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FDA Accepts New Drug Application for Seysara (sarecycline) for the Treatment of Moderate to Severe Acne

FDA Accepts New Drug Application for Seysara (sarecycline) for the Treatment of Moderate to Severe Acne

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Treatment for Acne

FDA Accepts New Drug Application for Seysara (sarecycline) for the Treatment of Moderate to Severe Acne

DUBLIN and BOSTON, Dec. 20, 2017 /PRNewswire/ — 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 plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

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.

Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections.

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.

Paratek Forward Looking Statements

This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing Seysara and preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for Seysara to serve as a once-daily, oral therapy for the potential treatment of moderate to severe acne in the community setting. and our ability to obtain regulatory approval of Seysara. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “believe,” “expect,” “well positioned,” “look forward,” “anticipated,” “continued,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

Allergan Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan’s Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

SOURCE Allergan plc

Posted: December 2017

Seysara (sarecycline) FDA Approval History

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