LONDON - Peptide Therapeutics Group plc, which is in discussions to be taken over, announced positive results in a pivotal U.S. Phase III trial of Arilvax, a live attenuated yellow fever vaccine.

Nick Higgins, commercial director, told BioWorld International this would lead to the submission of a biologics license application before the end of 2000. "Assuming the FDA takes 12 months, we will get in on the market by the end of 2001."

Peptide intends to market the vaccine directly to U.S. travel clinics, and Higgins said the company soon will begin to recruit a small marketing team of three or four people. "The market for the vaccine is very underdeveloped, with only 12 percent of travelers going to yellow fever areas bothering to get vaccinated."

Although Peptide's estimate of the market at US$25 million may seem small in pharmaceutical company terms, Higgins said, "It is big for us." The company retrenched in September 1999 to cut cash burn, and has promised investors it will not be asking for any more money. "In terms of our commercial prospects, these results mean we are on track to start to offset cash burn. This is the opening to making us self-sufficient."

The talks about a possible takeover, announced in April, are "still ongoing," and Higgins said he could make no comment on their progress.

In the trial in 1,440 healthy volunteers, Arilvax was shown to be safe and immunogenic, and to be "non-inferior" to the only other yellow fever vaccine, YF-VAX, manufactured by Aventis Pasteur, of Swiftwater, Pa. Arilvax can be stored under conventional refrigeration and has a two-year shelf life, giving it some advantages over YF-VAX, which is shipped on dry ice and has a shelf life of one year. Higgins could not say if Arilvax will have a price advantage.

Peptide, based in Cambridge, UK, licensed the U.S. rights to Arilvax from the UK company Medeva plc, which recently was acquired by Celltech Chiroscience plc. The vaccine already is on the market in Europe. It is manufactured at Medeva's plant in Liverpool, which Celltech is in the process of selling. Higgins said this sale was not expected to affect supplies.