FDA Approves Seasonique
FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive
May 27, 2006 -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy. Seasonique represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the Seasonale extended-cycle oral contraceptive in 2003.
Seasonique will be shipped to trade customers and will be available by prescription to women in July 2006. The Company intends to immediately initiate multiple marketing programs aimed at healthcare providers and patients. The Company will initiate full scale detailing for Seasonique to healthcare providers in August using its Duramed Sales Forces. Information about Seasonique will be available at http://www.seasonique.com.
"Seasonique joins Seasonale in offering American women a new option in extended-cycle oral contraception," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "The science involving extended-cycle oral contraceptives continues to evolve and Seasonique represents an exciting and unique development in this category. Seasonique provides continuous hormonal support in the form of a low-dose of estrogen in place of the seven placebo pills. There is no other product like Seasonique on the market today."
Downey continued, "We believe that our Seasonique product line, including our Lo Seasonique product that is currently in Phase III clinical studies, as well as other extended-cycle oral contraceptive products also in development, expands our commitment and leadership to a franchise that provides women with the option of four periods per year and low dose estrogen instead of a hormonal free interval."
The Company's application for Seasonique had received an Approvable Letter in August 2005. In March 2006, the FDA notified the Company that it had determined that additional clinical studies would not be required to support the approval of Seasonique. Following this notification, the Company submitted product labeling that has now gained approval.
Under the Seasonique extended-cycle regimen, women take active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year. The clinical data supporting the Seasonique NDA resulted from one large pivotal randomized, open-label, multi-center trial and one supportive randomized, open-label, multi-center trial, both of which ended in April 2004. The trials involved approximately 2,500 female patients between the ages of 18-40 at 43 sites in the United States. Patients were enrolled in the pivotal trial for the duration of 12 months (four (4) 91-day cycles).
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.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. The Company is the leading marketer and manufacturer of oral contraceptive products in the United States, based on industry data. The Company currently markets 22 generic oral contraceptive products under its Barr Laboratories, Inc. label and six proprietary (branded) oral contraceptive under the Duramed Pharmaceuticals, Inc. label.
Forward-Looking StatementsExcept for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: 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 outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; 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 on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; 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 our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Barr Pharmaceuticals, Inc.
Posted: May 2006
- Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive - March 17, 2006
- Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive - August 18, 2005
- Duramed's Seasonique NDA Accepted for Filing by FDA - December 22, 2004