DUBLIN--(BUSINESS WIRE)--Aug. 21, 2015--
Alkermes
plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has advised Alkermes that it will not be able to
complete its review of the New Drug Application (NDA) for ARISTADA™
(aripiprazole lauroxil) for the treatment of schizophrenia by the
Prescription Drug User Fee Act (PDUFA) action date of Aug. 22, 2015. The
FDA indicated that this delay was expected to be brief, measured in
terms of weeks, but could not confirm specific timing. The FDA also
indicated that no additional data or information is required from
Alkermes at this time.
“We are confident in the ARISTADA program and our NDA submission, and we
will work closely with the FDA as they complete their review,” said
Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We look forward
to bringing ARISTADA to market as a potential new treatment option to
help address the significant unmet medical needs of patients living with
schizophrenia.”
About ARISTADA™
ARISTADA is an injectable atypical antipsychotic with one-month and
extended-duration formulations in development for the treatment of
schizophrenia. Once in the body, ARISTADA converts to aripiprazole. As a
long-acting investigational medication based on Alkermes’ proprietary
LinkeRx® technology, ARISTADA is designed to have multiple
dosing options and to be administered in a ready-to-use, pre-filled
product format.
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company
developing innovative medicines for the treatment of central nervous
system (CNS) diseases. The company has a diversified commercial product
portfolio and a substantial clinical pipeline of product candidates for
chronic diseases that include schizophrenia, depression, addiction and
multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has
an R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and a manufacturing facility in
Wilmington, Ohio. For more information, please visit Alkermes’ website
at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including, but not
limited to, statements concerning the timing and outcome of FDA
regulatory review of the NDA submission for ARISTADA for the treatment
of schizophrenia and its potential therapeutic value, and the commercial
potential of ARISTADA. The company cautions that forward-looking
statements are inherently uncertain. Although the company believes that
such statements are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, the forward-looking
statements are neither promises nor guarantees and they are necessarily
subject to a high degree of uncertainty and risk. Actual performance and
results may differ materially from those expressed or implied in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: whether ARISTADA will be
approved by regulatory authorities for the treatment of schizophrenia;
if approved, whether ARISTADA will be commercialized successfully;
whether ARISTADA could be shown ineffective or unsafe; and those risks
described in the Alkermes plc Quarterly Report on Form 10-Q for the
period ended June 30, 2015 and Annual Report on Form 10-K for the fiscal
year ended Dec. 31, 2014, and in any other subsequent filings made by
the company with the U.S. Securities and Exchange Commission (SEC),
which are available on the SEC’s website at www.sec.gov.
The information contained in this press release is provided by the
company as of the date hereof, and, except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking information contained in this press release.
ARISTADA™ and LinkeRx® are trademarks of Alkermes Pharma
Ireland Limited.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150821005657/en/
Source: Alkermes plc
Alkermes Contacts:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166
