Anacor Hits Home Run with Crisaborole Phase III Trials, Predicts $1 Billion Potential Sales

Anacor Hits Home Run with Crisaborole Phase III Trials, Predicts $1 Billion Potential Sales
July 13, 2015
By Mark Terry, Breaking News Staff

Palo Alto, Calif.-based Anacor Pharmaceuticals, Inc. announced positive results today from two Phase III clinical trials of Crisaborole Topical Ointment for the treatment of mild-to-moderate atopic dermatitis in children and adults.

The medication showed statistically significant results for all primary and secondary endpoints in both clinical studies, and also showed a good safety profile. Both studies had over 750 patients enrolled, with patients as young as two years old. Anacor is also conducting an open-label long-term safety study to evaluate the drug’s intermittent use for up to 12 months.

Anacor stock took a big jump at the news. Shares traded for $76.86 on July 6. Stock is currently trading at $122.83. The stock has been on a very slow but steady rise for the last year. Shares traded for $18.02 on Aug. 8, 2014, rising to $68.16 on April 17, 2015.

“We are excited to announce,” said Paul Berns, company chief executive officer in this morning’s webcast “that in both of our two Phase III pivotal studies which enrolled over 750 patients each, that crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety endpoint consistent with previous studies.”

Steroids are the most common treatment. Topical calcineurin inhibitors (TCI) are another treatment for atopic dermatitis. There are two non-steroidal prescription drugs in this category, Elidel (pimecrolimus) and Protopic (tacrolimus). Elidel is licensed by Valeant Pharmaceuticals International, Inc. North America. Protopic is marketed by stellas Pharma US, Inc. Both drugs have a U.S. Food and Drug Administration (FDA) “black box” warning about a possible cancer risk.

This is partly why Anacor is emphasizing the safety evidence for crisaborole in its clinical trials. If approved, crisaborole would be the first non-steroidal treatment since 2000 and 2001. Prior to their black box warnings, the two TCIs, Elidel and Protopic, captured about 13 percent of the market for all inflammatory dermatologic conditions. After the boxed warnings, their market share dropped to about 2 percent of the 43 million subscriptions written annually, according to Anacor.

“Based on our market research, the success of the TCIs prior to the FDA’s public health advisory and the topline efficacy and safety results of the crisoborole Phase III pivotal studies, we continue to believe that, crisaborole, if approved, has the potential to exceed $1 billion in net revenues,” said Vince Ippolito, executive vice president and chief commercial officer in the webcast.

“Mild-to-moderate atopic dermatitis, or eczema, is a chronic, life-altering inflammatory skin disease that can be a constant challenge for patients and family members,” said Amy Paller, Walter J. Hamlin Professor and chair of dermatology at Northwestern University Feinberg School of Medicine in a statement. “Based on the safety and efficacy profile demonstrated by crisaborole in these Phase III privotal studies, crisaborole, if approved, could become a significant first-in-class treatment option for patients suffering from mild-to-moderate atopic dermatitis and the physicians who treat them.”

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