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Committee for Medicinal Products for Human Use (CHMP) Issues Positive Opinion for New Contraception Offering, NOMAC-E2

^{Published on 2011-03-18 05:51:24 - Market Wire}
 

UTRECHT, Netherlands & WHITEHOUSE STATION, N.J.--([ BUSINESS WIRE ])--Teva Pharmaceuticals Europe BV, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and MSD (known as Merck in the United States and Canada) (NYSE:MRK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for NOMAC-E2 (nomegestrol acetate 2.5 mg /17-estradiol 1.5 mg) an investigational monophasic combined oral contraceptive (COC) tablet indicated for the use by women to prevent pregnancy. NOMAC-E2 is a birth control pill that contains 2 steroid hormones nomegestrol acetate, a highly selective, progesterone-derived progestin and 17-beta estradiol (E2), an estrogen that is similar to the one naturally present in a womana™s body. The next step for marketing authorization is review by the European Commission.

"If approved, NOMAC-E2 has the potential to expand women's choices in contraception by providing another oral contraceptive offering and is the result of a fruitful collaboration with MSD."

"We are pleased with CHMPa™s recommendation to approve NOMAC-E2a, said Christophe Hubert, managing director of Th©ramex and vice-president Womena™s Health Teva Europe. aIf approved, NOMAC-E2 has the potential to expand women's choices in contraception by providing another oral contraceptive offering and is the result of a fruitful collaboration with MSD.a

"The achievement of this milestone highlights the strong collaborative relationship we have established with our colleagues at Th©ramex, now part of Teva,a said Terrie Curran, general manager and global franchise head, Women's Health at MSD. "This underscores our ongoing commitment to developing therapies that help improve the health of women worldwide."

The CHMP issued a positive opinion following a review of comprehensive data supporting the efficacy, safety and tolerability profile of NOMAC-E2 (nomegestrol acetate/17-estradiol). Should marketing authorization from the European Commission be granted, it will apply to all 27 European Union (EU) Member States plus the EEA-EFTA states (Iceland, Liechtenstein and Norway).

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in approximately 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva's leading innovative product, Copaxone^®, is the number one prescribed treatment for multiple sclerosis. Teva employs more than 40,000 people around the world and reached $16.1 billion in net sales in 2010.

About MSD

Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships

Teva's Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin^®, Lotrel^®, Protonix^® and Yaz^®, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone^® (including potential generic and oral competition for Copaxone^®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of ratiopharm), interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC")

MSD Forward-Looking Statement

This news release includes aforward-looking statementsa within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined companya™s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Mercka™s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Mercka™s ability to accurately predict future market conditions; dependence on the effectiveness of Mercka™s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Mercka™s 2010 Annual Report on Form 10-K and the companya™s other filings with the Securities and Exchange Commission (SEC) available at the SECa™s Internet site ([ www.sec.gov ]).

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