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ANI Pharmaceuticals Expands Injectable Portfolio with Distribution Agreement for FDA Approved Injectable Product


BAUDETTE, Minnesota (April 15, 2019) - ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that it has entered into a Distribution Agreement with a U.S. based injectable manufacturer to commercialize a unique specialty injectable product. Key terms of the 10-year Agreement include cumulative milestones of up to $2M, payable by ANI. Upon launch, ANI will receive a 50% share of net profits generated from product revenues. The product, for which there are currently no other generics commercially available, recently received FDA approval. The product will be commercialized in the ANI label.

ANI’s President and CEO, Arthur S. Przybyl, commented, "With today's announcement we have added a second specialty injectable product to our pipeline, the first product being Cortrophin Gel. We are excited to further expand into injectable dosage form drug products. We believe injectables represent future growth opportunities for ANI and as such we intend to pursue additional investments in the injectable space. These investments could be in the form of acquisitions, joint ventures and partnerships and may include vertical integration into injectable sterile manufacturing."

About ANI

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

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

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