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
Journal, 328(7447), 1063–1066.
6 National Association for Continence (NAFC). Nocturia.
NAFC website. Available at: http://www.nafc.org/nocturia/. Accessed
September 28, 2016.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc