22nd Nov 2006 07:02
AstraZeneca PLC22 November 2006 AstraZeneca signs distribution agreement with Par Pharmaceuticals for an authorized generic version of TOPROL-XL AstraZeneca today announced it has entered into a supply and distributionagreement with Par Pharmaceutical to distribute an authorized generic version ofmetoprolol succinate in the United States. Currently, the authorized genericproduct will be distributed in the 25 mg dosage strength. The signing of thisagreement does not affect the availability of AstraZeneca's branded version ofmetoprolol succinate, TOPROL-XL. AstraZeneca will continue to manufacture andmake TOPROL-XL available in the United States. A 25 mg version of metoprolol succinate was launched in the United Statesyesterday by Eon Labs, part of Sandoz. The 25 mg dose accounts for an estimated20 per cent of AstraZeneca's TOPROL-XL sales in the US. The Full Year EPS guidance of $3.85 to $3.95 announced with the Third Quarter2006 results excluded any one-off costs and inventory adjustments associatedwith the possible launch of generic metoprolol succinate. These one-off costsand inventory adjustments are now calculated to be approximately $150m or 8cents per share and will be charged in the fourth quarter. After accounting forthis, the company now expects the full year EPS guidance to be at the lower endof the $3.85 to $3.95 range previously announced. On January 17, 2006, a US District Court, in litigation involving KVPharmaceutical Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and EonLabs Manufacturing, Inc., held the patents covering TOPROL-XL (metoprololsuccinate) extended release tablets to be invalid and unenforceable.AstraZeneca strongly disagrees with the court's decision, and filed a Notice ofAppeal in February to the US Court of Appeals for the Federal Circuit. Adecision regarding this appeal is pending. The patent protecting TOPROL-XLexpires September 18, 2007. -ends - November 22, 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033Chris Major, Tel: +44 (0) 207 304 5028 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Jorgen Winroth, Tel: +1 (212) 579 0506Ed Seage, Tel: +1 302 886 4065 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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