Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company

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Thursday, 15 May 2014

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This week AstraZeneca demonstrated further evidence of continued progress of its science-led strategy, as the company updated on new data in advance of key medical and scientific congresses across all of its core therapeutic areas – oncology, cardiovascular and metabolic disease and respiratory, inflammation and autoimmunity.

Pascal Soriot, Chief Executive of AstraZeneca, said: “We continue to build our pipeline and we are encouraged by the progress in the development of key assets. We have complete confidence in our strategy as an independent company and remain focused on delivering new medicines for patients, which will continue to create significant value for our shareholders.”

AstraZeneca is targeting strong and consistent revenue growth leading to annual revenues of greater than $45 billion by 2023, as outlined in the 6th May financial update. These new data provide proof points for the progress being made on AstraZeneca’s pipeline across its core therapeutic areas.

Outlined below is a summary of the key data which will be presented at upcoming medical and scientific conferences. Please see links to full news releases.

Oncology

• MEDI4736 Phase I data demonstrated durable clinical activity and acceptable safety for this investigational anti-PD-L1 antibody. Read news
• Data from the large Phase I study of AZD9291 suggest it is well tolerated and clinically active in patients with EGFR mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) who have developed acquired resistance to EGFR tyrosine-kinase inhibitors (TKIs). Read news
• Encouraging efficacy data from a randomised Phase II study, conducted by the US National Cancer Institute (NCI), investigating the combination of PARP inhibitor olaparib and VEGF inhibitor cediranib in high-grade serous ovarian cancer. Read news
• The first MedImmune oncology immunotherapy targeting the PD-L1/PD-1 pathway progressed into Phase III. Read news
• MedImmune and Incyte announced collaboration on immuno-oncology combination clinical trial. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. Read news
  

We believe that our rich oncology pipeline has the potential to redefine the way that cancer patients are treated. We continue to deliver on our late stage assets and drive our scientific leadership in oncology, as clearly demonstrated by the recent accelerated development of key assets.

Cardiovascular / Metabolic Disease

• Positive results from Phase III study of saxagliptin/dapagliflozin combination in patients with type 2 diabetes inadequately controlled on metformin and outlines future development plans for the oral antidiabetic franchise. Read news
• AstraZeneca will commence a Phase III trial for dapagliflozin in patients with Type 1 diabetes in 2014.

Our metabolic disease area focuses on diabetes, diabetic nephropathy and obesity. We plan to continue building our existing brands and develop our research and clinical projects to meet patients’ unique medical needs and build a position of leadership.

Respiratory, Inflammation and Autoimmunity

• In collaboration with Amgen, Phase III study of brodalumab (AMG 827) in patients with moderate-to-severe plaque psoriasis met its primary and secondary endpoints. Read news
• Top-line results from the Phase IIb study of mavrilimumab, an investigational monoclonal antibody that inhibits a key pathway in the development of rheumatoid arthritis (RA), achieved its primary endpoints. Read news
• Top-line results from the Phase II study of sifalimumab (MEDI-545), a novel monoclonal antibody being investigated as a treatment for patients with moderate/severe systemic lupus erythematosus (SLE or lupus). The study met its primary endpoint. Read news
• Phase IIb asthma data on benralizumab, an investigational monoclonal antibody binding to the interleukin-5 receptor alpha (IL-5Rα). Phase IIb data for tralokinumab, a human monoclonal antibody which potently and selectively neutralises interleukin-13 (IL-13). Both showed improvement in key measures of asthma control for patients with specific, severe forms of asthma. Read news
• AstraZeneca intends to move tralokinumab into Phase III development for asthma and benralizumab into Phase IIl for COPD later this year.

We continue to focus on building our strong position in the respiratory area by delivering innovative, inhaled and targeted therapies that address the evolving unmet medical needs of patients with asthma COPD and idiopathic pulmonary fibrosis (IPF). In the inflammatory and autoimmunity therapy areas, we intend to help improve the lives of patients by developing a rheumatology franchise.

AstraZeneca will host a briefing for analysts and investors during the American Thoracic Society (ATS) conference, to be held in San Diego on 20 May 2014.

AstraZeneca will host a briefing for analysts and investors during the American Society of Clinic Oncology (ASCO) conference, to be held in Chicago on 2 June 2014.

NOTES FOR EDITORS

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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The revenue target for 2023 set out in this announcement is derived from the AstraZeneca Long Range Plan for 2014 to 2023 (the "LRP"). For further information regarding the LRP, attention is drawn to the announcement regarding AstraZeneca's strategy on 6 May 2014 and the key sources, bases and assumptions set out in that announcement.

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