BAUDETTE, Minn., Aug. 12, 2015 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that
it has completed an agreement with IDT Australia, Ltd. ("IDT")
to commercialize up to 18 previously marketed US generic drug
products. ANI paid IDT $1.0 million
for exclusive rights to commercialize the products in the North
American market. ANI will share in a percentage of net profits upon
commercialization, which percentage was not disclosed. The total
current annual U.S. market for these products is $538 million on a trailing 12 month basis per IMS
Health.
IDT anticipates filing a CBE-30 for the first product in the
fourth quarter of 2015.
Arthur S. Przybyl, President and
CEO of ANI Pharmaceuticals, stated, "This partnership represents a
substantial opportunity for ANI to further expand our marketed
generic product portfolio. We are excited to establish this
relationship with a high quality global generic manufacturer such
as IDT."
Dr. Paul MacLeman, Managing
Director and CEO of IDT, said, "In many ways ANI is an ideal US
partner for IDT as it has a proven track record having already
successfully commercialized its own generic drugs, is nimble and
shares IDT's zest for growth. Culturally the two companies are a
good fit and the terms of the agreement are fair to both parties.
We are very much looking forward to working with the ANI team to
grow sales and create value."
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 IDT
Established in 1975, IDT Australia, Ltd. is a public
Australian pharmaceutical manufacturing company. Based in Boronia,
Victoria IDT is commercializing a portfolio of specialty generic
drugs with aggregate addressable markets of over US$800 million. With extensive experience in the
development and production of high potency and high containment
pharmaceutical products for local and international markets, IDT's
facilities are fully cGMP compliant and are regularly audited by
the US FDA and Australian TGA. With an experienced and professional
team, operating within world-class facilities, IDT is also
committed to providing international pharmaceutical customers
services in drug development, scale-up, clinical services and
commercial drug manufacture.
Through CMAX, its clinical research services business based at
the Royal Adelaide Hospital in South
Australia, IDT also provides full Phase I clinical trials
management and delivery, recruitment in specific disease states for
Phase II and Phase III trials as well as being able to offer trial
packaging, distribution and pharmacy services from the cGMP Boronia
facilities.
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 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.