FDA Advisory Committee Recommends Approval of SER120 (desmopressin nasal spray)

Panel votes 14 to 4 in favor of drug in development for treatment of under-diagnosed urological disorder

    DUBLIN and MILFORD, Pa., Oct. 20, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Serenity Pharmaceuticals, LLC, announced today that the US Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-4 in favor of the benefit risk profile of the New Drug Application (NDA) for SER120 (desmopressin nasal spray). The vote was followed by a discussion of the indication among committee members. SER120 is an investigational drug developed for the treatment of nocturia, a common yet often under-diagnosed urological disorder, in adults who awaken two or more times per night to empty the bladder. Additionally, the committee voted 17-1 that there is substantial evidence to conclude that at least one of the SER120 doses is effective.

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    "Allergan is committed to the development of innovative therapies that fill significant unmet medical needs," stated David Nicholson, Chief R&D Officer, Allergan. "Nocturia is a common and problematic medical condition for many male and female patients, which can lead to impairment in quality of life. We look forward to the outcome of the SER120 new drug application discussions with the FDA."

    "Upon approval, SER-120 will be the first treatment for nocturia in the United States. The advisory committee's positive vote supports our belief in SER120 as a potential new treatment option for patients that have a history of more than two nocturic episodes per night.,"1,2,3 said Dr. Samuel Herschkowitz, Chief Executive Officer, Serenity. "We are encouraged by today's positive outcome and will continue to work with the FDA as the agency completes its review of the SER120 new drug application."

    The FDA is not bound by the Committee's recommendation, but takes its advice into consideration when reviewing investigational medicines. The FDA is expected to take action on the NDA for SER120 in the fourth quarter of 2016.

    About Nocturia

    Nocturia is a highly prevalent urological condition characterized by repeated awaking from sleep to empty the bladder.4 Nocturia has been found to have a role in numerous aspects of patients' health and wellbeing, contributing to fatigue, memory deficits, depression, increased risk of heart disease, gastrointestinal disorders, and, at times, traumatic injury through falls.5 More than one-third of adults over the age of 30 meet the clinical definition for nocturia, making at least two trips to the bathroom every night.6 Although common, nocturia is underdiagnosed, and patients tend not to report the condition to their doctors until it becomes unbearable or their quality of life during daytime hours is severely compromised.5

    About SER120

    SER120 is a novel, low dose, nasally administered investigational drug being evaluated for its efficacy and safety in the treatment of nocturia in adults who awaken two or more times per night to empty the bladder.

    About Serenity Pharmaceuticals, LLC

    Founded in 2006 and headquartered in Milford, Pa., Serenity develops patented pharmaceuticals using unique delivery mechanisms combined with low threshold efficacious formulations. This dual approach allows Serenity to engineer safer drugs with minimal side effects in targeted populations.

    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 pharmaceuticals, devices and biologic 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, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

    Our Company's success is powered by our more than 16,000 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.

    Serenity Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will receive regulatory approval or become a commercially successful product. Forward-looking statements in the press release should be evaluated together with the many uncertainties that can affect the full development of this pharmaceutical. Serenity undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Contact us at sherschkowitz@serenitypharma.com or 917-548-8181.

    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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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; 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

    1 US Census, 2015.
    2 US Census, 2016.
    3 Data on file, Allergan. 2013.
    4 Abrams, P., Cardozo, L., Fall, M., Griffiths, D., Rosier, P., Ulmsted, U., van Kerrebroek, P., Victor, A., Wein, A. (2002). The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standarisation Sub-committee of the International Continence Society. Neurology and Urodynamics, 21:167-178.
    5 Marinkovic, S. P., Gillen, L. M., & Stanton, S. L. (2004). Managing nocturia. BMJ : British Medical Journal328(7447), 1063-1066.
    6 National Association for Continence (NAFC). Nocturia. NAFC website. Available at: http://www.nafc.org/nocturia/. Accessed September 28, 2016.


    Lisa DeFrancesco
    (862) 261-7152

    Mark Marmur
    (862) 261-7558

    SOURCE Allergan plc

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