18th Oct 2007 17:34
AstraZeneca PLC18 October 2007 EPO Announces Symbicort(R) European Combination Patent Decision AstraZeneca today announced that the European Patent Office (EPO) TechnicalBoard of Appeal has made a final ruling that the European Combination patent forSymbicort(R) (formoterol and budesonide) (EPB0613371) has been revoked,following an appeal from a group of generic manufacturers: Liconsa, Miat,Generics UK and Norton Healthcare; but parties to the proceedings are also theadditional opponents (Chiesi Farmaceutici SpA, Zambon Group SpA, YamanouchiEurope B.V.). The EPB0613371 patent covers the Symbicort(R) combination (formoterol andbudesonide) and use thereof in asthma treatment in Austria, Belgium, Denmark,France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxemburg, Monaco, theNetherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Theoriginal patent expiry for this patent was 2012 with extension by SupplementaryProtection Certificate (SPC) to August 2015 in most European countries. "Although we are clearly disappointed with today's EPO decision, Symbicort(R)will remain an important part of our growth potential over the next few years inEurope and over the long term in other major markets, including the U.S. andJapan," said David Brennan, CEO of AstraZeneca. "We do not believe that the EPOdecision will have an immediate impact in the EU or any impact on the U.S. orJapanese patents. In fact, with the recent launch of Symbicort SMART(R) inEurope, we have a tremendous opportunity to transform the way asthma is managed,providing patients and physicians with important new options in controllingasthma." AstraZeneca will continue to defend and enforce its remaining intellectualproperty rights protecting Symbicort(R). This portfolio includes patents andapplications for processes, formulations, delivery devices (Turbuhaler), use inCOPD and use 'as needed' (Symbicort SMART), with expiration dates up to 2019.In addition to these patents, Symbicort(R) has data exclusivity valid until atleast August 2010 in most major European markets. Two granted patents (EPB1014993 and EPB 1210943) cover the use of Symbicort(R)for COPD and are currently under appeal and opposition respectively. Worldwide sales of Symbicort(R) reached $1.18 billion in 2006, with Europeaccounting for $1.02 billion. 18 October 2007 For further information contact:Media Enquiries: Steve Brown, +44 207 304 5033 Edel McCaffrey, +44 207 304 5034 Investor Enquiries: Jonathan Hunt, +44 207 304 5087 Ed Seage, +1 302 886 4065Karl Hard, +44 207 304 5322 Jorgen Winroth, +1 212 579 0506Mina Blair, +44 20 7304 5084 Peter Vozzo +1 301 398 4358 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Astrazeneca