AstraZeneca Annual Report and Form 20-F Information 2011

inflammation in COPD using oral routes of administration andhave commenced a Phase II study of AZD5069, a CXCR2 antagonistthat targets neutrophils. A biological approach, MEDI-8968, aMAb targeting the IL-1 receptor, has also commenced a Phase IItrial in COPD.We are targeting uncontrolled asthma/asthma exacerbations throughsmall molecule approaches such as a CRTh2 receptor antagonistand toll-like receptor 7 agonists (being developed in collaborationwith Dainippon Sumitomo) as well as biological approaches suchas benralizumab (MEDI-563), a MAb that binds to the interleukin-5receptor which results in depletion of eosinophils and basophils,and tralokinumab (CAT-354), a MAb that targets interleukin-13.RheumatologyRheumatoid arthritis (RA) is currently treated with generic diseasemodifyinganti-rheumatic agents and, where the relevant criteria aremet, biologic disease-modifiers. There remains a need for noveleffective treatments since only about a third of patients treated withbiologics achieve their treatment goals. We anticipate that the RAmarket will experience modest annual growth over the next decade ontop of the current revenues of approximately $10 billion to $12 billion 1 .Sales of the biologic tumour necrosis factor (TNF) alpha blockersaccounted for 75% of major-market RA sales in 2011. Use of otherbiologic approaches, currently reserved for TNF blocker failures,is expected to increase due to new entrants, new subcutaneousformulations and use earlier in the treatment pathway. Novel oral drugstargeting intra-cellular signalling pathways that provide anti-TNF-likelevels of efficacy and potentially more convenient dosing will likely beused both after and ahead of the TNF blockers, especially in patientswho currently choose not to take, are anxious about taking or areineligible to take, injectable biologic agents.Current treatment of systemic lupus erythematosus (SLE) focuseson controlling disease flares, preventing renal failure and suppressingsymptoms to an acceptable level while minimising toxicity. Althougha disease-modifying agent has been launched for SLE, mostemerging biologic agents will likely be used initially in combination withcorticosteroids or immunosuppressants to provide incremental benefitand/or allow reduced doses or numbers of these agents.In the pipelineFostamatinib (previously known as R788) was in-licensed from Rigelin 2010. Fostamatinib is at the most advanced stage of developmentof the oral spleen tyrosine kinase (SYK) inhibitors being evaluated foran RA indication. It is thought to block reversible signalling in multiplecell types involved in inflammation and tissue degradation in RA.The ongoing Phase III programme, called OSKIRA, commenced inSeptember 2010. A further Phase IIb monotherapy study (OSKIRA 4)was initiated in January 2011. This study will provide importantinformation on the profile of fostamatinib, unconfounded bybackground disease-modifying anti-rheumatic drugs, such asmethotrexate. The first anticipated regulatory filings based on theOSKIRA programme are currently anticipated for 2013.In 2011, we continued to invest in several novel multi-functional MAbsin inflammatory and autoimmune conditions. Sifalimumab (MEDI-545),which targets interferon-alpha, commenced a Phase IIb study inpatients with SLE. MEDI-546, which targets the Type I IFN receptor,is initiating a Phase IIb study in patients with SLE. Mavrilimumab(CAM-3001, licensed from CSL Limited) which targets the alphasub-unit of the granulocyte-macrophage colony stimulating factorreceptor, successfully completed a Phase II study evaluating theefficacy and safety in subjects with RA and is being prepared for aPhase IIb study in RA patients.Financial performance 2011/2010Performance 2011Reported performanceRespiratory & Inflammation (R&I) sales increased by 9% to$4,468 million compared with $4,099 million in 2010.Performance – CER growth ratesR&I sales increased by 6% globally.US sales of Symbicort were $846 million, an increase of 17%.Symbicort sales in other markets increased to $2,302 million, 9%ahead of last year, fuelled by strong growth in Japan, up 88% andin Emerging Markets, up 19%.US Pulmicort sales decreased by 9% to $279 million. Sales ofPulmicort outside the US increased by 4% to $613 million.Performance 2010Reported performanceR&I sales were down 1% to $4,099 million compared with $4,132 millionin 2009.Performance – CER growth ratesR&I sales were down 1%.Total sales of Symbicort were up 20% to $2,746 million with stronggrowth both in the US which was up 48% to $721 million and outsidethe US which was up 13% to $2,025 million.Sales of Pulmicort were down 34%, mainly as a result of US saleswhich decreased by 62% to $305 million as a result of the launch,under licence from AstraZeneca, of the Teva generic budesonideinhaled suspension product in December 2009. Sales of Pulmicortoutside the US were up 10% to $567 million.Business Review1Decision Resources 2011.AstraZeneca Annual Report and Form 20-F Information 2011Therapy Area Review Respiratory & Inflammation 75