BAUDETTE, Minn., April 27, 2018 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that
it has signed definitive agreements to acquire a portfolio of
generic products and other assets from Amneal Pharmaceuticals, LLC
and Impax Laboratories, Inc. (NASDAQ:IPXL) for undisclosed cash
consideration. The transaction is the result of a divestiture
process mandated by the Federal Trade Commission ("FTC") in
connection with Amneal Pharmaceutical's proposed business
combination with Impax Laboratories. The parties expect to
close the transaction in early May.
Upon closing the transaction, ANI will acquire a product
portfolio consisting of five approved generic ANDAs and one
pipeline product, Erythromycin IR tablets; ANI will also acquire a
license, supply and distribution agreement for a second pipeline
product, Diclofenac-Misoprostol DR tablets, with a pending
ANDA. The combined current annual U.S. market for these seven
products is approximately $1.7
billion, according to Iqvia/IMS Health.
Currently three of the five approved products are
commercialized: Ezetimibe-Simvastatin Tablets (ANDA 201890),
Felbamate Tablets (ANDA 202284) and Desipramine Tablets (ANDA
205153). Following the close of the transaction, ANI will
begin shipping these products to customers immediately. Two
generic products are approved but not yet commercialized:
Aspirin/Dipyridamole ER Capsules (ANDA 206964) and Methylphenidate
HCl ER Tablets (ANDA 208607). These products will be
manufactured and supplied to ANI under multi-year supply agreements
with Amneal, Impax, or pre-existing third-party contract
manufacturers under agreements that will be assigned to ANI.
ANI intends to immediately commence efforts to tech transfer the
manufacturing of the acquired ANDA for Aspirin/Dipyridamole ER
Capsules to the company's Baudette
manufacturing facility.
As part of the transaction, ANI will secure a supply agreement
with the option to receive generic Aspirin/Dipyridamole ER Capsules
from Amneal Pharmaceuticals beginning in late 2019 with a right to
distribute the product in the U.S. market through early 2021.
If ANI exercises this option it may be obligated to make a
milestone payment upon launch depending on the number of generic
products in the market at the time of launch.
In addition, ANI will acquire certain manufacturing equipment
currently installed at a third-party contract manufacturing site
for the manufacture of Methylphenidate HCl ER Tablets.
Arthur S. Przybyl, ANI's
President and CEO stated, "We are pleased to announce the agreement
to acquire these exciting generic products and assets. The
acquisition will align strongly with ANI's strategic focus to grow
our generic pipeline, expand our commercial portfolio, and leverage
our U.S. based manufacturing plants. Importantly, the
acquisition includes several products that compete in exciting
markets including Aspirin/Dipyridamole ER Capsules and
Methylphenidate ER Tablets. Following the close of the
transaction, ANI will immediately begin the work necessary to
pursue the launch of these approved ANDAs, which represent
considerable commercial opportunities. Finally, we are
pleased to have successfully participated in this FTC-related
acquisition and hope to leverage this experience to pursue similar
opportunities in the future."
About Ezetimibe-Simvastatin Tablets
Ezetimibe and simvastatin tablets, which contains a cholesterol
absorption inhibitor and an HMG-CoA reductase inhibitor (statin),
is indicated as adjunctive therapy to diet to:
- reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and
to increase HDL-C in patients with primary (heterozygous familial
and non-familial) hyperlipidemia or mixed hyperlipidemia.
- reduce elevated total-C and LDL-C in patients with homozygous
familial hypercholesterolemia (HoFH), as an adjunct to other
lipid-lowering treatments.
About Desipramine HCl Tablets
Desipramine HCl tablets are indicated for the treatment of
depression.
About Felbamate Tablets
Felbamate tablets are not indicated as a first line
antiepileptic treatment. Felbamate tablets are
recommended for use only in those patients who respond inadequately
to alternative treatments and whose epilepsy is so severe that a
substantial risk of aplastic anemia and/or liver failure is deemed
acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised
of the risk, and has provided written acknowledgement, felbamate
tablets can be considered for either monotherapy or adjunctive
therapy in the treatment of partial seizures, with and without
generalization, in adults with epilepsy and as adjunctive therapy
in the treatment of partial and generalized seizures associated
with Lennox-Gastaut syndrome in children.
About Aspirin/Dipyridamole ER Capsules
Aspirin/Dipyridamole ER Capsules are indicated to reduce the
risk of stroke in patients who have had transient ischemia of the
brain or completed ischemic stroke due to thrombosis.
About Methylphenidate HCl ER Tablets
Methylphenidate HCl ER Tablets are indicated for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD) in children 6
years of age and older, adolescents, and adults up to the age of
65.
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.