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.
- 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.
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.
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.
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For more information about ANI, please contact:Investor RelationsIR@anipharmaceuticals.com
SOURCE ANI Pharmaceuticals, Inc.