Oakrum Pharma and ANI Pharmaceuticals Announce the Launch of Betaine Anhydrous Powder, the first Generic Version of Cystadane® (betaine anhydrous for oral solution) Powder, Including 180 Days of Exclusivity

Rhea-AI Summary

On February 14, 2022, ANI Pharmaceuticals (NASDAQ: ANIP) announced FDA approval for a generic version of Cystadane® (betaine anhydrous) powder, with shipments starting in early February. This approval grants ANI 180 days of exclusivity under Competitive Generic Therapy. CEO Nikhil Lalwani emphasized the company's commitment to serving underserved rare disease patients and expanding its product lineup, which includes seven additional ANDAs filed with the FDA. This marks ANI's third generic orphan drug launch, enhancing its position in the pharmaceutical market.

Positive

• FDA approval for generic Cystadane enhances ANI's product portfolio.
• 180 days of exclusivity under Competitive Generic Therapy boosts market position.
• Collaboration with Oakrum Pharma adds to ANI's commitment to underserved patients.

Negative

• None.

SAINT LOUIS, Feb. 14, 2022 /PRNewswire/ -- Oakrum Pharma, LLC ("Oakrum Pharma"), in collaboration with ANI Pharmaceuticals (NASDAQ: ANIP), announce that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane®¹ (betaine anhydrous for oral solution) Powder in a 180 gm bottle and granted Competitive Generic Therapy (CGT) of 180 days of exclusivity.  Shipments of the generic product began in early February, 2022.

Marco Polizzi, CEO of Oakrum Pharma, stated, "This is the third generic orphan drug that we have launched since starting this business, and we remain committed to bringing rare disease patients affordable options of pharmaceutical products that currently have few or no generic options.  Oakrum currently has licensing rights to seven additional ANDAs filed with the FDA and expects to file additional generic orphan drugs later this year."

"Our collaboration with Oakrum furthers ANI's mission of bringing high-quality prescription pharmaceutical products to patients in need. Rare diseases are often overlooked, and we are especially pleased to continue identifying patient populations that are underserved and medicines that can help them. This approval with Competitive Generic Therapy status and resulting 180 days of exclusivity marks another milestone for ANI's R&D engine as a leader in bringing limited competition products to market," stated Nikhil Lalwani, CEO of ANI Pharmaceuticals.

¹ Cystadane® is a licensed trademark of Recordati Rare Diseases Inc.

About Oakrum Pharma, LLC 
Oakrum Pharma, LLC is a privately-owned biopharmaceutical company focusing on development and commercialization of affordable drug therapies. For more information, visit www.oakrumpharma.com.

About ANI Pharmaceuticals
ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information, please visit www.anipharmaceuticals.com.

Oakrum's Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Oakrum Pharma are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Oakrum Pharma intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Oakrum Pharma's actual results to be materially different from its historical results or from any results expressed or implied by said statements. Oakrum Pharma's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions and the need for regulatory approvals, Oakrum Pharma's ability to fund development of its technology and to successfully complete clinical trials, the length of time and costs required to complete clinical trials and to submit applications for regulatory approvals, products developed by competing companies, commercial acceptance of Oakrum Pharma's products, and other factors. Oakrum Pharma is not responsible for updating events occurring after the date of this press release.

ANI's 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, those relating to the development, manufacturing and commercialization of the product and any additional product launches from the Company's generic pipeline, 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; competition from other products; 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 ("SEC"), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. 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.

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SOURCE Oakrum Pharma, LLC

FAQ

What is the significance of the FDA approval for ANI Pharmaceuticals (ANIP)?

The FDA approval allows ANI Pharmaceuticals to launch a generic version of Cystadane, enhancing their product offerings and providing 180 days of market exclusivity.

When did shipments of the generic Cystadane begin for ANI Pharmaceuticals (ANIP)?

Shipments of the generic Cystadane started in early February 2022.

What does the Competitive Generic Therapy status mean for ANI Pharmaceuticals (ANIP)?

The Competitive Generic Therapy status grants ANI Pharmaceuticals 180 days of exclusivity, allowing them to market the generic product without competition during that period.

How many ANDAs does ANI Pharmaceuticals (ANIP) have filed with the FDA?

ANI Pharmaceuticals currently has licensing rights to seven additional ANDAs filed with the FDA.