ANI Pharmaceuticals and Sofgen Announce FDA Approval of Nimodipine 30mg Capsules

Jul 27, 2015, 08:00 ET from ANI Pharmaceuticals, Inc.

BAUDETTE, Minn., July 27, 2015 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that its ANDA collaboration partner Sofgen has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for Nimodipine 30mg Capsules. Trailing twelve-month sales for the product are $25 million, according to IMS Health, with two current competitors.  ANI and Sofgen expect to begin shipping to customers this year.

Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals stated, "This represents ANI's first ANDA approval with our partner Sofgen.  We are excited to have achieved this milestone and look forward to a successful launch."

About Nimodipine Capsules

Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e. Hunt and Hess Grades I-V).

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.

About Sofgen

Sofgen is a company established in Florida as a specialized developer and manufacturer of niche pharmaceutical products with high barriers to entry. Sofgen is part of the Procaps Group, who has a manufacturing network with facilities throughout North and South America, and a wealth of experience in soft capsules and related delivery technologies, servicing customers within the health sector in 50 different countries around the globe. For more information about Sofgen, please visit our web site www.sofgenpharma.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 therefore, 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; 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

 

SOURCE ANI Pharmaceuticals, Inc.



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