MONTVALE, N.J., Aug. 20 Barr Pharmaceuticals,Inc. (NYSE: BRL) today announced that its subsidiary, PLIVA - Lachema a.s.,has received final approval from the U.S. Food and Drug Administration (FDA)for its generic version of Pfizer Inc.'s Aredia(R) (pamindronate disodium)Injection, 30mg/mL, 60mg/mL, and 90mg/mL. The Company plans to launch itsproduct in the fourth quarter of calendar 2008. With this approval, Barr'sU.S. generic injectable portfolio now totals eight products.
Barr's generic Aredia (pamindronate disodium) product will compete in amarket that had total annual sales of approximately $21 million for the twelvemonths ended June 2008, based on IMS sales data.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical companythat operates in more than 30 countries worldwide and is engaged in thedevelopment, manufacture and marketing of generic and proprietarypharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Aholding company, Barr operates through its principal subsidiaries: BarrLaboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and itssubsidiaries. The Barr Group of companies markets more than 120 generic and 27proprietary products in the U.S. and approximately 1,025 products globallyoutside of the U.S. For more information, visit www.barrlabs.com.
This communication contains "forward-looking statements" which representthe current expectations and beliefs of management of Barr Pharmaceuticals,Inc. (the "Company") concerning the proposed merger of the Company with BoronAcquisition Corp., a wholly-owned subsidiary of Teva Pharmaceutical IndustriesLtd. (the "merger") and other future events and their potential effects on theCompany. The statements, analyses, and other information contained hereinrelating to the proposed merger, as well as other statements including wordssuch as "anticipate," "believe," "plan," "estimate," "expect," "intend,""will," "should," "may," and other similar expressions, are "forward-lookingstatements" under the Private Securities Litigation Reform Act of 1995. Theseforward-looking statements are not guarantees of future results and aresubject to certain risks and uncertainties that could cause actual results todiffer materially from those anticipated. Those factors include, withoutlimitation: the difficulty in predicting the timing and outcome of legalproceedings, including patent-related matters such as patent challengesettlements and patent infringement cases; the difficulty of predicting thetiming of FDA approvals; court and FDA decisions on exclusivity periods; theability of competitors to extend exclusivity periods for their products;market and customer acceptance and demand for our pharmaceutical products; ourdependence on revenues from significant customers; reimbursement policies ofthird party payors; our dependence on revenues from significant products; theuse of estimates in the preparation of our financial statements; the impact ofcompetitive products and pricing on products, including the launch ofauthorized generics; the ability to launch new products in the timeframes weexpect; the availability of raw materials; the availability of any product wepurchase and sell as a distributor; the regulatory environment in the marketswhere we operate; our exposure to product liability and other lawsuits andcontingencies; the increasing cost of insurance and the availability ofproduct liability insurance coverage; our timely and successful completion ofstrategic initiatives, including integrating companies (such as PLIVA d.d.)and products we acquire; fluctuations in operating results, including theeffects on such results from spending for research and development, sales andmarketing activities and patent challenge activities; the inherent uncertaintyassociated with financial projections; our expan