Anacor Pharmaceuticals Completes Enrollment in First of Two Phase 3 Trials of AN2690 for Onychomycosis

Tavaborole granted as generic name for AN2690

PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has completed enrollment in the first of two Phase 3 trials of tavaborole (formerly known as AN2690), a topical anti-fungal product candidate for the treatment of onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

"We have completed enrollment of approximately 600 patients in the first of two Phase 3 trials for tavaborole. We expect to complete enrollment in our second Phase 3 trial by year-end 2011," said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. "We believe that tavaborole can potentially offer significant improvements over the current standards of care for onychomycosis by combining the safety of a topical drug with significant efficacy. We anticipate top-line data from the first trial around year-end 2012."

The tavaborole Phase 3 program consists of two double-blind, vehicle-controlled trials with two-to-one randomization between tavaborole and vehicle (the topical formulation without the active ingredient). The tavaborole Phase 3 treatment regimen involves once-daily dosing for 48 weeks. The primary efficacy endpoint is a complete cure of the great toenail at week 52 as agreed upon under a Special Protocol Assessment with the FDA. Complete cure is a composite endpoint which requires both a mycologic cure and a completely clear nail. The length of the trial is determined primarily by the typical length of time that is required for new, clear nail to grow out to replace the diseased nail.

Tavaborole granted as generic name for AN2690

Anacor also announced that the United States Adopted Name (USAN) Council has granted tavaborole as the generic name for AN2690. The USAN Council serves health professions of the United States by selecting simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.

About Anacor Pharmaceuticals

Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered five compounds that are currently in clinical development, including its three lead programs: tavaborole, a topical antifungal for the treatment of onychomycosis; AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis; and GSK 2251052, or GSK ‘052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies' research and development agreement. In addition, Anacor is developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. For more information visit http://www.anacor.com.

Forward-Looking Statements

This press release may contain forward-looking statements that relate to future events including the development and commercialization of AN2690, and more specifically, the enrollment and conduct of the AN2690 Phase 3 programs. These forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements, including risks related to enrollment and successful completion of our trials, risk of unforeseen side effects and risks related to regulatory approval of new drug candidates. These statements reflect the views of Anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Anacor Pharmaceuticals
DeDe Sheel, 650-543-7575
Director, Investor Relations and Corporate Communications

Source: Anacor Pharmaceuticals

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