BAUDETTE, Minn., Jan. 17, 2017 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the appointment of Karen Quinn Ph.D as Vice President Corticotropin Regulatory Affairs, effective January 17, 2017.
Karen Quinn is a professional with over 30 years of leadership experience in Global Regulatory Affairs, specifically with a focus on drug products with biologically-derived active pharmaceutical ingredients. Dr. Quinn worked most recently with Takeda Pharmaceuticals International as Senior Director, Global Regulatory Affairs/CMC and Head of the Biologics Group. Dr. Quinn has also held various global regulatory affairs positions with The Dow Chemical Company, Proctor & Gamble Pharmaceuticals, Solvay Pharmaceuticals, Wyeth Pharmaceuticals and Millennium Pharmaceuticals.
Arthur S. Przybyl, ANI's President and Chief Executive Officer, stated, "I am pleased that Karen has joined ANI to help lead the advancement of our most exciting pipeline opportunity, which is the re-commercialization of our Corticotrophin NDAs. ANI intends to continue to expand resources devoted to this project as we enter what is going to be a very important year for development of our Corticotropin products."
Mark Ginski, ANI's Vice President of Corticotropin Product Development, stated, "I am confident that Karen's highly relevant regulatory affairs experience will bring valuable insight to the Corticotropin project. More specifically, Karen has led regulatory efforts that resulted in the successful FDA approval for an older biologically-derived drug product when it was demonstrated that it met updated FDA requirements for effectiveness, safety and manufacturing consistency."
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.
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.
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SOURCE ANI Pharmaceuticals