praxis vaccine "so-so." Armand said the company is "very hopeful that this product ...could protect these kids against meningitis after one shot." Outlining the remainder of the company's vaccine pipeline, Armand mentioned a polysaccharide typhoid vaccine the company registered in France in early December, with hopes of marketing the product abroad. In addition, a cholera vaccine is "in the registration phase in France and in some other countries," Armand said. "The beauty of this vaccine," he added, "is that [it] demonstrated cross protection against E. coli infection" for travellers subject to the virus. Institut Merieux is also expanding clinical trials in their second year for an acellular pertussis vaccine. The company plans to begin trials in the United States. Other vaccines in development include a measles/mumps/rubella vaccine, an inactivated polio virus vaccine, and an AIDS vaccine being developed jointly with Cambridge Bioscience. The company is also developing an immunomodulating agent for use in treating AIDS. Merieux's Imuthiol (diethyldithiocarbamate), "is an immunomediating agent which benefits from... the orphan drug status in the States," Armand noted. Citing a recent study published in Nature, Armand asserted that the drug "inhibits evolution of the pre-ARC disease into AIDS."