FDA Approves Duramed's SEASONIQUE(TM) Extended-Cycle Oral Contraceptive Company's Second Proprietary Extended-Cycle OC to be Available in July

May 25, 2006, 01:00 ET from Barr Pharmaceuticals, Inc.

    WOODCLIFF LAKE, N.J., May 25 /PRNewswire-FirstCall/ -- Barr
 Pharmaceuticals, Inc. (NYSE:   BRL) today announced that the U.S. Food and
 Drug Administration (FDA) has approved its 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 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(R) 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(TM) 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.
     SEASONIQUE
     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 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.
 
 

SOURCE Barr Pharmaceuticals, Inc.
    WOODCLIFF LAKE, N.J., May 25 /PRNewswire-FirstCall/ -- Barr
 Pharmaceuticals, Inc. (NYSE:   BRL) today announced that the U.S. Food and
 Drug Administration (FDA) has approved its 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 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(R) 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(TM) 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.
     SEASONIQUE
     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 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.
 
 SOURCE Barr Pharmaceuticals, Inc.

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http://www.barrlabs.com