BAUDETTE, Minn., Feb. 24, 2016 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that
its collaboration partner Dexcel Pharma Technologies Ltd.
("Dexcel") has received approval from the U.S. Food and Drug
Administration ("FDA") of the Abbreviated New Drug Application
("ANDA") for Donepezil HCl 23mg Tablets. Sales of the product for
calendar year 2015 were $44 million,
according to IMS Health, with five current generic
competitors. ANI and Dexcel expect to begin shipping to
customers shortly.
Arthur S. Przybyl, President and
CEO of ANI Pharmaceuticals stated, "We are excited to have achieved
this milestone with Dexcel and look forward to a successful
launch."
About Donepezil 23mg Tablets
Donepezil is an acetylcholinesterase inhibitor indicated for the
treatment of dementia of the Alzheimer's type. Efficacy has been
demonstrated in patients with mild, moderate, and severe
Alzheimer's Disease.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. For more information, please
visit our website www.anipharmaceuticals.com.
About Dexcel
Dexcel Pharma is a private international specialty
pharmaceutical group, dedicated to the development, manufacturing
and commercialization of novel drug formulations and complex
generics. Dexcel Pharma has a broad portfolio of branded and
generic products, sold in more than 30 countries worldwide. Dexcel
Pharma was established in 1968 and is headquartered in Israel.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about price increases, the Company's future
operations, products financial position, operating results and
prospects , the Company's pipeline or potential markets therefore,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risks that the Company may face with
respect to importing raw materials; increased competition;
acquisitions; delays or failure in obtaining product approval from
the U.S. Food and Drug Administration; general business and
economic conditions; market trends; products development;
regulatory and other approvals and marketing.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent annual report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on the Company's
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals