Jim Shrine

Bristol-Myers Squibb Co. will manufacture and market LidakPharmaceuticals' oral herpes treatment under a licensing agreementannounced Friday.

Bristol-Myers Squibb has rights to the product, topical Lidakol, forherpes simplex virus 1 in North America and much of the rest of theworld excluding Europe and Japan, where Lidak already haslicensing agreements. Lidak has completed four Phase III studies,three of which still are being analyzed.

Lidak, of La Jolla, Calif., received an up-front licensing fee and canget more in milestones tied to certain events before product approvaland commercialization. Bristol-Myers Squibb also will paydevelopment costs going forward and a royalty on product sales.Specific terms were not disclosed.

Part of the license agreement calls for the companies to jointlyexecute the final stages of product development, including thesubmission of a new drug application (NDA) that's expected laterthis year. Lidak retains rights to Lidakol (n-docosanol 10 percentcream) for genital herpes and all other non-oral herpes indications.Bristol-Myers Squibb has a rights of first offer to other Lidakol uses.

Three Phase III studies of Lidakol in the U.S. and Canada recentlywere completed. Two of the studies evaluated the product in earlystages of oral herpes; the other in late-stage episodes. Data analysisfrom those studies is expected by the end of March.

Last September Lidak reported that its Phase III study in Europeshowed that Lidakol had comparable activity to Zovirax (acyclovir) 5percent cream, London-based Glaxo Wellcome plc's product that'sapproved in Europe. The company didn't release further details fromthat study. (See BioWorld Today, Set. 28, 1995, p. 1.)

Michael Lorber, vice president and chief financial officer at Lidak,said Bristol-Myers Squibb, of New York, has seen the European databut not those from North America.

"It's a high priority for both companies," Lorber said. "We'll workon getting the NDA approved so we can start generating revenues."

The active ingredient in Lidakol is n-docosanol, a long-chain fattyacid, that Lidak believes works by interfering with the normal processin which the viral cell enters the target cell, Lorber said. "The normalentry process is interrupted by the n-docosanol and rendered unableto effectively replicate inside the cell. It is distinct from the moretraditional antivirals, like the nucleoside analogues."

Lidak's stock (NASDAQ:LDAKA) gained 9 percent, or 50 cents,Friday to close at $6.13. n

(c) 1997 American Health Consultants. All rights reserved.