BAUDETTE, Minn., May 13, 2015 /PRNewswire/ -- ANI Pharmaceuticals,
Inc. ("ANI") (NASDAQ: ANIP) today announced that it has acquired
the approved new drug application ("NDA") for a testosterone gel 1%
product previously licensed to Teva Pharmaceuticals. Upon
commercialization, ANI will pay Teva up to $5 million at a rate of 5% of the consideration
received by ANI as a result of commercial sale of the product.
According to IMS Health, the overall market for testosterone
gel 1% was approximately $300 million
in 2014.
Arthur S. Przybyl, President and
Chief Executive Officer said, "We are pleased to acquire this NDA
from Teva and will begin work immediately to maximize the value of
this product."
About Testosterone Gel 1%
Testosterone gel is an androgen indicated for replacement
therapy in males for conditions associated with deficiency or
absence of endogenous testosterone including primary hypogonadism
(congenital or acquired) and hypogonadotropic hypogonadism
(congenital or acquired).
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.
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 therefor,
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 risk that the Company may face with
respect to importing raw materials; increased competition; 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
(218) 634-3608
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.