Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in a referral procedure regarding the authorization of its extended-regimen oral contraceptive, Seasonique ® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01 mg) tablets) for the prevention of pregnancy. The CHMP concluded that the benefits of Seasonique ® outweigh its risks clearing the way for Seasonique ®’s approval by local health authorities of the European Union (EU) Member States and launch in select countries throughout Europe by the end of 2014. Seasonique ® is an extended regimen birth control option that contains 84 active pills made up of levonorgestrel/ethinyl estradiol and is followed by seven days of ethinyl estradiol tablets. The ethinyl estradiol tablets are used during the seven days, instead of a placebo interval, allowing women to have four scheduled periods a year and potentially lessening the withdrawal symptoms that result from a sudden, sharp decrease in hormones. Seasonique ® is backed by extensive clinical trials and real-world experience, and is more than 99 percent effective when taken as directed. “Seasonique’s approval will allow physicians to prescribe their patients an oral contraceptive that offers less frequent menses and is both safe and effective," noted Rossella Nappi, Associate Professor of Obstetrics and Gynecology, IRCCS Policlinico San Matteo, University of Pavia, Italy and investigator in the Seasonique ® EU study. “Women now starting on oral hormonal contraceptive will be able to choose to have a monthly menstrual period or not.” Data demonstrate that when informed that monthly menses is not medically necessary while on the pill, seven out of 10 women prefer to have fewer periods a year. In fact, a global survey of women in the U.S., Brazil and Germany indicated that a majority of respondents stated a preference to have just four periods a year.
“Teva is pleased with the EMA’s CHMP opinion which allows Seasonique ® to be accessible to more women throughout the world,” said Aine Scibelli, Senior Director, Global Marketing Women's Health. “Many women may not be aware that they can space their periods. Seasonique ® will offer women a new choice in contraception to achieve greater freedom and confidence in their birth control.”Seasonique ® has been available in the United States since 2006, where it gained 25 percent of the market share within two years, and was approved in Chile on 28 November, 2013 and most recently in Brazil on 14 April, 2014. Upon approval, it is expected to be launched in Austria, Slovakia and Poland with additional country launches to follow. About Seasonique ® Seasonique ® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01mg) tablets) is a 91-day extended-regimen oral contraceptive that contains a combination of female hormones that prevent ovulation. Seasonique ® is indicated for the prevention of pregnancy. Seasonique ® tablets are taken daily for three months and each subsequent 91-day pack is started the day after the last tablet of the previous pack. About Teva Teva Pharmaceutical Industries Ltd. (NYSE: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 leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:This release contains forward-looking statements, which 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 develop and commercialize additional pharmaceutical products; competition for our innovative products, especially COPAXONE ® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents); the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; our potential exposure to product liability claims that are not covered by insurance; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.