In recent years, researchers have taken an interest in boron as one of the few plausible alternatives to carbon in medicinal drug design because of the element’s unique characteristics of geometry and reactivity.
Developing small-molecule therapeutics based on its novel boron chemistry platform is biopharmaceutical company – Anacor Pharmaceuticals Inc. (ANAC: Quote).
For readers who are new to Anacor, here’s what to expect in the coming months…
The company’s lead compound is Tavaborole, a topical antifungal product candidate for the treatment of onychomycosis, a fungal nail infection. Tavaborole is under late-stage development, with two phase III trials underway.
In the phase III trials, once-daily dosing of Tavaborole for 48 weeks is evaluated against a vehicle. (*vehicle is the topical formulation without the active ingredient). The primary efficacy endpoint set for the trial is a complete cure of the great toenail at week 52.
Anacor expects to announce top-line data from the first phase III trial of Tavaborole in mid-January 2013 and from the second phase III trial approximately six weeks later.
If all goes well as planned, the New Drug Application for Tavaborole is expected to be filed in mid-2013.
Though onychomycosis is a cosmetic condition, it can have significant negative effects on a patient’s emotional and social well-being. Some of the FDA-approved therapies for onychomycosis include, Novartis AG’s (NVS) Lamisil, Johnson & Johnson subsidiary – Janssen Pharmaceutical’s Sporanox and Sanofi Aventis’ (SNY) Penlac. There are also laser treatments for onychomycosis like PinPointe FootLaser, Noveon Laser, CoolBreeze Laser, Q-Laser, K-Laser and GenesisPlus Laser.
It is estimated that about 35 million to 36 million people in the U.S. have onychomycosis. Before generic competition, in 2004, oral drug Lamisil had worldwide peak sales of $1.2 billion. Penlac, the topical agent for onychomycosis, had U.S. sales of $125 million in 2002, before generic entry.
According to Anacor, given the potential safety and efficacy profile, Tavaborole is capable of addressing the limitations of the current onychomycosis therapies.
Another topical antifungal product candidate of Anacor is AN2718, which successfully completed its phase I testing in March of 2009. The company intends to initiate a phase II trial of AN2718 for onychomycosis after completing phase III trials of Tavaborole.
The company’s topical anti-inflammatory compounds in the pipeline include, AN2728 and AN2898 in the indications of mild-to-moderate atopic dermatitis and psoriasis. However, given the safety profile exhibited by AN2728 and the greater unmet need in atopic dermatitis relative to psoriasis, for now, Anacor is focusing on the development of AN2728 for atopic dermatitis and has deferred further development of AN2898.
Two phase II studies of AN2728 – an open-label study of the safety, pharmacokinetics and efficacy of AN2728 ointment 2% when applied twice daily for up to 28 days, and a randomized, double-blind, bilateral dose-ranging study of AN2728 ointment, 2% and 0.5%, applied once daily or twice daily for up to 29 days, in the indication of atopic dermatitis in adolescents were initiated in the third quarter of 2012.
The company expects data from the phase II safety, pharmacokinetics and efficacy of AN2728 study in adolescents near the end of 2012 and from the phase II dose-ranging study in adolescents in early 2013.
A phase II study of the safety, pharmacokinetics and efficacy of AN2728 in children (ages 2 to 11) is expected to be initiated shortly after the completion of phase II trial in adolescents.
If things pan out the way as expected, AN2728 will progress into phase III testing in atopic dermatitis in mid-2013, according to the company.
Other compounds in Anacor’s pipeline are AN3365, formerly referred to as GSK ‘052, a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria; AN8194, a compound for the treatment of an animal health indication that is licensed to Eli Lilly and Co. (LLY) 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.
AN3365 was being developed in collaboration with GlaxoSmithKline for complicated urinary tract infections and complicated intra-abdominal infections.
In February of this year, GlaxoSmithKline halted enrollment in phase IIb clinical trials of AN3365 due to development of resistance in a small number of patients in the phase IIb trial for the treatment of complicated urinary tract infections. GlaxoSmithKline has discontinued further development of AN3365 and will be returning all rights to the compound to Anacor.
A quick look at the company’s balance sheet…
Since inception in March 2002, the company has never been profitable and has not generated any revenue from product sales. As of September 30, 2012, Anacor had an accumulated deficit of $202.7 million.
In Q3, 2012, Anacor’s net loss widened to $14.44 million or $0.46 per share from $4.40 million or $0.16 per share in the year-ago quarter. The revenue, which consisted primarily of contract revenue from collaboration agreements with Eli Lilly, GlaxoSmithKline and Medicis Pharmaceutical Corp. dropped to $2.47 million in Q3, 2012 from $12.64 million in Q3, 2011.
The company expects to have cash of $45.0 million at year-end 2012, sufficient to meet its anticipated operating requirements until mid-2013.
Anacor went public on November 24, 2010, offering its shares at a price of $5 each. The stock has thus far hit a 52-week low of $4.50 and a 52-week high of $7.55. ANAC closed Friday’s trading at $5.29, down 2.40% on more than 12 times the 3 month average volume of shares.
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by RTT Staff Writer
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