BAUDETTE, Minn., March 24, 2020 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP), an emerging leader in
the specialty pharmaceutical industry, today announced that it has
submitted a prior approval supplement (PAS) to the Endocrinology
Division at the FDA for re-commercialization of Purified
Cortrophin® Gel (Repository Corticotropin Injection USP)
(80 U/mL). The current annual market for Cortrophin® Gel is
approximately $950 million and has
only one competitor. Cortrophin® Gel was
originally approved by the FDA in 1954 and last used in patients in
the 1980s. Cortrophin® Gel has over 54 indications on its
previously approved label, including but not limited to acute
exacerbations of multiple sclerosis, rheumatoid arthritis, systemic
lupus erythematosus and ulcerative colitis.
ANI acquired the NDA for Cortrophin® Gel from Merck in January
of 2016 and has spent over four years and over $100 million to re-establish and validate the
commercial corticotropin active pharmaceutical ingredient (API) and
Cortrophin® Gel drug product manufacturing processes. This
effort has included rebuilding a U.S. based supply chain that
includes pig pituitaries, replicating and improving the
manufacturing process for corticotropin API and drug product, and
implementing modernized process controls, analytical methods and
process characterization to ensure compliance with current FDA
standards.
As part of the PAS, ANI has submitted a comprehensive
characterization package which demonstrates an unparalleled
understanding of both the API and Cortrophin® Gel. The drug
has been proven to meet both historical release specifications, as
well as modernized release specifications, to ensure compliance
with current FDA process validation, method validation and Quality
by Design approaches outlined in ICH Guidelines
Q8/Q9/Q10. "We are very pleased to have submitted this
PAS on schedule and in hopes of bringing Cortrophin® Gel back to
the market for both patients and physicians," said Dr. Mark Ginski, Vice President of Corticotropin
Development for ANI.
ANI's Cortrophin® Gel re-commercialization effort represents a
unique opportunity to re-introduce much needed competition, patient
and physician choice and substantial drug cost savings into a U.S.
corticotropin market currently monopolized by Mallinckrodt's H.P. Acthar® Gel. At one point
in the mid to late 20th century, there were over a half-dozen
approved and active corticotropin NDAs; however, all other NDAs,
except for ANI's Cortrophin® Gel and Cortrophin® Zinc, have been
withdrawn and are no longer marketed. In addition, a number
of potential competitors who were developing synthetic
corticotropin products have since ceased development.
Arthur S. Przybyl, ANI's
President and CEO commented, "Cortrophin® Gel represents the last
real hope for potential competition for H.P Acthar® Gel.
ANI's effort to re-commercialize Cortrophin® Gel has led to a
high-quality product that is the result of a robust modernization
plan with unparalleled process characterization and in-process
controls. In the past, these two products competed with each other
and were largely viewed as interchangeable."
ANI has publicly committed to offering Cortrophin® Gel at a
substantial discount when compared to the current price for H.P
Acthar® Gel. ANI's objective is to introduce direct
competition into this $950 million
monopoly and reduce drug costs for the U.S. Government,
specifically Medicare and Medicaid, which is responsible for
approximately 60% of corticotropin spend.
"Today's submission marks a significant milestone for our
company," said Mr. Przybyl. "I am incredibly proud of what
our Cortrophin® Gel team has accomplished over the past 4
years. This drug is truly a transformational opportunity for
ANI."
The FDA has a four-month PDUFA requirement to respond to ANI's
application and determine whether the Cortrophin® Gel PAS
submission is complete and acceptable for approval.
About Purified Repository Cortrophin® Gel
Injection
Purified Cortrophin® Gel has 54 indications on its previously
approved label. 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 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.