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FDA Approves Seasonale (Levonorgestrel/Ethinyl Estradiol) Extended-Cycle Oral Contraceptive

WOODCLIFF LAKE, NJ -- September 8, 2003 -- Barr Laboratories, Inc. (NYSE: BRL) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Seasonale® (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets, an extended-cycle oral contraceptive for the prevention of pregnancy. Seasonale, the first and only FDA-approved extended-cycle oral contraceptive, will be available by prescription to women at the end of October 2003.

To view the Multimedia News Release, complete with video, audio, and Hi-Res images, go to: http://www.prnewswire.com/mnr/Seasonale/11206/

The Seasonale regimen is designed to reduce the number of periods from 13 to 4 per year. Seasonale is a 91-day regimen taken daily as 84 active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol, followed by 7 inactive tablets. By contrast, oral contraceptive products currently available in the United States are based on a 28-day regimen.

"The Seasonale approval represents several 'firsts' for Barr. It is our first internally developed New Drug Application (NDA) product to gain FDA approval and we believe that it represents a significant advance in oral contraception," said Bruce L. Downey, Barr's Chairman and CEO. "The development of our Seasonale product underscores Barr's commitment to women's health care, especially in the area of oral contraception. It is the first of what we believe will be several additional new drug applications for women's healthcare products over the next several years." Seasonale was developed by Barr under an agreement with Eastern Virginia Medical School (EVMS).

"With today's approval of Seasonale, women have a new choice when deciding on oral contraception," said Carole S. Ben-Maimon, M.D., President and COO of Barr Research. "For those women who prefer the convenience of fewer periods, Seasonale offers a safe and effective alternative to the traditional 28-day oral contraceptive regimen."

The Company's 250-person Duramed Pharmaceuticals, Inc. women's healthcare sales force will promote the Seasonale oral contraceptive directly to physicians and healthcare providers. Duramed is a wholly owned subsidiary of Barr Laboratories, Inc., resulting from the 2001 merger of Barr and Duramed. The Duramed sales force currently promotes Cenestin® (Synthetic Conjugated Estrogens, A).

Clinical Data

The clinical data supporting FDA approval of the Seasonale (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets product resulted from a randomized, open-label, multi-center trial that ended in March 2002 and an extension to that trial. In the trials, Seasonale was found to prevent pregnancy and had a comparable safety profile to a more traditional oral contraceptive. In the trial, the most reported adverse events were nasopharyngitis, headache and intermenstrual bleeding or spotting.

Seasonale has been formulated using well-established components, long recognized as safe and effective when used in a 28-day regimen. Seasonale offers 4 periods per year as compared to 13 per year with traditional oral contraceptives. When prescribing Seasonale, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting. A recently published Roper study found that when given the choice, nearly two-thirds of women would be interested in reducing their number of periods to 4 times per year (1).

Important Information About Oral Contraceptives

It is estimated that more than 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious risks associated with birth control pills that can be life threatening include blood clots, stroke and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35.

Women who use oral contraceptives should not smoke. Some women should not use birth control pills, including women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding, and those who are or may be pregnant. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases. Use of Seasonale provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (an additional 9 weeks per year). While this added exposure may pose an additional risk of thrombotic and thromboembolic disease, studies to date with Seasonale have not suggested an increased risk of these disorders.

Cenestin® is a registered trademark of Barr Laboratories, Inc.

Reference: (1) Roper ASW Survey, February 2003, Table 8.


SOURCE: Barr Laboratories, Inc.

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