BAUDETTE, Minn., Feb. 1, 2016 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that
it has acquired the exclusive rights to distribute 1% and 2.5%
hydrocortisone cream for rectal use and the exclusive rights to
distribute the authorized generic of Lipofen® (fenofibrate capsules
50mg and 150mg USP) from H2-Pharma, LLC. In addition, ANI
also acquired an early stage development project for an undisclosed
generic injectable drug product.
In 2015 the combined market for 1% and 2.5% hydrocortisone cream
for rectal use was $73 million,
according to IMS Health. ANI intends to launch both strengths
during the second quarter of 2016 and will retain a portion of net
profits from its sales of these products.
In 2015 the authorized generic for Lipofen® (fenofibrate
capsules 50mg and 150mg USP) generated $21.9
million in revenues. According to the
distribution agreement with Kowa Pharmaceuticals America, Inc., ANI
will retain 7.5% of net profits from its sales of the authorized
generic for Lipofen®. Following a transition period, ANI intends to
launch the authorized generic for Lipofen® (fenofibrate capsules
50mg and 150mg USP) under its own label during the second quarter
of 2016.
Arthur S. Przybyl, ANI's
President and CEO stated, "We are excited to add these products to
our growing portfolio of commercial generic drugs. We
continue to pursue opportunities to expand our generic business and
mature brand portfolio."
Bryce M. Harvey, President of
H2-Pharma, stated, "This transaction resonates with our primary
goal at H2, which is to bring value to our partners' existing
product portfolios by utilizing our extensive industry experience
and knowledge. Our commitment is and will continue to be to foster
innovation within our industry by developing new ideas and programs
which will benefit each and every one of our partners."
About 1% and 2.5% Hydrocortisone Cream for Rectal Use
Topical corticosteroids such as 1% and 2.5% hydrocortisone cream
are indicated for the relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses.
About Lipofen® Capsules
Lipofen® (fenofibrate capsules) is a peroxisome proliferator
receptor alpha (PPARα) activator indicated as an adjunct to diet:
to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase
HDL-C in adult patients with primary hypercholesterolemia or mixed
dyslipidemia and for treatment of adult patients with severe
hypertriglyceridemia.
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 H2-Phama
H2-Pharma LLC is a privately-held pharmaceutical company focused
on the sales, marketing and development of generic
pharmaceuticals.
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
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.