MONTVALE, N.J., Aug. 28 Barr Pharmaceuticals,Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc.,received final approval from the U.S. Food & Drug Administration (FDA) tomanufacture and market a generic version of Ortho McNeil Janssen's Razadyne(R)(galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends tolaunch its generic Razadyne tablets product immediately.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food &Drug Administration (FDA) for Janssen's Razadyne (galantamine hydrobromide), 4mg, 8 mg and 12 mg tablets on February 28, 2005, the first day that an ANDAcontaining a Paragraph IV certification could be submitted based on theexpiration of the New Chemical Entity (NCE) exclusivity on the product.Following receipt of notification from the FDA of the application's acceptancefor filing, Barr notified the New Drug Application (NDA) holder and patentowner of Barr's challenge to the patents protecting Razadyne. On June 15,2005, Barr announced that Janssen had filed suit in the District Court for theDistrict of Delaware, and the trial occurred in May 2007.
On June 15, 2005, Barr announced that Janssen had filed suit in theDistrict Court of Delaware. Janssen announced in its Form 10-Q filed with theU.S. Securities & Exchange Commission on May 10, 2005 that it had receivedParagraph IV certifications for Razadyne from six other generic pharmaceuticalcompanies relating to the patents protecting Razadyne.
Earlier today, Barr announced that the U.S. District Court for theDistrict of Delaware has ruled in favor of its subsidiary, Barr Laboratories,Inc., in the challenge of U.S. Patent No. 4,663,318 ("the '318 patent") listedby Ortho McNeil Janssen in connection with Razadyne (galantaminehydrobromide), 4mg, 8mg and 12mg tablets. The Court's decision effectivelyended the 30-month stay with respect to Barr's generic Razadyne tablets andBarr's generic Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mgextended release capsules.
In her ruling, District Court Judge Robinson found that the '318 patent isinvalid for lack of enablement. Judge Robinson also denied Janssen's requestfor a Temporary Restraining Order which would have prevented Barr frommarketing its product. Ortho-McNeil Neurologics, a division ofOrtho-McNeil-Janssen Pharmaceuticals, Inc., has announced that it will appealthe decision.
Razadyne tablets had annual sales of approximately $102 million for thetwelve months ending June 2008, according to 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 o