WOODCLIFF LAKE, N.J., Aug. 18 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has issued an Approvable letter for Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE(TM) (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. To achieve final approval, the FDA has requested that the Company provide additional data to support SEASONIQUE's unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen. Once approved, the Company intends to market SEASONIQUE for the prevention of pregnancy in women who choose to take hormone products for contraception.
"We are pleased that the Agency has determined that our SEASONIQUE extended-cycle oral contraceptive product is approvable for the prevention of pregnancy, which was the clinical endpoint of our original study," said Bruce L. Downey, Barr's Chairman and CEO. "We intend to seek a meeting with the Agency within the next 30 days to discuss our on-going studies of SEASONIQUE and how they might satisfy FDA's request for additional information. We are confident that we can provide the information requested in the Agency's approvable letter."
The Company is committed to the extended-cycle oral contraceptive category it created with the launch of the SEASONALE(R) extended-cycle oral contraceptive in 2003. Over 1 million prescriptions have been written for SEASONALE since launch. In addition to SEASONIQUE, the Company's pipeline of extended-cycle oral contraceptive products also includes a NDA currently pending at the FDA for SEASONALE(R) Lo (levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets) extended-cycle oral contraceptive.
Under the SEASONIQUE extended-cycle regimen, women take active tablets of 0.15 mg 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). An extension study of the pivotal trial is currently ongoing.
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 five proprietary (branded) oral contraceptive products under the Duramed Pharmaceuticals, Inc. label.
Except 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, 2004.
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.