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Anacor Pharmaceuticals, Inc.’s (ANAC - Snapshot Report) pipeline includes several topical candidates including an anti-fungal onychomycosis candidate, tavaborole (AN2690). In Jul 2013, Anacor submitted a New Drug Application (NDA) for tavaborole to the U.S. Food and Drug Administration (FDA) for the prevention of onychomycosis. The U.S. FDA accepted Anacor’s NDA.

With the FDA accepting the NDA, a response regarding tavaborole should be out by Jul 29, 2014.

The NDA filing was based on two phase III studies on tavaborole in the onychomycosis indication, namely, 301 and 302. These studies were conducted under the FDA’s Special Protocol Assessment (SPA) program.

Study 301 met both the primary and secondary endpoints. The primary endpoint included the achievement of “complete cure” (6.5% of patients in the tavaborole arm compared to 0.5% in the vehicle-treated arm).

Secondary endpoints included the achievement of a "completely clear" or “almost clear" nail (26.1% of patients in the tavaborole arm compared to 9.3% in the vehicle-treated arm), achievement of mycological cure (31.1% of patients in the tavaborole arm compared to 7.2% in the vehicle-treated arm) and the achievement of "completely clear" or "almost clear" nail with mycological cure (15.3% of patients in the tavaborole arm compared to 1.5% in the vehicle-treated arm).

The 302 Study also met both the primary and secondary endpoints. The primary endpoint included the achievement of “complete cure” (9.1% of patients in the tavaborole arm compared to 1.5% in the vehicle-treated arm).

Secondary endpoints included the achievement of a "completely clear" or “almost clear" nail (27.5% of patients in the tavaborole arm compared to 14.6% in the vehicle-treated arm), achievement of mycological cure (35.9% of patients in the tavaborole arm compared to 12.2% in the vehicle-treated arm) and the achievement of "completely clear" or "almost clear" nail with mycological cure (17.9% of patients in the tavaborole arm compared to 3.9% in the vehicle-treated arm).

Our Take

We are encouraged by the progress of Anacor’s tavaborole. We note that Valeant Pharmaceuticals (VRX - Snapshot Report) is also looking to enter the market with its onychomycosis candidate, IDP-108 (efinaconazole). IDP-108 received a complete response letter (CRL) from the FDA in May this year.

Anacor currently carries a Zacks Rank #3 (Hold). Currently, companies like Jazz Pharmaceuticals Ltd. (JAZZ - Analyst Report) and Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).

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