Anacor Pharmaceuticals Announces Successful Completion of Pre-NDA Communications With the FDA for Tavaborole

  Anacor Pharmaceuticals Announces Successful Completion of Pre-NDA
  Communications With the FDA for Tavaborole

Business Wire

PALO ALTO, Calif. -- May 29, 2013

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

“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.

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 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 GlaxoSmithKlineLLC, 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

Forward-Looking Statements

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.


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