WOODCLIFF LAKE, N.J., Oct. 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Duramed Pharmaceuticals, Inc., and Paladin Labs Inc. have signed a License and Distribution agreement granting Paladin an exclusive license to seek approval for and to market SEASONALE(R) extended-cycle oral contraceptive in Canada. Paladin currently markets Duramed's Plan B(R) emergency contraceptive in Canada. The terms of the agreement were not disclosed.
On September 30, 2005, Paladin filed on behalf of Duramed the New Drug Submission (NDS) for SEASONALE(R) with the Therapeutic Products Directorate (TPD) of Health Canada. Currently, SEASONALE(R) is only approved and marketed in the United States where it was launched in October 2003. For the fiscal year ended June 30, 2005, Barr recorded sales of SEASONALE(R) of $87 million.
"The Canadian oral contraceptive market represents a significant, untapped opportunity," said Bruce L. Downey, Barr's Chairman and CEO. "Our agreement with Paladin, following Canadian regulatory approval, will enable us to provide Canadian women an additional, unique option in oral contraception. We are confident that Paladin will be able to effectively communicate the benefits of the SEASONALE(R) extended-cycle oral contraceptive regimen to this exciting, new market."
"We are excited to expand our relationship with Barr with the addition of SEASONALE(R)," said Jonathan Ross Goodman, President & CEO of Paladin Labs. "SEASONALE(R) will complement our growing women's health franchise, including Plan B(R) which obtained over-the-counter status in Canada earlier this year."
Under the SEASONALE(R) extended 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 placebo. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available are based on a regimen of 21 treatment days, followed by seven days of placebo.
Important Information About Oral Contraceptives
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.
About Paladin Labs Inc.
Paladin Labs, headquartered in Montreal, Canada, is a leading specialty pharmaceutical company focused on developing, acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Paladin Web Site at www.paladinlabs.com.
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 of Barr Pharmaceuticals, +1-201-930-3720,ccox@barrlabs.com; or Samira Sakhia of Paladin, +1-514-340-5067,info@paladin-labs.com
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