BAUDETTE, Minn., June 18, 2014 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. (NASDAQ: ANIP) has signed an exclusive
license and supply agreement with Dexcel Pharma Technologies Ltd.
("Dexcel") for an ANDA drug product. Dexcel submitted the ANDA
application in December 2011. Dexcel will be responsible for
obtaining FDA approval and manufacturing the product, and ANI
Pharmaceuticals will be responsible for marketing and distribution
in the U.S. The product generates combined brand and generic annual
U.S. sales of approximately $80
million, per IMS Health. Financial terms of the agreement
were not disclosed.
Arthur S. Przybyl, ANI's
President and CEO stated, "I am pleased to have entered this
collaboration project with Dexcel. This partnership is
aligned with our strategy of augmenting ANI's internal generic
product development efforts with acquisitions and partnerships for
late stage ANDA products and mature brands."
About ANI
ANI Pharmaceuticals, Inc. (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 Pharma
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 Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Such statements include, but are not limited
to, statements about the potential benefits of the recent Merger,
the effect of price increases, the Company's plans, objectives,
expectations and intentions with respect to future operations and
products and the timing or success of the introduction thereof, the
anticipated financial position, operating results and growth
prospects of the Company, the value of the Company's pipeline or
the size of 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. Forward-looking statements by their nature address
matters that are, to different degrees, subject to change. You
should not place undue reliance on those statements because they
are subject to numerous uncertainties, risks and other factors
relating to the Company's operations and business environment and
other factors, all of which are difficult to predict and many of
which are beyond the Company's control.
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 in the future
face increased difficulty in importing raw materials and/or
increased competition for its Esterified Estrogen with
Methyltestosterone Tablet product; competitive conditions for the
Company's other products may intensify; the Company may be required
to seek the approval of the U.S. Food and Drug Administration
("FDA") for its unapproved products or withdraw such products from
the market; general business and economic conditions; the Company's
expectations regarding trends in markets for the Company's current
and planned products; the Company's future cash flow and its
ability to support its operations; the Company's ability to obtain
additional financing as needed; the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals
and achieving market acceptance; and the marketing success of the
Company's licensees or sublicensees.
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
report on Form 10-Q, as well as its proxy statement/prospectus,
filed with the Securities and Exchange Commission on May 8, 2013. 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. ANI 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:
Arthur S. Przybyl
(218) 634-3608
arthur.przybyl@anipharmaceuticals.com
SOURCE ANI Pharmaceuticals, Inc.