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AstraZeneca and Isis Pharmaceuticals to discover and develop antisense drugs for cardiovascular, metabolic and renal diseases

Pressmeddelanden   •   2015-08-03 08:02 CEST

AstraZeneca and Isis Pharmaceuticals, Inc. today announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. The new collaboration builds on a broad existing relationship between the two companies and supports AstraZeneca’s strategic approach in these therapeutic areas using novel RNA-targeted treatments. It also enables Isis Pharmaceuticals to extend use of its antisense technology to diseases of the kidney.

Antisense drugs are short, chemically-modified, single-stranded nucleic acids (antisense oligonucleotides) that have the ability to target any gene product of interest. They offer new opportunities for therapeutic intervention because they act inside the cell to influence protein production by targeting RNA to either prevent the production of disease-causing proteins, increase the production of proteins deficient in disease, or target toxic RNAs that are unable to generate proteins.

AstraZeneca will pay an upfront fee of $65 million to Isis Pharmaceuticals plus development and regulatory milestones for each programme that AstraZeneca advances to clinical development. Isis Pharmaceuticals is also eligible to earn tiered double-digit royalties on annual net sales for each programme.

Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca, said: “Antisense-based therapies are rapidly gaining momentum in the clinic and becoming an important component of our early stage pipeline. This collaboration combines the world-class antisense drug research capabilities of Isis with our expertise in cardiovascular, metabolic and renal disease drug discovery and development.By working together we aim to uncover targets and pathways that can be manipulated using antisense drug therapy.”

B. Lynne Parshall, Chief Operating Officer at Isis Pharmaceuticals, said: “This expansion of our collaboration with AstraZeneca establishes our second strategic relationship. This new collaboration will help broaden the application of our antisense technology to targets in the kidney. AstraZeneca is committed to finding novel best-in-class therapies for some of the largest, most complex and fastest growing disease segments in the developed world. Combining our antisense technology with AstraZeneca’s strong knowledge, leadership and commitment in these areas should be very valuable in fully exploiting these opportunities and moving new therapies effectively and efficiently toward the market.”

This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.

– ENDS –

NOTES TO EDITORS

About Isis Pharmaceuticals, Inc.

Isis is exploiting its leadership position in RNA-targeted technology to discover and develop novel drugs for its product pipeline and for its partners.Isis’ broad pipeline consists of 38 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer.Isis has numerous drugs in Phase 3 development in severe/rare diseases and cardiovascular diseases. Isis’ patents provide strong and extensive protection for its drugs and technology.Additional information about Isis is available at www.isispharm.com.

About AstraZeneca

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

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Karen BirminghamUK/Global+44 20 7604 8120
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Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Isis Pharmaceuticals’ Forward-looking Statement

This press release includes forward-looking statements regarding Isis’ alliance with AstraZeneca, Isis’ research, development and commercial opportunities in developing antisense drugs to treat cardiovascular, metabolic and renal diseases.Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.As a result, you are cautioned not to rely on these forward-looking statements.These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2014, and its most recent quarterly report on Form 10-Q, which are on file with the SEC.Copies of these and other documents are available from the Company.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.

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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Resultat AstraZeneca PLC första halvåret 2015

Pressmeddelanden   •   2015-07-30 08:04 CEST

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AstraZeneca further sharpens focus through agreement with Genzyme for rare disease medicine Caprelsa

Pressmeddelanden   •   2015-07-27 08:02 CEST

27 July 2015

AstraZeneca today announced that it has entered into a definitive agreement with Genzyme to divest Caprelsa® (vandetanib), a rare disease medicine.

Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma, with global product sales of $48 million in 2014.

Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and develop Caprelsa, and further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. As an asset divestment, upfront receipt andany subsequent paymentswill be reported in Other Operating Income in the Company’s financial statements.

Luke Miels, Executive Vice President, Global Product & Portfolio Strategy and Corporate Affairs, AstraZeneca, said: “Caprelsa is a rare disease therapy and the divestment to Genzyme, an expert leader in endocrinology, demonstrates our commitment to ensure patients continue to have access to this medicine while we sharpen our focus on key disease areas.”

Genzyme’s President and CEO, David Meeker, MD, said: “The addition of Caprelsa represents a strong strategic fit for our rare endocrinology portfolio and underscores Genzyme’s commitment to addressing unmet needs in the thyroid community. We look forward to bringing our rare disease expertise to appropriate patients with advanced stage thyroid carcinoma.”

The divestment transaction is subject to closing conditions, including the receipt of antitrust clearance from the US Federal Trade Commission. The transaction is expected to complete in the second half of 2015 and does not impact AstraZeneca’s financial guidance for 2015.

– ENDS –

NOTES TO EDITORS

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to

making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com. Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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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Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRespiratory, Inflammation and Autoimmunity+44 20 7604 8233+44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17 6326 3994+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksInfection, Neuroscience and Gastrointestinal Disease+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
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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 into a definitive agreement with Genzyme to divest Caprelsa® (vandetanib), a rare disease medicine.

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AstraZeneca provides update on selumetinib

Pressmeddelanden   •   2015-07-22 08:02 CEST

22 July 2015

AstraZeneca today announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival.This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing.

Selumetinib is a MEK inhibitor in late-stage development, with a primary programme in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase III study in differentiated thyroid cancer and in a Phase II registration study in patients with neurofibromatosis Type 1.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “Selumetinib is supported by a strong development programme with different scientific rationale in multiple tumour types as both monotherapy and in alternative combinations. The findings from SUMIT have no impact on the other studies and we look forward to presenting the data in due course.”

– ENDS –

NOTES TO EDITORS

About Selumetinib in Uveal Melanoma

Selumetinib, licensed from Array BioPharma Inc.in 2003, inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumour from growing.

The Selumetinib in Uveal Melanoma Investigator Trial (SUMIT) is a randomised, double-blind, placebo controlled trial being carried out in 45 centres, across 11 countries.

Uveal melanoma is an orphan disease in which cancer cells grow in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas1,2. There are currently no effective treatments for advanced uveal melanoma and in April 2015, selumetinib was granted Orphan Drug Designation by the US Food and Drug Administration in recognition of the need for new, safe and effective therapies for the disease3.

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has a 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 a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation 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 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.

References

  • 2.Ramaiya KJ, Harbour JW. Current management of uveal melanoma. Expert Rev Ophthalmol 2007; 2:939–46

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Esra   Erkal-PalerUK/Global+44 20 7604   8030
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Michele   MeixellUS+ 1 302   885 6351
Investor   Enquiries
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Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRespiratory, Inflammation and   Autoimmunity+44 20 7604 8233+44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17   6326 3994+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
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Christer Gruvris+44 20 7604 8126+44 7827 836825
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Dial / Toll-Free+1 301   398 3251+1 866 381 7277

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 the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival.

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AstraZeneca enters option agreement with Kyowa Hakko Kirin for commercialisation of benralizumab in Japan

Pressmeddelanden   •   2015-07-16 08:05 CEST

16 July 2015

AstraZeneca today announced that it has entered an agreement with Kyowa Hakko Kirin Co. Ltd. (Kyowa Hakko Kirin) for an exclusive option to commercialise benralizumab for asthma and chronic obstructive pulmonary disease (COPD) in Japan.

Benralizumab is a monoclonal antibody in Phase III development for the treatment of severe uncontrolled asthma and COPD. It targets the IL-5 receptor and depletes eosinophils, which play a key role in inflammatory respiratory disease. The global Phase III results for benralizumab in severe asthma are expected to read out in 2016, with regulatory submissions anticipated later that year. Phase III results and regulatory filing in COPD are expected in 2018.

Currently, Kyowa Hakko Kirin holds exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia, while AstraZeneca has exclusive rights in all other countries including the US and Europe.

Under the terms of the agreement, AstraZeneca will pay Kyowa Hakko Kirin a $45 million up-front option fee and subsequent payments for regulatory filing, approval and commercial milestones, and sales royalties. Kyowa Hakko Kirin will continue to be responsible for the research and development of benralizumab in Japan. On exercising the option, AstraZeneca will be responsible for all sales and marketing in asthma and COPD in Japan. Kyowa Hakko Kirin will retain the rights to participate in certain commercial activities alongside AstraZeneca.

Marc Dunoyer, Chief Financial Officer, AstraZeneca, said: “Japan is the second largest pharmaceutical market in the world and one of our growth platforms. The agreement with Kyowa Hakko Kirin increases our focus on respiratory diseases, a main therapy area for AstraZeneca, and provides the opportunity to bring an innovative potential medicine to patients in Japan who are waiting for new treatment options.”

Masashi Miyamoto, PhD, Executive Officer, Director, Strategic Product Portfolio Department of Kyowa Hakko Kirin said: “We are delighted to enter this agreement with our long-standing strategic partner AstraZeneca. Through this newagreement, we will be able to maximise the medical benefits that this innovative new drug could bring to patients in Japan.”

The option agreement does not impact AstraZeneca’s financial guidance for 2015.

– ENDS –

NOTES TO EDITORS

About benralizumab

Benralizumab is an investigational humanised monoclonal antibody directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα) that depletes eosinophils, a key target cell in inflammatory respiratory disease.

Benralizumab is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.

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 inhaled corticosteroids (ICS) more than twice a year. Asthma treatment usually includes ICS 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 COPD

COPD 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. Although COPD is widely regarded as a disease of the elderly, 50 percent of patients are estimated to be between 50 and 65 years of age, meaning half of the COPD population is likely to be affected at a stage in their life when they are at the peak of their earning potential and are likely to have major family responsibilities.

About KyowaHakko Kirin

Kyowa Hakko Kirin is a research-based life sciences company with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/ allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, we are working to realise our vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and comfort of people around the world. More information can be found at http://www.kyowa-kirin.com

About AstraZeneca in Respiratory Disease
AstraZeneca has a strong heritage in developing innovative medicines for respiratory diseases with more than 40 years of experience and a strong franchise of marketed products. Our strategy is to deliver a range of differentiated inhaled therapies, including novel combinations, new devices, and innovative product offerings to treat respiratory diseases, including asthma, COPD and idiopathic pulmonary fibrosis (IPF). We believe innovative precision approaches will ensure the right treatment for the right patient – our vision is to improve the lives of 25 million patients by 2024.

The AstraZeneca Respiratory portfolio includes asthma and COPD medicine Symbicort and asthma medicine Pulmicort, as well as COPD treatments, Eklira Genuair / TudorzaPressair / Tudorza Genuair, Duaklir Genuair and Daliresp.

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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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
US
Dial / Toll-Free+1 301 398 3251+1 866 381 7277

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 Kyowa Hakko Kirin Co. Ltd. (Kyowa Hakko Kirin) for an exclusive option to commercialise benralizumab for asthma and chronic obstructive pulmonary disease (COPD) in Japan

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Iressa approved by US FDA for first-line treatment of patients with advanced EGFR mutation-positive non-small cell lung cancer

Pressmeddelanden   •   2015-07-13 21:34 CEST

13 July 2015

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved IRESSA (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

IRESSA is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the growth and survival of cancer cells. IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive NSCLC.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: “The approval of IRESSA provides physicians and patients in the US with a new choice of first-line treatment for metastatic non-small cell lung cancer. AstraZeneca is at the forefront of research into targeted therapies for EGFR mutated lung cancer and is committed to improving the outlook for patients at all stages of the disease.”

AstraZeneca has partnered with QIAGEN to provide the therascreen® EGFR companion diagnostic test for IRESSA in the US. The test rapidly identifies EGFR mutation status through a tumour tissue sample, in order to guide the use of IRESSA in the treatment of patients with metastatic NSCLC.

The FDA approval of IRESSA is based on data from the Phase IV IFUM1(IRESSAFollow-UpMeasure) study, assessing IRESSA as a first-line treatment for Caucasian patients with locally advanced or metastatic EGFR mutation-positive NSCLC. This was supported by results from the IPASS2(IRESSAPan-ASiaStudy) clinical trial.

IRESSA is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC. The safety profile of IRESSA is well established through a large, global clinical programme and extensive real world evidence. The most commonly reported adverse events for IRESSA are diarrhoea and skin reactions including rash, acne, dry skin and pruritus.

AstraZeneca is also studying IRESSA in combination with other investigational medicines, including the company’s anti-PD-L1 monoclonal antibody, durvalumab (MEDI4736) to assess its potential as a combination treatment for a broader range of lung cancer patients.

– ENDS –

NOTES TO EDITORS

1 Douillard JY et al. First-linegefitinibin Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br J Cancer 2014 Jan 7; 110, 55-62. doi: 10.1038/bjc.2013.721.

2 Masahiro F, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol 2011Jul 20; 29(21):2866-74. doi: 10.1200/JCO.2010.33.4235.

About the IFUM Study

The IFUM study was a multicentre, single arm study to characterise the efficacy and safety of gefitinib 250mg (once daily) as first-line treatment in Caucasian patients who have EGFR mutation-positive locally advanced or metastatic NSCLC. A total of 106 EGFR mutation-positive patients were enrolled to the study. The overall response rate (ORR) by investigators’ assessment was 70% (95% confidence interval (CI) 61% to 78%). ORR by a Blinded Independent Centre Review (BICR) was 50% (95% CI 41% to 59%).

The most common adverse events (AEs) in the IFUM study were rash (44.9%), diarrhoea (30.8%), vomiting (13.1%), asthenia, cough and dry skin (all 11.2%), and nausea (10.3%). Two patients (1.9%) experienced a serious AE that the investigator characterised as related to treatment, and 4 patients (3.7%) experienced drug related AEs that led to treatment discontinuation.

About IRESSA

IRESSA is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10 to 15 percent of NSCLC Caucasian patients and 30 to 40 percent of NSCLC patients in Asia.

IRESSA is approved in 91 countries worldwide.

In the US, AstraZeneca has partnered with QIAGEN to develop a companion diagnostic test to guide the use of IRESSA. In Europe, the collaboration between AstraZeneca and QIAGEN has resulted in IRESSA becoming the first EGFR tyrosine kinase inhibitor to have a European label supporting the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.

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 medicines is focused on four main disease areas - lung, ovarian, 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.

In lung cancer, AstraZeneca is at the forefront of development of targeted therapies, with more than 10 years’ experience in providing treatments for this challenging disease. In 2002, AstraZeneca was the first company to launch an EGFR TKI for patients with pre-treated metastatic NSCLC. We are committed to addressing the urgent unmet need for more effective treatments and are developing therapies that target all stages of the disease from primary treatment through to recurrence and re-treatment, in order to achieve sustained disease control. By making targeted, personalised treatment a reality at every stage, we hope to take important steps towards ultimately eradicating death from lung cancer.

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-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+ 1 302 885 6351
Investor   Enquiries
UK
Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRespiratory, Inflammation and Autoimmunity+44 20 7604 8233+44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17   6326 3994+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksInfection, Neuroscience and   Gastrointestinal Disease+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
US
Dial / Toll-Free+1 301   398 3251+1 866 381 7277

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 the US Food and Drug Administration (FDA) has approved IRESSA (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

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ASTRAZENECA SHARPENS FOCUS ON MAIN THERAPY AREAS THROUGH AGREEMENT WITH GASTROENTEROLOGY SPECIALIST TILLOTTS PHARMA FOR ENTOCORT

Pressmeddelanden   •   2015-07-09 08:36 CEST

09 July 2015

AstraZeneca announced today that it has entered into an agreement with Tillotts Pharma AG (Tillotts), part of the Zeria Group, for the divestment of global rights, outside the US, to Entocort (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease and ulcerative colitis. Entocort is currently available in over 40 countries, with total product sales of $53 million outside the US in 2014. A regulatory submission for Entocort in Japan is anticipated in the coming months.

Under the terms of the agreement, Tillotts will pay AstraZeneca $215 million upon completion of the transaction to acquire the rights to sell and develop Entocort capsules and enema formulations outside the US. The transaction does not include the transfer of any AstraZeneca employees or facilities.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy and Corporate Affairs, AstraZeneca, said: “Our agreement with Tillotts reinforces our strategic focus on selected therapy areas and puts this important medicine in the hands of a company with specialist expertise in gastroenterology, which will benefit patients.”

Thomas A. Tóth von Kiskér, CEO of Tillotts, commented: “Entocort perfectly complements our Asacol® portfolio marketed in 50 countries worldwide through our own European affiliates, our Japanese parent company Zeria Pharmaceutical and our trusted network of marketing partners. This acquisition underscores our commitment to continue to position Tillotts as a leading European specialised player in the field of gastroenterology, offering patients a wide range of treatments for the GI tract.”

Sachiaki Ibe, Chairman and CEO of Zeria Pharmaceutical, added: “We are excited to obtain a well-established brand such as Entocort and to expand its commercial reach to Japan and other countries. With this move, we confirm our expansion strategy of organic growth combined with merger and acquisition activities, while delivering increased value to our shareholders."

As AstraZeneca will no longer retain an interest in the ex-US rights to Entocort, the upfront receipt will be reported in Other Operating Income in the Company’s financial statements for 2015. The transaction is expected to complete in the second half of 2015, subject to customary closing conditions, and it does not impact AstraZeneca’s financial guidance for 2015.

– ENDS –

NOTES TO EDITORS

About Entocort®

In capsule formulation, Entocort is a first-line therapy indicated for the induction and maintenance of clinical remission of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. As an enema, Entocort is indicated for the induction and maintenance of clinical remission of distal ulcerative colitis in the rectum, sigmoid colon and descending colon.

AstraZeneca has a partnership with Par Pharmaceutical for the commercialisation of Entocort in the US.

About Tillotts

Tillotts Pharma AG, part of the Zeria Group, is a fast-growing specialty pharma company with over 200 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialisation of innovative pharmaceutical products, medical devices and diagnostics, all in the field of gastroenterology.

Tillotts successfully markets its own products Asacol® and Colpermin®, as well as VistaPrep® and in-licensed products, such as Simtomax®, in over 55 countries through its own affiliates within Europe and a carefully chosen network of gastroenterology-focused marketing partners throughout the world. For more information, please visit www.tillotts.com.

About Zeria

Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information, please visit www.zeria.co.jp.

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-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+ 1 302 885 6351
Investor   Enquiries
UK
Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRespiratory, Inflammation and   Autoimmunity+44 20 7604 8233+44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17   6326 3994+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksInfection, Neuroscience and   Gastrointestinal Disease+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
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Dial / Toll-Free+1 301   398 3251+1 866 381 7277

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 announced today that it has entered into an agreement with Tillotts Pharma AG (Tillotts), part of the Zeria Group, for the divestment of global rights, outside the US, to Entocort (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease and ulcerative colitis.

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AstraZeneca to collaborate with Inserm in type 2 diabetes and Chronic Kidney Disease studies

Pressmeddelanden   •   2015-06-17 08:02 CEST

AstraZeneca today announced a three-year research collaboration with the French National Institute of Health and Medical Research (Inserm) to investigate new therapeutic approaches to type 2 diabetes and Chronic Kidney Disease (CKD). The aim of the collaboration is to advance understanding of the biological mechanisms that underpin these conditions and develop new treatments based on this knowledge.

Under the terms of the collaboration, each project will comprise a joint team of investigators that will work across Inserm sites in Toulouse and Paris, and AstraZeneca’s research hub in Mölndal, Sweden. The collaboration will focus on three areas:

Understanding mineralocorticoid receptor (MR) activity as a route to treating CKD

Excessive MR activation is an important mechanism in the development of CKD; however, this receptor also plays a crucial role in maintaining the body’s electrolyte balance. AstraZeneca together with a team led by Professor Frederic Jaisser at the Cordeliers Research Centre (Inserm unit 1138) in Paris, will aim to better understand the complexities of MR activity as a potential treatment for CKD.

Enhancing tissue sensitivity to insulin

In healthy people, fat cells store lipids when the person is fed (state of energy excess) and release them in the fasting state. However, in obese and insulin-resistant patients, excess fat tissue leads to an uncontrolled release of lipids into the bloodstream. This leads to fat accumulation in tissues such as the liver and in muscle, triggering resistance to the action of insulin in those tissues and predisposing to type 2 diabetes. AstraZeneca together with a team led by Professor Dominique Langin at the Inserm/Paul Sabatier University Institute of Metabolic and Cardiovascular Disease (I2MC, Inserm unit 1048) in Toulouse will explore pharmacological ways to prevent the release of lipids into the circulation, normalise fat deposition and increase insulin sensitivity in peripheral tissues.

Exploring loss of insulin production

Beta cells are a type of cell found in the pancreas which produce and release insulin. In type 2 diabetes, both the quantity of beta cells and their ability to produce and secrete insulin are decreased. AstraZeneca together with a team led by Dr Raphaël Scharfmann at the Inserm/University Paris-Descartes unit 1016 "Cochin Institute" in Paris, will develop models of human beta cells which have lost their ability to produce and release insulin to better understand the biology of this effect and how it cn be corrected through treatment.

Marcus Schindler, Head of Cardiovascular and Metabolic Diseases Innovative Medicines unit, AstraZeneca said: “Over the last few years AstraZeneca has been focusing on pioneering research into cardiovascular and metabolic disease. By joining forces with Professors Langin, Jaisser and Scharfmann and their eminent research groups at Inserm, we strengthen further this ambition because their focus represents an ideal fit with our research strategy.”

Professor Christian Boitard, Director of the Inserm institute for Physiopathology, Metabolism and Nutrition, said: “This collaboration is focusing our efforts in beta cells, mineralocorticoid receptor and lipids handling by tissues. Combining the AstraZeneca and Inserm scientists, expertise and platforms represents a great opportunity for advancing research in these important fields, with the operational support of Inserm Transfert teams.”

-ENDS-

NOTES TO EDITORS

About Inserm

Founded in 1964, the French National Institute of Health and Medical research (Inserm) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research and the Ministry of Social Affairs, Health and women's Rights. Inserm is the only French public research institute to focus entirely on human health with nearly 15000 researchers, engineers, technicians, post-doctoral students and more than 300 laboratories. The mission of its scientists is to study all diseases, from the most common to the rarest. Inserm is a member of Aviesan*, the French National Alliance for Life Sciences and Health founded in 2009.
* Other founding members of Aviesan : CEA, CNRS, CHRU, CPU, INRA, INRIA, Inserm, Institut Pasteur, IRDInserm Transfert, its private subsidiary, has full responsibility for all technology transfer activities of Inserm. www.inserm.fr

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

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

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

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 three-year research collaboration with the French National Institute of Health and Medical Research (Inserm) to investigate new therapeutic approaches to type 2 diabetes and Chronic Kidney Disease (CKD).

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AstraZeneca to collaborate with the University of Michigan to advance treatments for chronic kidney disease

Pressmeddelanden   •   2015-06-17 08:02 CEST

AstraZeneca today announced a two-year research collaboration with the University of Michigan to advance the treatment of chronic kidney disease (CKD) through the improved understanding of the disease. The collaboration will tackle the challenging area of identifying novel targets for the treatment of CKD, focusing on the use of patient tissue and validation of preclinical models.

CKD is a condition in which the kidneys are damaged and cannot filter blood effectively, leading to waste from the blood remaining in the body, which may cause other health problems such as cardiovascular disease, heart attack or stroke. Most patients progress eventually to end-stage renal disease and require haemodialysis and kidney transplantation.

Under the terms of the collaboration, scientists from AstraZeneca’s laboratories in Mölndal, Sweden, will work with a team of investigators at the University of Michigan led by Matthias Kretzler, Professor of Internal Medicine and Computational Medicine and Bioinformatics to:

  • examine databases of biopsies from CKD patients to identify biological targets and pathways which predict disease progression
  • create improved animal models that better reflect the human disease condition
  • identify biomarkers in patient samples which are associated with disease progression and response to treatment

Marcus Schindler, Head of the Cardiovascular and Metabolic Diseases (CVMD) Innovative Medicines Unit, AstraZeneca, said: “Current approaches to treating the complications of diabetes mean that patients need expensive treatment options which are often limited, so there is a significant unmet medical need. Through this collaboration, we will generate increasing evidence that we are pursuing the right therapeutic targets to treat CKD which will shift clinical therapy to a more focused patient population, giving a better response to treatments and slowing disease progression.”

Matthias Kretzler said: “The collaboration builds on the promise of combining basic university research, which can uncover specific targets for precise-acting drugs, with drug compound development by AstraZeneca.Steered by science, we will examine new approaches to treating the damage that diabetes inflicts on the kidneys of millions of people.”

– ENDS –

NOTES TO EDITORS

About the University of Michigan

The University of Michigan Health System creates the future of health care through medical education, patient care and research. UMHS is a community of more than 26,000 faculty, staff, trainees and volunteers, including 3 hospitals and 40 outpatient locations. The University of Michigan Medical School consistently ranks among the top research universities in the United States and world. With one of the nation's largest research budgets, The University of Michigan finds new ways to understand, diagnose, treat, manage and prevent many human diseases.

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

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

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

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 two-year research collaboration with the University of Michigan to advance the treatment of chronic kidney disease (CKD) through the improved understanding of the disease.

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AstraZeneca appoints Pam Cheng as Executive Vice President, Operations and IT

Pressmeddelanden   •   2015-06-16 08:02 CEST

AstraZeneca today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT. Pam will succeed David Smith, who is retiring after nearly ten years with AstraZeneca.

Pam will be responsible for manufacturing operations and supply chain, procurement and information technology globally. In the role she will oversee continued progress in driving efficiency and delivering excellence in these areas.

Pam joins AstraZeneca from Merck/MSD, where she gained extensive experience in pharmaceuticals manufacturing and supply chain management. She played a lead role in restructuring and upgrading the company’s manufacturing technology and engineering capabilities as Director of Global Planning and Capacity Management, and as Head of Global Supply Chain Management and Logistics led the transformation of the company’s supply chains across its global network. Most recently, Pam was Chief Operating Officer and then President of MSD China. Prior to joining Merck, Pam held Process Engineering roles at Union Carbide and GAF Chemicals.

Pascal Soriot, Chief Executive Officer, said: “I am delighted to welcome Pam to AstraZeneca at a very exciting time for our business. As our pipeline delivers, we will bring an increasing number of new medicines to patients across the globe over the coming years, including important biological therapies as our product mix shifts. Pam will be able to bring to bear her wealth of experience in manufacturing and supply chain management, as well as her experience in emerging markets, particularly China, a key priority for our company.”

“I also want to take the opportunity to thank David Smith for the invaluable contribution he has made to the leadership of AstraZeneca and to streamlining and expanding our global manufacturing footprint. The quality, reliability and cost effectiveness of our supply chain will be his legacy for many years to come.”

Pam will report to Pascal Soriot and will be a member of AstraZeneca’s Senior Executive Team.

Pam holds bachelor’s and master’s degrees in Chemical Engineering from Stevens Institute of Technology in New Jersey and an MBA in Marketing from Pace University in New York.

– ENDS –

NOTES TO EDITORS

To obtain a photograph of Pam Cheng please visit www.astrazeneca.com/media/photo-library or contact the media team (details below).

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 today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT.

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Kontaktpersoner 3 kontaktpersoner

  • Presskontakt
  • Presschef
  • jacob.lund@astrazeneca.com
  • 08 553 260 20 Mobil: 072 560 21 57

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