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The patent challenge was initiated by Kali Laboratories, Inc. (sinceacquired by Par) and PLIVA Inc. (since acquired by Barr). Under the terms ofan earlier agreement between PLIVA and Kali, Kali developed DIASTAT and PLIVAassumed responsibility for the litigation and its associated costs.
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DIASTAT(R) and DIASTAT(R) AcuDial(TM) had combined sales of approximately$75 million for the twelve months ended August 2007, based on IMS sales data.The product is indicated for the management of selected, refractory, patientswith epilepsy, on stable regimens of anti-epileptic medications (AEDs), whorequire intermittent use of diazepam to control bouts of increased seizureactivity.
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 115 generic and 25proprietary products in the U.S. and more than 1,200 products globally outsideof the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the statementsmade in this press release constitute forward-looking statements within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities Exchange Act of 1934. Forward-looking statements can be identifiedby their use of words such as "expects," "plans," "projects," "will," "may,""anticipates," "believes," "should," "intends," "estimates" and other words ofsimilar meaning. Because such statements inherently involve risks anduncertainties that cannot be predicted or quantified, actual results maydiffer materially from those expressed or implied by such forward-lookingstatements depending upon a number of factors affecting the Company'sbusiness. These factors include, among others: the difficulty in predictingthe timing and outcome of legal proceedings, including patent-related matterssuch as patent challenge settlements and patent infringement cases; theoutcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predictingthe 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 andfor the costs we expect; market and customer acceptance and demand for ourpharmaceutical products; our dependence on revenues from significantcustomers; reimbursement policies of third party payors; our dependence onrevenues from significant products; the use of estimates in the preparation ofour financial statements; the impact of competitive products and pricing onproducts, including the launch of authorized generics; the ability to launchnew products in the timeframes we expect; t
