Barr Begins Detailing SEASONALE(R) to Physicians and Healthcare Providers
Tuesday, November 18, 2003 10:30 AM ET Printer-friendly version
Promotional Activities, Education Campaign Support First and Only Extended-Cycle Oral Contraceptive
WOODCLIFF LAKE, N.J., Nov. 18 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. (NYSE: BRL, news) today announced that it has begun promoting SEASONALE® (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets directly to physicians and other healthcare providers. SEASONALE is the first and only FDA-approved extended-cycle oral contraceptive indicated for the prevention of pregnancy and designed to reduce periods from 13 to 4 per year. The Company has initiated physician detailing and promotional activities using the 250-person Duramed Pharmaceuticals, Inc. Women's Healthcare Sales Force. Duramed is a wholly owned subsidiary of Barr Laboratories, Inc.
The Company began shipping SEASONALE in mid-October. Promotional Programs directed to physicians include a variety of patient education initiatives, various medical education programs and a publication plan that includes journal advertising. Women and healthcare professionals who would like to learn more about SEASONALE, including full prescribing information, should visit seasonale.com or call the toll-free number 800-719-FOUR (3687).
"We are excited to begin marketing this new choice in oral contraception to healthcare providers and patients through extensive promotional activities and an education campaign," Bruce L. Downey, Barr's Chairman and CEO said. "Our market research indicates that the extended-cycle regimen represents a substantial opportunity with patients and we believe that the already high awareness of SEASONALE will be even higher among target physicians and patients following the launch of our promotional activities and detailing by our Women's Healthcare Sales Force."
"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 and is designed to reduce the number of periods from 13 to 4 per year," explained Dr. Carole S. Ben-Maimon, President and Chief Operating Officer of Barr Research. "With SEASONALE, women now have an FDA-approved, safe and effective alternative to the traditional 28-day oral contraceptive regimen."
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.
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 as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and 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. The convenience of fewer menses (4 vs. 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding/spotting.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Forward-Looking Statements
The following sections contain a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission.
Source: Barr Laboratories, Inc.
Contact: Carol A. Cox, Barr Laboratories, Inc., +1-201-930-3720, ccox@barrlabs.com |
