AstraZeneca

Sammanfattning:

Intäkterna under andra kvartalet uppgick till 6 454 MUSD, en ökning med 4% i fasta valutakurser (CER), det andra kvartalet i rad med intäktstillväxt (Q2 2013: 6 232 MUSD).

Vinst per aktie för kärnverksamheten (CORE EPS) under andra kvartalet ökade med 13% till 1,30 USD i fasta valutakurser. Vinsten per aktie för kärnverksamheten för halvåret minskade med 1%.

Avtalet med Almirall tillför strategiskt och långsiktigt värde till AstraZenecas verksamhet inom sjukdomar i andningsvägarna, en viktig tillväxtplattform. Verksamhetssamordningen kommer att leda till omedelbara och växande produktintäkter med vinsttillskott från 2016, samt att den förstärker portföljen inom astma och KOL med nya bronkodilatorer.

Betydande framsteg har gjorts mot att uppnå ledarskap inom forskning i våra centrala terapiområden. Forskningsportföljen innehåller nu 14 projekt i fas III eller under registrering, en ökning från 8 för ett år sedan. Starka vetenskapliga data presenterades vid American Thoracic Society (ATS) avseende biologiska läkemedel inom andningsvägar, vid American Society of Clinical Oncology (ASCO) avseende portföljen inom immunonkologi och AZD9291, olaparib och cediranib, samt vid American Diabetes Association (ADA) avseende kombinationen av saxagliptin och dapaglifozin.

AstraZeneca höjer sin prognos för intäkter och vinst per aktie för kärnverksamheten för hela året. Intäkterna förväntas ligga i nivå med 2013, i fasta valutakurser, en ökning jämfört med den tidigare prognosen om en låg till medelhög ensiffrig procentuell nedgång. För vinsten per aktie för kärnverksamheten förväntas en låg tvåsiffrig nedgång i fasta valutakurser, vilket är en uppdatering jämfört med tidigare prognos på en procentuell nedgång "in the teens". Prognosen utgår från att en generisk variant av Nexium lanseras i USA den 1 oktober 2014.

Styrelsen har rekommenderat en utdelning för första halvåret på 0,90 USD.

Investor Day planeras den 18 november 2014.

Pascal Soriot, koncernchef, kommenterar resultatet: "Vi har gjort betydande framsteg under första halvåret i år, med synligt momentum inom terapiområdena hjärt/kärlsjukdom, diabetes och sjukdomar i andningsvägarna, samt stark tillväxt för tillväxtmarknaderna. Detta har lett till intäktstillväxt för andra kvartalet i rad och resulterat i en ökning av vinsten per aktie med 13% för kärnverksamheten under kvartalet. Takten i genomförandet av vår strategi och de underliggande prestationerna av våra medarbetare gör att vi med tillförsikt kan höja prognosen för helåret 2014.

"Verksamhetssamordningen med Almirall kommer att tillföra strategiskt långsiktigt värde när vi sammanför de två innovativa portföljerna för att ytterligare stärka vårt engagemang inom sjukdomar i andningsvägarna och bidra till vår tillväxt.

Vi har nu en av de mest spännande forskningsportföljerna i branschen med 14 projekt i sen utvecklingsfas. Under de senaste veckorna har vi presenterat övertygande data som visar vår potential när det gäller att väsentligt utveckla hur patienter behandlas, inklusive inom immunonkologi. Kvaliteten på den omvandling vi ser inom alla kärnområden av vår verksamhet stärker ytterligare vårt förtroende för AstraZenecas framtidsutsikter."

Intäkterna under halvåret ökade 3%, med de fem tillväxtplattformarna som pådrivande faktor:

o Brilinta/Brilique: vår trombocythämmare nådde en tillväxt på 84% i global försäljning, med fortsatt momentum i USA och Europa.

o Diabetes: vi nådde 128% tillväxt efter framgångsrik integrering av BMS tillgångar och stark lansering av Farxiga i USA.

o Andningsvägar: Försäljningen under halvåret ökade med 9%, med tillväxten på 25% för Symbicort i USA som pådrivande faktor.

o Tillväxtmarknader: Tillväxtmarknaderna ökade med 11%, med en tillväxt i Kina på 23%.

o Japan: Försäljningen i Japan ökade med 1% under halvåret, påverkad av prissänkningar vartannat år.

Vi fortsätter att göra betydande framsteg mot att uppnå ledarskap inom forskning:

o Inom immunonkologi påbörjades fas III-studie med PD-L1 (MEDI4736) avseende icke småcellig lungcancer (NSCLC) och beslut fattades om att inleda registreringsstödjande studier inom huvud- och halscancer under 2014.

o Fas II studie avseende tremelimumab (CTLA-4) inom mesteliom utökades för att stödja registrering.

o Fas III-studier inleddes för roxadustat avseende kronisk njursjukdom och terminal njursvikt.

o Olaparib-programmet utökades med fas III-studie avseende tilläggsbehandling av BRCAm bröstcancer

o Benralizamub-programmet utökades med randomisering av första patient i fas III-studie rörande KOL.

o Investeringsbeslut rörande fas III för PD-L1 i kombination med tremelimumab, AZD9291 vid förstahandsbehandling (1st line) av NSCLC och Forxiga vid typ 1-diabetes.

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Den fullständiga rapporten på engelska i bifogad pdf-fil.

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Användbar information:

AstraZeneca’s strategy update den 6 maj 2014 

Q1 2014 Financial Results Statement

Photography of AstraZeneca senior management, sites and logo

Kontaktpersoner:
Esra Erkal-Paler +44 020 7604 8030(UK/Global)
Vanessa Rhodes +44 020 7604 8037(UK/Global)
Ayesha Bharmal +44 020 7604 8034(UK/Global)
Jacob Lund +46 8 553 260 20(Sweden)

AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.

The study will evaluate AstraZeneca’s anti-PD-L1 antibody, MEDI4736, in combination with Kyowa Hakko Kirin’s anti-CCR4 antibody, mogamulizumab, and AstraZeneca’s anti-CTLA-4 antibody tremelimumab, in combination with mogamulizumab.

MEDI4736, tremelimumab, and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which use the body's own immune system to help fight cancer. MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.

Under the terms of the agreement, AstraZeneca and Kyowa Hakko Kirin will co-fund the study, which will be conducted by Kyowa Hakko Kirin. The Phase I part of the study is expected to establish a recommended dose regimen and Phase Ib will assess the safety and efficacy of the two combinations. Results from these studies will determine the future clinical development of the combinations.

Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “We believe that combination therapy in immuno-oncology has the potential to be one of the most effective ways of treating cancer. Our partnership with Kyowa Hakko Kirin provides the opportunity to explore two novel and exciting combinations.”

“With recent progress in the field of cancer immunotherapy, we have the potential to bring significant benefits to patients,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “Given the potential synergistic activity of our anti-CCR4 antibody when combined with immune checkpoint inhibitors, we look forward to collaborating with AstraZeneca to explore these combinations in multiple types of cancer.”

AstraZeneca and MedImmune have a broad programme of immuno-oncology combination trials underway, including MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360 and MEDI4736 with Advaxis’ immunotherapy vaccine, ADXS-HPV.

– ENDS –

NOTES TO EDITORS

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 is being developed, alongside other immunotherapies (IMTs), to empower the patient’s immune system and attack the cancer.

About tremelimumab
Tremelimumab is an investigational, fully human monoclonal IgG2 antibody which binds to the protein CTLA-4, expressed on the surface of activated T cells. It is one of the only molecules in development for treating mesothelioma by blocking CTLA-4 to strengthen immune system response.

About mogamulizumab
Mogamulizumab is a novel, humanised monoclonal antibody directed against CC chemokine receptor 4. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorisation for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014. Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.

About Kyowa-Hakko 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
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 2677 (US)

Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

Business combination will provide boost to revenue as well as creating long-term value, strengthening AstraZeneca’s respiratory franchise with a complementary pipeline and inhaled device capabilities in asthma and COPD

AstraZeneca today announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira® (aclidinium); LAS40464, the combination of aclidinium with formoterol which has been filed for registration in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in Phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and Phase I (LAS190792); and multiple pre-clinical programmes. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca.

The business combination will give AstraZeneca immediate access to on-market revenues, contributing to the company’s return to growth. The company expects the transaction to be neutral to Core EPS in 2015 and accretive from 2016. AstraZeneca intends to finance the transaction from existing cash resources and short-term credit facilities. Based on the anticipated timing of completion, the transaction will have no impact on AstraZeneca’s guidance for 2014.

Almirall’s pipeline of novel respiratory assets and its device capabilities further strengthen AstraZeneca’s respiratory portfolio, which includes Symbicort® and Pulmicort®, as well as the company’s investigational medicines in development. The addition of aclidinium and the combination of aclidinium with formoterol, both in proprietary Genuair® device, will allow AstraZeneca to offer patients a choice between dry powder inhaler and metered dose inhaler devices across a range of molecules and combinations.

AstraZeneca and Almirall anticipate that, subject to local consultation and legislation, a significant number of employees dedicated to the respiratory business, including Almirall Sofotec employees, will transfer to AstraZeneca.

Pascal Soriot, Chief Executive Officer of AstraZeneca said: “Our agreement with Almirall brings strategic and long-term value to AstraZeneca’s strong respiratory franchise, one of our key growth platforms. We will benefit from immediate and growing product revenues which we anticipate will be rapidly accretive to earnings. Chronic respiratory disease affects hundreds of millions of people around the world. By combining our innovative portfolios and leveraging AstraZeneca’s global scientific and commercial capabilities, we will strengthen our ability to address the entire spectrum of care in asthma and COPD. I very much look forward to welcoming the Almirall people to our company.”

Jorge Gallardo, President of Almirall said: “This important agreement allows us to better develop our assets and expertise in respiratory with AstraZeneca, an experienced player in this therapeutic area. It also allows us to better balance the costs, risks and returns of the respiratory business while retaining an important economic interest in its future success. All this constitutes a very solid baseline to move more aggressively in specialty areas and particularly towards becoming a global dermatology player. R&D will remain a key part of Almirall’s business going forward and hopefully a significant long-term growth driver."

The transaction is subject to certain competition law clearances as well as other customary terms and conditions. The companies anticipate the transaction will complete by the end of 2014.

An overview presentation about the transaction will be available at: www.astrazeneca.com/Investors.

– ENDS –

NOTES TO EDITORS

About COPD
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide and is predicted to be the third leading cause of death by 2020. Although COPD is widely regarded as a disease of the elderly, 50 per cent 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 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 Almirall
Almirall is a global company based in Barcelona dedicated to providing valuable medicines through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated profitable growth allows us to devote our talent and efforts in the respiratory and dermatology areas, with a focused interest in gastroenterology and pain. Our size enables us to be agile and flexible so that we can accomplish the purpose of taking our innovative products wherever they are needed.

Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2013, its revenues totalled €825 million and, with more than 3,000 employees, it has gradually built up a trusted presence across Europe, as well as in the US, Canada and Mexico. For more information please visit www.almirall.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 2677 (US)

Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729
Eugenia Litz +44 207 604 8233 mob: +44 788 473 5627

AstraZeneca today announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC).

The companion diagnostic test is designed to identify epidermal growth factor receptor (EGFR) mutations in both tumour tissue and plasma derived from patients with NSCLC, and to optimise the clinical development of AZD9291 for patients who are resistant to first-generation EGFR tyrosine kinase inhibitors (TKI).

Currently, patients who have been treated with EGFR-TKIs in whom the disease has progressed have to undergo a repeat biopsy to assess whether they have a specific mutation, T790M. Diagnostic tests based on circulating DNA (ctDNA) in plasma samples provide an alternative method of identifying the T790M mutation.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca said: “We are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of each individual’s tumour and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are diagnosed and treated.”

“Currently, late-stage lung cancer patients have to undergo surgery to collect tissue from a tumor so it can be sent for molecular testing,” said Paul Brown, Head of Roche Molecular Diagnostics (RMD). “In some cases, collecting enough tissue for testing is not possible. This collaboration will enable molecular testing through plasma specimens and provide the information needed to inform treatment decisions without the complications of surgery, consequently increasing the level of care clinicians can give to the patient.”

NSCLC represents approximately 80 to 85 per cent of all lung cancers. Unfortunately, at the time of diagnosis approximately 70 per cent of NSCLC patients have developed advanced or metastatic disease not amenable to surgical resection.

-ENDS-

About AZD9291
AZD9291 is a highly selective, irreversible inhibitor of both the activating sensitising EGFR mutation (EGFRm+) and the activating resistance mutation, T790M, while sparing the activity of wild type EGFR. Patients with EGFRm+ NSCLC are particularly sensitive to treatment with currently available EGFR 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 half of patients, this resistance is caused by the secondary mutation known as T790M. There are currently no targeted therapies approved for the treatment of tumours with this resistance mutation. In the ongoing Phase I study, AZD9291 has shown early evidence of activity as a once-daily monotherapy with clinical responses observed in an EGFRm+ population of patients with NSCLC who have previously failed on EGFR TKIs and also in patients with the T790M mutation. To date, AZD9291 has been well-tolerated with low rates of side effects.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.

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

AstraZeneca Media Enquiries
Esra Erkal-Paler +44 20 7604 8030 (UK/Global)
Ayesha Bharmal +44 20 7604 8034 (UK/Global)
* Vanessa Rhodes +44 20 7604 8037 (UK/Global)
Jacob Lund +46 8 553 260 20 (Sweden)
Michele Meixell + 1 302 885 6351 (US)

Roche Media
Enquires Bob Purcell +1 925 730 8114 (US)

AstraZeneca Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.

IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with IRESSA, through a blood test. Currently the main method of assessing EGFR mutation status involves the collection of tumour tissue by needle biopsy or during resection.

QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.

This collaboration is part of a long standing relationship between AstraZeneca and QIAGEN. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: “By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately.”

“We are excited about this new partnership with AstraZeneca”, said Peer M. Schatz, CEO of QIAGEN. “Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option.”

-ENDS-

NOTES TO EDITORS

About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of March 31, 2014, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at www.qiagen.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
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

22 July 2014

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’ lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.  

Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. MEDI4736 is designed to counter the tumour’s immune-evading tactics by blocking a signal that helps tumours avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumour.  Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumour response.

“Our collaboration with Advaxis is further evidence of MedImmune’s commitment to explore novel combination approaches as we progress our immuno-oncology portfolio,” said Dr. Bahija Jallal, Executive Vice President, MedImmune.  “We believe there could be an important clinical benefit from the combination of MEDI4736 with Advaxis’s antigen-specific cancer vaccine.” 

Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination.  The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted.  

Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types.  MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.

“We are excited to be partnering with MedImmune and evaluating MEDI4736 in combination with our immunotherapy,” said Daniel J. O’Connor, Chief Executive Officer, Advaxis. “This is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies.  As multiple companies vie for a competitive advantage in the future PD-L1 market, the ability of our immunotherapy platform to attack multiple tumour targets makes it an attractive combination therapy.”

AstraZeneca and MedImmune have recently initiated other immuno-oncology combination trials, including a collaboration with biopharmaceutical company Incyte to study MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.

– ENDS –

NOTES TO EDITORS

About HPV-associated head and neck cancers
The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the WHO, approximately 15-20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck
cancer is growing fastest in developed countries like the US.

About cervical cancer
There are 500,000 new cases of cervical cancer caused by HPV worldwide every year,  according to the WHO Human Papillomavirus and Related Cancers, World Summary Report 2010. Current preventative vaccines cannot protect the 20 million women who are already infected with HPV, and of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines. Challenges with acceptance, accessibility, and compliance have resulted in only a third of young women being vaccinated in the US and even less in other countries around the world.  HPV is associated with 20-50 percent of oral squamous cell carcinomas.

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 is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer.

About ADXS-HPV
ADXS-HPV is Advaxis’s lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer and anal cancer. In cervical cancer, a recently completed Phase 2 study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy, which warrants further development of the molecule. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.

About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform that redirects the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only cancer immunotherapy shown to actively suppress Tregs and MSDCs are key components in the cancer microenvironment that contribute to tumour growth and protect it from immunologic attack.

In addition to ADXS-HPV, Advaxis’s second immunotherapy candidate, ADXS-cHER2, targets the HER2 receptor, which is overexpressed in certain solid-tumour cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, a model for human bone cancer. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other immunotherapy constructs to a major animal-health company.  For more information, please visit www.advaxis.com.

About MedImmune
MedImmune is the global 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

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

Vanessa Rhodes 
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+44 20 7604 8034 (UK/Global)

Tracy Rossin
+1 301 3981468 (US)

Jacob Lund
+46 8 553 260 20 (Sweden)

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08 July 2014

AstraZeneca today announced an agreement with the Max Planck Institute of Molecular Physiology (MPI), Germany, to establish a ‘satellite unit’ in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit (iMed) in Mölndal, Sweden, to study new modalities chemistry.  

The new collaboration will see AstraZeneca scientists working side-by-side with researchers from the Max Planck Institute of Molecular Physiology, in the Department of Chemical Biology, led by Professor Herbert Waldmann. The satellite unit will focus on novel chemistry and chemical biology in areas of new modality chemistry such as stabilised peptides, macrocycles and conjugation chemistry.

Marcus Schindler, Vice President and Head of CVMD iMed, AstraZeneca, said: “I’m very pleased to collaborate with an internationally recognised academic institution such as the
Max Planck Institute of Molecular Physiology. Based on our excellent ongoing
collaboration with Professor Waldmann’s group and the interdisciplinary Chemical
Genomics Centre, we are confident that this innovative new partnership will
result in exciting scientific findings, addressing chemical challenges
primarily in the field of new modalities.”

Professor Herbert Waldmann, Director of the Department of Chemical Biology, MPI Dortmund,
said: “This novel concept for a strategic alliance between an innovation-driven pharmaceutical company and a leading biomedical institute like the Max Planck Institute of Molecular Physiology promises to break new ground for drug discovery. AstraZeneca is one of the leading global
pharmaceutical companies and we are pleased and very much looking forward to
the collaboration. Uniting our strengths will give rise to novel innovative
approaches to drug discovery.”

Cardiovascular and metabolic diseases represent one of AstraZeneca’s
three core therapy areas, with the aim of developing innovative treatments that
address the underlying biology to stop, reverse or cure diseases with high
unmet medical need. The collaboration with the Max Planck Institute will support identification of new targets in the company’s three areas of research focus in CVMD: cardiac regeneration, islet health (diabetes) and diabetic nephropathy.

In March 2013 AstraZeneca initiated a similar collaboration with the Swedish medical university Karolinska Institutet that created an Integrated Translational Research Centre (ICMC) for cardiovascular and metabolic disease and regenerative medicine located at Karolinska Institutet’s site in Stockholm, Sweden. The ICMC conducts preclinical and clinical studies aimed at advancing
the understanding of cardiovascular and metabolic disease pathophysiology and assessing new drug targets for AstraZeneca’s two biotech units, the iMed and MedImmune.

-ENDS-

Notes to editorsAbout Max Planck Institute of Molecular Physiology

Following its scientific mission, "From molecule to man.", the Max Planck
Institute of Molecular Physiology, Dortmund conducts basic biomedical research.
At the interface between structural biology, molecular cell biology and chemical
biology, the Institute’s scientists pursue interdisciplinary research leading
to a unique liaison between chemistry and biology. Identification and synthesis
of near-natural active substances enables accurate modulation of intracellular
processes to unravel and understand the molecular causes
of diseases. For more information, please visit: www.mpi-dortmund.mpg.de.

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)

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

AstraZeneca today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy.

The ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.

AstraZeneca filed the US regulatory submission for olaparib in February 2014. The FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of 3 October 2014.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “Patients with germline BRCA-mutated serous ovarian cancer have few options available to treat this disease. We are disappointed with today’s recommendation, and strongly believe that olaparib has the potential to provide patients with relapsed BRCA-mutated ovarian cancer and their doctors with a much-needed treatment option. We look forward to continuing to work with the FDA as it evaluates the Advisory Committee recommendation and completes its review of the application. In the meantime, we are continuing with our Phase III clinical programme to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015.”

The NDA filing was based on a subgroup analysis of Phase II data recently published in Lancet Oncology1. The Phase II study was a randomised, double-blind, placebo-controlled trial which evaluated olaparib versus placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen. The study met its primary endpoint of progression-free survival by Response Evaluation Criteria in Solid Tumours guidelines. A pre-defined subgroup analysis was conducted in patients who have germline BRCA mutations.

In addition, as part of its commitment to bring the potential benefits of olaparib to ovarian cancer patients, AstraZeneca has initiated and is committed to complete the Phase III SOLO programme, designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.

– ENDS –

NOTES TO EDITORS

1 Ledermann JA, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised Phase II study. The Lancet Oncology 2014. http://dx.doi.org/10.1016/S1470-2045(14)70228-1.

About olaparib
Olaparib is an innovative, investigational, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to selectively induce cancer cell death. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies.

PARP is a key enzyme in one of the DNA repair pathways in human cells. Inhibition of PARP results in a build-up of DNA damage in the cell, requiring repair via an alternative pathway called Homologous Recombination repair (HR). Cancer cells that already have a HR pathway deficiency (HRD) are limited in their ability to repair their DNA, overloading them with DNA damage and causing them to die. A number of abnormalities can cause HRD in cancer cells including BRCA gene mutations. HRD is associated with a range of tumor types, in particular with breast and ovarian cancers.

In addition to ovarian cancer, olaparib is being investigated in combination with chemotherapy in second-line gastric cancer in the GOLD study, while Phase III studies evaluating olaparib in adjuvant and metastatic breast cancer with BRCA mutations have recently been initiated.

About ovarian cancer
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide, mainly because it is often diagnosed late and has an extremely poor prognosis. For the 75% of ovarian cancer patients whose cancer has spread by the time of diagnosis, the five-year survival rate is less than 50%, so there is a real need for additional therapies beyond current standard of care, which is platinum-based chemotherapy.

Women with BRCA1 or BRCA2 mutations have an increased risk of developing ovarian cancer, and the course of their disease is similar to that of the overall patient population. Up to 40% of patients with platinum-sensitive relapsed ovarian cancer harbour a BRCA mutation, which is the most common cause of HRD.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization 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)
Michele Meixell +1 302 885 2677 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

Platserna tog snabbt slut och väntelistorna är långa till AstraZenecas Sommarforskarskola 2014 som drar i gång idag. Intresset står i kontrast till den sedan länge förutspådda bristen på ingenjörer, tekniker och naturvetare de kommande åren.

-När elevernas egen nyfikenhet sätts i centrum så ser vi att naturvetenskap och teknik blir attraktivt och roligt, säger Laura Alexis, koordinator för AstraZenecas Sommarforskarskola.

52 elever i åldern 14-17 år deltar mellan 16-27 juni i spännande laborationer, lektioner och studiebesök. De bygger till exempel egna ”vindkraftverk” samt odlar bakterier som de sedan undersöker i egenkonstruerade mikroskop. Det arbetas med problembaserat lärande på temat ”En hållbar värld”. Verksamheten håller till i moderna labbsalar på KTH i Stockholm. Handledarna är studenter på naturvetenskapliga och tekniska utbildningar.

-Det ska bli spännande att se elevernas egen upptäckarglädje få chans att blomma ut. Med en pedagogik som kopplar studierna till verkligheten, och med handledare som själva är ungdomar, är vår förhoppning att man kan väcka inspiration och vilja att välja en framtid inom naturvetenskap och teknik, säger Laura Alexis .

Journalister är välkomna att besöka sommarforskarskolan på KTH i Stockholm, vardagar mellan 9.00-15.00, 16-27 juni

Kontakt:

Laura Alexis, koordinator AstraZenecas Sommarforskarskola, 0730-37 86 02, laura@sommarforskarskolan.se

AstraZenecas Sommarforskarskola arrangeras av Unga Forskare i samarbete med AstraZeneca. Vi ger elever perspektiv på naturvetenskapens betydelse i samhället genom att utgöra en mötesplats för skola och arbetsliv. Dessutom får eleverna träffa nya kompisar och förebilder inom naturvetenskap. Vi är en del av AstraZenecas arbete för att öka ungas intresse för naturvetenskap och teknik.

www.sommarforskarskolan.se

Förbundet Unga Forskare är en ideell förening med
syfte att utveckla ungdomars intresse för naturvetenskap och teknik. Vi har
funnits sedan 1977 och vårt motto är unga för unga.

 www.ungaforskare.org

KTH är Sveriges äldsta och största tekniska
universitet. Utbildningarna är starkt kopplade till forskning och näringsliv.

 www.kth.se

AstraZeneca announced today that the majority of US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes MOVANTIKTM (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC) for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.

The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on 11-12 June 2014. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee’s recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is 16 September 2014.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer said: “We are pleased that the Committee did not find it necessary to require a cardiovascular outcomes trial for the PAMORA class. We look forward to the outcome of the FDA’s review of the New Drug Application for MOVANTIK and the potential to provide patients with chronic non-cancer pain affected by OIC with an additional treatment option.”

Opioids play an important role in chronic pain relief by binding mu-receptors in the brain, but they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop OIC. In fact, the incidence of OIC can be as high as 81% in patients taking opioids. There is a significant unmet need for safe, effective treatment options for patients with OIC. An estimated 235 million prescriptions for opioids are written in the US each year, of which 20% are for chronic pain. For patients taking prescription opioids for chronic pain, constipation is one of the most common side effects and one not adequately relieved by laxatives.

If approved, MOVANTIK has the potential to be the first once-daily, oral PAMORA for the treatment of OIC for patients with chronic non-cancer pain. MOVANTIK is also under regulatory review with health agencies in the European Union and Canada.

On 4 June 2014 the New England Journal of Medicine published data online from two pivotal Phase III studies of MOVANTIK, KODIAC-4 and KODIAC-5. Both studies met their primary endpoint, showing an improvement in treatment effect versus placebo: more OIC non-cancer pain patients treated with MOVANTIK at a 25 mg dose had a consistent response of increased spontaneous bowel movements through 12 weeks of treatment compared to placebo.

-ENDS-

NOTES TO EDITORS

About MOVANTIKTM (naloxegol oxalate)
MOVANTIK is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. In the Phase III clinical studies, MOVANTIK was administered as a once-daily tablet and is designed to block the binding of opioids to the opioid receptors in the gastrointestinal (GI) tract without impacting the opioid receptors in the brain.

MOVANTIK is part of the exclusive worldwide licence agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics. MOVANTIK was developed using Nektar’s oral small molecule polymer conjugate technology.

About Opioid-Induced Constipation (OIC)
Opioids play an important role in chronic pain relief by binding mu-receptors in the brain. But they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop opioid-induced constipation (OIC). In fact, the incidence of OIC varies and has been reported as high as 81% in patients taking opioids.

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)
Michele Meixell +1 302 885 2677 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Colleen Proctor +44 207 604 8128 mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729