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Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes

Pressmeddelanden   •   Maj 27, 2016 14:18 CEST

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes. The fixed-dose combination of saxagliptin and dapagliflozin has the potential to be the first DPP-4i/SGLT-2i combination product approved in Europe.

Saxa/dapa is a fixed-dose combination of saxagliptin and dapagliflozin being developed as a treatment for patients with type-2 diabetes in adults aged 18 years and older. It is recommended to be indicated as a treatment to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of saxa/dapa alone do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin.

The submission included data from three studies in type-2 diabetes. In two studies, the combination of dapagliflozin and saxagliptin with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy. An additional study showed that the combination of dapagliflozin and saxagliptin added on to metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with dapagliflozin or saxagliptin alone added to metformin. In these trials, the safety profile of saxa/dapa was similar to the known safety profiles of saxagliptin and dapagliflozin.

The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final decision by the EC is expected in the coming months, and will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.

– ENDS –

NOTES TO EDITORS

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. Our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.

As a strategic therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. 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

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Craig Marks Oncology Finance +44 7788 354619 +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes. .

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AstraZeneca’s Faslodex met primary endpoint in first-line treatment of advanced breast cancer

Pressmeddelanden   •   Maj 27, 2016 08:06 CEST

AstraZeneca today announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer.

Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of extended progression-free survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure. Faslodex has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio.”

A full evaluation of the data is ongoing and the results are expected to be presented at a medical meeting in 2016.

Aromatase inhibitors (such as Arimidex) are the current standard of care in first-line treatment for postmenopausal women with advanced HR+ breast cancer.[i]

Faslodex 500mg is approved for the treatment of postmenopausal womenwith oestrogen-receptor (ER)-positive locally-advanced or metastatic breast cancer whose cancer has progressed following anti-oestrogen therapy.[ii] Most recently, on 2 March 2016, the US Food and Drug Administration approved Faslodex 500mg, in combination with palbociclib, for the treatment of women with hormone-receptor-positive, human-epidermal-growth-factor-receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy.[iii]

– ENDS –

NOTES TO EDITORS

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapyNaïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial. The trial compared the anti-tumour effects and tolerability profile of a 500mg dose of Faslodex plus placebo with a 1mg dose of Arimidex plus placebo, in postmenopausal women with hormone-receptor-positive, locally-advanced or metastatic breast cancer who have not been treated previously with any hormonal therapy.

About Advanced breast cancer (ABC)

ABC is the most advanced stage of breast cancer (stage IV), and occurs when cancer cells have spread beyond the initial tumour siteto other parts of the body outside of the breast. Since thereisnocurefor ABC, thegoalof currenttreatmentistodelaydiseaseprogression.[iv]

About Faslodex 500mg (fulvestrant)

Faslodex 500mg is indicated for the treatment of postmenopausal women with ER+, locally-advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.2

In the US, Faslodex 500mg is also approved, in combination with palbociclib, for the treatment of US women with HR+, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy. Faslodex 500mg represents a hormonal therapy approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor - a key driver of disease progression.[v]

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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

References

i Journal of Clinical Oncology. Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline. Available at: http://jco.ascopubs.org/content/early/2016/05/19/JCO.2016.67.1487.full.pdf+html. Last accessed 25.05.2016

iiFASLODEX Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000540/WC500021174.pdf. Last accessed 25/02/2016

iiiFASLODEX full Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE

ivNational Cancer Institute. What Is Cancer?: Metastatic Cancer. Available online at: http://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact-sheet. Last accessed 25/04/2016.

vHowell A. Is fulvestrant (“Faslodex”) just another selective estrogen receptor modulator? Int J Gynecol Cancer. 2006;16 (suppl 2):521-523.

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Craig Marks Oncology Finance +44 7788 354619 +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer

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AstraZeneca receives Complete Response Letter from US FDA for sodium zirconium cyclosilicate (ZS-9) for oral suspension for treatment of hyperkalaemia

Pressmeddelanden   •   Maj 27, 2016 08:03 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA.

AstraZeneca remains committed to the development of sodium zirconium cyclosilicate as a treatment option for patients with hyperkalaemia. Interactions are ongoing with other health authorities in the European Union and Australia, where sodium zirconium cyclosilicateis currently under separate regulatory review.

– ENDS –

NOTES TO EDITORS

About sodium zirconium cyclosilicate (ZS-9) for oral suspension

Sodium zirconium cyclosilicate (ZS-9) is an insoluble, non-absorbed compound with a structure that was designed to preferentially trap potassium ions. The unique potassium selectivity of sodium zirconium cyclosilicate enables high in-vitro binding capacity for potassium ions even in the presence of other competing ions. Sodium zirconium cyclosilicate has been studied in three double-blind, placebo controlled trials and in one ongoing 12 month open label clinical trial in patients with hyperkalemia which represents over 1,600 patients treated. Sodium zirconium cyclosilicate is an investigational product that is not currently approved for any indication in any market.

About Hyperkalaemia

Hyperkalaemia (high potassium levels > 5.0 mEq/L in the blood serum) occurs in 23-47% of patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death (mortality of up to 30% in patients with severe hyperkalaemia if not treated rapidly). Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia. Current therapeutic options are limited, leaving high unmet medical need.

About ZS Pharma ZS Pharma was founded in 2008, became a public company in 2014 and, in December 2015, joined the AstraZeneca Group. ZS Pharma is focused on the development and commercialisation of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders. Additional information about ZS Pharma is available at www.zspharma.com.

About AstraZeneca in Cardiovascular & Metabolic Disease (CVMD)

Cardiovascular, metabolic disease and chronic kidney disease are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. Our patient-led strategy is focused on addressing the multiple risk factors facing CVMD and CKD patients at different stages of their disease, with the goal of reducing morbidity and mortality through life changing medicines.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Craig Marks Oncology Finance +44 7788 354619 +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca

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STUDIE VISAR ATT ”MOBIL-APP” FÖRBÄTTRADE FÖLJSAMHET TILL BEHANDLING EFTER HJÄRTINFARKT

Pressmeddelanden   •   Maj 25, 2016 14:31 CEST

Resultaten från den svenska SUPPORT-studien, som undersökt effekten på följsamhet och förebyggande insatser efter hjärtinfarkt med hjälp av en mobiltelefonapplikation, publiceras nu i American Heart Journal. Studien visar att de patienter som fick ett interaktivt patientverktyg i form av en ”mobil-app” i högre grad tog sitt blodproppshämmande läkemedel ticagrelor enligt läkarens ordination.

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AstraZeneca highlights continued progress of oncology pipeline at ASCO 2016 - Leadership in DNA damage response therapies

Pressmeddelanden   •   Maj 19, 2016 08:06 CEST

73 abstracts presented at ASCO with 19 related to Lynparza and new potential medicines targeting DNA damage response in multiple tumour types

Continued momentum of immuno-oncology medicines including new data on durvalumab in bladder cancer, underpinning the Breakthrough Therapy Designation,
and new data in first-line NSCLC

Further insights on Tagrisso’s ability to penetrate the blood-brain barrier in patients with metastatic lung cancer, and acalabrutinib in chronic lymphocytic leukaemia

AstraZeneca and its global biologics research and development arm, MedImmune,will provide an update on their extensive oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA, on 3-7 June 2016.

Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programmes, and showcase small-molecule developments including Tagrisso (osimertinib) in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO, we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for Lynparza. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year.”

DDR: A promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimise the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially kill cancer cells, while minimising the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor Lynparza (olaparib); Wee1 inhibitor AZD1775, ATM inhibitor AZD0156; ATR inhibitor AZD6738, and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to prevent tumour cells from reproducing.

At the ASCO congress, DDR presentations will highlight:

  • The potential for maintenance of DDR therapies as shown by Lynparza overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a “Best of ASCO” abstract.
  • Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with Lynparza or a VEGFR inhibitor, cediranib, in women's cancers (Abstract # 3015)
  • The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (abstract #4041)
  • The potential of DDR therapies against multiple biological DDR targets in different tumour types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumours (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)

Immuno-Oncology: Robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade - through the combination of durvalumab and tremelimumab - may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

  • Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
  • Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
  • New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
  • Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer (DANUBE trial - Abstract # TPS4574) and SCCHN (KESTREL trial - Abstract # TPS6101)
  • Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumours and sample age (Abstract # 3025)

Tagrisso in brain metastasis; acalabrutinib in CLL

AstraZeneca’s strong heritage in developing innovative targeted small molecules was underscored by the recent approval of Tagrisso as the first indicated treatment for EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan. At ASCO, new data will highlight the importance of Tagrisso activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumour DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include presentation on the potential of our potent, highly-selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL):

  • Data from the BLOOM study of Tagrisso in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC(Abstract # 9002)
  • Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
  • Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)

To download additional supporting material including abstract chart, animations, video and infographics please visit AstraZeneca ASCO 2016

Supporting material covers:

DDR • IO • Ovarian • Lung

– ENDS –

NOTES TO EDITORS

A Media Briefing on Saturday, 4 June 2016, 18:00-19:00 CDT, at the Hyatt Regency (room Columbus I-J) will update journalists on latest advances in AstraZeneca’s oncology portfolio being reported at ASCO. In addition, the briefing will focus on the potential of DDR therapies as a breakthrough paradigm in cancer treatment.

If you are interested to attend, please contact:

Neil Burrows (neil.burrows@astrazeneca.com; +44 7842 350541)

Karen Birmingham (Karen.birmingham@astrazeneca.com; +44 7818 524012)

An Investor science event on Monday, 6 June 2016, 19:00-20:30 CDTwill highlight the continuing momentum behind new developments in AstraZeneca’s Oncology therapy area.

Investors and analysts wishing to attend are invited to register here or contact the Investor Relations Team (details below).

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD, RIA +44 7717 618834
Henry Wheeler Craig Marks Oncology Finance +44 7788 354619 +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​73 abstracts presented at ASCO with 19 related to Lynparza and new potential medicines targeting DNA damage response in multiple tumour types Continued momentum of immuno-oncology medicines including new data on durvalumab in bladder cancer, underpinning the Breakthrough Therapy Designation, and new data in first-line NSCLC

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AstraZeneca provides top-line results from Lynparza GOLD trial in advanced gastric cancer

Pressmeddelanden   •   Maj 18, 2016 08:03 CEST

AstraZeneca today announced that Lynparza (olaparib) in combination with paclitaxel chemotherapy, compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival (OS) in the Phase III GOLD trial in advanced gastric cancer patients, in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein. Whilst there was a numerical survival trend in the Lynparza plus paclitaxel arm, it did not meet statistical significance.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “While there was a numerical trend for survival benefit with Lynparza plus paclitaxel in the GOLD trial, we are disappointed that this did not reach statistical significance. The particular regimen in the GOLD study, at a low dose and in combination with chemotherapy, differs from other Phase III trials in the Lynparza programme. We look forward to presenting the GOLD data and remain confident in Lynparza’s clinical activity in a range of tumour types, including its approved use in BRCA-mutated ovarian cancer.”

GOLD was a randomised, double-blinded, placebo-controlled, multicentre Phase III trial to assess the efficacy and safety of Lynparza in combination with paclitaxel, compared with paclitaxel alone. The trial enrolled Asian patients with advanced HER2-negative gastric cancer (including the gastro-oesophageal junction) who had progressed following 1st-line therapy.The trial, conducted in China, Japan, South Korea and Taiwan where gastric cancer is particularly prevalent, enrolled a total of 525 patients - 18% of whom had tumours that tested ATM negative by immunohistochemistry (IHC). Lynparzawas given orally at a dose of 100mg twice daily in combination with paclitaxel IV infusion over 1 hour at 80mg/m2 weekly on days 1, 8 and 15 of a 28 day schedule.

The reported incidence of adverse events for Lynparza in combination with paclitaxel compared with paclitaxel alone was similar.

A full evaluation of the data is ongoing and the results will be submitted for presentation at an upcoming medical meeting.

Lynparza is approved in over 40 countries for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is approved in the US as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

- ENDS -

NOTES TO EDITORS

About Gastric Cancer

Gastric and Gastroesophageal Junction (GEJ) adenocarcinomas account for around 84% of all cancers of the stomach. The incidence of gastric cancer (GC) is disproportionally high in East Asia, where annual incidence is around 9 times higher than those in the G6 countries combined.¹

About Lynparza

Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is the first PARP inhibitor to be approved by regulatory authorities in the EU and US for the treatment of women with BRCA-mutated (BRCAm) ovarian cancer.

About AstraZeneca in OncologyAstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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

¹Kantar Health, CancerMpact

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
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Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD, RIA +44 7717 618834
Henry Wheeler
Craig Marks
Oncology
Finance
+44 7788 354619
+44 7881 615764

Christer Gruvris

ING, Consensus Forecasts

+44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced that Lynparza (olaparib) in combination with paclitaxel chemotherapy, compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival (OS) in the Phase III GOLD trial in advanced gastric cancer patients, in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein.

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AstraZeneca tillkännager positiva resultat från fas III-studier med benralizumab vid behandling av svår astma

Pressmeddelanden   •   Maj 17, 2016 08:02 CEST

Benralizumab är AstraZenecas första biologiska läkemedel för sjukdomar i andningsvägarna som slutfört studier i fas III

AstraZeneca meddelar idag att benralizumab, en potentiell ny medicin och anti-eosinofil monoklonal antikropp, tolererades väl och uppnåde det primära effektmåttet i två pivotala fas III registreringsstudier (Sirocco och Calima) och visar en signifikant minskning av antalet akuta astmaanfall per år jämfört med placebo.

Sean Bohen, vice VD, Global Medicines Development och Chief Medical Officer, säger: "Svår astma påverkar hälsan och livskvaliteten för miljontals människor runt om i världen, och akuta astmaanfall kan vara livshotande för dessa patienter. Vi är nöjda med de övergipande resultaten från dessa pivotala studier eftersom de visar vilken potential benralizumab har att förbättra situationen för patienter med svår astma. Benralizumab är AstraZenecas första biologiska läkemedel inom sjukdomsområdet andningsvägar och dess utveckling understryker vårt engagemang för att förändra behandlingen av astma och kroniska sjukdomar i andningsvägarna med vår nästa generation av läkemedel. "

Den fullständiga pressreleasen på engelska finns som en bifogad PDF.

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com eller följ oss på twitter. Https:/twitter.com/AstraZenecaSE.

Kontaktperson:

Jacob Lund, tel: 08-553 26020, mob: 072 560 21 57

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Benralizumab är AstraZenecas första biologiska läkemedel för sjukdomar i andningsvägarna som slutfört studier i fas III

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AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference

Pressmeddelanden   •   Maj 12, 2016 09:04 CEST

New data reflect advancements across novel inhaled therapies, respiratory biologics and research into underlying disease pathways

AstraZeneca will demonstrate the breadth and depth of its industry-leading respiratory disease medicines with more than 60 abstracts and scientific presentations at the American Thoracic Society (ATS) 2016 International Conference in San Francisco, California, 13-18 May 2016.

Data support AstraZeneca’s novel inhaled combinations, respiratory biologics and innovative science, which targets new pathways in asthma and chronic obstructive pulmonary disease (COPD). Highlights include:

14 abstracts focused on unmet need in COPD as well as Bevespi Aerosphere (glycopyrrolate/formoterol fumarate),recently approved by the US FDA, a novel fixed-dose dual bronchodilator pMDI utilising the latest co-suspension technology for the treatment of COPD, including 24-hour lung function data compared totiotropium bromide inhalation sprayand placebo.

Biomarker data on benralizumab, an anti–eosinophil monoclonal antibody currently in Phase III trials in both severe asthma and COPD. The data evaluate the potential for high baseline blood eosinophils as well as baseline serum biomarkers of the IL-13 pathway to predict treatment response. These data may be of value for both benralizumab and tralokinumab (IL-13 monoclonal antibody).

Data highlighting breakthrough science aimed at addressing and potentially modifying the underlying causes of respiratory diseases, with a research focus on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

In addition, data will be presented evaluating the effects on lung function and airway inflammation of Daxas (roflumilast), the oral PDE4 inhibitor, initiated in addition to standard therapy with corticosteroids and antibiotics at the onset of an acute exacerbation of COPD.

Tom Keith-Roach, Vice President, Global Product Strategy for Respiratory, Inflammation and Autoimmunity, said: “Respiratory is one of AstraZeneca’s main therapy areas and it’s exciting that the data being shared at ATS demonstrate how rapidly our pipeline and portfolio are developing. We believe Bevespi Aerosphere and investigational medicines such as benralizumab can make a real difference in the lives of patients living with respiratory conditions worldwide.”

AstraZeneca key presentations at ATS 2016:

Lead author Abstract title Presentation details
COPD, Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT010 (budesonide/glycopyrrolate/formoterol)
Ding B A cross-sectional assessment of the burden of chronic obstructive pulmonary disease (COPD) symptoms in the United States and Europe using the National Health and Wellness Survey Oral Tuesday, 17 May, 3:00 PM Abstract #A6156
PINNACLE-1 & PINNACLE-2 Martinez F Pooled analyses from PINNACLE-1 and -2; the novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI shows significant improvement versus monocomponents in patients with COPD
Wednesday, 18 May, 9:00 AM Abstract #A6782
PINNACLE-3 Hanania N Safety and efficacy of a novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI: Results of a one-year extension study in patients with COPD (PINNACLE-3) Wednesday, 18 May, 9:00 AM Abstract #A6791
Arora S 24-hour lung function profile of novel co-suspension glycopyrrolate/formoterol metered dose inhaler versus placebo and Spiriva® Respimat®, in patients with moderate-to-very-severe chronic obstructive pulmonary disease Wednesday, 18 May, 9:00 AM Abstract #A6823
Arora S 24-hour lung function following the novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI, in patients with moderate-to-very-severe COPD Wednesday, 18 May, 9:00 AM Abstract #A6792
Martinez F The novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI significantly improves health status in symptomatic patients with COPD Wednesday, 18 May, 9:00 AM Abstract #A6784
Mack P Drug delivery from a novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI: Evidence of consistency, robustness and patient-use reliability Tuesday, 17 May, 9:00 AM Abstract #A5839
Orevillo C Pharmacokinetic and safety profile of a novel co-suspension technology fixed-dose combination of budesonide/glycopyrrolate/formoterol delivered by metered dose inhaler (PT010) in healthy adult subjects Wednesday, 18 May, 9:00 AM Abstract #6827

SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

Inoue H Proportion and characteristics of asthma– chronic obstructive pulmonary disease (COPD) overlap syndrome among COPD patients in Japan Late-Breaker Poster Discussion Tuesday, 17 May, 2:15 PM-4:15 PM Abstract #A7889

Respiratory Biologics

Newbold P High blood eosinophil concentrations and serum biomarkers of low IL-13 pathway activation at baseline predict exacerbation rate reduction by benralizumab for patients with moderate to severe asthma Monday, 16 May, 2:15 PM Abstract #A4351
Ranade K Dipeptidyl peptidase 4 (DPP4) is a novel predictive biomarker for the investigational anti-IL13 targeted therapy tralokinumab Monday, 16 May, 2:15 PM Abstract #A4332

Eklira (aclidinium)

Beier J
Improvement in lung function and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post-hoc analysis of a Phase IIIb study Wednesday, 18 May 9:00 AM Abstract #6817

Magnussen H

The effect of aclidinium bromide 400 µg on lung function, sleep quality and physical activity in patients with chronic obstructive pulmonary disease: Results of a Phase IV pilot study Wednesday, 18 May 9:00 AM Abstract #6820

Duaklir (aclidinium/formoterol)

Miravitilles M Efficacy of aclidinium/formoterol on bronchodilation and symptoms in symptomatic and asymptomatic patients with COPD: pooled analysis of two Phase III studies Wednesday, 18 May 9:00 AM Abstract #6773
Singh D Reduction in clinically important deterioration in chronic obstructive pulmonary disease in patients treated with aclidinium/formoterol combination Wednesday, 18 May 9:00 AM Abstract #A6771

Daliresp/Daxas (roflumilast)

TREAT Mackay AJ Roflumilast initiated at onset of acute exacerbation of COPD enhances lung function recovery: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT) Tuesday, 17 May 9:00 AM Abstract #A5180
TREAT Mackay AJ Reduction of airway inflammation with roflumilast initiated at onset of acute exacerbation of COPD: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT) Tuesday, 17 May 9:00 AM Abstract #A5181

Emerging and Disease Modification Science

Mardh CK A novel inhaled non-steroidal modulator of inflammation for the control of asthma; AZD7594 Sunday, 15 May, 9:00 AM Abstract #A1329
Jackson S Safety and tolerability of AZD1419, an inhaled oligonucleotide-based toll-like receptor 9 agonist in healthy volunteers: a potential new therapy for asthma Sunday, 15 May, 9:00 AM Abstract #A1326
Goransson M SIK inhibition: A novel opportunity to modulate disease phenotype in COPD Tuesday, 17 May, 9:00 AM Abstract #5837
- ENDS -

About Asthma

Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Despite current and available treatment options, asthma continues to effect the health and day-to-day lifestyles of more than 300 million children, men and women worldwide. By 2020, asthma will likely increase in numbers to affect as many as 400 million people.

Approximately 10% of asthma is severe, of which a reported 40% is uncontrolled. Severe, uncontrolled asthma has eight times higher risk of mortality. Uncontrolled asthma can lead to a dependence on oral corticosteroids (OCS). Systemic steroid exposure leads to serious & irreversible adverse effects, including osteoporosis, anxiety, depression, weight gain, glaucoma and diabetes. There is also a significant physical and socio-economic burden of asthma with 10% of severe patients accounting for 50% of asthma related health costs.

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

About Respiratory, Inflammation and Autoimmunity Diseases

Respiratory, Inflammation and Autoimmunity (RIA) is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our strong pipeline has the potential to deliver up to seven launches between 2016 and 2020. In respiratory disease, our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care; precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.

In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead programme in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity.

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.

Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Abigail Bozarth US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD, RIA +44 7717 618834
Henry Wheeler Oncology +44 7788 354619
Craig Marks Finance +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, CVMD +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

New data reflect advancements across novel inhaled therapies, respiratory biologics and research into underlying disease pathways

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Selumetinib granted Orphan Drug Designation in the US for adjuvant treatment of differentiated thyroid cancer

Pressmeddelanden   •   Maj 12, 2016 08:02 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

DTC is diagnosed in approximately 60,000 people in the US each year,1 and radioactive iodine (RAI) is recommended for those with known/suspected metastases at diagnosis and those at high risk of recurrence. 2 Asmall proportion of patients do not benefit from currently available treatment with RAI because they do not express sufficient sodium/iodine symporter (NIS) which is important for RAI uptake into thyroid cells. 3,4 Selumetinib is being tested for its ability to increase expression of NIS with the potential to add a treatment option for patients who do not respond well to RAI.

Sean Bohen Executive Vice President, Global Medicines Development and Chief Medical Officer, at AstraZeneca, said: “Uptake of RAI is crucial for patients with thyroid cancer where no other therapies have proven beneficial. Selumetinib could significantly enhance currently available treatment options for these patients. The Orphan Drug Designation is an important achievement as we advance our development plans for this potential treatment in differentiated thyroid cancer.”

The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.5

Selumetinibinhibits the MEK pathway in cancer cells to prevent tumour growth. It is being tested in the Phase III ASTRA trial in patients with DTC who are at high risk of recurrence. 6 In a Phase II study of selumetinib in patients with advanced thyroid cancer, clinically meaningful increases in iodine uptake and retention were seen in patients with thyroid cancer that was refractory to RAI.7

In addition to DTC, selumetinib is being tested in SELECT-1, a Phase III trial of patients with KRAS-mutant advanced non-small cell lung cancer (NSCLC) and in a Phase II registration trial of paediatric and adolescent patients with neurofibromatosis Type 1 in collaboration with the US National Cancer Institute.

– ENDS –

NOTES TO EDITORS

About thyroid cancer

Cancer of the thyroid gland is diagnosed in approximately 60,000 people in the US each year.1 Nearly 95% of patients have differentiated tumours with an associated five-year survival of over 90%.2 DTC is usually treated by surgery and thyroxine hormone replacement therapy, and radioactive iodine treatment (RAI) is recommended for patients with known/suspected metastases at diagnosis and for those at high risk of recurrence.2 Up to 30% of patients experience recurrence of DTC after initial treatment.2

Approximately 5-15% of patients with DTC do not respond to RAI.3 Ten year survival in patients who fail to take up radioactive iodine into tumour cells is 10% compared to nearly 60% in those with normal uptake.8 Traditional chemotherapy has minimal efficacy in patients with metastatic DTC.2

About selumetinib

Selumetinib is an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway which is frequently activated in cancer, including those with the KRAS mutation, which is present in 20% of human cancers and 20-30% of non-small cell lung cancer tumours.

MAPK activation also inhibits expression of thyroid hormone biosynthesis genes, including the sodium/iodine symporter (NIS) which facilitates iodine uptake into cells.7 Pre-clinical studies have suggested that following MAPK inhibition, iodine uptake by thyroid tumour cells is regained.7

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. in 2003.

About the ASTRA trial

ASTRA is a Phase III randomised, double blind study which is comparing the complete remission rate following a 5-week course of selumetinib or placebo and single dose adjuvant radioactive iodine therapy in patients with differentiated thyroid cancer.5

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Abigail Bozarth US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Henry Wheeler Craig Marks Oncology Finance +44 7788 354619 +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

1American Cancer Society. Key statistics for thyroid cancer. Available at: http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-key-statistics. Accessed May 2016.

2 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Thyroid Cancer. Version 2.2015

3 WordenF. Treatment strategies for radioactive iodine-refractory differentiatedthyroid cancer.Ther Adv Med Oncol. 2014 Nov;6(6):267-79.

4 Lakshmanan Aet al. Modulation of sodium iodide symporter in thyroid cancer. Horm Cancer. 2014 Dec;5(6):363-73.

5 US Food and Drug Administration. Developing Products for Rare Diseases & Conditions http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. Accessed May 2016.

6 National Institutes of Health. Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer. (ASTRA) https://clinicaltrials.gov/ct2/show/NCT01843062. Accessed May 2016

7 Ho AL et al. Selumetinib-Enhanced Radioiodine Uptake in Advanced Thyroid Cancer N Engl J Med. 2013 February 14; 368(7): 623–632.

8 Durante C et al. Long-term outcome of 444 patients with distant metastases from papillary and follicularthyroidcarcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 2006 Aug;91(8):2892-9. 

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

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Positive CHMP opinion for CAZ AVI in the EU for serious bacterial infections

Pressmeddelanden   •   Apr 29, 2016 13:52 CEST

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

CAZ AVI is being developed to treat a broad range of Gram-negative bacterial infections that are increasingly resistant to antibiotics, including multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae. Increasing antibiotic resistance in Gram-negative bacteria is a growing public health concern because of the limited new treatment options for these serious infections. In Europe, Gram-negative bacteria are responsible for two thirds of the annually reported 25,000 deaths resulting from antimicrobial resistance.1

The recommendation is for intravenous use in the treatment of adult patients with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) including pyelonephritis, and hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). The CHMP also recommended that CAZ AVI be indicated for the treatment of infections caused by aerobic Gram-negative organisms in adult patients who have limited treatment options.

The CHMP’s positive opinion is based on a review of data from an extensive clinical trial programme demonstrating the safety and efficacy of CAZ AVI. The submission included data from three Phase III studies in cIAI; Phase II and III studies in cUTI; and data from a Phase I study for HAP/VAP. An additional Phase III study, which evaluated the efficacy of CAZ AVI in ceftazidime-resistant cUTI and cIAI compared to the best available therapy, was also included for consideration.

The CHMP’s positive opinion on CAZ AVI will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final decision by the EC is expected in the coming months and will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.

CAZ AVI is being jointly developed by AstraZeneca and Allergan. AstraZeneca holds the global rights to commercialise ceftazidime-avibactam, with the exception of North America, where the rights are held by Allergan.

– ENDS –

NOTES TO EDITORS

About CAZ AVICAZ AVI is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of a combination of avibactam and ceftazidime - a third generation antipseudomonal cephalosporin with a well-established efficacy and safety profile. Avibactam is a first-in-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D, β-lactamases.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by β-lactamases. CAZ AVI offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of Enterobacteriaceae including those that produce ESBL and KPC together with activity against difficult to treat P. aeruginosa.

About Complicated Intra-abdominal Infection (cIAI)

Most intra-abdominal infections (IAI) are a result of processes involving inflammation and perforations of the gastrointestinal tract, such as appendicitis, peptic ulcer disease, and diverticulitis (a common digestive disease which involves the formation of
pouches within the bowel wall). IAI is an important cause of morbidity and mortality. In fact, it is the second most commonly identified cause of severe sepsis in the intensive care unit (ICU).

About Complicated Urinary Tract Infection (cUTI)

Complicated urinary tract infections (cUTI) are defined as a clinical syndrome characterized by pyuria and a documented microbial pathogen on culture of urine or blood. Patients usually present with symptoms including fever, chills, malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness, that occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization.

About Hospital Acquired Pneumonia (HAP) including Ventilator Associated Pneumonia (VAP)

Hospital-acquired pneumonia (HAP) refers to the development of lung infections after a patient has been hospitalised for a minimum of 48 hours. If, after 48 hours the infection develops despite the use of intubation and mechanical ventilation, the condition is then called Ventilator associated Pneumonia (VAP).

VAP is generally a severe illness, with patients requiring treatment in the intensive care unit (ICU). Some non-intubated patients with HAP can have either mild or more severe pneumonia.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. 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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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se