Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor’s first approved drug, KERYDIN® (tavaborole) topical solution, 5%, is an oxaborole antifungal approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails. In July 2014, Anacor entered into an exclusive agreement with Sandoz Inc., a Novartis company, pursuant to which PharmaDerm, the branded dermatology division of Sandoz, distributes and commercializes KERYDIN in the United States. In September 2014, PharmaDerm launched KERYDIN in the United States. Anacor’s lead product candidate is crisaborole, an investigational non-steroidal topical PDE-4 inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis and psoriasis. Beyond KERYDIN and crisaborole, Anacor has discovered three investigational compounds that it has out- licensed for further development. The first compound is licensed to Eli Lilly and Company for the potential treatment of an animal health indication. The second compound, AN5568, also referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases initiative for the potential treatment of human African trypanosomiasis (HAT, or sleeping sickness) and the third compound is licensed to GlaxoSmithKline LLC for development in tuberculosis. Anacor also has a pipeline of other internally discovered topical and systemic boron-based compounds in early stages of research and development. These include AN3365, an investigational Gram-negative antibiotic, and certain other wholly-owned investigational product candidates.
Anacor was founded based on technology created by board members and scientific advisory board co-chairs, Dr. Lucy Shapiro at Stanford University and Dr. Stephen Benkovic at Pennsylvania State University
Entered into a $21.6 million contract with the Department of Defense to explore the use of boron chemistry in biodefense
Explored potential uses of boron in drug development and generated data showing that boron platform had potential applications in a variety of diseases including bacterial, fungal, viral, and parasitic infections as well as inflammatory diseases
First compound entered clinical trials
Entered into agreements with the Global Alliance for TB Drug Development (TB Alliance) and Drugs for Neglected Diseases initiative (DNDi) to apply our boron chemistry platform in the area of neglected diseases
Initiated Phase 3 trial for mild-to-moderate onychomycosis
AN3365 (GSK ‘052)
Reported Phase 1 results showing that AN3365 appeared to be safe and well-tolerated, after which GSK exercised its option to obtain an exclusive license to develop and commercialize AN3365. Upon exercise of the option, Anacor received a fee of $15.0 million
Entered into a research agreement with Eli Lilly and Company, or Lilly, to discover products for a variety of animal health applications
Entered into a research agreement with not-for-profit Medicines for Malaria Venture (MMV) develop new therapeutics for the treatment of malaria
Entered research and development collaboration agreement with UCSF's Sandler Center to discover new drug therapies to treat River Blindness
Completed Initial Public Offering
Completed successful End of Phase 2 meeting with the FDA for crisaborole in mild-to-moderate psoriasis and received Special Protocol Assessment (SPA) on major parameters of Phase 3 trial design of crisaborole in mild-to-moderate psoriasis.
Crisaborole and AN2898
Successfully completed Phase 2a trial in mild-to-moderate atopic dermatitis
GSK initiated two Phase 2 trials in complicated urinary tract infections and complicated intra-abdominal infections
DNDi initiated a Phase 1 study of AN5568 for HAT in France.
Announced positive results from two Phase 3 studies of KERYDIN for the treatment of mild-to-moderate onychomycosis
New Drug Application (NDA) accepted by the U.S. Food and Drug Administration (FDA) for review
Completed third Phase 2 study of crisaborole in mild-to-moderate atopic dermatitis
Signed $17.7 million research agreement with the Bill & Melinda Gates Foundation and received $5 million investment in common stock
Received $142.5 million from Valeant Pharmaceuticals to settle disputes related to Dow Pharmaceutical Sciences and Medicis Pharmaceutical Corporation
Approved by the FDA for the topical treatment of onychomycosis of the toenails
Entered into an exclusive agreement with Sandoz to distribute and commercialize KERYDIN in the United States through PharmaDerm, the branded dermatology division of Sandoz
Launched KERYDIN in the United States
Held successful End of Phase 2 meeting with the FDA for Crisaborole in the treatment of mild-to-moderate atopic dermatitis
Initiated Phase 3 trials of crisaborole in mild-to-moderate atopic dermatitis
Our objective is to discover, develop and commercialize proprietary boron-based drug compounds with superior efficacy, safety and convenience for the treatment of a variety of diseases. The key elements of our strategy to achieve this objective are to:
Drive rapid, efficient discovery of novel boron-based compounds. We believe the unique characteristics of boron and the expertise we have developed allow us to design novel product candidates that target a broad range of diseases and drive a rapid and efficient drug development process. We have discovered and advanced seven compounds into development in ten years and, in addition, have other active and ongoing research and development programs.
Focus development activities in our core therapeutic areas. We intend to focus our development activities in our core therapeutic areas of fungal, inflammatory and bacterial diseases. To fully leverage our boron chemistry platform, we have established and will continue to pursue development partnerships in these therapeutic areas.
Commercialize our products ourselves in specialty markets in the United States. We intend to build a sales force to focus on domestic specialty markets, such as dermatology. We have entered into and will continue to seek commercialization partners for products in non-specialty and international markets.
Leverage partnerships for non-core therapeutic areas. We believe boron chemistry has utility in a broad range of diseases outside of our core therapeutic areas. To maximize the value of our boron chemistry platform and to provide non-dilutive capital to support development in our core therapeutic areas, we have entered into and will continue to seek partnerships early in development for compounds in non-core areas, such as parasitic, cancer and ophthalmic indications and for applications in animal health.
Expand and protect our intellectual property. We intend to expand and aggressively prosecute our intellectual property in the area of boron chemistry and boron-based compounds. Since a relatively limited amount of research has been done in the area of boron-based drug development, we believe that we can establish a defensible and valuable intellectual property portfolio.