WOODCLIFF LAKE, N.J., Nov. 6 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its Duramed Pharmaceuticals, Inc. subsidiary has initiated shipment of the dual-label Plan B(R) (levonorgestrel) emergency contraceptive OTC/Rx product to customers and that the product will be available in pharmacies across the United States by mid-November. The Company is also announcing that the U.S. Food and Drug Administration (FDA) has granted Duramed a three-year exclusivity for its Plan B OTC/Rx product, based on clinical studies conducted for Over-the-Counter (OTC) approval, that is valid until August 2009.
Approved on August 24, 2006, the Plan B OTC/Rx dual-label product is an OTC product for consumers 18 years of age and older and prescription-only for women 17 and younger, and replaces the Plan B prescription-only product that has been marketed in the United States since 1999. Because Plan B remains a prescription product for women 17 and younger, it is sold only in retail pharmacy outlets from behind the pharmacy counter and under the supervision of a pharmacist.
The Company’s 250-Person Duramed Women’s Healthcare Sales Force, which had been promoting the Plan B prescription-only product, is now promoting the dual-label Plan B OTC/Rx to a professional audience that includes pharmacists, physicians and other healthcare providers. Women and healthcare professionals who would like to learn more about Plan B OTC/Rx, including full prescribing information, should visit www.Go2PlanB.com or call the toll-free number 800-330-1271.
The Company has also implemented a CARE(SM) program (Convenient Access, Responsible Education) to provide information to pharmacists, physicians and other healthcare providers, as well as consumers, regarding the appropriate distribution, use and monitoring for compliance with prescription age requirements of Plan B OTC/Rx. The program also includes a comprehensive education program for healthcare professionals and consumers. In addition, the Company has initiated various continuing education programs for pharmacists and other healthcare practitioners, and a publication plan that includes journal advertising. The Company has been and continues to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA’s prescription age requirement for the dispensing of the product.
“We are pleased that a majority of American women of child-bearing age now have more immediate access to the Plan B emergency contraceptive in the event of a contraceptive failure or incident of unprotected intercourse,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “The FDA’s historic decision to enable us to provide Plan B without a prescription for consumers 18 and older will now remove a medically unnecessary requirement that had served as a barrier to timely access. We will continue to work to ensure the appropriate distribution of the product by pharmacies, and to educate consumers, physicians and healthcare providers about the availability of and appropriate use of this emergency contraceptive.”
About Plan B(R)
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
There are nearly three million unintended pregnancies each year in the United States. Unintended pregnancy is a major public health issue, affecting women in all reproductive age groups and socio-economic backgrounds. Plan B has been well-studied and shown to reduce the pregnancy rate, after a single incident of unprotected intercourse, from 8% to 1%, an 89% reduction. Plan B should not be used as routine contraception and does not protect against HIV/AIDS and sexually transmitted diseases (STDs).
Contraindications for Plan B(R)
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Company markets more than 120 generic and 25 proprietary products in the U.S. and more than 550 products globally outside of the U.S.
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 (including PLIVA d.d.) 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; our expansion into international markets through the completion of the PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our increased debt obligations as a result of the PLIVA acquisition; 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, 2006.
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
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