BAUDETTE, Minn., Oct. 3, 2019 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the
receipt of clinical data on Cortrophin® Gel (80 units/mL) from
a study that evaluated the blood-level cortisol response in a
20-person healthy volunteer population.
Key results:
- The results indicate that ANI's Cortrophin® Gel (80 units/mL)
is effective for its intended use.
- In addition, the clinical data demonstrate that ANI's
modernized Cortrophin® Gel (80 units/mL) drug product has a
cortisol response profile consistent with that observed in
historical scientific literature that evaluated Cortrophin® Gel (44
units/mL) drug product manufactured in the 1960s (Brombacher et.
al, 1969).
- No adverse safety events to be reported and minor events were
as expected.
The final data set from this study will be locked on
October 25, 2019.
Arthur S. Przybyl, ANI's
President and CEO commented, "These results represent a significant
milestone for ANI in our re-commercialization effort for
Cortrophin® Gel. In conjunction with our positive
results in process and product characterization at commercial
scale, method development and validation, release of clinical
material and viral clearance, I believe this study demonstrates
that we have successfully reproduced the Cortrophin® Gel drug
previously manufactured in the 1990s. As such, I believe we
will have an approvable drug product. We are excited to submit the
Cortrophin® Gel comprehensive supplemental NDA filing currently
planned for March 2020."
About Purified Cortrophin® Gel
Cortrophin® Gel is purified corticotropin (ATCH) manufactured in
sterile gelatin to allow prolonged activity. The product
stimulates the functioning adrenal cortex to produce and secrete
adrenocortical hormones.
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.