15th Apr 2008 07:00
AstraZeneca PLC15 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 itsNexium patent infringement litigation against Ranbaxy Laboratories Ltd. and itsaffiliates ("Ranbaxy"). The agreement settles the patent infringement litigation filed by AstraZenecafollowing Ranbaxy's submission to the United States Food & Drug Administrationof an Abbreviated New Drug Application for a generic version of Nexium. Underthe settlement agreement, Ranbaxy concedes that all six patents asserted byAstraZeneca in the patent litigation are valid and enforceable. Ranbaxy alsoaccepts that four of the patents would be infringed by the unlicensed sale ofRanbaxy's proposed generic product. The settlement agreement will allow Ranbaxy to commence sales of a genericversion of Nexium under a licence from AstraZeneca on 27 May 2014. This datemarks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca'spatents protecting Nexium have expiration dates that range from 2014 through2019. AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Courtfor the District of New Jersey reflecting the terms of the settlement agreement.With the Court now having entered the Consent Judgment, the settlement agreementis final, and the patent infringement litigation against Ranbaxy has beendismissed. Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck'srestructured partnership with AstraZeneca announced in 1998, has also enteredinto the settlement agreement. AstraZeneca's Nexium patent infringement litigations against Teva/IVAX and DrReddy's Laboratories remain ongoing. "I believe that this agreement is the right business decision and givesincreased clarity and stability to allow us to continue investing substantiallyin our growing pipeline of new medicines for patients. We continue to haveconfidence in the strength of our patents and will vigorously defend ourintellectual property," said David Brennan, Chief Executive Officer ofAstraZeneca. Manufacturing and Distribution Agreements AstraZeneca and Ranbaxy have separately entered into agreements under whichRanbaxy will formulate a portion of AstraZeneca's US supply of Nexium from May2010, including provisions for the manufacture of esomeprazole magnesium, theactive pharmaceutical ingredient in Nexium, from May 2009. AstraZeneca and Ranbaxy have also entered into two separate agreementsdesignating Ranbaxy as the US distributor for authorised generic versions ofPlendil (felodipine) and 40mg Prilosec (omeprazole). Ranbaxy will becompensated for its distribution services on standard commercial terms. In compliance with the Medicare Modernization Act of 2003, AstraZeneca will fileall of the above agreements with the United States Federal Trade Commission andthe 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 704032Mina Blair +44 20 7304 5084 mob: +44 7718 581021Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043Peter 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 ofcell which is found in the stomach. In doing so, it lowers the level of acidityin the stomach and helps to heal erosions in the esophagus or ulcers in theduodenum. Nexium is an effective treatment for patients with gastroesophageal refluxdisease (GERD), but is particularly appropriate for those suffering frompersistent, recurrent GERD which can cause disruptive, long term symptoms.Nexium has been demonstrated to provide enduring relief from the impact of GERDamongst 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 hypertensionand angina. About Prilosec Prilosec (omeprazole), marketed as Losec in some countries, was the first PPIand 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 andsupplier for healthcare services. AstraZeneca is one of the world's leadingpharmaceutical companies with healthcare sales of US $29.55 billion and is aleader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncologyand infection product sales. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index. Broadcast quality footage is available to download from the Media section of ourwebsite 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 ExchangeRelated Shares:
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