BAUDETTE, Minn., May 17, 2016 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the
signing of an exclusive distribution and supply agreement with
Aspen Global Incorporated for Hydroxyprogesterone Caproate
Injection ("HPC") USP 250mg/mL in 5mL vials. Aspen will be responsible for supplying the
finished goods and ANI Pharmaceuticals will be responsible for
marketing and distribution in the U.S. Aspen's product was approved by FDA in
August 2015 (ANDA# 200271) and ANI
intends to commercialize HPC in the near term. For product
inquiries, please contact ANI at 218-634-3601.
Arthur S. Przybyl, ANI's
President and CEO stated, "We are excited to enter into this
exclusive strategic distribution partnership with Aspen and introduce to the U.S. market a
product that addresses a high-need patient population. We
hope to build on the launches of HPC and our previously disclosed
anti-cancer product (pending FDA approval, TAD June 2016) to strategically advance a portfolio
of oncolytic products in the future. Finally, this launch
will also serve to establish ANI's commercial presence in the
specialty pharmacy distribution channel, one that we intend to
build upon with future product introductions from our existing
pipeline."
About Hydroxyprogesterone Caproate Injection USP
HPC USP is indicated in non-pregnant women: for the treatment of
advanced adenocarcinoma of the uterine corpus (Stage III or IV); in
the management of amenorrhea (primary and secondary) and abnormal
uterine bleeding due to hormonal imbalance in the absence of
organic pathology, such as submucous fibroids or uterine cancer; as
a test for endogenous estrogen production and for the production of
secretory endometrium and desquamation.
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;
acquisitions; contract manufacturing arrangements; 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-enters-into-exclusive-distribution-and-supply-agreement-for-hydroxyprogesterone-caproate-injection-usp-300269792.html
SOURCE ANI Pharmaceuticals, Inc.