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Allergan Acne Candidate Meets Endpoints in Phase III Studies

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Allergan plc (AGN - Free Report) in collaboration with Paratek Pharmaceuticals, Inc. (PRTK - Free Report) has announced positive results from two phase III studies on sarecycline. The companies are developing sarecycline for the treatment of moderate to severe acne. The companies said the studies met their 12-week primary endpoints.

The efficacy study evaluated sarecycline for the potential treatment of moderate to severe acne in the community setting, which is dosed once daily orally. The drug is a narrow spectrum antibiotic derived from tetracycline.

A look at Allergan’s share price movement over the past six month shows that the stock has outperformed the Zacks classified Medical – Generic Drugs industry. Specifically, Allergan gained 3.7% during this period, while the industry lost 11.7%. Also shares of Paratek closed 9.15% up yesterday.

Coming back to the latest news, SC1401 and SC1402 were double-blinded, placebo-controlled studies, which evaluated the efficacy and safety of treatment with sarecycline compared to placebo in patients with moderate to severe acne, which was the primary endpoint of the study. Results revealed that patients treated with sarecycline (1.5 mg/kg) demonstrated a statistically significant improvement (p < 0.004) compared to placebo across the primary endpoint

Allergan owns the rights for the development and commercialization of sarecycline in the U.S. Based on the positive data, Allergan is planning to file a new drug application (NDA) with the FDA in the second half of this year.

Foamix Pharmaceuticals Ltd. (FOMX - Free Report) is also conducting a study to evaluate the safety and efficacy of its drug, FMX101, for the treatment of moderate to severe acne.

We remind investors that in order to focus on its branded segment, Allergan sold its generics business to Teva Pharmaceutical Industries Limited (TEVA - Free Report) last year.

Both Allergan and Paratek currently carry a Zacks Rank #3 (Hold).

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