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AstraZeneca and Lilly to collaborate on immuno-oncology combination clinical trial in solid tumours

Pressmeddelanden   •   2015-05-29 08:02 CEST

AstraZeneca and Eli Lilly and Company (Lilly) today announced that they have entered into a clinical trial collaboration to evaluate the safety and preliminary efficacy of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with ramucirumab (CYRAMZA®), Lilly’s VEGF Receptor 2 antiangiogenic cancer medicine. The planned study will assess the combination as a treatment for patients withadvancedsolid tumours.

The Phase I study is expected to establish the safety and a recommended dosing regimen, with the potential to open expansion cohorts in various tumours of interest, for the combination of MEDI4736 and ramucirumab.Under the terms of the agreement, the trial will be sponsored by Lilly. Additional details of the collaboration, including tumour types to be studied and financial terms, were not disclosed.

MEDI4736 is a monoclonal antibody developed by MedImmune, AstraZeneca’s global biologics research and development arm, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Preclinical data indicate that combining VEGFR inhibitors with immune checkpoint blockades, such as PD-L1 targeted agents, has the potential to enhance anti-tumour activity.

Robert Iannone, Head of Immuno-oncology, Global Medicines Development at AstraZeneca, said: “We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated. MEDI4736 is supported by a comprehensive development programme and is emerging as a cornerstone of our combination-focused immuno-oncology pipeline targeting multiple tumour types. Our collaboration with Lilly is a great addition to our programme and provides the opportunity to explore another exciting, novel combination that could deliver important clinical benefit to cancer patients.”

“The development of immune checkpoint inhibitors has been one of the more exciting research advancements in recent oncology history, but it is going to be even more interesting to see how these inhibitors can be combined with other proven targeted therapies,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs, Lilly Oncology. “This collaboration represents the next wave of immuno-oncology research by bringing together two innovative medicines – Lilly’s CYRAMZA and AstraZeneca’s MEDI4736 – as a novel combination that we hope will one day provide new cancer treatment solutions.”

– ENDS –

NOTES TO EDITORS

About Ramucirumab (CYRAMZA®)

In the EU, ramucirumab has been granted marketing authorisation for use in adults, in combination with paclitaxel, for the treatment of advanced gastric or gastro-oesophageal junction adenocarcinoma following prior chemotherapy, and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.

Ramucirumab is approved in the U.S. for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in the U.S. in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved in the U.S. with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

There are several additional studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumour types.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

About MEDI4736

MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.

MEDI4736 was accelerated into Phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

A comprehensive development programme for MEDI4736 is underway across multiple tumour types, stages of disease, lines of therapy, and in combination with both immuno-oncology compounds as well as small molecules.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

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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UK
Thomas   Kudsk Larsen+442076048199mob: +447818524185
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Karl HårdOncology+442076048123mob: +447789654364
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AstraZeneca provides update on brodalumab development programme

Pressmeddelanden   •   2015-05-22 22:29 CEST

Amgen today announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab, an investigational IL-17 receptor inhibitor in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The announcement follows Amgen’s decision to concentrate on other portfolio priorities after observing suicidal ideation and behaviour events in the brodalumab programme which may result in restrictive labelling.

AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Data from the three AMAGINE Phase III pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit.We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine.”

– ENDS –

NOTES TO EDITORS

About Brodalumab (AMG 827)

Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

About the Amgen and AstraZeneca Collaboration

In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio.With oversight from joint governing bodies, Amgen leads clinical development and commercialisation for brodalumab and AMG 557/MEDI5872 (Phase Ib for autoimmune disease, such as systemic lupus erythematosus).AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialisation for MEDI7183/AMG181 (Phase II for ulcerative colitis and Crohn’s disease), MEDI2070/AMG139 (Phase II for Crohn’s disease) and MEDI9929/AMG157 (Phase II for asthma).

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

CONTACTS

Media Enquiries

Esra Erkal-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185
Eugenia LitzRespiratory, Inflammation and Autoimmunity+44 20 7604 8233mob: +44 7884 735627
Nick StoneCardiovascular   and Metabolic Disease+44 17   6326 3994mob: +44 7717 618834
Karl HårdOncology+44 20 7604 8123mob: +44 7789 654364
Craig MarksInfection, Neuroscience and Gastrointestinal Disease+44 20 7604 8591mob: +44 7881 615764
Christer Gruvris+44 20 7604 8126mob: +44 7827 836825

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

Amgen today announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab, an investigational IL-17 receptor inhibitor in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.

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AstraZeneca investerar i ny anläggning i Södertälje för tillverkning av biologiska läkemedel

Pressmeddelanden   •   2015-05-18 10:10 CEST

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AstraZeneca to update on progress with Immuno-Oncology pipeline and combination treatments at ASCO 2015

Pressmeddelanden   •   2015-05-13 23:05 CEST

  • 61 data abstracts - with 6 oral presentations - to be featured from across AstraZeneca’s broad pipeline, including in lung, ovarian and breast cancers.
  • Increased confidence in the potential of anti-PD-L1 MEDI4736 as a cornerstone for combination treatments with other immuno-oncology and small molecule investigational medicines.
  • Updated data will be presented on the safety and clinical activity of MEDI4736 + tremelimumab in patients with NSCLC.
  • Data will also be presented on the safety of MEDI4736 in combination with EGFR inhibitors gefitinib and AZD9291, as well as the triple combination with trametinib (MEK inhibitor) + dabrafenib (BRAF inhibitor)1.
  • In small molecule combinations, data will be presented on AZD9291 with savolitinib (cMET inhibitor) or selumetinib (MEK inhibitor), being investigated as potential treatments for overcoming newly-identified forms of resistance in EGFR mutated lung cancer.

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, 29 May-2 June 2015. 61 scientific abstracts2 will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are pleased to update on the breadth and depth of our oncology pipeline at ASCO. Our small molecule and biologic treatments target multiple areas of tumour biology across a diverse range of cancers, alone or in combination. It is especially encouraging to see the potential impact of our work in non-small cell lung cancer at different stages of the disease pathway and for different types of patients.”

“In immuno-oncology, we are starting to see the transformational potential of combination therapies, which are at the heart of our vision of redefining cancer treatment. The maturing data reinforce our confidence in this strategy, and, in particular, in MEDI4736, which is showing durable activity across multiple tumour types and in different combinations. This progress offers the possibility of helping patients who don’t respond to standard of care or current monotherapies.”

Bahija Jallal, Executive Vice President, MedImmune, said: “Our understanding of the potential of immuno-oncology is fast evolving as we begin to unlock its benefits for a greater number of patients – however we have only scratched the surface so far. Our comprehensive, combination-focused development programme aims to rapidly deepen our scientific understanding, exploring all the critical areas of the immune system that cancer can hijack to escape destruction. Through the use of companion diagnostics, we can also fully understand the clinical value of our investigational immunotherapies, both as monotherapy and in combination, for different types of patients and across many different types of cancer.”

Highlights at the ASCO Annual Meeting will include data from across the Company’s broad pipeline of next-generation investigational medicines, which target cancer through key areas of tumour biology including immunotherapy, the genetic drivers of cancer and acquired resistance and DNA damage repair.

Immuno-oncology

Immunotherapies use the body's own immune system to help fight cancer. There are three major components to an effective cancer immune response:priming and activation of T-cells (white blood cells that play a central role in immune response) through cancer antigen presentation; optimising T-cell mediated cancer cell killing by overcoming inhibitory mechanisms employed by the cancer; and overcoming immune suppressive mechanisms in the tumor microenvironment to further enhance an effective anti-tumour immune response.

At the ASCO Annual Meeting AstraZeneca will provide an update on its comprehensive immuno-oncology development programme, which

includes 31 ongoing clinical trials targeted across this cycle of anti-tumour immunity. Data to be presented at ASCO are supported by a number of recent milestones including:

  • Start of the combination arm of the Phase III ARCTIC study of MEDI4736 with tremelimumab in non-small cell lung cancer (NSCLC) patients who have received at least two prior systemic treatment regimens.
  • Start of the Phase II CONDOR study of MEDI4736 and tremelimumab as monotherapies and in combination in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).

Fast-Track designation granted by the FDA for the investigation of MEDI4736 as a monotherapy treatment for patients with advanced NSCLC, who have received at least two prior systemic-treatment regimens, who do not have EGFR mutations or anaplastic lymphoma kinase (ALK) alterations, and have tumours that are determined to be PD-L1 positive.

In addition to testing the potential of immunotherapies in solid tumours, AstraZeneca recently entered into a strategic collaboration with Celgene, a global leader in haematological cancers, on a broad development programme for MEDI4736, both as monotherapy and in combination with other molecules, across a range of blood cancers including multiple myeloma, non-Hodgkin’s lymphoma and myelodysplastic syndrome.

Presentations to include:

  • Safety and efficacy of MEDI4736in combination with tremelimumabin patients with NSCLC [Abstract #3014]. Updated data on additional patients and activity in both PD-L1 positive and negative patients to be presented.
  • Safety and efficacy of the triple combination of MEDI4736 with BRAF (dabrafenib) and/or MEK (trametinib) inhibitors in patients with advanced melanoma [Oral Abstract #3003].
  • An open-label study of MEDI4736 in combination with MEDI0680 (anti-PD-1) in patients with advanced malignancies [Trials in Progress Poster #TPS3087].
  • Updates reinforcing the clinical activity of MEDI4736 as monotherapy in patients with NSCLC [Abstract #8032], in patients with recurrent or metastatic SCCHN [Abstract #3011], and on the development of a PD-L1 companion diagnostic assay [Abstract #8033].

Genetic drivers of cancer and resistance

AstraZeneca has a strong legacy in research into the genetic drivers of cancer and resistance. Iressa (gefitinib) was the first epidermal growth factor receptor (EGFR) inhibitor, providing the first truly targeted treatment for advanced lung cancer. Data to be presented at ASCO will focus on AZD9291, an investigational, highly selective, irreversible inhibitor of both the activating sensitising EGFR mutation (EGFRm) and the activating resistance mutation, T790M.

Patients with EGFRm NSCLC are particularly sensitive to treatment with currently available EGFR tyrosine kinase inhibitors (TKIs), which block the cell signalling pathways that drive the growth of tumour cells. However, tumour cells almost always develop resistance to treatment, leading to disease progression. In approximately two thirds of patients, this resistance is caused by the secondary mutation, T790M. No currently targeted therapies are approved for the treatment of tumours with this resistance mutation.

AZD9291 presentations at ASCO to include:

  • Early efficacy and safety data from the multi-arm Phase Ib TATTON study, testing AZD9291 in combination with one of three treatments in patients with advanced, EGFR-mutant NSCLC who have progressed on prior EGFR TKI therapy [Abstract #2509]. The treatments are MEDI4736; savolitinib (AZD6094), an investigational, highly potent and selective c-MET inhibitor; or selumetinib, a potent, selective inhibitor of MEK1/2 kinases.
  • Detail on the Phase III FLAURA clinical trial testing AZD9291 versus standard doses of gefitinib or erlotinib in treatment-naïve patients with EGFR-mutant advanced NSCLC [Trials in Progress Poster #TPS8102].
  • Data from the Phase I AURA study testing AZD9291 as first-line therapy for patients with NSCLC, compared against currently approved EGFR medicines [Abstract #8000].

Data presented at ASCO build on the updated progression-free survival (PFS) data for AZD9291 as second line therapy for patients with EGFR-mutated NSCLC, who also have the T790M resistance mutation, which was presented at the recent European Lung Cancer Conference. The data demonstrated a median PFS of 13.5 months (95% confidence interval (CI) 8.3 months to not calculable (NC)).These PFS findings relate to independently reviewed data from 63 patients with T790M tumours treated with AZD9291 at a dose of 80mg per day, and are based on only 38% of patients having tumour progression. In patients treated with AZD9291 80mg, the most common all-cause adverse events (AEs) of any grade were rash, 38% (0% Grade ≥3) and diarrhea, 36% (1% Grade ≥3). Investigator-determined treatment-related Grade ≥3 AEs occurred in 14% of patients.

DNA Damage Repair

AstraZeneca has the largest portfolio of potential medicines targeted at DNA damage repair, including the recently launched Lynparza (olaparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, for BRCA-mutated ovarian cancer.

During ASCO, new data will be presented on Lynparza and on AZD1775, a small molecule designed to inhibit the tyrosine kinase called Wee1, which helps to regulate the cell-division cycle, and is undergoing testing for the treatment of ovarian cancer. AZD1775 is designed to cause certain tumour cells to divide without undergoing the normal DNA repair processes, ultimately leading to cell death. Preclinical evidence suggests that the combination of AZD1775 and DNA damage-inducing chemotherapy agents can enhance anti-tumour properties, in comparison to chemotherapy alone.

  • Data on the genomic characterisation of long-term responders to Lynparza will provide further insight into the physiology of ovarian cancer patients seeing benefit from the medicine [Abstract #5566].
  • Data from an international biomarker-directed randomised Phase II trial of AZD1775 used in combination with paclitaxel and carboplatin for the treatment of women with platinum-sensitive, TP53 mutated ovarian cancer [Oral Abstract #5506].
  • Data from a Phase II study of AZD1775 plus carboplatin in patients with TP53 mutated ovarian cancer refractory or resistant (three or fewer months) to standard first line therapy [Oral Abstract #2507].

Key AstraZeneca abstracts to be featured at ASCO

MoleculeIndicationAbstract #, Title and   Author*Time (CDT) / Location
Immunotherapy
MEDI4736Squamous cell carcinoma of the head and neckAbstract #3011Safety and efficacy of MEDI4736, an anti-PD-L1 antibody, in patients   from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort.Segal N.H., et al.Saturday 30 May8:00 AM – 11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Immunotherapy

Poster Discussion:

3:00 PM – 4:15 PM

Location: S406

Poster Board#: 337

MEDI4736 + tremelimumabAdvanced NSCLCAbstract #3014Phase Ib study of MEDI4736, a programmed cell death ligand-1 (PD-L1)   antibody, in combination with tremelimumab, a cytotoxic   T-lymphocyte-associated protein-4 (CTLA-4) antibody, in patients (pts) with   advanced NSCLC.Antonia S.J., et al.Saturday 30 May8:00 AM– 11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Immunotherapy

Poster Discussion:

3:00 PM– 4:15 PM

Location: S406

Poster Board#: 340

MEDI4736Squamous cell carcinoma of the head and neckAbstract #TPS3090Phase I study to evaluate the safety and efficacy of MEDI4736 in   combination with tremelimumab in patients with recurrent or metastatic (R/M)   squamous cell carcinoma of the head and neck (SCCHN).Siu L.L., et al.Saturday 30 May8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics - Immunotherapy

Poster Board#: 414b

MEDI4736Advanced solid tumoursAbstract #3039Phase I study to evaluate   the safety and tolerability of MEDI4736, an anti-programmed cell death   ligand-1 (PD-L1) antibody, in Japanese patients with advanced solid tumors.Iguchi H., et al.Saturday 30 May8:00 AM–11:30 AM Location: S Hall A

Poster Session: Developmental Therapeutics – Immunotherapy

Poster Board#: 365

MEDI4736NSCLCAbstract #3047Safety and tolerability   results from a phase I study of MEDI4736, a human IgG1 anti-programmed cell   death-ligand-1 (PD-L1) antibody, combined with gefitinib in patients (pts)   with non-small-cell lung cancer (NSCLC).Creelan B.C., et al.Saturday 30 May8:00 AM–11:30 AM Location: S Hall A

Poster Session: Developmental Therapeutics – Immunotherapy

Poster Board#: 373

MEDI4736 + MEDI0680 Advanced malignanciesAbstract #TPS3087Phase I, open-label study of MEDI0680, an anti-programmed cell death-1   antibody, in combination with MEDI4736, an anti-programmed cell death   ligand-1 antibody, in patients with advanced malignancies.Hamid O., et al.Saturday 30 May8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Immunotherapy

Poster Board#: 413a

MEDI4736Myelodysplastic Syndrome (MDS)Abstract #TPS7103Phase 1 study to evaluate   the safety and tolerability of MEDI4736, an anti-programmed cell death   ligand-1 (PD-L1) antibody, in myelodysplastic syndrome (MDS) after treatment   with hypomethylating agents.Garcia-Manero G., et al. Sunday 31 May8:00 AM–11:30 AM Location: S Hall A

Poster Session: Leukemia,   Myelodysplasia, and Transplantation

Poster Board#: 87b

MEDI4736Advanced NSCLCAbstract #TPS8104A phase III study of MEDI4736 (M), an anti-PD-L1 antibody, in   monotherapy or in combination with Tremelimumab (T), versus standard of care   (SOC) in patients (pts) with advanced non-small cell lung cancer (NSCLC) who   have received at least two prior systemic treatment regimens (ARCTIC).Planchard D., et al.Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Lung Cancer—Non-Small Cell Metastatic

Poster Board#: 428a

MEDI4736NSCLCAbstract #8032Safety and clinical   activity of MEDI4736, an anti-programmed cell death-ligand 1 (PD-L1)   antibody, in patients with NSCLC.Rizvi N.A., et al.Monday 1 June8:00 AM–11:30 AM Location: S Hall A

Poster Session: Lung   Cancer—Non-Small Cell Metastatic

Poster Board#: 354

MEDI4736NSCLC and Squamous cell carcinoma of the head and neckAbstract #8033Development of a PD-L1   companion diagnostic assay for treatment with MEDI4736 in NSCLC and SCCHN   patients.Rebelatto M., et al. Monday 1 June8:00 AM–11:30 AM Location: S Hall A

Poster Session: Lung   Cancer—Non-Small Cell Metastatic

Poster Board#: 355

MEDI4736MelanomaAbstract #3003Phase I study combining anti-PD-L1 (MEDI4736) with BRAF (dabrafenib)   and/or MEK (trametinib) inhibitors in advanced melanoma.Ribas A., et al.Monday 1 June1:15 PM – 4:15 PMLocation: S406

Oral Abstract Session: Developmental Therapeutics – Immunotherapy

Oral Presentation:

2:15 PM - 2:27 PM

MEDI4736Glioblastoma (GMB)Abstract #TPS2077Phase II study to   evaluate the clinical efficacy and safety of MEDI4736 in patients with glioblastoma   (GBM).Reardon D.A., et al.Monday 1 June1:15PM – 4:45PM Location:   S Hall APoster Session: Central   Nervous System Tumors

Poster Board#: 66b

Genetic drivers of cancer and   resistance
AZD9291Advanced NSCLCAbstract #2509Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291   combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer.Oxnard G.R., et al.Saturday 30 May8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Clinical   Pharmacology and Experimental Therapeutics

Poster Discussion:

1:15 PM–2:30 PM

Location: S406

Poster Board#: 225

AZD5363Advanced solid malignanciesAbstract #2577Results of OAK: A phase 1, open-label, multicenter study to compare   two dosage forms of AZD5363 and to explore the effect of food on the   pharmacokinetic (PK) exposure, safety, and tolerability of AZD5363 in   patients with advanced solid malignancies. Dean E.J., et al.Saturday 30 May8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Clinical   Pharmacology and Experimental Therapeutics

Poster Board#: 293

SelumetinibSolid TumoursAbstract #2583A phase I dose escalation study of the tolerability of the oral VEGFR   and EGFR inhibitor vandetanib (V) in combination with the oral MEK inhibitor   selumetinib (S) in solid tumors.Saka W.O,, et al.Saturday 30 May8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics – Clinical Pharmacology and   Experimental Therapeutics

Poster Board#: 299

AZD9291Advanced NSCLCAbstract #8000AZD9291, a mutant-selective EGFR inhibitor, as first-line treatment   for EGFR mutation-positive advanced non-small cell lung cancer: Results from   a phase 1 expansion cohort.Ramalingam S.S., et al.Sunday 31 May8:00 AM–11:00 AMLocation: N Hall B1

Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic

Oral Presentation:

8:00 AM – 8:12 AM

AZD4547FGFR amplifiedtumoursAbstract #4014A randomized, open-label phase II study of AZD4547 (AZD) versus   Paclitaxel (P) in previously treated patients with advanced gastric cancer   (AGC) with Fibroblast Growth Factor Receptor 2 (FGFR2) polysomy or gene   amplification (amp): SHINE study. Bang Y-J., et al. Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Gastrointestinal (Noncolorectal) Cancer

Poster Discussion: 3:00PM-4:15PM

Location: E Hall D1

Poster Board#: 123

AZD3759NSCLC and brain metastasis Abstract #8016AZD3759, an EGFR inhibitor with blood brain barrier (BBB) penetration   for the treatment of non-small cell lung cancer (NSCLC) with brain metastasis   (BM): Preclinical evidence and clinical cases.Kim D-W., et al.Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Lung Cancer – Non-Small Cell Metastatic

Poster Discussion: 3.00PM - 4.15PM

Location: E Hall D2

Poster Board#: 338

AZD8931Oesophago-gastric adenocarcinomaAbstract #4037A phase I dose-escalating and safety study of AZD8931 in combination   with oxaliplatin and capecitabine chemotherapy in patients with   oesophago-gastric adenocarcinoma. Thomas A.L., et al. Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Gastrointestinal (Noncolorectal) Cancer

Poster Board#: 146

AZD9291Advanced NSCLCAbstract #TPS8102A randomized, Phase III study (FLAURA) of AZD9291, a novel EGFR-TKI,   versus gefitinib or erlotinib in treatment-naïve patients with advanced   non-small cell lung cancer and an EGFR-TKI-sensitizing mutation Ramalingam S., et al.Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Lung Cancer – Non-Small Cell Metastatic

Poster Board#: 427a

SelumetinibAdvanced NSCLCAbstract #8046A phase Ib study of selumetinib in patients (pts) with previously    untreated metastatic Non-Small Cell Lung Cancer (NSCLC) receiving standard   chemotherapy: NCIC Clinical Trials Group IND.215. NCT01783197.Nicholas G.A.N., et al. Monday 1 June8:00 AM–11:30 AMLocation: S Hall A

Poster Session: Lung Cancer – Non-Small Cell Metastatic

Poster Board#: 369

AZD5363Breast and gynecological cancersAbstract #2500A pharmacokinetically (PK) and pharmacodynamically (PD) driven phase I   trial of the pan-AKT inhibitor AZD5363 with expansion cohorts in PIK3CA   mutant breast and gynecological cancers.Banerji U., et al.Tuesday 2 June8:00 AM–11:00 AMLocation: S100a

Oral Abstract Session: Developmental Therapeutics - Clinical   Pharmacology and Experimental Therapeutics Oral Presentation:

8:00 AM – 8:12 AM

AZD4547FGFR amplifiedtumoursAbstract #2508Phase II multicenter proof of concept study of AZD4547 in FGFR   amplified tumours.Smyth EC., et al.Tuesday 2 June8:00 AM–11:00 AMLocation: S100a

Oral Abstract Session: Developmental Therapeutics – Clinical   Pharmacology and Experimental Therapeutics

Oral Presentation:

10:12 AM – 10:24 AM

DNA damage repair
Lynparza (olaparib)Breast CancerAbstract #1038A phase I/II trial of olaparib in combination with eribulin in   patients with advanced or metastatic triple negative breast cancer (TNBC)   previously treated with anthracyclines and taxanes: First results from phase   I.Yasojima H., et al.Saturday 30 May8:00 AM – 11:30 AMLocation: S Hall A

Poster Session: Breast Cancer - Triple-Negative/Cytotoxics/Local   Therapy

Poster Board#: 152

Lynparza (olaparib)Breast CancerAbstract #TPS1109OlympiA: A randomized phase III trial of olaparib as adjuvant therapy   in patients with high-risk HER2-negative breast cancer (BC) and a germline   BRCA1/2 mutation (gBRCAm).Tutt A.N.J., et al. Saturday 30 May8:00 AM – 11:30 AMLocation: S Hall A

Poster Session: Breast Cancer - Triple-Negative/Cytotoxics/Local   Therapy

Poster Board#: 218b

Lynparza (olaparib)Advanced solid tumoursAbstract #2565Effect of itraconazole and rifampin on the pharmacokinetics of   olaparib tablet formulation in patients with advanced solid tumours: Phase I   open-label studies.Plummer E.R., et al.Saturday 30 May8:00 AM – 11:30 AMLocation: S Hall A

Poster Session: Developmental Therapeutics - Clinical Pharmacology and   Experimental Therapeutics

Poster Board#: 281

Lynparza (olaparib)Ovarian CancerAbstract #5514Phase I/Ib study of the PARP inhibitor (PARPi) olaparib (O) with   carboplatin (C) in heavily pretreated high-grade serous ovarian cancer   (HGSOC) at low genetic risk (NCT01445418).Chiou V.L., et al.Saturday 30 May1:15 PM – 4:45 PMLocation: S Hall A

Poster Session: Gynecologic Cancer

Poster Discussion:

4:45 PM – 6:00 PM, Location: E354b

Poster Board#: 72

AZD1775Ovarian CancerAbstract #TPS5608Multicenter randomized Phase II study of AZD1775 plus chemotherapy   versus chemotherapy alone in patients with platinum-resistant TP53-mutated   epithelial ovarian, fallopian tube, or primary peritoneal cancer.Moore K.N., et al. Saturday 30 May1:15 PM – 4:45 PMLocation: S Hall A

Poster Session: Gynecologic Cancer

Poster Board#: 164b

Lynparza (olaparib)Ovarian CancerAbstract #5566Genomic characterization of long-term responders to olaparib.Lheureux S., et al.Saturday 30 May1:15 PM–4:45 PMLocation: S Hall A

Poster Session: Gynecologic Cancer

Poster Board#: 124

AZD1775Ovarian CancerAbstract #5506An international, biomarker-directed, randomized Phase II trial of   AZD1775 plus paclitaxel and carboplatin for the treatment of women with   platinum-sensitive, TP53-mutant ovarian cancer.Oza A.M., et al.Monday 1 June8:00 AM–11:00 AMLocation: E354b

Oral Abstract Session: Gynecologic cancer

Oral Presentation:

10:00 AM – 10:12 AM

AZD1775Ovarian CancerAbstract #2507Phase II study with Wee1 inhibitor AZD1775 plus carboplatin in   patients with p53 mutated ovarian cancer refractory or resistant (<3   months) to standard first line therapy.Leijen S., et al.Tuesday 2 June8:00 AM–11:00 AMLocation: S100a

Oral Abstract Session: Developmental Therapeutics – Clinical   Pharmacology and Experimental Therapeutics

Oral Presentation:

10:00 AM – 10:12 AM

– ENDS –

NOTES TO EDITORS

1Novartis medicines for treatment of patients with metastatic melanoma.

2 Data included in abstracts are preliminary only and do not represent full data sets.

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the Company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation investigational medicines is focused on four main disease areas - ovarian, lung, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

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.

CONTACTS

Media Enquiries

Esra Erkal-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

Ayesha Bharmal  +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185
Eugenia LitzRespiratory, Inflammation and   Autoimmunity+44 20 7604 8233mob: +44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17   6326 3994mob: +44 7717 618834
Karl HårdOncology+44 20 7604 8123mob: +44 7789 654364
Craig MarksInfection, Neuroscience and   Gastrointestinal Disease+44 20 7604 8591mob: +44 7881 615764
Christer Gruvris+44 20 7604 8126mob: +44 7827 836825

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, 29 May-2 June 2015

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AstraZeneca and Abbott to develop companion diagnostic tests for tralokinumab in severe asthma

Pressmeddelanden   •   2015-05-13 08:02 CEST

AstraZeneca today announced that it has entered an agreement with Abbott, a global healthcare company, to develop companion diagnostic tests to identify patients with severe asthma who are most likely to benefit from the investigational biological therapy, tralokinumab. To date, no companion diagnostic blood tests have been approved for use in asthma.

Under the terms of the agreement, Abbott will develop and commercialise diagnostic tests to measure serum levels of the proteins periostin and DPP4 (dipeptidyl peptidase-4), which have been identified as potential predictive biomarkers of up-regulated IL-13 in severe asthma. The tests will be developed in conjunction with AstraZeneca’s Phase III trial of tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by the company’s biologics research and development arm, MedImmune. Periostin has been previously described as a potential biomarker for asthma1, and DPP4 is a novel and promising predictive biomarker identified by MedImmune.

The tralokinumab Phase III programme will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting β2-agonist.The programme will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether serum periostin or DPP4 could identify patients who are most likely to benefit from tralokinumab.

Bing Yao, Senior Vice President and Head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit said: “This partnership with Abbott to develop companion diagnostics for tralokinumab is an important step in delivering on our ambition to bring innovative options for patients who continue to suffer with severe asthma. We anticipate that physicians will ultimately use these tests to better identify patients likely to benefit most from tralokinumab to bring their condition under control. We are on the cusp of a new era in personalised healthcare, one which will see great improvements for patients treated with respiratory medicines.”

Personalised healthcare is at the centre of AstraZeneca’s approach to drug discovery and development and this collaboration is part of the company’s strategy to seek external partners to develop companion diagnostics that will help transform patients’ lives.

– ENDS –

REFERENCES

1.Brightling CE, She D, Ranade K, et al. Efficacy and safety of tralokinumab, an anti-il-13 monoclonal antibody, in a phase 2b study of uncontrolled severe asthma. Poster presented at the American Thoracic Society Congress, San Diego, May 16-21 2014.

NOTES TO EDITORS

About Asthma

Asthma is a chronic inflammatory disorder of the airways in which the bronchi are reversibly narrowed. It affects people of all ages and is a significant source of morbidity and mortality worldwide. Asthma can be allergic (induced by an immune response to inhaled allergens such as pollen, fungal spores or dust mite particles) or non-allergic (induced by exercise, cough, viral respiratory infection, or inhalation of smoke or chemicals in the workplace). The airway narrowing characteristic of asthma is a response of the immune system to the asthma trigger.

Severe persistent asthma is classified by the frequency of symptoms throughout the day and night, use of reliever inhalers, interference with daily activities, peak flow readings and whether asthma exacerbations require use of oral systemic corticosteroids more than twice a year. Asthma treatment usually includes inhaled corticosteroids that reduce inflammation of the airways to prevent asthma symptoms and exacerbations, combined with long-acting β2-agonist bronchodilators and a short-acting β2-agonist or other bronchodilator for relief.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. 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 centers. 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.

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Karen Birmingham+44 20 7604 8120 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185

Karl Hård+44 20 7604 8123 mob: +44 7789 654364

Eugenia Litz +44 20 7604 8233mob: +44 7884 735627

Craig Marks+44 20 7604 8591mob: +44 7881 615764

Christer Gruvris+44 20 7604 8126 mob: +44 7827 836825

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

AstraZeneca today announced that it has entered an agreement with Abbott, a global healthcare company, to develop companion diagnostic tests to identify patients with severe asthma who are most likely to benefit from the investigational biological therapy, tralokinumab.

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AstraZeneca and Montreal Heart Institute to screen 80,000 samples for cardiovascular and diabetes genetic traits

Pressmeddelanden   •   2015-05-13 08:02 CEST

AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions and their complications. The analysis will also uncover which genetic traits are linked to better treatment outcomes.

Under the collaboration, MHI will genotype up to 80,000 DNA samples from AstraZeneca’s extensive biobank. The samples include both tissue and blood samples, which have been collected over a period of 12 years under informed consent from patients who have entered clinical trials to test cardiovascular or diabetes treatments.

MHI’s Beaulieu-Saucier Pharmacogenomics Centre will initially use an approach called genome-wide SNP analysis to identify regions of DNA that predispose to, or cause, cardiovascular diseases and diabetes or are associated with responses to treatments. They will then apply other technologies, such as next-generation sequencing, to carry out full gene sequencing of areas of interest to identify new genes associated with disease, with complications such as heart attacks, strokes, diabetic nephropathy or retinopathy, and with treatment outcomes in terms of responsiveness to medication.

The knowledge gained from genotyping the samples will be applied to the development of new medicines tailored to treat subsets of patients with particular genetic profiles. The information will also enable a personalised healthcare approach to the use of existing treatments, which means using specific medicines to treat the patient populations that are most likely to respond. Currently, approximately 80% of AstraZeneca’s pipeline benefits from a personalised healthcare approach.

Ruth March, Vice President, Personalised Healthcare and Biomarkers at AstraZeneca said: “We’re delighted to be working with the Montreal Heart Institute, which has the expertise and technological know-how to deliver this transformational programme which will unlock an unprecedented amount of genetic information about cardiovascular diseases and diabetes. Together, we are taking personalised healthcare beyond its great heritage in oncology to bring targeted medicines to patients with cardiovascular disease and diabetes using biomarkers and diagnostic tests.”

Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and holder of both the Canada Research Chair in personalised and translational medicine and the Université de Montréal endowed research chair in atherosclerosis, said: “This large-scale partnership between AstraZeneca and the Montreal Heart Institute holds great potential for breakthroughs in personalised cardiovascular medicine and diabetes whereby medications will be tailored to responsive patients based on their genetic profile. Here at the MHI Pharmacogenomics Centre we have the expertise and high-throughput genomic platforms to carry out successfully and efficiently this important research programme.”

According to its ‘open innovation’ approach to research and development, AstraZeneca will work with MHI to publish findings in peer-reviewed journals, contributing to broader scientific understanding of these disease conditions.

- ENDS -

About the Montreal Heart Institute

Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training and prevention. It is affiliated with the Université de Montréal.

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

CONTACTS

Media Enquiries

Esra Erkal-Paler  +44 20 7604 8030 (UK/Global)

Karen Birmingham+44 20 7604 8120 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

Ayesha Bharmal  +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185

Karl Hård+44 20 7604 8123 mob: +44 7789 654364

Eugenia Litz +44 20 7604 8233mob: +44 7884 735627

Craig Marks+44 20 7604 8591mob: +44 7881 615764

Christer Gruvris+44 20 7604 8126 mob: +44 7827 836825

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes.

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Svenska Lungcancerstudiegruppen (SLUSG) delar ut stipendium

Pressmeddelanden   •   2015-05-08 11:17 CEST

Idag tilldelas Leg.läk. Professor Rolf Lewensohn, verksam vid Karolinska Institutet och Överläkare vid Onkologiska kliniken Karolinska Universitetssjukhuset i Stockholm, SLUSG-stipendiet 2015. Stipendiet har instiftats av Svenska Lungcancerstudiegruppen (SLUSG) och AstraZeneca och uppmärksammar personer som bidrar med betydande insatser inom lungcancerområdet. Rolf Lewensohn har genomfört många värdefulla studier inom tidig utveckling av nya cancerläkemedel och strålterapi av framför allt lungcancer. Stipendiet möjliggör nu fortsatt forskning inom lungcancer-området kopplat till molekylärbiologi.

Stipendiet, som i år utdelas för sjunde året i rad av Svenska Lungcancerstudiegruppen, SLUSG, syftar till att uppmärksamma personer som gör extraordinära insatser inom ett av våra svåraste sjukdomsområden, lungcancer. Stipendiaten utses av styrelsen i Svenska lungcancerstudiegruppens insamlingsstiftelse. Stipendiesumman är 75 000 kronor och är instiftad för att möjliggöra framtida insatser till fördel för svenska lungcancerpatienter.

Årets stipendiat Rolf Lewensohn är Professor i onkologi vid Karolinska Institutet, överläkare vid Karolinska Sjukhusets onkologiska klinik och leder en forskargrupp med cirka 20 medarbetare på institutionen för onkologi-patologi. Han är drivande i att etablera ”personalized cancer medicine” vid Karolinska Institutet och studerar bl a hur kemoterapi och strålbehandling orsakar skador i tumörcellernas DNA och nedströms signalering.

Av motiveringen till SLUSG-stipendiet 2014 framgår att:

Rolf Lewensohn har tilldelats Svenska Lungcancerstudiegruppens stipendium som ett stöd till fortsatta studier rörande lungcancer. Han har genomfört många värdefulla studier inom tidig utveckling av nya cancerläkemedel och strålterapi av framför allt lungcancer och även starkt bidragit till kunskaper om värdet av och risker med stereotaktisk strålbehandling vid lungcancer och därmed bidragit till att denna behandlingsform ökat kraftigt till stor nytta för många patienter. Han har också arbetat för större och bättre biobanker, en mycket betydelsefull faktor för fortsatta molekylärbiologiska studier och som utgör grunden för studier kring individualiserad behandling. Det är med stora förväntningar om fortsatt värdefullt arbete för lungcancerpatienternas bästa, som Rolf tilldelas 2015 års lungcancerstipendium.

-Att bli tilldelad årets SLUSG-stipendium är mycket hedrande. Jag uppfattar det som ett uttryck bland Sveriges lungcancer läkare att uppmärksamhet bör fästas vid lungcancerforskning som har sitt ursprung i Sverige och som i sin karaktär innebär att svenska upptäckter och nya behandlingsmetoder särskilt vid lungcancer är viktiga att vidareutveckla kliniskt med Sverige som ledande part, kommenterar Rolf Lewensohn.

Svenska Lungcancerstudiegruppen är sedan 23 år tillbaka en fristående sammanslutning av kliniskt verksamma läkare och sjuksköterskor inom lungcancerområdet.

-Rolf Lewensohn gör en mycket viktig insats för lungcancerforskningen i Sverige. Hans arbete kring individualiserad cancerbehandling känns speciellt spännande inför framtiden. Det känns därför roligt och mycket välförtjänt att Rolf tilldelas årets SLUSG-stipendium som ett stöd för fortsatt arbete bland annat inom detta viktiga område, säger Gunnar Wagenius, sekreterare i Svenska Lungcancerstudiegruppens insamlingsstiftelse och överläkare vid Radiumhemmet, Onkologiska kliniken, Karolinska Universitetsjukhuset Solna.

SLUSG-stipendiet 2015 delas ut i samband med SLUSGs årsmöte fredagen den 8 maj i Sigtuna.

Om SLUSG, Svenska lungcancerstudiegruppen

SLUSG bildades 1992. SLUSG är en sammanslutning av läkare, som arbetar kliniskt med lungcancer, framför allt onkologer, lungläkare och thorax­kirurger. Gruppens årliga möte fokuserar på lägesrapporter kring pågående kliniska studier, presentation av förslag till nya studier och föredrag inom lungcancer. Flera pågående kliniska behandlingsstudier i Sverige har diskuterats och accepterats vid SLUSG-möten.

SLUSG verkar för att:

Förbättra överlevnaden vid lungcancer genom bättre behandling.

Snabbare och bättre utredningar av patienter med misstänkt lungcancer, bland annat genom att göra stadieindelning mer korrekt och arbeta på att göra histopatologisk klassificering mer optimal genom att söka tillämpa nya molekylärbiologiska metoder.

Förbättra registreringen av patienter med lungcancer.

Förbättra omhändertagande och rehabilitering av patienter med lungcancer.

Fakta om lungcancer

Omkring 3 700 personer får diagnosen lungcancer årligen i Sverige. De allra flesta är mycket sjuka när diagnosen ställs. Lungcancer är den cancerform som skördar flest liv i Sverige – mer än 3 000 personer avlider årligen till följd av lungcancer. Icke småcellig lungcancer är den vanligaste typen av lungcancer. Den andra huvudtypen benämns småcellig lungcancer.

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. För mer information, sewww.astrazeneca.seoch www.astrazeneca.com

För mer information:

Rolf Lewensohn,Leg.läk. Professor vid Karolinska Institutet och Överläkare vid Onkologiska kliniken Karolinska Universitetssjukhuset i Stockholm, tel 070-729 31 88, e-post Rolf.Lewensohn@ki.se

Gunnar Wagenius, sekreterare i Svenska Lungcancerstudiegruppens insamlingsstiftelse,

tel 070-624 15 53, e-post Gunnar.Wagenius@karolinska.se

Petra Eurenius, Kommunikationschef, AstraZeneca Nordic-Baltic, tel 08-553 513 96,

tel 0709-186 562, e-post petra.eurenius@astrazeneca.com

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

Idag tilldelas Leg.läk. Professor Rolf Lewensohn, verksam vid Karolinska Institutet och Överläkare vid Onkologiska kliniken Karolinska Universitetssjukhuset i Stockholm, SLUSG-stipendiet 2015.

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US FDA grants Priority Review for potential new indication for BRILINTA

Pressmeddelanden   •   2015-04-29 08:02 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for BRILINTA® (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: "Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event free after the first 12 months. There is a clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction. Today’s milestone reinforces the importance of investigating clinical questions that address unmet patient need and we look forward to working with the FDA as they review our submission.”

A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The PEGASUS TIMI-54 study was presented during the opening late-breaking clinical trial session of the American College of Cardiology’s 64th Annual Scientific Session and Expo on 14 March 2015, and was also simultaneously published in the New England Journal of Medicine.

PEGASUS-TIMI 54 is part of AstraZeneca’s PARTHENON programme. The PLATO study, involving over 18,000 patients, was the first study in the programme and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.

– ENDS –

NOTES TO EDITORS

About BRILINTA®

BRILINTA is a direct-acting, selective and reversiblybinding P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation.

BRILINTA (90mg) is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention, it also reduces the rate of stent thrombosis.

BRILINTA is a registered trademark of the AstraZeneca group.

About the PEGASUS-TIMI 54 study

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. The study assessed BRILINTA® (ticagrelor) tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke. It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

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

CONTACTS

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Esra Erkal-Paler  +44 20 7604 8030 (UK/Global)

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Positive phase III results for two antibiotics, ZINFORO™ and investigational ceftazidime-avibactam, presented at leading Infectious Diseases Conference

Pressmeddelanden   •   2015-04-27 11:24 CEST

Encouraging new data of relevance to Global public health crisis, presented at 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

COPENHAGEN, Denmark – AstraZeneca today presented positive Phase III data demonstrating the efficacy and safety of ceftazidime-avibactam (CAZ-AVI), an investigational antibiotic being developed to treat serious Gram-negative bacterial infections including complicated intra-abdominal infections. New Phase III data was also presented for ZINFORO™ (ceftaroline fosamil), an antibiotic approved for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP).

AstraZeneca held a symposium at the congress, which highlighted the need for new treatment strategies to address antibiotic resistant infections, which remains a rapidly accelerating global concern. Epidemiological data was presented at the symposium which demonstrated the high clinical burden associated with Gram-positive and Gram-negative infections, including those caused by multidrug-resistant (MDR) pathogens.

‘Multi-resistant bacteria are a growing problem worldwide. Globalisation, travel and migration mean that those which evolve in one place swiftly reach others, adding risk, cost and complexity to treatment,’ said Professor David Livermore,University of East Anglia, Norwich, UK and speaker at the symposium. ‘New antibiotics - along with better stewardship and infection control - are our best answers to this challenge. And, in this context, ceftaroline and ceftazidime-avibactam are both welcome developments.’

AstraZeneca’s presence at ECCMID builds upon its continued commitment to scientific advancement in the area of infection and to working together with the wider infection community in order to translate this science into solutions to address the challenges faced.

CAZ-AVI Phase III Study Results: Complicated Intra-Abdominal Infections

Full Phase III results for the global RECLAIM-1 and RECLAIM-2 studies were presented at ECCMID. Both studies evaluated the safety and efficacy of CAZ-AVI, administered intravenously (IV) as a two hour infusion (2000 mg / 500 mg) every eight hours plus metronidazole 500 mg IV as a one hour infusion every eight hours, compared to meropenem, administered intravenously as a 30 minute infusion (1 g) every eight hours, in hospitalised adult patients with presumed or definite diagnosis of complicated intra-abdominal infections.1Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).2

Results showed CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The number of patients randomised to CAZ-AVI plus metronidazole was 532, with 534 randomised to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). Findings also showed CAZ-AVI treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem.2

The adverse event rate for CAZ-AVI in combination with metronidazole was similar to meropenem (45.9% vs 42.9% with serious adverse event rates of 7.9% and 7.6% respectively). The most commonly reported adverse events for CAZ-AVI in combination with metronidazole were diarrhoea, nausea, vomiting and fever, which were not unexpected based on the known safety profiles of ceftazidime and metronidazole.2

CAZ-AVI Phase III Study Results: Resistant Pathogens

Full Phase III results from the global REPRISE study were also presented at ECCMID. This study evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) in patients with complicated intra-abdominal or complicated urinary tract ceftazidime-resistant gram-negative infection. Patients with complicated intra-abdominal infection also received metronidazole. CAZ-AVI was compared to best available therapy.3

Results showed that efficacy for CAZ-AVI and Best Available Treatment was similar as reflected by the primary endpoint of clinical response at Test of Cure (TOC) visit. CAZ-AVI showed that in patients with complicated urinary tract infection (cUTI), microbiological cure rates at TOC (and beyond) were substantially higher in patients treated with CAZ-AVI. 4

Ceftaroline fosamil Phase III Study Results

The Phase III COVERS trial evaluated the safety and efficacy of ceftaroline fosamil for cSSTI patients with evidence of systemic inflammatory response or underlying comorbidities, administered via a 600 mg IV infusion over 120 minutes every eight hours, rather than the currently approved 600 mg every 12 hours dosing regimen. The study included patients from Asia, Europe, North and South America who were randomised 2:1 to receive ceftaroline fosamil 600 mg every eight hours, or to vancomycin 15 mg/kg every 12 hours plus aztreonam 1 g every eight hours for five to 14 days.5

Results demonstrated that ceftaroline fosamil was effective and well-tolerated for these patients at the adjusted dose, demonstrating non-inferiority versus vancomycin plus aztreonam. Ceftaroline fosamil was well tolerated with 45.6% and 45.5% patients treated with ceftaroline fosamil and vancomycin plus aztreonam respectively, experiencing ≥1 adverse event. The qualitative safety profile of ceftaroline fosamil 600 mg every eight hours was similar to previous trials with the 12 hour dosing, with no new safety signals identified.6

John Rex, Senior VP and Head of Infection, Global Medicines Development, AstraZeneca, said ‘These positive results for both CAZ-AVI and ceftaroline fosamilare extremely encouraging, particularly at a time when resistance to existing treatments is rapidly on the rise. We are proud of our antibiotic portfolio, which is contributing towards reinvigorating the pipeline of new treatment options in areas of enormously high unmet need.”

– ENDS –

NOTES TO EDITORS

About ceftaroline fosamil

Ceftaroline fosamil is an intravenous cephalosporin antibiotic intended for use as a monotherapy in the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP).7 Ceftaroline fosamil is bactericidal and works by binding to and inhibiting penicillin-binding proteins (PBPs). PBPs are involved in bacterial cell wall synthesis and repair and their inhibition leads to reduced bacterial cell replication and/or cell death.7-9

Ceftaroline fosamil was granted Marketing Authorisation by the European Commission (EC) for the treatment of adult patients with cSSTI or CAP on 28 August, 2012. Ceftaroline fosamil is marketed as TEFLARO™ in the U.S.

About CAZ-AVI

  • CAZ-AVI (ceftazidime-avibactam) is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. CAZ-AVI is 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 beta-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D, beta-lactamases.10

CAZ-AVI offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its activity against a broad range of isolates of carbapenem-resistant Enterobacteriaceae and difficult to treat Pseudomonas aeruginosa combined with robust coverage of extended spectrum beta-lactamase-expressing pathogens.10

CAZ-AVI is being jointly developed by AstraZeneca and Actavis. AstraZeneca holds the global rights to commercialise the product, with the exception of North America where the rights are held by Actavis. In the U.S., CAZ-AVI is marketed under the brand name AVYCAZ™ (ceftazidime-avibactam) for injection.

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


CONTACTS

Media Enquiries

Petra Eurenius, AstraZeneca Nordic-Baltic, mobile phone +46 709 186562

Alicia Dunn, AstraZeneca Global Media team, mob +1 202 304 7674

Investor Enquiries

Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185

Karl Hård+44 20 7604 8123mob: +44 7789 654364

Eugenia Litz +44 20 7604 8233mob: +44 7884 735627

Craig Marks+44 20 7604 8591mob: +44 7881 615764

Christer Gruvris+44 20 7604 8126mob: +44 7827 836825

###

References

  1. ClinicalTrials.gov. Compare ceftazidime-avibactam + metronidazole      versus meropenem for hospitalized adults with complicated intra-abdominal      infections. NCT01499290. Available at: https://clinicaltrials.gov/ct2/show/NCT01499290      Last accessed March 2015.
  2. Mazuski JE, Gasnik      L, Armstrong J, et al. Efficacy and safety of ceftazidime-avibactam      plus metronidazole versus meropenem in the treatment of complicated      intra-abdominal infection – results from a Phase III program. Abstract to      be presented at 25th ECCMID, Copenhagen, April 2015.
  3. ClinicalTrials.gov.Ceftazidime-avibactam for the treatment of infections      due to ceftazidime resistant pathogens. NCT01644643. Available at: https://clinicaltrials.gov/ct2/show/NCT01644643      Last accessed April 2015.
  4. Carmeli Y,      Armstrong J, Laud P, et al. Efficacy and safety of ceftazidime-avibactam      and best available therapy in the treatment of ceftazidime-resistant      infections – results from a Phase III study.Abstract      to be presented at 25th ECCMID, Copenhagen, April 2015.
  5. ClinicalTrials.gov.      Evaluation of ceftaroline fosamil versus vancomycin plus aztreonam in the      treatment of patients with skin infections. NCT01499277. Available at: https://clinicaltrials.gov/ct2/show/NCT01499277      Last accessed March 2015.
  6. Dryden M, Wilson D, Iaconis J, et al. A Phase III      trial of ceftaroline fosamil 600 mg q8h versus vancomycin plus aztreonam      in patients with cSSTI with systemic inflammatory response or underlying      comorbidities. Abstract to be presented at 25th ECCMID, Copenhagen, April      2015.
  7. ZINFOROTM      (ceftaroline fosamil) European Summary of Product Characteristics November      2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002252/WC500132586.pdf      Last accessed March 2015.
  8. Laudano JB.      Ceftaroline fosamil: a new broad-spectrum cephalosporin. J Antimicrob Chemother.      2011;66(Suppl 3):iii11-iii18.
  9. Biek D, Critchley IA, Riccobene TA, Thye DA. Ceftaroline      fosamil: a novel broad-spectrum cephalosporin with expanded      anti-Gram-positive activity. J      Antimicrob Chemother. 2010;65(Suppl 4):iv9-iv16.
  10. Lagace-Wiens      P, Walkty A, Karlowsky JA. Ceftazidime–avibactam: an evidence-based review      of its pharmacology and potential use in the treatment of Gram-negative      bacterial infections. Core Evidence.      2014;9:13-25.

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

Encouraging new data of relevance to Global public health crisis, presented at 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

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AstraZeneca PLC: Delårsrapport för första kvartalet 2015 - sammanfattning. Bifogat finns den fullständiga rapporten

Pressmeddelanden   •   2015-04-24 08:06 CEST

Det finansiella resultatet för kvartal 1 2015 ger stöd åt upprepad helårsprognos för 2015.

oTotala intäkter (definierat som produktförsäljning och intäkter från externa samarbeten1) ökade med 1% i fasta valutakurser 2 (CER) till 6 057 MUSD (Q1 2014: 6 460 MUSD)

oVinst per aktie för kärnverksamheten (Core EPS) minskade med 3% till1,08 USD i takt med att vi fortsätter att investera i att uppnå ledarskap inom forskningen.

oDet redovisade rörelseresultatet ökade med 15% till 933 MUSD (Q1 2014: 836 MUSD)

Uppnå ledarskap inom forskningen: vår fokuserade, accelererade och forskningsbaserade portfölj fortsätter att leverera ett starkt nyhetsflöde; ansökningar om 7–8 potentiella NME:er under 2015–16 fortskrider enligt plan.

  • o13 NME:er finns i fas III eller är under registrering.
  • oUSA-ansökan för godkännande av lesinurad mot gikt och saxagliptin/dapagliflozin mot diabetes
  • oPositiva fas III-data för PT003 mot KOL.
  • oPositiva fas IIb-data för anifrolumab mot lupus och investeringsbeslut för fas III.
  • oPositiva fas III-data för Brilinta för patienter med tidigare hjärtinfarkt, samt registreringsansökningar i USA och EU.
  • oSenaste resultat för AZD9291 mot icke-småcellig lungcancer visade på stark klinisk nytta med 13,5 månaders progressionsfri överlevnad.
  • oSärläkemedelsstatus beviljas av amerikanska FDA för tremelimumab mot mesteliom och selumetinib mot uveal melanom.
  • oFast-track status beviljades av amerikanska FDA för MEDI4736 mot icke-småcellig lungcancer och MEDI8897 för behandling av luftvägsinfektion orsakad av RSV-viruset hos små barn.

Tillbaka till tillväxt: tillväxtplattformarna ökade med 13% under kvartalet, vilket motsvarar 56% av de totala intäkterna.

oBrilinta/Brilique: 45% tillväxt under kvartalet, vilket understöddes av publiceringen av positiva PEGASUS-resultat på ACC-konferensen i mars.

oDiabetes: ökade med 47%, understött av en särskilt god tillväxt för Farxiga/Forxiga.

oSjukdomar i andningsvägarna: vår växande verksamhet inom sjukdomar i andningsvägarna ökade med 7%, med stabil försäljning av Symbicort och starkt resultat för Pulmicort.

oTillväxtmarknaderna: växte med 18% under kvartalet, med stöd av en tillväxt på 28% i Kina, där försäljningen inom sjukdomar i andningsvägarna ökade med 35%.

oJapan: försäljningen minskade 2% under kvartalet på grund av de slutliga effekterna av de föreskrivna prissänkningarna som görs vart annat år.

Vårt fokus på externa samarbeten accelererar i linje med vår affärsmodell och skapar ytterligare värde för patienter och aktieägare tack vare den starka forskningsportföljen.

Samarbetsavtal med Daiichi Sankyo i USA avseende marknadsföring av Movantik, som lanserades i mars mot opioid-inducerad förstoppning; överenskommelsen innefattade 200 MUSD i förskott som extern samarbetsintäkt, vilket ingår i de totala intäkterna för Q1 2015.

Strategiskt samarbete med Celgene Corporation för att utveckla vår immunonkologi-portfölj mot blodcancer.

Pascal Soriot, koncernchef, kommenterar resultatet:

”Våra lovande resultat under kvartalet ger stöd åt vår helårsprognos. De totala intäkterna ökade med 1%, där tillväxtplattformarna står för 56%, efter särskilt starka resultat på tillväxtmarknaderna och för Brilinta/Brilique. Vårt samarbetsavtal för Movantik i USA är ett bra exempel på hur vi kommer att föra ut viktiga läkemedel till patienter och hur detta kan ge ett värde för externa samarbeten till våra aktieägare.

”Vår portfölj har utvecklats väl inom alla våra terapiområden. Höjdpunkter innefattar de positiva första resultaten från PINNACLE-programmet i fas III för vårt läkemedel PT003 mot sjukdomar i andningsvägarna samt data från PEGASUS-studien för Brilinta/Brilique mot hjärt-/kärlsjukdomar. Vi fick två godkända ansökningar för nya läkemedel, samt två särläkemedel och två godkännanden om fast-track status av FDA. Vi ser fram emot att presentera närmare uppgifter under året.

”Vi har också fortsatt att stärka vår cancer-verksamhet och har nu 72 prövningar på gång, bland annat 31 inom immunonkologi. De senaste resultaten för AZD9291, som visade på stark klinisk nytta, med 13,5 månaders progressionsfri överlevnad och fast-track status av FDA för MEDI4736, vilka båda är avsedda för patienter med lungcancer, visar på vilka snabba framsteg vi gör på det här området. Vår strategiska allians med Celgene, ledande inom hematologi, kommer att maximera potentialen av våra immunonkologitillgångar för de mycket viktiga hematologi-indikationerna, och vårt samarbete med Innate Pharma kommer att ytterligare stärka vår verksamhet inom immunonkologi.”

Vi räknar med fortsatt starkt nyhetsflöde kring forskningsportföljen under året, bland annat:

oKommande registreringsansökningar för AZD9291 mot icke-småcellig lungcancer och cediranib mot äggstockscancer och brodalumab mot psoriasis.

oKommande regulatoriska beslut för Iressa mot icke-småcellig lungcancer,Brilinta/Brilique för patienter med tidigare hjärtinfarkt, lesinurad mot gikt, saxagliptin/dapagliflozin vid diabetes typ II.

Prognos för 2015:

Bolaget upprepar den prognosen som gavs den 6 mars 2015

  • oHelår 2015 Totala intäkter förväntas minska med medelhög ensiffrig procentuell siffra (mid single-digit)
  • oVinst per aktie (Core EPS ) väntas öka med en låg ensiffrig procentuell siffra (low single digit percent) .

1Ytterligare detaljer om presentationen av de totala intäkterna finns i tillkännagivandet som offentliggjordes av Företaget den 6 mars 2015.

2Alla tillväxtsiffror är i fasta valutakurser

---------------------

Den fullständiga pressreleasen på engelska hittar du som bifogad pdf.

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Användbar information:

Full Year 2014 Financial Results Statement

First Quarter 2014 Financial Results Statement

AstraZeneca’s strategy update on 18th November 2014

Photography of AstraZeneca senior management, sites and logo

Kontaktpersoner:

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Jacob Lund+46 8 553 260 20 (Sverige)

Michele Meixell+1 302 885 6351(USA)

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, 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