Nexium

AstraZeneca PLC 15 April 2008 For Business and Financial Media. AstraZeneca Settles US Nexium Patent Litigation with Ranbaxy Companies Also Sign Manufacturing and Distribution Agreements AstraZeneca today announced it has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its affiliates ('Ranbaxy'). The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy's proposed generic product. The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca's patents protecting Nexium have expiration dates that range from 2014 through 2019. AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed. Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement. AstraZeneca's Nexium patent infringement litigations against Teva/IVAX and Dr Reddy's Laboratories remain ongoing. 'I believe that this agreement is the right business decision and gives increased clarity and stability to allow us to continue investing substantially in our growing pipeline of new medicines for patients. We continue to have confidence in the strength of our patents and will vigorously defend our intellectual property,' said David Brennan, Chief Executive Officer of AstraZeneca. Manufacturing and Distribution Agreements AstraZeneca and Ranbaxy have separately entered into agreements under which Ranbaxy will formulate a portion of AstraZeneca's US supply of Nexium from May 2010, including provisions for the manufacture of esomeprazole magnesium, the active pharmaceutical ingredient in Nexium, from May 2009. AstraZeneca and Ranbaxy have also entered into two separate agreements designating Ranbaxy as the US distributor for authorised generic versions of Plendil (felodipine) and 40mg Prilosec (omeprazole). Ranbaxy will be compensated for its distribution services on standard commercial terms. In compliance with the Medicare Modernization Act of 2003, AstraZeneca will file all of the above agreements with the United States Federal Trade Commission and the United States Department of Justice. 15 April 2008 Media Enquiries: Chris Sampson +44 20 7304 5130 (24 hours) Neil McCrae +44 207 304 5045 (24 hours) Steve Brown +44 207 304 5033 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Mina Blair +44 20 7304 5084 mob: +44 7718 581021 Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518 About Nexium Nexium belongs to a class of medicines known as proton-pump inhibitors (PPIs). It works by binding to, and inhibiting, the acid pumps of a particular type of cell which is found in the stomach. In doing so, it lowers the level of acidity in the stomach and helps to heal erosions in the esophagus or ulcers in the duodenum. Nexium is an effective treatment for patients with gastroesophageal reflux disease (GERD), but is particularly appropriate for those suffering from persistent, recurrent GERD which can cause disruptive, long term symptoms. Nexium has been demonstrated to provide enduring relief from the impact of GERD amongst patients. Nexium was first launched in Europe in 2000 and in 2001 in the US. About Plendil Plendil (felodipine) is a calcium antagonist for the treatment of hypertension and angina. About Prilosec Prilosec (omeprazole), marketed as Losec in some countries, was the first PPI and is used for the short-term treatment of acid-related diseases. About AstraZeneca AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. Broadcast quality footage is available to download from the Media section of our website at: http://br.thenewsmarket.com/Astrazeneca/br/Login/ LoginPreRegistration.aspx Journalists will be required to register to access this feature. - Ends - This information is provided by RNS The company news service from the London Stock Exchange

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