ANI Pharmaceuticals Announces FDA Acceptance of Purified Cortrophin® Gel Supplemental New Drug Application for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis, and Nephrotic Syndrome

Rhea-AI Summary

ANI Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application for Purified Cortrophin Gel. This is a significant milestone with a target action date set for October 29, 2021. The company plans to launch this second ACTH-based treatment, which is vital for patients with chronic autoimmune disorders like multiple sclerosis and rheumatoid arthritis. ANI Pharmaceuticals aims to strengthen its market position through this new drug while continuing to enhance its generics business.

Positive

• FDA accepted the sNDA for Purified Cortrophin Gel, indicating progress towards approval.
• Potential to offer a much-needed treatment option for patients with chronic auto-immune disorders.

Negative

• Approval is still pending with a target date of October 29, 2021, indicating uncertainty until then.
• The market for Cortrophin Gel may face competition from existing treatments.

-- Prescription Drug User Fee Act (“PDUFA”) target action date is October 29, 2021 --

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq:ANIP) today announced that the Company’s supplemental New Drug Application (“sNDA”) for Purified Cortrophin^® Gel (“Cortrophin Gel”) has been accepted by the U.S. Food and Drug Administration (“FDA”) for review.

“FDA’s acceptance of our sNDA for Cortrophin Gel marks a significant milestone for ANI. With a PDUFA target action date of October 29, 2021, we are one step closer to bringing a much-needed product to patients and healthcare providers. We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel,” stated Nikhil Lalwani, Chief Executive Officer of ANI Pharmaceuticals.

Chris Mutz, Chief Commercial Officer and Head of Rare Disease of ANI Pharmaceuticals, stated, “The availability of a second corticotropin – or ACTH-based – treatment is meaningful for patients struggling with the devastating consequences of chronic auto-immune disorders, including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.”

About Purified Cortrophin Gel

Purified Cortrophin Gel (Repository Corticotropin Injection USP) is a purified adrenocorticotropic hormone (ACTH) previously approved in the U.S. for multiple indications including multiple sclerosis (MS), rheumatoid arthritis (RA), and nephrotic syndrome (NS).

About ANI

ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words 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. These forward-looking statements include statements regarding the timing of approval of our sNDA for Cortrophin Gel, the clinical development of Cortrophin Gel, and the potential benefit of Cortrophin Gel to patients and size of the market opportunity to the Company if approved by the FDA. Risks and uncertainties that may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements include, but are not limited to, uncertainties inherent in the development of pharmaceutical products, ANI’s reliance on third parties over which it may not always have full control, costs and regulatory requirements relating to contract manufacturing arrangements, delays or failure in obtaining product approvals from the FDA, increased competition and strategies employed by competitors, uncertainties regarding the COVID-19 pandemic, market trends for our products, regulatory environment and changes, regulatory and other approvals related to product development and manufacturing, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the U.S. Securities and Exchanges Commission.

Any 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. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210831005322/en/

Investors:

Lisa M. Wilson, In-Site Communications, Inc.

212-452-2793

lwilson@insitecony.com

Media:

Sherry Korczynski, ANI Pharmaceuticals, Inc.

412-215-4333

sherry.korczynski@anipharmaceuticals.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is ANI Pharmaceuticals' latest announcement regarding Cortrophin Gel?

ANI Pharmaceuticals announced that the FDA accepted their supplemental New Drug Application for Purified Cortrophin Gel.

What is the PDUFA target action date for Cortrophin Gel?

The PDUFA target action date for Cortrophin Gel is October 29, 2021.

What are the potential benefits of Purified Cortrophin Gel?

Purified Cortrophin Gel may provide a critical treatment option for patients suffering from chronic autoimmune disorders.

How might the acceptance of Cortrophin Gel impact ANI Pharmaceuticals' stock?

The acceptance of Cortrophin Gel could positively influence ANI's stock by enhancing its market position and growth potential.

What challenges does ANI Pharmaceuticals face with Cortrophin Gel?

The approval is pending, and there may be competition from existing ACTH-based treatments.