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AstraZeneca to collaborate with the Harvard Stem Cell institute in diabetes

Pressmeddelanden   •   2015-03-25 08:04 CET

AstraZeneca today announced that it has entered into a five-year research collaboration with the Harvard Stem Cell Institute (HSCI) to adapt a technique that creates human beta cells from stem cells for use in screens of AstraZeneca’s compound library in the search for new treatments for diabetes. The collaboration also aims to better understand how the function of beta cells declines in diabetes and research findings will be made available to the broader scientific community through peer-reviewed publications.

In people with Type 1 diabetes, beta cells are destroyed by an autoimmune response and patients must inject insulin to maintain normal blood glucose levels. In Type 2 diabetes, the beta cells either fail to function properly or their numbers decrease. Human beta cells for research are extremely limited in number and availability. However, a team led by HSCI co-chairman and Howard Hughes Medical Institute Investigator, Professor Doug Melton, has developed a technique which allows limitless quantitiesof beta cells to be produced from human induced pluripotent stem cells generated directly from adult cells, similar in all important respects to those found in healthy individuals1.

AstraZeneca will provide funding for a team of investigators at HSCI lead by Professor Melton as well as establishing an in-house team in Mölndal, Sweden, dedicated to the collaboration. Scientists from each organisation will work together to understand the biology behind the loss of human beta cell function and mass in diabetes, and to screen compounds against the cells produced to search for potential new medicines that could restore beta cell activity in diabetic patients.

Marcus Schindler, Head of Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development, AstraZeneca, said: “We are excited about the potential of this latest collaboration with Harvard University. Professor Melton’s group has made an extraordinary breakthrough in the differentiation of human stem cells into human beta cells and our scientists are extremely excited to be working alongside his team. Harnessing this new technology has the potential to transform the research and development of new treatments for patients with diabetes.”

Isaac T. Kohlberg, Head of the Office of Technology Development at Harvard University, said: “AstraZeneca’s commitment to establish and fund this collaboration will help advance the development of new medicines that may ameliorate the need for diabetics to inject insulin, and prevent the numerous, potentially fatal complications of diabetes. This collaboration is an ideal example of how academia and industry should work together to serve the public interest and make a difference in the lives of patients.”

The collaboration is aligned with AstraZeneca’s strategic research approach in diabetes which is aimed at restoring the function of the pancreatic beta cells as well as insulin sensitivity, irrespective of therapeutic modality.

– ENDS –

NOTES TO EDITORS

About the Department of Stem Cell and Regenerative Biology and Harvard Stem Cell Institute (HSCI)

The Department of Stem Cell and Regenerative Biology at Harvard University and HSCI advance the understanding of human development and disease, support the discovery of stem cell-based therapies and cures for diseases, create collaborations across traditional institutional and disciplinary boundaries, and teach and train the next generation of leading stem cell scientists.

About Harvard University’s Office of Technology Development

The Harvard Office of Technology Development (OTD) is responsible for all activities pertaining to the evaluation, patenting and licensing of new inventions and discoveries made at Harvard University and Harvard Medical School. OTD also serves to further the development of Harvard technologies through the establishment of sponsored research collaborations with industry. OTD's mission is to promote the public good by fostering innovation and translating new inventions made at Harvard into useful products available and beneficial to society.

About AstraZeneca

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

CONTACTS

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

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

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Jacob Lund+46 8 553 260 20 (Sweden)

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

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

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1. Felicia W. Pagliuca, Jeffrey R. Millman, Mads Gürtler et al., (2014) Generation of Functional Human Pancreatic β Cells In Vitro.Cell 159; 2, 428–439.

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 five-year research collaboration with the Harvard Stem Cell Institute (HSCI) to adapt a technique that creates human beta cells from stem cells for use in screens of AstraZeneca’s compound library in the search for new treatments for diabetes.

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AstraZeneca och Daiichi Sankyo kommer att marknadsföra MOVANTIK gemensamt i USA

Pressmeddelanden   •   2015-03-19 08:03 CET

AstraZeneca meddelar idag att man ingått ett samarbetsavtal med Daiichi Sankyo Inc. avseende marknadsföring av MOVANTIK™ (naloxegol) i USA. Detta går i linje med företagets strategi att leverera värde både genom egen utveckling och kommersiell kompetens, samt genom externa samarbeten. MOVANTIK är den första FDA-godkända orala, perifert verkande my-opioidantagonisten (PAMORA) för daglig behandling som utvecklats speciellt för behandling av opioidinducerad förstoppning (OIC) hos vuxna patienter med kronisk, icke-cancerrelaterad smärta.

MOVANTIK godkändes av US Food and Drug Administration i september 2014. Den togs bort från US Drug Enforcement Administrations lista över kontrollerade substanser i januari 2015. Lansering av MOVANTIK i USA är planerad att starta i början av april 2015.

Enligt villkoren i avtalet kommer Daiichi Sankyo att betala ett engångsbelopp på 200 miljoner USD, samt framgent försäljningsrelaterade betalningar på upp till 625 miljoner USD. AstraZeneca kommer att ansvara för tillverkning, bokföring av försäljning, samt betala försäljningsrelaterade provisioner till Daiichi Sankyo. Båda företagen kommer att ansvara gemensamt för kommersiella aktiviteter. AstraZenecas finansiella prognos för 2015, som meddelades den 6 mars 2015, berörs inte av dagens tillkännagivande.

Paul Hudson, AstraZeneca US and Executive Vice President, North America säger: ”Vi är glada över att samarbeta med Daiichi Sankyo för att utöka våra marknadsföringssatsningar i USA för att få ut detta viktiga läkemedel till alla de patienter som lider av opioidinducerad förstoppning. Vårt avtal speglar den affärsmodell som växer fram genom att skapa värde från vår portfölj genom externaliseringsaktiviteter. Tillsammans kommer vi att öka potentialen för denna viktiga behandling samtidigt som vi kan behålla en betydande andel i långsiktig, kommersiell framgång för MOVANTIK på vår största marknad.”

Ken Keller, President of US Commercial på Daiichi Sankyo Inc. säger: ”Vi är stolta över att bidra med vår beprövade primär- och specialistvårdsexpertis i detta samarbete med AstraZeneca.  MOVANTIK innebär en möjlighet för oss att hjälpa patienter att hantera en av de vanligaste biverkningarna av allmänt förskrivna smärtstillande läkemedel, liksom en möjlighet att fortsätta att bygga upp Daiichi Sankyo US portfölj av läkemedel inom detta terapiområde.” 

Avtalet är i linje med AstraZenecas affärsmodell som inkluderar värdeskapande genom externa samarbeten, baserat på den starka vetenskapliga grund vår forskningsportfölj och kommersiella portföljer bygger på. Denna strategi syftar till att skapa värde för patienter genom att samarbeta med experter inom området som kan hjälpa oss att få viktiga behandlingar på marknaden samtidigt som den genererar intäkter.

–Slut–

NOTES TO EDITORS

About MOVANTIK™ (naloxegol) tablets

MOVANTIK (naloxegol) tablets is the first FDA approved once-daily oral PAMORA specifically designed for the treatment of OIC in adult patients with chronic non-cancer pain. In the Phase III clinical studies, MOVANTIK was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors, in tissues such as the gastrointestinal tract.

MOVENTIG® (naloxegol) also received Marketing Authorisation from the European Commission in December 2014 for the treatment of OIC in adult patients who have had an inadequate response to laxative(s).

MOVANTIK/MOVENTIG is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar’s oral small-molecule polymer conjugate technology.

About OIC

OIC is a condition caused by prescription opioid pain medicines. Millions of patients are treated with opioids each year. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. The incidence of OIC in patients with chronic pain varies and has been suggested to be as high as 81%.

About Daiichi Sankyo, Inc.

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a ‘Hybrid Business Model’ to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.

About AstraZeneca in Neuroscience

A significant unmet medical need remains in the areas of cognitive disorders, chronic pain, and other central nervous system disorders. With a rich heritage and a research and development focus on specific aspects of neurodegenerative diseases, analgesia and psychiatry, AstraZeneca continues to push the boundaries of science in neuroscience in collaboration with others across industry and academia. Notably, in September 2014, AstraZeneca announced an alliance with Eli Lilly for the joint development ofAZD3293/LY3314814, an oral beta secretase cleaving enzyme (BACE) inhibitor as a potential treatment for Alzheimer’s disease, which is currently being studied in a pivotal Phase II/III trial.

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 6351 (US)

Jacob Lund  +46 8 553 260 20 (Sweden)

Investor Enquiries

Thomas Kudsk Larsen +44   20 7604 8199 mob: +44 7818 524185
Karl Hård +44   20 7604 8123 mob: +44 7789 654364
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627
Craig Marks +44 20 7604 8591 mob: +44 7881 615764
Christer Gruvris +44 20 7604 8126 mob: +44 7827 836825

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca meddelar idag att man ingått ett samarbetsavtal med Daiichi Sankyo Inc. avseende marknadsföring av MOVANTIK™ (naloxegol) i USA.

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AstraZeneca announces positive phase III top-line results for PT003 from the PINNACLE 1 and PINNACLE 2 studies in COPD

Pressmeddelanden   •   2015-03-18 08:06 CET

AstraZeneca today announced positive top-line results from the Phase III PINNACLE programme, which included two pivotal 24-week studies (PINNACLE 1 and PINNACLE 2) to investigate the potential of PT003 to improve lung function in patients with Chronic Obstructive Pulmonary Disease (COPD).

PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). PT003 is the first LAMA/LABA combination to be delivered in a pressurised metered dose inhaler (pMDI) using the unique porous particle co-suspension technology developed by Pearl Therapeutics, which was acquired by AstraZeneca in 2013. The development programme also included assessment of the individual components of PT003 – glycopyrronium pMDI (PT001) and formoterol fumarate (PT005) pMDI. The successful completion of the PINNACLE studies marks the first Phase III outcomes from a series of pipeline candidates under development by AstraZeneca using Pearl’s novel technology.

In both the PINNACLE 1 and PINNACLE 2 studies, the primary objective was to assess benefits on lung function as measured by trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in trough FEV1 versus PT001, PT005 and placebo. Both PT001 and PT005 also demonstrated statistically significant improvements in trough FEV1 compared to placebo.

In PINNACLE 1 and PINNACLE 2, the most common adverse events across all treatment arms, including placebo, were nasopharyngitis, upper respiratory tract infection, and dyspnea. The incidence of adverse events was generally similar across all treatment groups. The Phase III programme also included a 28-week extension study, PINNACLE 3, the safety information from which is not yet available.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These positive top-line results demonstrate the potential of PT003 as a novel treatment for patients suffering with the debilitating and chronic symptoms of COPD. The ability to deliver a unique LAMA/LABA formulation in a single pressurised metered dose device is important for helping some 30% of patients around the world who use an aerosol inhaler. Today’s results are also encouraging for the development of our investigative triple-drug combination of LAMA/LABA and inhaled corticosteroids.”

AstraZeneca plans to file global regulatory applications for PT003 commencing in 2015. Data from the PINNACLE 1, 2, and 3 Phase III studies will be presented at a scientific meeting later in the year.

- ENDS -

NOTES TO EDITORS

The PINNACLE Phase III Pivotal Programme

The PT003 Phase III pivotal programme consists of PINNACLE 1, PINNACLE 2, and an extension study, PINNACLE 3. Overall the Phase III pivotal programme enrolled over 3,700 patients with COPD at over 275 study sites.

PINNACLE 1 and PINNACLE 2 were Phase III randomised, double-blind, multi-centre, placebo-controlled studies. In both studies, the efficacy and safety of PT003 administered twice daily via pressurised metered dose inhaler (pMDI) was compared to its monotherapy components: glycopyrronium (PT001), a LAMA, and formoterol fumarate (PT005), a LABA, and placebo. PT001 and PT005 were also compared to placebo. In PINNACLE 1, open-label tiotropium was included as an active control. Both studies were conducted over 24 weeks in subjects with COPD.

The primary objective of both studies was improvement in lung function as assessed by trough forced expiratory volume in one second (FEV1).

PINNACLE 3 was a multi-centre, randomised, double-blind, parallel-group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week studies (PINNACLE 1 and 2). It was designed to evaluate the long-term safety, tolerability, and efficacy of PT003 administered twice daily via pMDI compared to PT001 and PT005 in patients with moderate to very severe COPD over a total observation period of 52 weeks. Open-label tiotropium served as the active control.

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. It affects an estimated 300 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 Pearl Therapeutics

Pearl Therapeutics is a wholly owned subsidiary of AstraZeneca, following its acquisition in 2013. The company is focused on developing inhaled combination therapies for the treatment of highly prevalent respiratory diseases, including COPD and asthma. Pearl Therapeutics’ unique porous particle co-suspension technology allows for the production of unique fixed-dose combinations of different classes of drugs at different concentrations in a single pressurised metered dose inhaler (pMDI) device. Fixed-dose combination therapies can simplify treatment for patients, improving the potential for convenience and compliance versus the use of separate inhalers. Non-adherence is a well-documented issue in COPD and is associated with detrimental effects on patient outcomes.

About AstraZeneca in Respiratory Disease
AstraZeneca has a long heritage in respiratory disease with 40 years of experience and a strong franchise of marketed products. Our efforts to find ground-breaking medicines and to develop new technologies are underpinned by a deep understanding of the biology of respiratory diseases and our extensive experience in primary care medicine.

Our strategy is to deliver a range of differentiated therapies, including novel combinations, new devices, and innovative product offerings to treat respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). Our innovative precision approaches will ensure the right treatment for the right patient.

AstraZeneca’s respiratory portfolio includes asthma and COPD medicine Symbicort and asthma medicine Pulmicort as well as COPD treatments, Eklira Genuair, Tudorza Pressair and Duaklir Genuair.

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 8199 mob: +44 7818 524185
Karl Hård +44 20 7604 8123mob: +44 7789 654364
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627
Craig Marks+44 20 7604 8591mob: +44 7881 615764

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

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca today announced positive top-line results from the Phase III PINNACLE programme, which included two pivotal 24-week studies (PINNACLE 1 and PINNACLE 2) to investigate the potential of PT003 to improve lung function in patients with Chronic Obstructive Pulmonary Disease (COPD).

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PEGASUS-TIMI 54 studien visar att långtidsbehandling med BRILINTA/BRILIQUE minskade aterotrombotiska händelser hos patienter med tidigare hjärtinfarkt

Pressmeddelanden   •   2015-03-14 16:07 CET

Data från en studie med 21 000 patienter presenterades på den 64:e årliga vetenskapliga kongressen som hålls av American College of Cardiology och publicerades parallellt i New England Journal of Medicine

AstraZeneca meddelar idag de fullständiga resultaten från studien PEGASUS-TIMI 54, en storskalig utfallsstudie som undersökte behandling med BRILINTA/BRILIQUE tabletter® (ticagrelor) samt en låg dos av acetylsalicylsyra (ASA), jämfört med placebo samt en låg dos av ASA, för kronisk sekundärprevention av aterotrombotiska händelser hos patienter med en hjärtinfarkt ett till tre år före studiestart.

Viktiga studieresultat:

Båda dosernar på 90 mg och 60 mg ticagrelor tillsammans med ASA, minskade signifikant det primära sammansatta effektmåttet: kardiovaskulär död, hjärtinfarkt eller stroke jämfört med placebo tillsammans med ASA

Som förväntat med en peroral trombocythämmare, och i linje med tidigare studier hos liknande patientpopulationer, visades att studiens primära säkerhetsmått, TIMI större blödning1, var högre för båda doserna av ticagrelor plus ASA, jämfört med placebo plus ASA. Viktigt är att förekomsten av intrakraniella blödningar (blödning innanför skallbenet) och fatala blödningar var låga i antal och lika mellan studiegrupperna och placebo.

Data om PEGASUS-TIMI 54 studien presenterades under öppningsanförandet på den 64:e årliga vetenskapliga kongressen som hålls av American College of Cardiology och publicerades också parallellt i onlineversionen av New England Journal of Medicine.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development på AstraZeneca, säger: ”Vi är som företag engagerade i att bygga vidare på vår forskning om hjärtkärlsjukdomar och vi är stolta över att kunna presentera PEGASUS-TIMI 54 studien, AstraZenecas största kliniska studie som har involverat fler än 21 000 patienter över hela världen. Den positiva PEGASUS-studien bygger på den tidigare publicerade PLATO-studiens resultat om akut kranskärlssjukdom och stärker de solida evidens som finns för BRILINTA/BRILIQUE. PEGASUS-TIMI 54 är den första prospektiva studien som utvärderar långvarig dubbel trombocythämmande behandling med BRILINTA/BRILIQUE för högriskpatienter med en tidigare hjärtinfarkt.

”Vi har precis lämnat in registreringsansökningar till European Medicines Agency och US Food and Drug Administration och vi ser fram emot att samarbeta med dessa myndigheter för att få godkännande av en potentiell ny indikation på dessa stora marknader.”

Nyligen publicerad forskning visar att en av fem patienter med hjärtinfarkt kommer att drabbas av ytterligare hjärtinfarkt, stroke eller kardiovaskulär död inom tre år efter sin första hjärtinfarkt även om patienterna klarat sig utan en ny händelse de första 12 månaderna2.För patienter där det gått mer än ett år efter hjärtinfarkten är den nuvarande standardbehandlingen enbart ASA. Studien PEGASUS-TIMI 54 var designad för att undersöka effekten av att lägga till ticagrelor i en dos av 60 mg, respektive 90 mg, till ASA vad gällde minskad risk för hjärtkärlrelaterade dödsfall, hjärtinfarkt eller stroke hos patienter som är 50 år eller äldre med en tidigare hjärtinfarkt samt ytterligare en hjärtkärlrelaterad riskfaktor.

Effektresultat

I denna studie visade båda doserna med ticagrelor en signifikant minskning av det primära effektmåttet kardiovaskulär död, hjärtinfarkt eller stroke jämfört med placebo. Andelen händelser vid tre års uppföljning var 7,85% med ticagrelor 90 mg, 7,77% med ticagrelor 60 mg och 9,04% med placebo (Riskkvoten för ticagrelor 90 mg jämfört med placebo var 0,85, 95% CI 0,75–0,96, P = 0,0080; riskkvoten för ticagrelor 60 mg jämfört med placebo var 0,84, 95% CI 0,74–0,95, P = 0,0043).

Effekten av ticagrelor på var och en av variablerna i det primära effektmåttet var enhetligt. En minskning i absoluta tal avseende det sekundära effektmåttet kardiovaskulär död och dödlighet oavsett orsak observerades, men uppnådde inte statistisk signifikans.

Dessutom visade båda doserna av ticagrelor enhetliga resultat för det primära effektmåttet i större subgrupper, såsom ålder, kön, initial typ av hjärtinfarkt (STEMI/NSTEMI), tiden efter initial hjärtinfarkt, diabetes, dos av ASA, tidigare perkutan intervention (PCI) och geografisk region.

Säkerhetsresultat

Som förväntat var TIMI större blödning högre för båda doserna av ticagrelor jämfört med placebo. Andelen händelser vid tre års uppföljning var 2,60% med ticagrelor 90 mg, 2,30% med ticagrelor 60 mg och 1,06% med placebo (riskkvoten för ticagrelor 90 mg jämfört med placebo var 2,69, 95% CI 1,96–3,70, P < 0,001; riskkvoten för ticagrelor 60 mg jämfört med placebo var 2,32, 95% CI 1,68–3,21, P < 0,001).

Antal fatala blödningar eller intrakraniella blödningar var dock låga och likvärdiga mellan behandlingsarmarna.

Andelen fatala blödningar vid tre års uppföljning var låg, 0,11% med ticagrelor 90 mg, 0,25% med ticagrelor 60 mg och 0,26% med placebo (riskkvoten för ticagrelor 90 mg jämfört med placebo var 0,58, 95% CI 0,22–1,54, P = 0,27; riskkvoten för ticagrelor 60 mg jämfört med placebo var 1,00, 95% CI 0,44–2,27, P = 1,00).

Andelen intrakraniella blödningar vid tre års uppföljning var 0,56% med ticagrelor 90 mg, 0,61% med ticagrelor 60 mg och 0,47% med placebo (riskkvoten för ticagrelor 90 mg jämfört med placebo var 1,44, 95% CI 0,83–2,49, P = 0,19; riskkvoten för ticagrelor 60 mg jämfört med placebo var 1,33, 95% CI 0,77–2,31, P = 0,31).

Studien PEGASUS-TIMI 54, som är AstraZenecas största utfallsstudie, med över 21 000 patienter från fler än 1 100 studiecenter i 31 länder, ingår i PARTHENON-programmet. PLATO studien, som omfattade över 18 000 patienter, var den första studien i PARTHENON-programmet och utgör den bas på vilken ticagrelor har godkänts i över 100 länder för behandling av akut kranskärlssjukdom och läkemedlet ingår globalt i 12 större riktlinjer för behandling av akut kranskärlssjukdom. I ytterligare pågående PARTHENON-studier utvärderas ticagrelor för förebyggande av kardiovaskulära händelser hos patienter med perifer artärsjukdom, ischemisk stroke eller transitorisk ischemisk attack (TIA), samt hos patienter med diabetes och koronar ateroskleros.

BRILINTA/BRILIQUE är inte godkänt för sekundär prevention av aterotrombotiska händelser hos patienter en historik av tidigare hjärtinfarkt längre änett år eller för prevention av kardiovaskulära händelser hos patienter med perifer artärsjukdom, stroke eller transitorisk ischemisk attack (TIA) eller diabetespatienter med utbredd koronar ateroskleros.

– SLUT –

NOTES TO EDITORS

1TIMI Major Bleeding Classification:

  • Any intracranial bleeding, or
  • Clinically overt signs of haemorrhage associated with a drop in hemoglobin (Hgb) of ≥5 g/dL (or, when hemoglobin is not available, a fall in hematocrit of ≥15%), or
  • Fatal bleeding (a bleeding event that directly led to death within 7 days).

2Rapsomaniki E, Thuresson M, Yang E, et al. International comparison of outcomes among 140,880 patients stable after acute MI; real world evidence from electronic health and administrative records. Presented at European Society of Cardiology Congress, Barcelona, Spain; 30 August – 3 September 2014.

About PEGASUS-TIMI 54

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

About BRILINTA/BRILIQUE®

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

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

BRILINTA is a registered trademark of the AstraZeneca group.

About the Thrombolysis in Myocardial Infarction (TIMI) Study Group

The TIMI Study Group is affiliated with Brigham and Women’s Hospital and Harvard Medical School and is located in Boston, Massachusetts. It is one of the oldest cardiovascular academic research organisation in the United States and has conducted numerous practice-changing clinical trials in patients with CV disease or risk factors for CV disease.

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

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

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

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

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

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Data från en studie med 21 000 patienter presenterades på den 64:e årliga vetenskapliga kongressen som hålls av American College of Cardiology och publicerades parallellt i New England Journal of Medicine

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AstraZeneca refines its financial reporting in line with evolving business model

Pressmeddelanden   •   2015-03-05 19:28 CET

fredag 6 mars  2015

AstraZeneca today announces an update to the presentation of its Statement of Comprehensive Income, which will see revenue from externalisation becoming more visible to enhance transparency for investors. The change is effective from 1 January 2015 and will be reported as part of the Company’s first quarter financial results on 24 April 2015. The impact is presentational and therefore does not impact Reported or Core profit.

As previously outlined, AstraZeneca’s business model includes an increasing level of externalisation activity to create value from the strong science that exists in the pipeline. This will benefit patients whilst sharpening further the focus on our main therapy areas - Respiratory, Inflammation & Autoimmunity; Cardiovascular & Metabolic Disease and Oncology. The Company’s two biotech centres, the Innovative Medicines Unit and MedImmune, continue to increase R&D productivity. Consequently AstraZeneca will consider opportunities to out-licence technologies and potential new medicines to ensure these reach patients as quickly as possible.

The updated financial reporting structure reflects the Company’s entrepreneurial approach and provides a clear picture of a growing additional revenue stream.

Historically, reported revenues reflected only product sales (formerly known as sales revenue), with externalisation revenue forming part of other operating income presented below cost of goods sold (COGS). From 1 January 2015 externalisation revenues, alongside product sales, contribute to total revenue, which is shown above COGS. Externalisation revenue includes development, commercialisation, partnership and out-licence revenues, such as royalties and milestone receipts, together with income from services or repeatable licences.

Income will be recorded as externalisation revenue when the Company has an ongoing interest in the product and/or it is repeatable business and there is no derecognition of an intangible asset. Disposals of assets and businesses, where AstraZeneca does not retain an interest, will continue to be recorded in other operating income.

The Company has updated its revenue accounting policy with effect from

1 January 2015 and the prior-year financial results will be restated accordingly. An illustration of the change to the presentation of prior-period Core financial performance is shown in the appendix. These numbers are unaudited and are indicative of the impact of the change in policy.

2015 Financial Guidance

To reflect the change outlined above, the Company today provides 2015 total revenue guidance. Total revenue is expected to decline by mid single-digit percent at constant exchange rates (CER). This is consistent with previous guidance stating that sales revenue was expected to decline by mid single-digit percent at CER. Core EPS guidance is unchanged and Core EPS is expected to increase by low single-digit percent at CER.

The Company also provides the following non-guidance information related to currency sensitivity: Based on current exchange rates1, total revenue is expected to decline by low double-digit percent. This is consistent with previous expectations stating an anticipated sales revenue decline of low double-digit percent. Core EPS is expected to be broadly in line with 2014. For additional currency sensitivity information, please see below:

Average exchange rates versus USDImpact of 5% weakening in exchange rate versus USD   ($m)2
CurrencyPrimary relevance2014YTD Feb 20151Change%Total revenueCore operatingprofit
EURProduct sales0.750.87(13)(194)(119)
JPYProduct sales105.87118.55(11)(105)(75)
CNYProduct sales6.166.23(1)(113)(48)
SEKCosts6.868.22(16)(5)95
GBPCosts0.610.66(7)(34)104
Other3(213)(123)
  • 1Based on average daily spot rates YTD to the end of February 2015.
  • 2Based on 2014 actual group currency exposures.
  • 3Other important currencies include AUD, BRL, CAD, KRW and RUB.

– ENDS –         

          

 
  

        

          
2

  
Appendix

Impact of Revenue Accounting Changes

All numbers shown below are at actual exchange rates in $m unless otherwise stated.

Core Q1   2013Core Q2   2013Core Q3   2013Core Q4   2013Core FY   2013
RestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresented
Product Sales6,3856,3856,2326,2326,2506,2506,8446,84425,71125,711
Externalisation Revenue12-47-12-12-83-
Total Revenue6,3976,3856,2796,2326,2626,2506,8566,84425,79425,711
Cost of Sales(1,136)(1,136)(1,105)(1,105)(1,103)(1,103)(1,289)(1,289)(4,633)(4,633)
Gross Profit5,2615,2495,1745,1275,1595,1475,5675,55521,16121,078
Distribution(77)(77)(76)(76)(81)(81)(72)(72)(306)(306)
R&D(963)(963)(1,040)(1,040)(1,061)(1,061)(1,205)(1,205)(4,269)(4,269)
SG&A(2,055)(2,055)(2,173)(2,173)(2,154)(2,154)(2,483)(2,483)(8,865)(8,865)
Other Income158170171218164176176188669752
Operating   Profit2,3242,3242,0562,0562,0272,0271,9831,9838,3908,390

   

          
3



All numbers shown below are at actual exchange rates in $m unless otherwise stated.

Core Q1   2014Core Q2   2014Core Q3   2014Core Q4   2014Core FY   2014
RestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresentedRestatedAsFormerlyPresented
Product Sales6,4166,4166,4546,4546,5426,5426,6836,68326,09526,095
Externalisation Revenue49-302-69-41-461-
Total Revenue6,4656,4166,7566,4546,6116,5426,7246,68326,55626,095
Cost of Sales(1,193)(1,193)(1,156)(1,156)(1,180)(1,180)(1,359)(1,359)(4,888)(4,888)
Gross Profit5,2725,2235,6005,2985,4315,3625,3655,32421,66821,207
Distribution(72)(72)(77)(77)(87)(87)(88)(88)(324)(324)
R&D(1,098)(1,098)(1,208)(1,208)(1,275)(1,275)(1,360)(1,360)(4,941)(4,941)
SG&A(2,317)(2,317)(2,460)(2,460)(2,486)(2,486)(2,953)(2,953)(10,216)(10,216)
Other Income1672161764781872562202617501,211
Operating   Profit1,9521,9522,0312,0311,7701,7701,1841,1846,9376,937

  

          
4

  

NOTES TO EDITORS

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.

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)

Investor Enquiries
Thomas   Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185
Karl   Hård+44 20 7604 8123mob: +44 7789 654364
Eugenia   Litz+44 20 7604 8233mob: +44 7884 735627
Craig   Marks+44 20 7604 8591mob: +44 7881 615764
Christer   Gruvris+44 20 7604 8126mob: +44 7827 836825

5

 

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 announces an update to the presentation of its Statement of Comprehensive Income, which will see revenue from externalisation becoming more visible to enhance transparency for investors. The change is effective from 1 January 2015 and will be reported as part of the Company’s first quarter financial results on 24 April 2015.

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AstraZeneca to participate in US FDA Endocrinologic and Metabolic Drugs Advisory Committee

Pressmeddelanden   •   2015-03-04 13:02 CET

AstraZeneca today announced it will participate in the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on 14 April 2015 to discuss the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for ONGLYZA® (saxagliptin) and Kombiglyze® XR (saxagliptin and metformin HCI extended-release).

The topic of the Advisory Committee is based on an ongoing review of a previously submitted supplemental New Drug Application to the FDA for ONGLYZA and Kombiglyze XR.

AstraZeneca welcomes the opportunity to discuss the SAVOR cardiovascular outcomes data with the Advisory Committee.

– ENDS –

NOTES TO EDITORS

About SAVOR

The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin) was a randomised, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus and at an elevated risk for CV events. The SAVOR study was conducted as part of the Postmarketing Requirement for the US New Drug Application approval of Onglyza in accordance with the 2008 FDA guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The primary objective of this trial was to determine that the addition of saxagliptin to standard of care in this patient population did not significantly increase the incidence of major cardiovascular events as compared to placebo.

About DPP-4 inhibitors

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. Incretin hormones decrease elevated blood sugar levels (glucose) by increasing the body’s utilisation of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose. DPP-4 inhibitors work by increasing the activity of the incretin hormones, increasing the release of insulin when glucose levels are elevated and reducing the levels of sugar produced by the liver.

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in the US. Type 2 diabetes is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.

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

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

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

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

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

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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AstraZeneca completes acquisition of rights to Actavis’ branded respiratory portfolio in the US and Canada

Pressmeddelanden   •   2015-03-03 08:22 CET

Acquisition strengthens AstraZeneca’s aclidinium respiratory franchise and adds  immediate revenues with long-term growth potential

AstraZeneca today announced that it has completed the transaction to acquire the rights to Actavis’ branded respiratory business in the US and Canada.

As previously announced, the strategic transaction strengthens AstraZeneca’s respiratory franchise globally and builds on the acquisition of Almirall’s respiratory portfolio in 2014 by extending the company’s development and commercialisation rights into the US for both Tudorza Pressair and Duaklir Genuair.

AstraZeneca owns the development and commercial rights in the US and Canada to TudorzaTM PressairTM (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), and to Daliresp® (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD, in the US. AstraZeneca also owns the development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir® Genuair®.

On completion of the acquisition, AstraZeneca is paying Actavis $600 million of initial consideration and agreed to pay low single-digit royalties above a certain revenue threshold. AstraZeneca has also paid Actavis an additional $100 million for a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis.

– ENDS –

NOTES TO EDITORS

About Tudorza Pressair

Tudorza Pressair (aclidinium bromide inhalation powder) 400 mcg is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. When given by inhalation, aclidinium produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites.

Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window and audible “click” which confirm successful inhalation of the dose and a dose indicator to let patients know how many doses remain in the inhaler.

About Daliresp

Daliresp (500mcg) is a selective PDE4 inhibitor that is indicated as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA.

While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in the lung cells. Daliresp is not a steroid, is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

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 300 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 Actavis

Actavis Plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis’ website at www.actavis.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)

Michele Meixell+1 302 885 2677 (US)

Jacob Lund+46 8 553 260 20 (Sweden)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Acquisition strengthens AstraZeneca’s aclidinium respiratory franchise and adds immediate revenues with long-term growth potential

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AstraZeneca announces Non-Executive Board changes

Pressmeddelanden   •   2015-02-17 08:03 CET

AstraZeneca today announced that Dr Cornelia (Cori) Bargmann will be proposed to shareholders for election as a Non-Executive Director at the Company’s Annual General Meeting (AGM) on 24 April 2015.On election, the Board also proposes appointing Dr Bargmann to AstraZeneca’s Science Committee.

Cori is the Torsten N. Wiesel Professor and head of the Lulu and Anthony Wang Laboratory of Neural Circuits and Behavior at The Rockefeller University, New York, and a Howard Hughes Medical Institute investigator.

John Varley, senior independent Non-Executive Director and Dame Nancy Rothwell, Non-Executive Director, both intend to retire from the Board at the close of the AGM on 24 April 2015, each having served as a Board member for nine years. John is currently Chairman of the Remuneration Committee and a member of the Nomination and Governance Committee.Dame Nancy Rothwell is currently Chairman of the Science Committee, and a member of the Remuneration Committee and the Nomination and Governance Committee.

As a result of the retirement of John Varley and Dame Nancy Rothwell, the following Board Committee changes will take place with effect from the close of the AstraZeneca 2015 AGM:

  • Rudy Markham will become senior independent Non-Executive Director.
  • Graham Chipchase will become Chairman of the Remuneration Committee and a member of the Nomination and Governance Committee.
  • Bruce Burlington will become Chairman of the Science Committee and a member of the Nomination and Governance Committee.
  • Geneviève Berger will oversee sustainability matters on behalf of the Board.

In addition, Shriti Vadera will become a member of the Remuneration Committee with immediate effect.

Leif Johansson, AstraZeneca Chairman, said: “John Varley and Dame Nancy Rothwell have been committed and hard-working Board members, serving the Company and its shareholders for the best part of a decade. I would like to pay tribute to their experience, wisdom, common sense and collegiality, as well as their leadership of the Remuneration Committee and the Science Committee respectively. I speak for all of my colleagues on the Board in saying that we will miss them and their contribution to our work; they go with our very best wishes for their future endeavours.”

“Their retirement has provided us with an opportunity to propose the appointment of new Board members. We welcomed Ann Cairns last year and are delighted that Cori Bargmann has agreed to join the Board in April. Cori will bring a wealth of experience in scientific research, fitting the needs of AstraZeneca’s Board very well.”

All other current Directors will be presenting themselves for re-election at the AGM, in accordance with AstraZeneca's normal practice.

In making the proposals and Board Committee appointments described above, the Board considered and satisfied itself as to the availability and time commitment of the Directors concerned.

In relation to the proposed election of Cori Bargmann as a Non-Executive Director, there are no directorships to disclose under paragraph (1) and no disclosure obligations arise under paragraphs (2) to (6) of LR 9.6.13 R of the UK Listing Authority's Listing Rules.

-ENDS-

NOTES TO EDITORS

Dr Cori Bargmann - biographical details

Dr Cori Bargmann is the Torsten N. Wiesel Professor and head of the Lulu and Anthony Wang Laboratory of Neural Circuits and Behavior at The Rockefeller University, New York.She has been a Howard Hughes Medical Institute investigator since 1995.She is a neurobiologist who studies the relationships between genes, neural circuits and behaviour using C. elegans, a tiny roundworm, as the model for her work.Many of the genes and neural pathways in C. elegans are similar to those of mammals and their study provides an insight into the development and functioning of neural circuits.

Cori holds a degree in biochemistry from the University of Georgia and a Ph.D. from the Massachusetts Institute of Technology, where she studied oncogenes with Robert Weinberg.She pursued a postdoctoral fellowship with H. Robert Horvitz at MIT until 1991, when she accepted a faculty position in the Department of Anatomy at the University of California, San Francisco, spending 13 years there, latterly as Vice-Chair of the department.She took up her current position at The Rockefeller University in 2004.

Cori is the recipient of the 2015 Benjamin Franklin Medal in Life Science, one of nine individuals who will be presented with awards by The Franklin Institute, Philadelphia this year.The award is for her contributions to neurobiology that have led to major discoveries elucidating the relationship between genes, neurons, neural circuits and behaviour.

Membership of AstraZeneca Board Committees, with effect from the close of the AGM on 24 April 2015

Audit Committee

Rudy Markham (Chairman of the Committee)

Bruce Burlington

Ann Cairns

Jean-Philippe Courtois

Shriti Vadera

Remuneration Committee

Graham Chipchase (Chairman of the Committee)

Leif Johansson

Rudy Markham

Shriti Vadera

Nomination and Governance Committee

Leif Johansson (Chairman of the Committee)

Bruce Burlington

Graham Chipchase

Rudy Markham

Science Committee

Bruce Burlington (Chairman of the Committee)

Cori Bargmann

Geneviève Berger

Marcus Wallenberg

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)

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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

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AstraZeneca to acquire rights to Actavis’ branded respiratory portfolio in the US and Canada

Pressmeddelanden   •   2015-02-05 08:08 CET

Agreement strengthens AstraZeneca’s aclidinium respiratory franchise and adds immediate revenues with long-term growth potential

AstraZeneca and Actavis Plc today announced that they have entered into a definitive agreement under which AstraZeneca will acquire the rights to Actavis’ branded respiratory business in the US and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold.

Upon completion of the transaction, AstraZeneca will own the development and commercial rights in the US and Canada to TudorzaTM PressairTM (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), and Daliresp® (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD. AstraZeneca will also own development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir® Genuair®.

The strategic transaction strengthens AstraZeneca’s respiratory franchise globally and builds on the acquisition of Almirall’s respiratory portfolio in 2014 by extending the company’s development and commercialisation rights into the US for both Tudorza Pressair and Duaklir Genuair. The acquisition of Tudorza Pressair and Daliresp will immediately add on-market revenues and complements AstraZeneca’s respiratory portfolio by broadening the choice of treatments and formulations offered to patients and physicians. The two products had combined annual sales in the US of approximately $230 million in 2014.

AstraZeneca will also pay Actavis an additional $100 million and Actavis has agreed to a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis.

Paul Hudson, President, AstraZeneca US and Executive Vice President, North America, AstraZeneca, said: “Our agreement with Actavis builds on our acquisition of Almirall’s respiratory portfolio and brings long-term value to one of our key growth platforms. With the addition of Tudorza and Daliresp, we will benefit from an immediate boost to revenue in our biggest market, further strengthening our growing respiratory franchise. This combined portfolio helps us to offer an even broader range of innovative treatments and formulations to physicians and pulmonary specialists for patients suffering with COPD.”

Brent Saunders, CEO and President of Actavis, said: “This divestiture will permit Actavis to sharpen our strategic focus and sales and marketing activities on our larger, core therapeutic categories in CNS, Women’s Health, Urology, GI, Anti-infectives and Cardiovascular, as well as in Dermatology/Aesthetics and Ophthalmology, which will be added to our global brand portfolio following the completion of the Allergan acquisition later this year. It will also enhance our options in the near term to invest in further expansion through business development or accelerate debt repayment. The decision to divest these brand respiratory products will have no impact on our commitment to investing in and developing our generic respiratory product line.”

The transaction is subject to antitrust law clearance as well as other customary terms and conditions. It is anticipated that the transaction will complete in the first quarter of 2015.

– ENDS –

NOTES TO EDITORS

About Tudorza Pressair

Tudorza Pressair (aclidinium bromide inhalation powder) 400 mcg is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. When given by inhalation, aclidinium produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites.

Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window and audible “click” which confirm successful inhalation of the dose and a dose indicator to let patients know how many doses remain in the inhaler.

About Daliresp

Daliresp (500mcg) is a selective PDE4 inhibitor that is indicated as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA.

While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in the lung cells. Daliresp is not a steroid, is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

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 300 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 Actavis

Actavis Plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis’ website at www.actavis.com.

Actavis Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis’ current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis’ current expectations depending upon a number of factors affecting Actavis’ business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis’ products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis’ periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

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

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

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

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

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

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

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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AstraZeneca PLC : Bokslutsrapport för fjärde kvartalet och helåret 2014 - Sammanfattning

Pressmeddelanden   •   2015-02-05 08:05 CET

Det finansiella resultatet för 2014 är i linje med den höjda prognosen som lämnades i samband med resultatet för tredje kvartalet 2014.

  • Intäkterna för helåret ökade med 3 % i fasta valutakurser (CER) till 26 095 MUSD (HÅ 2013: 25 711 MUSD).
  • Intäkterna under fjärde kvartalet ökade med 2 % till 6 683 MUSD i fasta valutakurser, det fjärde kvartalet i följd med intäktstillväxt (Q4 2013: 6 844 MUSD).
  • Vinst per aktie för kärnverksamheten för helåret uppgick till 4,28 USD, en minskning med 8 %. Vinst per aktie för kärnverksamheten för fjärde kvartalet uppgick till 0,76 USD, en minskning med 28 %.

Rekord med sex produktgodkännanden under 2014. Framsteg med forskningsportföljen sedan resultatet för det tredje kvartalet 2014 inkluderar:

  • Sjukdomar i andningsvägarna:Duaklir Genuair: EU-godkännande för KOL. Brodalumab: överlägset ustekinumab i andra och tredje pivotala fas III-studierna mot psoriasis. Lesinurad: EU har accepterat registreringsansökan för behandling av gikt.
  • Hjärt/kärlsjukdomar:Brilinta PEGASUS-studien nådde sina primära effektmål. Ansökan om marknadsgodkännande för Saxagliptin/dapagliflozin i fast doskombination har lämnats in i USA.
  • Onkologi:Lynparza har godkänts i USA och EU för BRCA-muterad framskriden äggstockscancer. Registreringsansökan i USA för Iressa har accepterats av FDA.
  • Neurovetenskap:Moventig har godkänts i EU för opioidframkallad förstoppning. Movantik ”descheduled” av amerikanska DEA (Drug Enforcement Administration).

Intäkterna för våra tillväxtplattformar steg 15 % 2014 och bidrog med 53 % av de totala intäkterna.

  • Brilinta/Brilique:Vår trombocythämmare nådde en tillväxt på 70 % i global försäljning, med fortsatt momentum i samtliga regioner.
  • Diabetes: Vi uppnådde en tillväxt på 139 %, integrerade framgångsrikt förvärvade tillgångar från BMS, gjorde en framgångsrik lansering av Farxiga/Forxiga, samt fick ett bra mottagande för nya Bydureon Pen i USA.
  • Sjukdomar i andningsvägarna: Försäljningen har ökat med 10 %, med en tillväxt på 27 % på tillväxtmarknaderna och en inbromsande tillväxt i USA på +15 %.
  • Tillväxtmarknader: +12 %, med en tillväxt i Kina på 22 %, vilket gör Kina till AstraZenecas näst största nationella marknad.
  • Japan: -3 %, beroende på föreskrivna prissänkningar, ökad användning av generiska läkemedel och återkallning av Nexium under det fjärde kvartalet.

Styrelsen har tillkännagivit en utdelning för andra halvåret på 1,90 USD (15,62 SEK) per aktie, vilket innebär att utdelningen för helåret blir 2,80 USD (21,82 SEK). Styrelsen står fast vid bolagets progressiva utdelningspolicy.

Pascal Soriot, koncernchef, kommenterar resultatet:

”2014 var ett anmärkningsvärt år för AstraZeneca. Vi uppnådde rekordmånga produktgodkännanden (sex stycken) när vi accelererade vår forskningsportfölj inom alla huvudterapiområden. Dessutom har vi levererat fyra kvartal med intäktstillväxt, där viktiga tillväxtplattformar nu bidrar till över hälften av våra intäkter. Vår starka resultatutveckling på tillväxtmarknaderna utmärker sig särskilt, Kina har blivit vår näst största nationella marknad, medan den försenade introduktionen av Nexium-generika i USA hjälpte oss att öka investeringar relaterade till våra nylanseringar samt vår snabbt accelererande forskningsportfölj.

”Prognosen för 2015 speglar vårt fokus på att skapa värde genom att investera i våra nya varumärken och vår spännande forskningsportfölj, samtidigt som vi fortsätter att förbättra produktiviteten för att skydda vår lönsamhet med tanke på kommande patentutgångar. Tack vare den tunga forskningen och det momentum vi har byggt upp inom organisationen är vi på god väg att återgå till tillväxt 2017 och är väl positionerade att leverera enligt våra långsiktiga mål.”

Under 2015 räknar företaget med att fortsätta sin betydande process för att bli ledande inom forskning:

  • Pivotala data kommer att presenteras för MEDI4736 i tredje linjens behandling av icke-småcellig lungcancer; tremelimumab mesoteliom; selumetinib uveal melanom; PT003 KOL.
  • Planerade registreringsansökningar är AZD9291 andra linjens behandling av icke-småcellig lungcancer; cediranib äggstockscancer (EU); brodalumab psoriasis.
  • Beslut om eventuellt godkännande kommer att fattas avseende saxagliptin/dapagliflozin i fast doskombination (USA); Iressa (USA); lesinurad (USA).

Prognos för 2015: Intäkterna förväntas minska med en medelhög ensiffrig procentuell siffra (mid single-digit) i fasta valutakurser. I linje med företagets affärsmodell kommer bolaget att fortsätta att ingå samarbetsavtal och licensiera utvalda produkter och teknologier i syfte att få ytterligare intäkter. Vinst per aktie för kärnverksamheten förväntas öka med en låg ensiffrig procentuell siffra (low single-digit) i fasta valutakurser.

Den fullständiga pressreleasen på engelska hittar du som bifogad pdf.

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Telekonferens för media

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Ange som kod: 74513477. Du måste ange den här koden för att komma med i konferensen.

Användbar information:

Third Quarter 2014 Financial Results Statement

Full Year 2013 Financial Results Statement

AstraZeneca’s strategy update on 18th November 2014

Photography of AstraZeneca senior management, sites and logo

Kontaktpersoner:

Esra Erkal-Paler+44 020 7604 8030 (Storbritannien/globalt)

Vanessa Rhodes+44 020 7604 8037 (Storbritannien/globalt)

Ayesha Bharmal+44 020 7604 8034 (Storbritannien/globalt)

Jacob Lund+46 8 553 260 20 (Sverige)

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

Läs vidare »

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