PITTSBURGH, Aug. 6 /PRNewswire-FirstCall/ — Mylan Inc. announced today that it has completed an agreement with Famy Care Ltd, a global, India-based manufacturing leader of women’s health care products, to develop and supply 22 oral contraceptive (OC) medicines to customers in the United States. The agreement also provides Mylan with a right of first refusal for additional oral contraceptive products and certain additional markets, including Australia and Japan, where Mylan has a significant presence. Terms of the agreement were not disclosed.
“Through our partnership with Famy Care, we have met another longstanding commitment by expanding our portfolio to create a women’s health care franchise for Mylan,” said Mylan Vice Chairman and CEO Robert J. Coury. “We anticipate filing ANDAs as early as the next few months and beginning to commercialize them in 2010.
“After working on this initiative for some time, we have found an outstanding partner in Famy Care, the world’s largest manufacturer of oral contraceptives. Famy Care is a well-established and well-respected global company, deeply committed to quality and customer satisfaction. We’re delighted to have completed this agreement with an organization considered a world leader in generic contraceptives, and we look forward to bringing these OC medicines to U.S. customers as quickly as possible.”
“We discussed aligning Famy Care with a number of highly qualified companies, but Mylan clearly became the partner-of-choice,” said Sanjeev Taparia, Famy Care’s managing director. “We based our decision on Mylan’s strong presence in the United States, expanded global commercial footprint and its high quality and customer service standards. Mylan is well-positioned to help us achieve the vast potential we see in our diverse women’s health care product portfolio.”
Currently, total U.S. OC market sales are approximately $3.3 billion, according to IMS. Of the 42 OC products available, 31 are sold generically. OCs are dispensed primarily in retail pharmacies, although certain clinic channels, such as Planned Parenthood, are important, particularly for new customers.
Based in Mumbai, India, Famy Care manufactures a wide range of reproductive health care products, including oral and emergency contraceptives, intra-uterine devices (IUDs) and tubal ligation rings. Incorporated in 1990, the company exports its products to more than 50 countries on four continents. The company has established strong manufacturing and R&D capabilities with state-of-the-art facilities throughout India.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest – and highest quality — product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
This press release includes statements that constitute “forward-looking statements,” including with regard to Mylan’s agreement with Famy Care and the anticipated ANDA filings and product commercializations. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks inherent in product development and regulatory matters; the effect of any changes in customer and supplier relationships and customer purchasing patterns; changes in third-party relationships; the impacts of competition; changes in economic and financial conditions of the Company’s business; and uncertainties and matters beyond the control of management. These cautionary statements should be considered in connection with any subsequent written or oral forward-looking statements that may be made by the Company or by persons acting on its behalf and in conjunction with its periodic SEC filings. In addition, please refer to the cautionary statements and risk factors in the Company’s Form 10-Q for the quarter ended March 31, 2008, and in its other filings with the SEC. The Company undertakes no obligation to update statements herein for revisions or changes after the date of this release.
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Web site: http://www.mylan.com/