By Randall Osborne
West Coast Editor
ViroPharma Inc. submitted a new drug application to the FDA for its common-cold treatment Picovir (pleconaril), and is looking for a partner to develop and promote the oral small molecule.
¿Our target is to secure a partner by the end of third quarter,¿ said Kori Beer, director of corporate communications for Exton, Pa.-based ViroPharma. The NDA is a little ahead of schedule, she added.
¿Originally we had it in 2001, and then we pushed it back to before the end of the third quarter,¿¿ she said.
Investors reached for the Kleenex last year when Picovir failed a Phase III trial ¿ news of which sent the firm¿s stock plummeting 68 percent ¿ but in March the company reported positive preliminary data from two more pivotal studies, and full results from those studies are expected this fall at the Interscience Conference on Antimicrobial Agents and Chemotherapy. (See BioWorld Today, April 12, 2000, and March 16, 2001.)
Meanwhile, in February, ViroPharma and Sanofi-Synthelabo, of Paris, revised their licensing agreement for Picovir, which works by entering the picornavirus capsid to stop replication. (See BioWorld Today, Feb. 28, 2001.)
¿We have a very good partnership with Sanofi, and their area of focus is not in the U.S. marketplace,¿ Beer said. ¿They recognize that if we attract a strong partner [in the U.S.], that stands to benefit them as well.¿
The new deal reduced royalty rates for Sanofi-Synthelabo for U.S. and Canadian sales after a co-promotion partner is chosen, and Sanofi pays less in royalties to ViroPharma elsewhere. Also as part of the deal, ViroPharma got strengthened intellectual property rights, and Sanofi agreed to buy 4.6 percent of the firm, or 750,000 shares of common stock, Beer said.
Picovir originally was being tested in viral respiratory infection (VRI), or the common cold, in adults and viral meningitis in adults and children. ¿We knew we had to revisit the [Sanofi] agreement, because it was written with the assumption that we would pursue the meningitis indication first,¿ Beer told BioWorld Today, adding that the meningitis indication is ¿on hold.¿
ViroPharma is asking the FDA for a label prescribing the drug for the treatment of VRI in adults, and ¿in the near term¿ will seek to show Picovir¿s value in treatment of the virus in children, as well as prevention in adults, Beer said.
More than 4,000 patients have been treated with Picovir so far. For the first Phase III problems, the company blamed variability of the patient population. The ¿signal-to-noise [ratio] confounded our ability to determine which patients were benefiting,¿ Beer said.
In the new study, participant requirements were stricter. All patients entering the trial had to have a moderate to severe runny nose ¿ the hallmark cold symptom ¿ and had to limit other treatments to Tylenol and Benylin. No one with allergies was allowed.
ViroPharma has another small-molecule compound, VP 50406, in Phase II testing in hepatitis C, partnered with American Home Products Corp., of Madison, N.J., and VP 14637, also a small-molecule therapeutic for respiratory syncytial virus, has completed Phase I testing, with Phase II trials expected to begin in the second half of this year. That product is not partnered.
The company¿s stock (NASDAQ:VPHM) closed Tuesday at $27.52, down 79 cents.