ANI Pharmaceuticals Expands Branded Products Portfolio Through Acquisition of Sandoz Inc. NDAs
April 06 2021 - 6:50AM
Business Wire
-- Accretive transaction in line with growth
strategy laid out for Branded Products business --
ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ:ANIP) today announced
that it has acquired the new drug applications (“NDAs”) for
OXISTAT® Lotion, VEREGEN® Ointment, and Pandel® Cream and the
abbreviated new drug application (“ANDA”) for ApexiCon® E Cream
from Sandoz Inc. Pandel® Cream will be transitioned later upon
receiving the requisite approvals. Collectively, these products
generated net revenues of $13.2 million in 2020. The acquisition
was funded through borrowings under the Company’s pre-existing
revolver credit facility.
In conjunction with the acquisition, ANI and Sandoz have entered
into a multi-year manufacturing and supply agreement for OXISTAT®
Lotion, Pandel® Cream and ApexiCon® E Cream. ANI intends to
transfer the manufacture and packaging of these three products to
its own manufacturing sites in the future.
“This acquisition is in line with our strategy to expand our
established brands business through accretive deals. Importantly,
ANI will ensure that patients in need continue to receive these
high-quality dermatology products. The acquisition leverages our
innovative brand commercialization infrastructure and our North
American manufacturing footprint,” stated Nikhil Lalwani, President
and CEO.
The Company previously shared the four pillars of its strategy
for delivering sustainable future growth:
- Build a successful Cortrophin franchise;
- Strengthen the Generics business by enhancing development
capabilities and increased focus on niche opportunities;
- Maximize the value from established brands through programmatic
business development and innovative access and go-to-market
strategies; and
- Expand CDMO business leveraging unique North American-based
manufacturing capabilities.
About OXISTAT® (oxiconazole nitrate) Lotion 1%
OXISTAT Lotion is indicated for the topical treatment of the
following dermal infections: tinea pedis, tinea cruris, and tinea
corporis due to Trichophyton rubrum, Trichophyton mentagrophytes,
or Epidermophyton floccosum.
About Pandel® (hydrocortisone probutate) Cream 0.1%
Pandel is a corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in patients 18 years of age or
older.
About VEREGEN® (sinecatechins) Ointment 15%
VEREGEN is a topical ointment indicated for the treatment of
external genital and perianal warts (Condylomata acuminata) in
immunocompetent patients 18 years and older.
About ApexiCon® E Cream (diflorasone diacetate cream USP
0.05% [emollient])
ApexiCon E Cream is a topical corticosteroid indicated for
relief of the inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
For more information, including the complete list of indications
and usages, please see the Full Prescribing Information.
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 the Company's strategy, 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 transitioning these products; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210406005249/en/
Investor Relations: Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793 E: lwilson@insitecony.com
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