BAUDETTE, Minn., June 18, 2014 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has signed an exclusive license and supply agreement with Dexcel Pharma Technologies Ltd. ("Dexcel") for an ANDA drug product. Dexcel submitted the ANDA application in December 2011. Dexcel will be responsible for obtaining FDA approval and manufacturing the product, and ANI Pharmaceuticals will be responsible for marketing and distribution in the U.S. The product generates combined brand and generic annual U.S. sales of approximately $80 million, per IMS Health. Financial terms of the agreement were not disclosed.
Arthur S. Przybyl, ANI's President and CEO stated, "I am pleased to have entered this collaboration project with Dexcel. This partnership is aligned with our strategy of augmenting ANI's internal generic product development efforts with acquisitions and partnerships for late stage ANDA products and mature brands."
ANI Pharmaceuticals, Inc. (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 Dexcel Pharma Dexcel Pharma is a private international specialty pharmaceutical group, dedicated to the development, manufacturing and commercialization of novel drug formulations and complex generics. Dexcel Pharma has a broad portfolio of branded and generic products, sold in more than 30 countries worldwide. Dexcel Pharma was established in 1968 and is headquartered in Israel. 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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include, but are not limited to, statements about the potential benefits of the recent Merger, the effect of price increases, the Company's plans, objectives, expectations and intentions with respect to future operations and products and the timing or success of the introduction thereof, the anticipated financial position, operating results and growth prospects of the Company, the value of the Company's pipeline or the size of 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. Forward-looking statements by their nature address matters that are, to different degrees, subject to change. You should not place undue reliance on those statements because they are subject to numerous uncertainties, risks and other factors relating to the Company's operations and business environment and other factors, all of which are difficult to predict and many of which are beyond the Company's control.