Anacor Pharmaceuticals (NASDAQ:ANAC) today announced its financial results for the third quarter ended September 30, 2013.
“We had an eventful third quarter – we filed an NDA for tavaborole, our most advanced product candidate, and received acceptance for filing from the FDA. In addition, in October we negotiated a $142.5 million settlement of our disputes with Valeant Pharmaceuticals, which will provide us with significant flexibility as we pursue our business plan,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals.
Third Quarter 2013 Highlights and Recent Developments
Clinical Update and Anticipated Milestones
- Tavaborole – our lead topical antifungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
- On October 1, 2013, we announced that our New Drug Application (NDA) for tavaborole was accepted for filing by the U.S. Food and Drug Administration (FDA) indicating that the application was sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) V goal date is July 29, 2014.
- Subject to FDA approval, we anticipate launching tavaborole in the second half of 2014.
- AN2728 – our lead topical anti-inflammatory product candidate for the treatment of atopic dermatitis and psoriasis. Atopic dermatitis is a chronic rash characterized by inflammation and itching and affects an estimated 40 million people in the seven major pharmaceutical markets, including approximately 10% to 20% of infants and young children.
- In July 2013, we initiated a MUSE (maximal use systemic exposure) study in children with atopic dermatitis to measure blood levels when AN2728 is applied under maximal use conditions. We expect results from this study by the end of 2013.
- In August 2013, we initiated a TQT (thorough QT) study in approximately 180 healthy volunteers. We expect results from this study by the end of 2013.
- Subject to the results of the MUSE and TQT studies, and an End of Phase 2 Meeting with the FDA, we expect to initiate a Phase 3 study in atopic dermatitis in the first half of 2014.