BAUDETTE, Minn., May 7, 2018 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that
it has completed the acquisition of a portfolio of six generic
products, related manufacturing and supply agreements, and
equipment and technical know-how from Amneal Pharmaceuticals, LLC
and Impax Laboratories, Inc. (NASDAQ: IPXL) for cash consideration
of $2.3 million. The portfolio
of generic products has a combined current annual U.S. market of
$1.7 billion according to Iqvia/IMS
Health.
This transaction provides ANI with:
- Immediate revenue and profit from twelve SKUs of three
currently commercialized products: Ezetimibe-Simvastatin tablets,
Felbamate tablets and Desipramine tablets. Starting today ANI will
commence shipping to customers.
- Approved ANDAs for Aspirin/Dipyridamole ER capsules and
Methylphenidate ER tablets; these products require successful
validation prior to launch. ANI will immediately begin validation
efforts for these two products.
- An option with a date certain launch for Aspirin/Dipyridamole
ER capsules of no later than October 1,
2019. The option allows ANI to source the product from
Amneal through March 1, 2021 or until
ANI launches its own product, whichever date is earlier. If ANI
elects to exercise the option to launch product supplied by Amneal
it will owe a milestone payment of between $0 and $10 million
depending on the number of generic products in the market at the
time of launch. Currently this is a $120
million annual U.S. market with only one generic competitor,
according to Iqvia/IMS Health.
- Two pipeline products: Erythromycin IR tablets and
Diclofenac-Misoprostol DR tablets. ANI acquired a development
package for Erythromycin IR tablets and will assume the development
work for this product with the goal of filing an ANDA in the near
future. Currently there is only one generic competitor for
Erythromycin IR tablets. In addition, ANI has assumed a multi-year
license, supply and distribution agreement for
Diclofenac-Misoprostol DR tablets.
Arthur S. Przybyl, ANI's
President and CEO stated, "We are excited to add these products and
the revenue and profit generated by today's three product launches
to our generic platform. Importantly, we look forward to
launching Aspirin/Dipyridamole ER capsules no later than
October 1, 2019. At the same
time, we will begin validation efforts for Methylphenidate ER
tablets, which represents a compelling opportunity for ANI."
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
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SOURCE ANI Pharmaceuticals, Inc.