Full Press Release Details
ANI Pharmaceuticals Expands Branded Products
Portfolio Through Acquisition of Sandoz Inc. NDAs
-- Accretive transaction in line with growth strategy
laid out for Branded Products business --
Minnesota (April 6, 2021) - 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:
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])
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.
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.
Lisa M. Wilson, In-Site Communications, Inc.
SOURCE: ANI Pharmaceuticals, Inc.