AstraZeneca Annual Report and Form 20-F Information 2011

Our strategic objectivesWe aim to develop our position in gastrointestinal (GI) treatments bycontinuing to focus on our existing proton pump inhibitors (PPIs).Our focusOur key marketed productsNexium is marketed in approximately 120 countries and is available inoral (tablet/capsules and oral suspension) and intravenous (i.v.) dosageforms for the treatment of acid-related diseases. Nexium is an effectiveshort-term and long-term therapy for patients with GERD. In the US,the EU and other markets Nexium is approved for use in childrenfrom the age of one year for the treatment of GERD. In December,the FDA approved Nexium for delayed-release oral suspension forthe treatment of erosive esophagitis due to acid-mediated GERD inpatients aged one month to less than one year. In the EU, Nexium incombination with antibiotics is also approved for use for the treatmentof duodenal ulcers caused by Helicobacter pylori (H. pylori) infectionin children from the age of four years. In the EU and other markets,Nexium is approved for the healing and prevention of ulcers associatedwith NSAID therapy, including cyclooxygenase 2 selective inhibitors.In the US, Nexium is approved for reducing the risk of gastric ulcersassociated with continuous NSAID therapy in patients at risk ofdeveloping gastric ulcers. Nexium is also approved in the US, the EU,Canada and Australia for the treatment of patients with the rare gastricdisorder, Zollinger-Ellison syndrome.In September, AstraZeneca launched Nexium 10mg and 20mgcapsules in Japan for the treatment of acid-related conditions includingNERD, reflux esophagitis and PUD, following regulatory approval inJuly. Nexium also received regulatory approval for prevention ofrecurrence of gastric ulcer and duodenal ulcer in patients treated withNSAIDs. AstraZeneca and Daiichi Sankyo will co-promote Nexiumin Japan under the terms of a 2010 agreement. AstraZeneca willmanufacture and develop the product and Daiichi Sankyo will beresponsible for its distribution.Following treatment with Nexium i.v., oral Nexium is approved inthe EU and other markets for the maintenance of haemostasis andprevention of re-bleeding of gastric or duodenal ulcers.Nexium i.v. is used when oral administration is not suitable for thetreatment of GERD and upper GI side effects induced by NSAIDs. It isapproved in the EU and other markets for the short-term maintenanceof haemostasis and prevention of re-bleeding in patients followingtherapeutic endoscopy for acute bleeding gastric or duodenal ulcers.Nexium i.v. is approved for use in children from one year in the EU andfrom age one month in the US.In May 2010, AstraZeneca received a Complete Response Letter forthe sNDA for Nexium which was submitted for the risk reduction oflow-dose aspirin-associated peptic ulcers. AstraZeneca has workedwith the FDA and provided additional information. Due to the timedelay caused by the Complete Response Letter and subsequentreview, AstraZeneca withdrew the sNDA in the US in May.Losec/Prilosec was first launched in 1988 and is approved for thetreatment of GERD. We continue to maintain certain patent propertycovering Losec/Prilosec. Losec/Prilosec is available both as aprescription-only medication and, in some countries, as an OTCmedication where it offers consumers a more effective self-medicationoption for the treatment of heartburn compared with antacids and H2receptor antagonists.In the pipelineOur activities in the field of reflux inhibition and hypersensitivity therapyhave been discontinued. We have commenced work with IL-13inhibition in ulcerative colitis.Financial performance 2011/2010Performance 2011Reported performanceGI sales decreased by 9% to $5,536 million from $6,088 millionin 2010.Performance – CER growth ratesGI sales decreased by 11%.Nexium sales in the US decreased 11% to $2,397 million.Nexium sales in other markets decreased by 13% to $2,032 million.Sales in Western Europe decreased by 39% largely due to genericcompetition, with France accounting for almost half the decline. Salesin Established ROW increased by 10%, as the launch in Japan morethan offset the impact of generic competition in Canada. Sales inEmerging Markets increased by 20%.Prilosec sales in the US decreased by 21% to $38 million. Losec salesoutside the US decreased by 10% to $908 million.Performance 2010Reported performanceGI sales grew by 1% to $6,088 million in 2010 from $6,011 millionin 2009.Performance – CER growth ratesGlobal GI sales were unchanged. This was due to Nexium sales beingunchanged from 2009 at $4,969 million and Losec/Prilosec salesshowing a small increase of 1% to $986 million. Nexium sales in theUS were down 5% to $2,695 million, although this was offset by salesoutside the US which were up 6% to $2,274 million.Business ReviewAstraZeneca Annual Report and Form 20-F Information 2011Therapy Area Review Gastrointestinal 63