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Anacor Pharmaceuticals, Inc. (ANAC - Snapshot Report) recently held a pre-NDA (New Drug Application) meeting with the US Food and Drug Administration (FDA) for its anti- fungal onychomycosis candidate, tavaborole (AN2690).

During interactions with the FDA, Anacor came to an agreement regarding the content and format of the proposed NDA for tavaborole. It discussed matters with the regulatory body related to the safety, efficacy, manufacturing and packaging. Anacor intends to seek US approval for the candidate in mid-2013.

In the first quarter of 2013, Anacor announced positive results from two phase III studies on tavaborole in the onychomycosis indication, namely 301 and 302. These were conducted under the FDA’s Special Protocol Assessment (SPA) program.

Study 301 is the first of two phase III clinical trials of tavaborole in onychomycosis. The study 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 0.25% 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 15% 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. Moreover, we note that Valeant Pharmaceuticals' (VRX - Snapshot Report) onychomycosis candidate, IDP-108 (efinaconazole), received a complete response letter (CRL) from the FDA recently.

Anacor currently carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. and Salix Pharmaceuticals Ltd. (SLXP - Analyst Report) look well-positioned with a Zacks Rank #1 (Strong Buy).

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