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Duramed Pharmaceuticals, Inc. (BRL) Launches LoSEASONIQUE(TM) Oral Contraceptive


5/1/2009 9:08:13 AM

A New Lower-Dose, Extended-Cycle Oral Contraceptive for the Prevention of Pregnancy

WOODCLIFF LAKE, N.J., April 30 /PRNewswire/ -- Duramed Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd., announces the launch of its marketing campaign for LoSEASONIQUE(TM) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg), a new low-dose extended-cycle oral contraceptive. It is currently available to women by prescription from their healthcare provider. LoSEASONIQUE(TM) is the latest addition to the extended-cycle oral contraceptive category introduced by Duramed in 2003, which includes Seasonique(R).

"The launch of LoSEASONIQUE(TM) demonstrates our commitment to providing women who are seeking oral contraception with even more options to have fewer scheduled periods," stated Amy Niemann, General Manager and Senior Vice President, Women's Health, at Duramed Pharmaceuticals. "Women want options when it comes to birth control and we will continue to provide innovative products to meet their needs."

While patients taking LoSEASONIQUE get four periods a year, they're also more likely to have bleeding or spotting between periods. This can range from light spotting to a flow like a regular period and should decrease over time.

The Duramed Contraceptive sales force will begin introducing LoSEASONIQUE(TM) to healthcare providers in April. In addition, Duramed will launch a marketing campaign to educate healthcare providers and patients about the product. For information about LoSEASONIQUE(TM) including full prescribing information visit www.loseasonique.com.

LoSEASONIQUE(TM)

On the LoSEASONIQUE(TM) extended-cycle regimen, women take combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84 consecutive days, followed by 0.01 mg ethinyl estradiol tablets for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.

The clinical data supporting the LoSEASONIQUE(TM) NDA resulted from one large, multi-center, open label clinical trial that evaluated the safety and efficacy of LoSEASONIQUE(TM) . The trial involved approximately 2,200 patients between the ages of 18-41 at 56 sites in the United States. Patients were enrolled in the pivotal trial for the duration of 12 months (four (4) 91-day cycles).

LoSEASONIQUE(TM) is the first Duramed product launched in the US since the acquisition by Teva in December 2008. The combination of these two companies and launch of LoSeasonique(TM) firmly establishes its leadership role in women's healthcare.

Safety Information

LoSEASONIQUE(TM) tablets are indicated for the prevention of pregnancy. While you get 4 periods a year you're more likely to have bleeding or spotting between periods. This can be slight to a flow like a regular period and should decrease over time. Like other birth control pills, prescription LoSEASONIQUE(TM) has serious risks including blood clots, stroke and heart attack. Smoking increases these risks, especially if you're over 35. If you've ever had any of these conditions, certain cancers, or if you could be pregnant, you should not take the Pill. The Pill does not protect against HIV or STDs.

For more information, please visit www.loseasonique.com.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

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(R), Lotrel(R) and Protonix(R), the current economic conditions, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the effects of competition on our innovative products, especially Copaxone(R) sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals, Inc., the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, 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").

CONTACT: Denise Bradley, Teva North America, +1-215-591-8974,
denise.bradley@tevausa.com

Web site: http://www.loseasonique.com/


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