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GEN News Highlights : Feb 12, 2010

Merck & Co. Passes Late-Stage Onychomycosis Therapy Back to Anacor

Anacor will start Phase III trials once transfer is complete but will evaluate new partnering options.

Merck & Co. is giving up its worldwide development and commercialization license to Anacor Pharmaceuticals’ onychomycosis candidate, AN2690. The drug is poised to start in Phase III trials, and Anacor says that it will initiate the late-stage studies as soon as the process of passing back the AN2690 program has been completed. The firm will also investigate new partnering opportunities for the drug.

Merck says that the decision to give up AN2690 resulted from a reassessment of its pipeline as a result of its $41.1 billion merger with Schering-Plough, which was completed in November 2009. “We are conducting a comprehensive and rigorous prioritization of our newly combined pipeline,” comments David Nicholson, svp and head of worldwide licensing and knowledge management at Merck. “This process has required us to make some challenging decisions.”

AN2690 is a topical antifungal drug that Anacor claims works by inhibiting a validated drug target in a novel manner. It was identified utilizing the company’s small molecule, boron-based chemistry platform.

The worldwide development and commercialization deal for AN2690 was originally signed with Schering-Plough in 2007. The agreement was worth $50 million up front and $10 million in financing to Anacor. Schering-Plough took on the responsibility for all costs associated with AN2690’s development for onychomycosis and other indications. Anacor retained an option to co-promote the drug to dermatologists in the U.S. and was eligible to receive regulatory and commercial milestones payments potentially exceeding $575 million. 

Anacor’s boron-based chemistry platform is being exploited for the discovery and development of drugs primarily for the treatment of fungal, inflammatory, and bacterial diseases. Clinical-stage candidates include topical antifungals against skin and onychomycosis infections. The company has also progressed a number of topical anti-inflammatories against psoriasis and atopic dermatitis into Phase II trials.

Anacor is separately developing a series of systemic anti-infectives in collaboration with GlaxoSmithKline. The deal covers the discovery, development, and worldwide commercialization of boron-based systemic therapeutics for up to four targets. One of these will target HCV, and the others will be antibiotic candidates.

Under the terms of the 2007 agreement, Anacor received $12 million up front and a $10 million equity financing commitment from GSK. Anacor retains responsibility for the development of products through clinical proof of concept, at which point GSK will have an exclusive option to license each compound for further development and commercialization on a worldwide basis. Phase I trials with the lead candidate, AN3365, were initiated in November 2009 in patients with hospital infections caused by Gram-negative bacteria.