AstraZeneca Annual Report and Form 20-F Information 2011

Therapy Area ReviewIn the pipelineIn April 2011, our biologics capabilities submitted a supplementalBiological License Application for MEDI-3250, a quadrivalent versionof FluMist containing protection against two A strains and both Blineages of influenza. The PDUFA date is 29 February 2012 and,if approved, launches are anticipated in the US for the 2013-2014influenza season.It is anticipated that the MAA and other regulatory submissions forMEDI-3250 will be made from the third quarter of 2012 onwards.SepsisSepsis is a life-threatening condition resulting from uncontrolled severeinfections. It remains a significant problem in medical management,with approximately three million worldwide incidents annually and a30% mortality rate. Current treatment options for patients with severesepsis or septic shock are extremely limited and, although industrypipelines are focused on the development of products specificallyfor registration for the treatment of sepsis or septic shock, there arefew products in late stage development.In the pipelineOur potential treatment for severe sepsis licensed from ProthericsInc. (now part of the BTG plc group) AZD9773 (formerly known asCytoFab), is an anti-TNFα polyclonal antibody fragment andcontinues in Phase II development with two studies: a global300-patient Phase IIb study (still recruiting) and a small Phase IIstudy in Japan for which recruitment is complete. AZD9773 hasthe potential to be one of a limited number of medicines specificallydeveloped for patients with severe sepsis.TuberculosisTuberculosis (TB) remains a worldwide threat and is newlydiagnosed in over eight million people worldwide every year. It isone of the greatest causes of death from infectious disease in thedeveloping world.Financial performance 2011/2010Performance 2011Reported performanceInfection sales decreased by 15% to $1,856 million from $2,176 millionin 2010.Performance – CER growth ratesInfection sales decreased by 15%.US Synagis sales decreased by 12% to $570 million. Outside the US,sales were up 3% to $405 million.FluMist sales were $161 million, a 7% decline from 2010.Sales of Merrem/Meronem decreased by 30% in 2011 as a result ofgeneric competition in the US and Western Europe.Performance 2010Reported performanceInfection sales were down 17% to $2,176 million from $2,631 millionin 2009.Performance – CER growth ratesInfection sales were down 18% as the sales of the H1N1 pandemicinfluenza vaccine in 2009 were not repeated in 2010. There were only$39 million of sales recorded in 2010 for US government orders for theH1N1 pandemic influenza vaccine. These sales were recorded in thefirst quarter of 2010 and compare with $389 million of sales in 2009.This strain has now been incorporated into the traditional seasonalinfluenza vaccine.FluMist sales were $174 million, a 20% increase over 2009.Global Synagis sales were down 4%, with sales in the US down 17%to $646 million being partially offset by strong growth in WesternEurope where sales were up 31% to $392 million.As part of our commitment to make a contribution to improvinghealth in the developing world, we are working to find new, improvedtreatments for TB. Work ongoing at our research facility in Bangalore,India focuses on finding drugs that will act on multi-resistant strains,will simplify the treatment in (current regimens are complex andlengthy, meaning many patients give up before the infection is fullytreated) and will be compatible with HIV/AIDS therapies (TB and HIV/AIDS form a lethal combination, each speeding the other’s progress).Bangalore scientists work closely with our infection research centre inBoston, US as well as with academic leaders in the field, and have fullaccess to all AstraZeneca’s platform technologies, such as ‘highthroughput screening’ and compound libraries.TB remains a complex research area in which collaborations playa very important role. Our discovery collaboration with the GlobalAlliance for TB Drug Development continues to work towardsprogressing suitable compounds through to the lead optimisationstage. Research funded by a Wellcome Trust grant under the ‘R&Dfor Affordable Healthcare in India’ initiative, which will be used toidentify novel lead molecules for the treatment of TB, continues.Our most advanced programme, AZD5847 (a novel anti-tubercularoxazolidinone antibiotic), has completed its Phase I programme andis expected to enter Phase IIa trials with support from The NationalInstitute of Allergy and Infectious Diseases in 2012.66 Therapy Area Review InfectionAstraZeneca Annual Report and Form 20-F Information 2011