WOODCLIFF LAKE, N.J., April 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Duramed Pharmaceuticals, Inc., has withdrawn its New Drug Application (NDA) for Lo SEASONALE(R) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg) extended-cycle oral contraceptive for the prevention of pregnancy in women who choose to take hormone products.
The decision to withdraw the application resulted from the Company's ongoing discussions with the U.S. Food & Drug Administration (FDA) regarding the Lo SEASONALE NDA and the discussions for its SEASONIQUE(TM) (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. Based on those discussions, the Company has concluded an additional, larger clinical trial may be necessary to support continued consideration of the Lo SEASONALE application.
"Our continued communication with the Agency resulting in part from the review of our SEASONIQUE application has provided us with better insight on the magnitude of clinical trials necessary to support our expansion of the extended-cycle oral contraceptive product franchise," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "Rather than continue to devote additional resources to the Lo SEASONALE NDA, we have made the strategic decision to withdraw the application, and concentrate on the approval of SEASONIQUE and the expansion of the SEASONIQUE product franchise with the Lo SEASONIQUE(TM) product that is currently in Phase III clinical trials. We remain committed to developing a franchise of extended-cycle products, and believe that the SEASONIQUE products will ultimately become the flagships of our extended-cycle oral contraceptive franchise."
The Company submitted its Lo SEASONALE NDA on June 24, 2005. Under the Prescription Drug User Fee Act (PDUFA), the action date for the Lo SEASONALE NDA would have been April 24, 2006.
On March 16, 2006, the Company confirmed that the FDA had determined that additional clinical studies would not be required to support the approval of the SEASONIQUE extended-cycle oral contraceptive. The Company is continuing to work with FDA to resolve outstanding issues including product labeling and post marketing commitments, and working toward the ultimate launch of SEASONIQUE in the near future.
SEASONIQUE
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.
Lo SEASONIQUE
Under the Lo SEASONIQUE extended-cycle regimen, women take active tablets of 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The clinical data that the Company expects to support its NDA filing for Lo SEASONIQUE will result from one large pivotal randomized, open-label, multi-center trial that is expected to end during the Company's fiscal 2007 fourth quarter ending June 30, 2007. Based on this timeline, the Company anticipates filing its NDA for Lo SEASONIQUE during the Company's fiscal 2007 second quarter ending December 31, 2007.
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.
Forward-Looking Statements
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, 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.CONTACT: Carol A. Cox, +1-201-930-3720, ccox@barrlabs.com
Web site: http://www.barrlabs.com/
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