By Mary Welch

Talks with regulatory authorities worldwide are still progressing as BioCryst Pharmaceuticals Inc. and partner R.W. Johnson Pharmaceutical Research Institute (RWJPRI) await approval to start Phase III trials for RWJ-270201, a influenza neuraminidase inhibitor drug.

RWJPRI has notified U.S. investigators that FDA discussions are continuing and that it expects to have more information about the timing of U.S. trials in the coming weeks.

"People are reading more into this than is there," said A.K. Schleusner, BioCryst's director of business development. "Our stock is down but J&J's is up. Honestly, there is not much more to say. Discussions are ongoing and we will initiate the trials as soon as plans are finalized. There is not a holdup, even though some may perceive it like that. This is the normal process and people are making a mountain out of a molehill. If there were a delay, we would say it."

BioCryst's stock (NASDAQ:BCRX) closed Friday at $21.625, down $6.75, or 24 percent.

Marc Monseau, RWJPRI's manager of corporate communications, agreed. "Basically what we are saying is that talks are ongoing and we expect to initial Phase III trials during this year's flu season."

He refused to say what, if anything, has prevented approval earlier. BioCryst had expected to start the trials for the 1999-2000 season, which runs from November through April, according to the World Health Organization's definition. Nor would Monseau say how quickly the company could gear up to start a trial once approval is given.

BioCryst is confident it will start Phase III trials during this flu season. "The season is unpredictable," Monseau said. "It hasn't infiltrated all 50 states yet. Plus, we're talking worldwide. So somewhere someone is in the flu season. For South America, it's May through October.

A delay could be costly as competition is keen for a flu drug. Relenza, the influenza therapy marketed by Glaxo Wellcome Inc., a U.S. subsidiary of London-based Glaxo Wellcome plc., has been approved as was Tamiflu (formerly GS4104), developed by Gilead Sciences Inc., of Foster City, Calif., and licensed to Hoffmann-La Roche Inc., of Nutley, N.J. Relenza is designed to stop the function of neuraminidase and limit the course of the disease. It was developed by Melbourne, Australia-based Biota Holdings Ltd., and licensed to Glaxo. It was approved in July. (See BioWorld Today, July 28, 1999, p. 1.)

Tamiflu was approved in October. Relenza and Tamiflu are the only approved drugs that fight both the A and B strains of influenza and reduce the duration of flu symptoms. (See BioWorld Today, Oct. 29, 1999, p. 1.)

BioCryst had stated earlier that it did not expect to be on the market before the 2002 flu season.

"Our timetable is still the same," Schleusner said.

BioCryst, based in Birmingham, Ala., licensed BCX-1812 (nowRWJ-270201) to RWJPRI, and Ortho-McNeil Pharmaceutical Inc., both of Raritan, N.J., and both Johnson & Johnson companies.