SmithKline Beecham and Applied Microbiology Inc.(NASDAQ:AMBI) have forged an agreement to jointly developoral care and oral hygiene products using AMBI's anti-microbial agent Ambicin N, the companies announcedThursday.

Under the agreement, SmithKline Beecham (SKB) ofPhiladelphia will incorporate Ambicin N into its oral caredevelopment program, which currently covers toothpastes andmouth rinses. This entails taking any products through clinicaltrials and regulatory hoops, as well as overseeing eventualsales and marketing of approved products.

During product development SKB (NYSE:SBH) has agreed toachieve certain time-related milestones. And AMBI will grantSKB an exclusive worldwide license to use these products forseveral years after market introduction.

"The exclusivity is for a relatively short period of time,"explained Peter Blackburn, AMBI's vice president of scientificaffairs, "but it's well within the terms of the patents" (onAmbicin, the latest of which issued last November and coversthe use of Ambicin to treat conditions of the oral cavity).

The agreement with SKB is not AMBI's first attempt to developoral applications for Ambicin, which is a form of the naturallyoccurring anti-bacterial peptide nisin. Proctor & Gamble Co. inFebruary 1992 decided not to continue a joint developmentproject, and Pfizer Inc. ended an agreement on the product inJune 1991.

The overriding lesson from those agreements was that "theway the peptide is delivered is critical for its performance,"Blackburn told BioWorld. He added that "we had a number ofpreclinical tests that showed efficacy," but preliminary resultsfrom a human trial were less than satisfactory. "We tookAmbicin back in-house and determined some of theparameters for its performance in humans."

In fact, AMBI of New York and SKB have already run somehuman trials on Ambicin, "incorporating new parameters fordelivery ... as well as for trial design and how the productneeds to be used" in double-blinded studies in the UnitedKingdom, Blackburn said.

Those trials have been run by SKB. However, AMBI may getinvolved in the clinical development of its product; if so, SKB"will pick up the costs," explained Blackburn. "There are no setpayments (in this agreement), but there are budget estimates,"he added.

-- Jennifer Van Brunt Senior Editor

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