Teva Receives European Marketing Authorization for ZOELY™ Oral Contraceptive
-- New OC Offers Innovative Combination which Includes a Natural Estrogen in a Convenient Dosing Regimen --
-- Teva Holds Marketing Rights in Four Key European Countries --
-- Launch Expected Before End 2011 --
Unlike currently available contraceptive pills, ZOELY™ is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of 2 steroid hormones; 17-beta estradiol, an estrogen that is structurally identical to the major estrogen produced by the ovaries of healthy non-pregnant women, and nomegestrol acetate, a highly selective progesterone-derived progestin. This innovative combination will be made available in a convenient 24 day active and 4 day placebo dosing regimen.
“The EU Marketing Authorization for ZOELY™ marks an important step in creating a strong women’s healthcare franchise for Teva in Europe,” said Dr
Teva holds exclusive marketing rights for ZOELY™ in
The approval of ZOELY™ applies to the 27 EU Member States plus
About Teva
Teva’s Safe Harbor Statement under the
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 version of Protonix®, 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 Cephalon), 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
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