WOODCLIFF LAKE, N.J., July 14 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News) today announced that its subsidiary, Duramed Pharmaceuticals, Inc., and Common Sense have entered into a development, manufacturing and supply agreement for the AL-SENSE® detecting strip. The AL-SENSE product is a panty liner-like device that includes a proprietary polymer-coated polyester strip designed to detect amniotic fluid, which could indicate a potential problem with a pregnancy. The parties intend to develop and seek approval to market the product as a medical device in the United States and Canada.
“Our partner, Common Sense, has developed a product that we believe physicians and women who have had, or may be at risk of having, amniotic fluid leakage during pregnancy will find very helpful,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “The product is a self-administered test designed to identify and detect amniotic fluid leakage utilizing a proprietary polymer-coated polyester strip. If approved, this product would be available to women by prescription and would provide a significant advance in the treatment of female patients at risk for amniotic fluid leakage. This product further extends the franchise of female healthcare and reproductive products that would be offered by Duramed.”
Common Sense is responsible for all regulatory filings and expects to file a 510-K application for the product in late 2006 and gain approval in the first half of 2007. Under the terms of the agreement, the Company has agreed to make a one-time payment to Common Sense following U.S. Food and Drug Administration (FDA) approval. Common Sense will manufacture and package the product, which Duramed would then purchase and assume responsibility for detailing to physicians and healthcare practitioners utilizing its Duramed Specialty Sales Force. Barr will record net sales of the product and will pay Common Sense for product delivered.
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. For more information, visit Barr’s website at http://www.barrlabs.com.
About Common Sense Ltd.:
Common Sense was founded in 1999 and is a leading developer and manufacturer of indicators utilizing common hygienic products such as panty- liners and diapers as a platform for non-intrusive diagnosis and health condition monitoring. Common Sense also develops unique, easy to use, Point of Care solutions, which assist physicians in determining the source of various vaginal infections. Common Sense products have been marketed in West Europe countries since 2003. For more information, visit Common Sense’s website at http://www.cs-commonsense.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.
[EDITOR’S ADVISORY: Barr Pharmaceuticals, Inc. news releases are available free of charge through PR Newswire’s News On-Call site at http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate information are also available on Barr’s website (http://www.barrlabs.com). For complete indications, warnings and contraindications, contact Barr’s Drug Information Department at 1-800-Barr Lab. All trademarks referenced herein are the property of their respective owners.]
Source: Barr Pharmaceuticals, Inc.
