Anacor Pharmaceuticals Announces Successful Completion of Pre-NDA Communications With the FDA for Tavaborole
Anacor PharmaceuticalsDeDe Sheel, 650-543-7575Director, Investor Relations and Corporate Communications
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has successfully completed its pre-NDA (New Drug Application) communications with the Food and Drug Administration (FDA) related to tavaborole, its drug candidate for the topical treatment of onychomycosis. In its pre-NDA communications, Anacor achieved concurrence from the FDA on the content and format of the proposed NDA for tavaborole including required data related to safety, efficacy, manufacturing and packaging. Anacor remains on schedule to file the NDA in mid-2013.
“We continue to dedicate significant efforts to ensuring the FDA review process for tavaborole proceeds smoothly. We have been pleased with our interactions with the FDA regarding our planned NDA for tavaborole,” said David Perry, Chief Executive Officer of 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 eight compounds that are currently in development. Its two lead product candidates are topically administered dermatologic compounds — tavaborole, a topical antifungal for the treatment of onychomycosis, and AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of atopic dermatitis and psoriasis. In addition to its two lead programs, Anacor has discovered three other wholly-owned clinical product candidates — AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively, and AN3365 (formerly known as GSK2251052, or GSK ‘052), an antibiotic for the treatment of infections caused by Gram-negative bacteria, which previously was licensed to GlaxoSmithKline LLC, or GSK. GSK has returned all rights to the compound to us and we are considering our options for further development, if any, of this compound. We have discovered three other compounds that we have out-licensed for further development — two compounds for the treatment of animal health indications that are licensed to Eli Lilly and Company and AN5568, also referred to as SCYX-7158, for human African trypanosomiasis (HAT, or sleeping sickness), which is licensed to Drugs for Neglected Diseases initiative, or DNDi. We also have a pipeline of other internally discovered topical and systemic boron-based compounds in development. For more information, visit .
This press release may contain forward-looking statements that relate to future events including the timing for filing of a new drug application, or NDA, related to tavaborole and the potential FDA approval of tavaborole. 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 regulatory approval of new drug candidates. Reference should be made to Anacor’s Annual Report on Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission under the heading “Risk Factors” and Anacor’s subsequent Quarterly Reports on Form 10-Q for a more detailed description of such factors. 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.