|View printer-friendly version|
|FDA Accepts New Drug Application for Seysara™ (Sarecycline) for the Treatment of Moderate to Severe Acne|
DUBLIN, Ireland and BOSTON, Dec. 20, 2017 (GLOBE NEWSWIRE) -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of therapies based upon tetracycline chemistry, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) to review Seysara™ (sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. Seysara™ (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.
“We are pleased that the FDA has accepted our application and look forward to advancing our conversations toward a potential U.S. approval of Seysara in the second half of 2018,” said David Nicholson, Chief Research and Development Officer at Allergan. “This milestone reinforces our commitment to advancing research and bringing new therapies to patients, and our dermatology customers.”
“The FDA’s NDA acceptance is encouraging as results shown in the Seysara (sarecycline) Phase 3 trials involving 2,002 patients demonstrate that Seysara if approved, has the potential to be a new, effective, safe and well-tolerated treatment option for physicians treating patients with moderate to severe acne,” said Evan Loh, MD, President, Chief Operating Officer and Chief Medical Officer, Paratek.
“Having an additional treatment option for those of us managing acne patients is not only important but also welcomed,” said Leon Kircik, MD, Associate Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, NY.
The application includes two identically-designed, large, multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies, which demonstrated that once-daily sarecycline 1.5 mg/kg significantly improved acne severity based on Investigator’s Global Assessment (IGA) success and significantly reduced inflammatory lesion count vs placebo at week 12 in patients with moderate to severe facial acne vulgaris. In March 2017, Allergan announced positive results of these Phase 3 studies, which met their primary efficacy endpoints.
Allergan completed the NDA submission in October 2017, and expects the Prescription Drug User Fee Act (PDUFA) action date to occur in the second half of 2018. Allergan has U.S. rights to the development and commercialization of Seysara. Paratek retains all ex-U.S. rights.
About Allergan plc
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 55+ mid-to-late stage pipeline programs currently in development.
Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
About Paratek Pharmaceuticals, Inc.
Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and is preparing to submit marketing applications in the United States and European Union. Paratek has licensed development and commercialization rights for omadacycline to Zai Lab for the greater China region, and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit http://www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Paratek Forward Looking Statements
Allergan Forward-Looking Statement