-- NOMAC-E2* is an Investigational Oral Combination Contraceptive Pill --
JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) 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, an investigational contraceptive pill combining 1.5 mg of 17-beta-estradiol with 2.5 mg of nomegestrol acetate in a 24/4 monophasic regimen.
Unlike currently available contraceptive pills, NOMAC-E2 is a monophasic regimen containing an estrogen which is structurally identical to the major estrogen produced by the ovaries of healthy non pregnant women, combined with a selective progesterone analogue (nomegestrol acetate).
“We are pleased with CHMP’s recommendation to approve NOMAC-E2”, said Gerard van Odijk, President and CEO Teva Europe. “NOMAC-E2, which became part of our innovative pipeline following the acquisition of Théramex, has the potential to expand women's choices in contraception by providing a unique oral contraceptive offering with natural estrogen in a modern regimen. If approved, NOMAC-E2 will provide an important addition to Teva’s women’s health product portfolio and will advance our efforts to expand our women's health franchise globally”.
The CHMP issued its positive opinion following a review of data derived from clinical trials evaluating NOMAC-E2.
If approved for marketing by the European Commission, NOMAC-E2 will be marketed by Teva/Théramex in select European markets.
*NOMAC-E2 stands for nomegestrol acetate/17 beta estradiol combination.
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 1,450 molecules and a direct presence in about 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 approximately 40,000 people around the world and reached $16.1 billion in net sales in 2010.
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 Gemzar®, 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.
Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
Teva North America
Kevin C. Mannix, 215-591-8912
Teva Pharmaceutical Industries Ltd.
Yossi Koren, 972 (3) 926-7687
Teva North America
Denise Bradley, 215-591-8974
KEYWORDS: United States North America New York Middle East Israel
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical Other Health