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Ticagrelor (BRILIQUE) i samband med kranskärlskirurgi ger färre blödningskomplikationer jämfört med clopidogrel

Pressmeddelanden   •   2015-09-01 10:00 CEST

En ny studie som presenteradesden 1 september under den Europeiska hjärtläkarkongressen i London (ESC) visar att ticagrelor jämfört med clopidogrel minskar risken för allvarliga blödningar i samband med kranskärlskirurgi.

För att undvika blodproppar är de flesta hjärtpatienter ordinerade trombocythämmare, som förhindrar att blodplättarna klumpar ihop sig. Idag är trombocythämmande behandling standardbehandling efter akut hjärtinfarkt och sedan 2011 är ticagrelor ett förstahandsval enligt Socialstyrelsens riktlinjer för hjärtsjukvård 2011 samt 2015. Under åren 2012-2014 användes främst två olika trombocythämmare, clopidogrel och ticagrelor.

En komplikation av trombocythämmande läkemedel att de kan öka risken för allvarliga blödningar i samband med hjärtoperation. Forskare vid Sahlgrenska akademin, Göteborgs Universitet, har i en nationell retrospektiv registerstudie kartlagt 2 244 patienter, behandlade med ticagrelor eller clopidogrel och som genomgått kranskärlskirurgi efter akut hjärtinfarkt syndrom mellan år 2012-2013. Syftet med studien har varit att undersöka sambandet mellan allvarliga blödningskomplikationer och det trombocythämmande läkemedel patienterna behandlats med efter sin hjärtinfarkt.

Studien visar att patienter som behandlades med clopidogrel efter akut hjärtinfarkt i högre utsträckning drabbades av allvarliga blödningskomplikationer än patienter som fick ticagrelor (17.6 procent för clopidogrel,12.9 procent för ticagrelor). Efter korrigering för andra faktorer som påverkar blödningsrisken var det 28 procent färre blödningskomplikationer i patienter som behandlades med ticagrelor.

Enligt europeiska riktlinjer, så bör behandlingen med blodförtunnande medel om möjligt avslutas fem dagar före operationen för att minska för blödning i samband med kirurgi. Studien från Sahlgrenska akademin visar att för patienter som behandlas med ticagrelor och är i behov av subakut kirurgi, så kan behandlingen sättas ut tre dagar före operationen, utan att det ökar risken för stora blödningskomplikationer jämfört med att sätta ut behandlingen fem dagar före operation.

– För patienten minskar därmed risken att drabbas av nya hjärtproblem i väntan på operationen. Det sparar också sjukvårdsresurser, eftersom patienterna behöver ligga inne på sjukhus färre dagar i väntan på operation. Med tanke på att vårddygnen på en hjärtintensivavdelning är mycket dyra kan det ge stora besparingar för sjukvården, säger Anders Jeppsson, överläkare och hjärtforskare vid Sahlgrenska akademin, Göteborgs universitet, som har lett studien.

En artikel ”Coronary artery bypass grafting-related bleeding complications in patients treated with ticagrelor or clopidogrel: a nationwide study” publicerades i European Heart Journal den 1 september, samtidigt som studien presenterades under European Society of Cardiology's årliga möte i London.

ESC är världens största hjärtläkarkonferens med omkring 30 000 deltagare.

Studien är en prövarinitierad studie som har delfinansierats av 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

Kontakt:

Anders Jeppsson, professor vid Sahlgrenska akademin, Göteborgs universitet och överläkare vid Sahlgrenska Universitetssjukhuset

031-3427515, 0736-601787

Petra Eurenius, Kommunikationschef AstraZeneca Nordic-Baltic, telefon 0709 186 562.

876241.011 08/2015 SE

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

En ny studie som presenteradesden 1 september under den Europeiska hjärtläkarkongressen i London (ESC) visar att ticagrelor jämfört med clopidogrel minskar risken för allvarliga blödningar i samband med kranskärlskirurgi.

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AstraZeneca och Valeant i samarbete om brodalumab

Pressmeddelanden   •   2015-09-01 08:11 CEST

AstraZeneca fortsätter att skärpa fokus på sina viktigaste terapiområden och ett samarbete med en expert inom dermatologi förväntas snabba på utvecklingen av brodalumab för patienter med psoriasis och tillgodose ett betydande ouppfyllt behandlingsbehov

Inlämning av registreringsansökan till myndigheterna i USA och EU för behandling av medelsvår till svår psoriasis planeras till fjärde kvartalet 2015

AstraZeneca meddelar i dag att ett samarbete har inletts med Valeant Pharmaceuticals International, Inc. som får exklusiv licens för att utveckla och kommersialisera brodalumab.

Brodalumab är en monoklonal antikropp riktad mot IL-17-receptorn och är under utveckling för behandling av patienter med medelsvår till svår plackpsoriasis och psoriasisartrit. Avtalet innebär att Valeant har exklusiv rätt att utveckla och kommersialisera brodalumab globalt, förutom i Japan och vissa andra asiatiska länder, där rättigheterna innehas av Kyowa Hakko Kirin Co., Ltd enligt ett tidigare avtal med Amgen Inc., som ursprungligen tog fram brodalumab. Valeant kommer att stå för alla utvecklingskostnader i samband med det regulatoriska godkännandet av brodalumab. Inlämning till registreringsmyndigheterna i USA och EU för godkännande av brodalumab för behandling av medelsvår till svår psoriasis planeras till fjärde kvartalet 2015.

Enligt avtalet kommer Valeant att betala ett förskott till AstraZeneca på 100 miljoner US-dollar som följs av ytterligare milstolpsbetalningar på upp till 170 miljoner US-dollar före lansering, samt försäljningsrelaterade milstolpsbetalningar på upp till 175 miljoner US-dollar efter lansering. Efter godkännandet kommer AstraZeneca och Valeant att dela vinsterna.

Brodalumab stöds av fas III-data från de tre pivotala AMAGINE-studierna[1]. Resultaten visar att brodalumab har en effektiv verkningsmekanism som ger klinisk nytta och har potential att hjälpa ett betydande antal patienter med medelsvår till svår plackpsoriasis att helt slippa sin hudsjukdom. Vid dosen 210 mg visades brodalumab ge fullständig effekt på hudsymtomen vid psoriasis jämfört med placebo och var överlägset ustekinumab vid 12 veckor i två replikatstudier med jämförelseläkemedel med över 3 500 deltagande patienter.

Pascal Soriot, vd: "Genom vårt avtal kommer Valeants expertis på dermatologi bidra till att föra ut brodalumab till patienter med psoriasis som behöver nya behandlingsalternativ."

J. Michael Pearson, styrelseordförande och vd för Valeant: "Vi är glada att vi har lyckats få till ett licensavtal med AstraZeneca för att kommersialisera brodalumab, som potentiellt sett är den mest effektiva behandlingen av medelsvår till svår psoriasis. Vårt fortsatta fokus är dermatologi och vår forskningsportfölj kommer att fortsätta att växa genom internt utvecklade produkter och förvärvade produkter”.

Affären är föremål för sedvanliga avslutsvillkor, förväntas slutföras under fjärde kvartalet 2015 och kommer inte att ha någon avgörande inverkan på AstraZenecas finansiella prognos för 2015. Eftersom AstraZeneca fortsatt har ett betydande intresse i brodalumab planeras direktbetalningen och potentiella efterföljande milstolpsbetalningar att rapporteras som intäkter från externalisering.

– SLUT –

NOTES TO EDITORS

[1] AstraZeneca and Amgen press release 11 Nov 2014: http://www.astrazeneca.com/Media/Press-releases/Article/11112014--amgen-and-astrazeneca-announce-positive-results

AstraZeneca and Amgen press release 25 Nov 2015: http://www.astrazeneca.com/Media/Press-releases/Article/20141125-amgen-and-astrazeneca-positive-results-brodalumab

AstraZeneca and Amgen press release 11 Dec 2015: http://www.astrazeneca.com/Media/Press-releases/Article/20141211-astrazeneca-amgen-amagine1-brodalumab

About brodalumab

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

About the Amgen and AstraZeneca Collaboration

In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise six monoclonal antibodies from Amgen's clinical inflammation portfolio, including brodalumab. Following Amgen’s decision to discontinue development of brodalumab on 22 May 2015, AstraZeneca has terminated its contractual relationship with Amgen with regard to brodalumab as at the end of August 2015. The collaboration arrangements remain in place for the other programmes.

About Valeant

Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorder, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.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-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Karen   BirminghamUK/Global+44 20 7604 8120
Jacob LundSweden+46   8 553 260 20
Michele   MeixellUS+1 302 885   2677
Investor Enquiries
UK
Thomas Kudsk   Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRIA+44   20 7604 8233+44 7884   735627
Nick StoneCVMD+44 20 7604 8236+44 7717   618834
Karl HårdOncology+44   20 7604 8123+44 7789   654364
Craig MarksING+44   20 7604 8591+44 7881   615764
Christer   Gruvris+44   20 7604 8126+44   7827 836825
US
Lindsay   TrickettING+1 301 398 5118+1   301 398 5118
Dial /   Toll-Free+1 301 398 3251+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, 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 fortsätter att skärpa fokus på sina viktigaste terapiområden och ett samarbete med en expert inom dermatologi förväntas snabba på utvecklingen av brodalumab för patienter med psoriasis och tillgodose ett betydande ouppfyllt behandlingsbehov

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Subgruppsanalys från PEGASUS-TIMI 54-studien visar vikten av fortsatt underhållsbehandling med BRILINTA/BRILIQUE i mer än ett år efter en hjärtinfarkt

Pressmeddelanden   •   2015-08-31 16:16 CEST

Data som presenterades vid European Society of Cardiologys kongress 2015 betonar behovet av långsiktig sekundärprevention för att förhindra nya hjärt-kärlhändelser

AstraZeneca meddelar i dag nya data från en subgruppsanalys av PEGASUS-TIMI 54-studien, som har undersökt vilken effekt BRILINTA® (ticagrelor) har avseende minskning av aterotrombotiska händelser hos patienter med tidigare hjärtinfarkt, baserat på tiden från utsättning av tidigare behandling med P2Y12-hämmare. De aktuella europeiska riktlinjerna rekommenderar att dubbel trombocythämmande behandling sätts ut 12 månader efter en hjärtinfarkt. PEGASUS-TIMI 54-studien rekryterade patienter som hade haft hjärtinfarkt ett till tre år tidigare.

Data från studien presenterades under en Clinical Trial Update hotline-session vid European Society of Cardiologys årliga kongress. Data visar vidare att utsättning av behandling med P2Y12-hämmare är förknippat med ökad risk för ischemiska händelser, såsom kardiovaskulär död, hjärtinfarkt och stroke.

Patienter som rekryterades till PEGASUS-TIMI 54-studiens placeboarm och nyligen hade slutat tidigare behandling med P2Y12-hämmare (inom 30 dagar) löpte ökad risk att drabbas av en ischemisk händelse jämfört med dem som hade slutat för mer än 30 dagar sedan, detta oberoende av tiden från den ursprungliga hjärtinfarkten. Detta kan bero på skillnader i egenskaper vid inklusion in till studien, även om analysen justerade för detta, eller kvarstående risk när 12 månaders behandling med trombocythämmare sätts ut.

För de patienter som randomiserades till ticagrelor inom 30 dagar från utsättning av ordinarie behandling minskade risken att drabbas av en efterföljande händelse med 27 %. Nyttan av behandlingen med ticagrelor var störst i denna grupp. Effekten av ticagrelor sjönk med tiden från utsättning av tidigare trombocythämning [≤30 dagar HR 0,73, >30 dagar till 360 dagar HR 0,86, >360 dagar HR 1,01].

Dr. Marc P. Bonaca, MD, MPH, vid Brigham and Women's Hospital och huvudprövare för subgruppsanalysen samt prövare hos TIMI Study Group: "Dessa resultat tyder på en större nytta med att fortsätta med P2Y12-hämmare längre än 12 månader utan avbrott än att återinsätta sådan behandling hos patienter som har varit stabila i över 2 år efter sin hjärtinfarkt och i mer än 1 år utan behandling med P2Y12-hämmare."

Marc Ditmarsch, Global Development Lead för BRILINTA: "Vi välkomnar resultaten av subanalysen. De ökar vår förståelse av den underliggande hjärtkärlrisken för patienter med tidigare hjärtinfarkt. Analysen ger också ny insikt om vilka patienter som sannolikt har störst nytta av långtidsbehandling med ticagrelor."

PEGASUS-TIMI 54-studien undersökte effekt och säkerhet för ticagrelor vid både 60 mg och 90 mg två gånger dagligen i kombination med en låg dos ASA, jämfört med placebo i kombination med en låg dos ASA för långtidsprevention av aterotrombotiska händelser hos patienter med tidigare hjärtinfarkt ett till tre år innan de rekryterades till studien. De fullständiga resultaten från PEGASUS-TIMI 54-studien publicerades i New England Journal of Medicine1 i mars 2015. BRILINTA bedöms nu i EU och USA för kronisk sekundär prevention av aterotrombotiska händelser hos patienter med tidigare hjärtinfarkt inom ett till tre år.

– SLUT –

NOTES TO EDITORS

1 Bonaca MP, Bhatt DL, Cohen M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372:1791-800.

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 withmore than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia.2 It is being conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

The PEGASUS-TIMI 54 study investigated the efficacy and safety of both BRILINTA 60mg and 90mg, twice daily, compared to placebo on a background of low dose aspirin, for the long-term prevention of atherothrombotic events in patients who suffered a heart attack one to three years prior to enrolment. The primary efficacy endpoint is time to first occurrence of any event from the composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction or non-fatal stroke.

About PARTHENON

The PEGASUS-TIMI 54 study is a key study in the PARTHENON life cycle management program, an AstraZeneca-funded, long-term and evolving global research initiative, designed to address unanswered questions in the management of patients with atherothrombotic disease and to investigate the impact of BRILINTA on reducing atherothrombotic events, including death.

PARTHENON is part of AstraZeneca’s commitment to understanding and advancing treatments for CV diseases to improve patient health.

About BRILINTA

BRILINTA is an oral antiplatelet treatment for acute coronary syndrome (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.

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 an Academic Research Organization (ARO) that has conducted numerous practice-changing clinical trials in patients with CV disease or risk factors for CV disease. Amongst its notable achievements, the group developed the TIMI Risk Score, which assesses the risk of death and ischaemic events in patients experiencing unstable angina or a non-ST elevation myocardial infarction.

About AstraZeneca

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

CONTACTS

Media   Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
Michele MeixellUS+1 302 885   2677
Investor   Enquiries
UK
Thomas Kudsk Larsen+44 20 7604 8199+44 7818   524185
Eugenia LitzRIA+44 20 7604 8233+44 7884   735627
Nick StoneCVMD+44 20 7604 8236+44 7717   618834
Karl HårdOncology+44 20 7604 8123+44 7789   654364
Craig MarksING+44 20 7604 8591+44 7881   615764
Christer Gruvris+44 20 7604 8126+44   7827 836825
US
Dial / Toll-Free+1 301 398 3251+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

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 som presenterades vid European Society of Cardiologys kongress 2015 betonar behovet av långsiktig sekundärprevention för att förhindra nya hjärt-kärlhändelser

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AstraZeneca to present further research into long-term prevention of cardiovascular events for patients with a history of heart attack at ESC Congress 2015

Pressmeddelanden   •   2015-08-29 09:32 CEST

Over 20 scientific abstracts from AstraZeneca’s cardiovascular and metabolic disease portfolio will be presented at this year’s European Society of Cardiology (ESC) Congress 2015 in London, including five oral presentations. Data being presented will focus on the early management of Acute Coronary Syndromes (ACS) and long-term secondary prevention of atherothrombotic events in patients who have previously suffered a heart attack.

Presentation of the data, including sub-analyses of the BRILINTA® PEGASUS-TIMI 54 study, coincides with updates to the ESC guidelines on treatment of Non-ST Segment Elevation Myocardial Infarction patients, which will be presented at the congress on Sunday, 30 August. The updated guidelines will provide insight into long term dual antiplatelet therapy for patients with a history of heart attack.

The PEGASUS-TIMI 54 study sub-analyses will provide further understanding of the types of patients most likely to benefit from long-term treatment with BRILINTA. The data will also provide insight into the relationship between the time from a patient’s last treatment with P2Y12 antiplatelet therapy and their risk of a subsequent heart attack, stroke or cardiovascular death as well as the effect of BRILINTA in this setting.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “It is encouraging to see guideline updates recognise the continuing risk for patients more than one year after their heart attack and consider how this risk can be managed. We are looking forward to the presentation of the PEGASUS-TIMI 54 sub-analyses during the ESC Congress 2015 and to continuing the debate about the long-term use of dual antiplatelet therapy for these patients.”

In March 2015, based on the results of the PEGASUS-TIMI 54 study1, the US Food and Drug Administration (FDA) granted Priority Review for BRILINTA for the prevention of atherothrombotic events in patients who have previously experienced a heart attack.

Additional sub-analyses of the PEGASUS-TIMI 54 study also being presented at the ESC Congress 2015 include research into the relationship between renal function and risk of ischaemic and bleeding events, evaluated in a subset of high-risk patients with reduced renal function, and a gender comparison sub-analysis, assessing the relative safety and efficacy of ticagrelor in women versus men.

Other data highlights at the ESC Congress 2015 include:

  • Data from the APOLLO real-world evidence study, exploring the impact of associated risk factors (such as age ≥65 years, diabetes, history of >1 prior myocardial infarction or renal disease) on the likelihood of recurrent cardiovascular events [abstract P2467], as well as long-term national healthcare costs post-heart attack [abstract 3662], will be featured as poster presentations on Sunday 30 August and Monday 31 August.
  • Data from the ATLANTIC-H24 analysis, exploring the effect of pre-hospital versus
    in-hospital administration of ticagrelor during the first 24 hours post-procedure, specifically among patients who underwent percutaneous coronary intervention (PCI), will feature on Monday 31 August, as part of the Clinical Trial Update II - Antiplatelet therapy session [abstract 3914].
  • Two additional sub-analyses from ATLANTIC, exploring the study results according to gender [abstract P551] and within the French sub-population [abstract P556] will also be featured as poster presentations.
  • Data from the SUPPORT study demonstrating the impact of a new interactive smartphone application on improving patient adherence and quality of life [abstract 6649] will be explored during a rapid fire abstract session on Wednesday 2 September.
  • A VOYAGER meta-analysis examining the role of statin therapy, such as CRESTOR® (rosuvastatin) [poster P6465], in risk of atherosclerotic cardiovascular disease over a 10 year period will be presented in a poster session on Tuesday 1 September.

ASTRAZENECA ABSTRACTS TO BE FEATURED AT THE ESC CONGRESS 2015

Abstract #,   Title and AuthorTime (BST) / Session
BRILINTA   abstracts
Abstract P551Worse short-term outcome for women with   STEMI. Insights from the ATLANTIC studySwahn E, et alSaturday 29 August11:00 – 16:00Poster session 1: Infarction acute phase   STEMI II
Abstract P556Pre-hospital ticagrelor in ST-segment   elevation myocardial infarction: the French subgroup analysis of the ATLANTIC   studyCayla G, et alSaturday 29 August11:00 – 16:00Poster session 1: Infarction acute phase   STEMI III
Abstract P1115Dual anti-thrombotic effects of ticagrelor   on Arterial Thrombosis: an anti-platelet agent with anti-coagulant propertiesReiner MF, et alSunday 30 AugustModerated poster presentation 10:34 –   10:42Session: Clinical impact and modulation   of endothelial (dys)function
Abstract P2463High event rate in patients with acute coronary   syndromes and atrial fibrillation: Results from the prospective EPICOR   RegistryZeymer U, et alSunday 30 August14:00 – 18:00Poster session   3: STEMI I
Abstract 3032Efficacy and safety of ticagrelor for   long-term secondary prevention of atherothrombotic events in relation to   renal function: Insights from the PEGASUS-TIMI 54 trialMagnani G, et alMonday 31 AugustOral presentation 09:24 – 09:41Session: Antithrombotic drugs - An ongoing research
Abstract P3317The efficacy and safety of ticagrelor in   women versus men with a prior myocardial infarction: Insights from the   PEGASUS-TIMI 54 trialO’Donoghue M, et al Monday 31 August10:00 – 11:00Best posters session 4
Abstract P3318Ticagrelor 60 mg twice-daily provides   effective platelet inhibition in patients with prior myocardial infarction –   the PEGASUS-TIMI 54 platelet function substudyStorey R, et al Monday 31 August10:00 – 11:00Best posters session 4
Abstract 3914Effect of pre-hospital ticagrelor in   STEMI patients in the first 24 hours after primary PCI: The ATLANTIC-H24   analysisMontalescot G, et al Monday 31 August Rapid fire abstract 14:15 – 14:30Session: Clinical Trial Update II - Antiplatelet therapy
Abstract 3918Ischemic risk and efficacy of ticagrelor   in relation to time from P2Y12 inhibitor withdrawalBonaca MP, et alMonday 31 AugustOral presentation 15:15 – 15:30Session:   Clinical Trial Update II - Antiplatelet therapy
ACS abstracts
Abstract P172Biomarker-based prediction model for   recurrent ischemic events in revascularized patients with acute coronary   syndromesLindholm D, et alSaturday 29 August Moderated poster presentation 12:38 –   12:47 Session: Post infarction period
Abstract P2467Cardiovascular risk in post-myocardial   infarction patients: Nationwide real-world data on distribution and impact of   combination of risk factors in a real-life settingJernberg T, et alSunday 30 August14:00 – 18:00Poster session   3: STEMI I
Abstract 3662Long-term healthcare costs after   myocardial infarction in a clinical practice setting in Sweden; results from   a contemporary nationwide registry studyJanzon M, et alMonday 31 August08:30 – 12:30Poster session   4: Improvement of medical care in cardiovascular patients: social and   economic issues
Abstract 3030Effect of Time to interventional   treatment on NSTE-ACS Outcomes in PLATOPollack C, et alMonday 31 AugustOral   presentation 08:50 – 09:07Session: Antithrombotic drugs - An ongoing   research
Abstract 3031Treatment and long-term results   of acute coronary syndrome (ACS) in patients on chronic oral anticoagulants   (OAC): data from the EPICOR (NCT01171404) studyStepinska J, et alMonday 31 August Oral   presentation 09:07 – 09:24Session: Antithrombotic drugs - An ongoing   research
Abstract P3319Differences in dual antiplatelet   treatment for acute coronary syndrome patients undergoing PCI or not: a   Danish nationwide population-based cohort studyGislason G,   et alMonday 31 August10:00 – 11:00 Best posters session 4
Abstract P5340Prognostic value of elevated   high-sensitivity cardiac troponin T levels in patients with stable coronary   artery diseaseBiener M, et alTuesday 1 September 08:30 – 12:30Poster session   6: Coronary artery disease and comorbidities I
Abstract 4972Treatment pattern of dual   antiplatelet therapy in 104,012 patients with acute coronary syndrome; a   Swedish nationwide population based cohort studyAngeras O, et alTuesday 1 SeptemberRapid fire abstract 08:39 – 08:48Session: Flash   news on antithrombotics
Abstract 4975Balancing the risk of ischaemic   and bleeding events in ACSDucrocq G, et alTuesday 1 SeptemberRapid fire abstract 08:57 – 09:06Session: Flash news on antithrombotics
Abstract 6649Effects of interactive patient support   with a smartphone app on drug adherence and lifestyle changes in myocardial   infarction patientsVarenhorst C, et alWednesday 2 SeptemberRapid fire abstract 08:57 09:06Session: Cardiovascular prevention: what works for whom?
Abstract 6654Health outcomes and platelet-aggregation   inhibition after acute myocardial infarction in   clinical practice. Findings from the PIPER studyEsposti LD, et alWednesday 2 SeptemberRapid fire abstract 09:42 – 09:51Session: Cardiovascular prevention: what works for whom?
CRESTOR   abstracts
Abstract P6465Estimating the reduction in   10-year atherosclerotic cardiovascular disease risk with statin therapy: a   VOYAGER meta-analysisKarlson B, et alTuesday 1 September 14:00 – 18:00Poster   session 7: Surveillance of risk factors and interventions
Abstract P6551YKL-40 in chronic heart failure: Analysis   from the controlled rosuvastatin multinational trial in heart failure (CORONA)Kanwal AF, et alTuesday 1 September 14:00 – 18:00Poster   session 7: Prognosis II

– ENDS –

NOTES TO EDITORS

1 Bonaca MP, Bhatt DL, Cohen M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372:1791-800.

About BRILINTA®

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

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

BRILINTA is a registered trademark of the AstraZeneca group.

About the PEGASUS TIMI-54 study

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group)is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa andAustralia/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 AstraZeneca

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

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
Michele MeixellUS+1 302   885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen+44 20 7604   8199+44 7818 524185
Eugenia LitzRIA+44 20 7604 8233+44 7884 735627
Nick StoneCVMD+44 20 7604   8236+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksING+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
US
Dial / Toll-Free+1 301 398   3251+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

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

Over 20 scientific abstracts from AstraZeneca’s cardiovascular and metabolic disease portfolio will be presented at this year’s European Society of Cardiology (ESC) Congress 2015 in London, including five oral presentations.

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AstraZeneca and Peregrine Pharmaceuticals to collaborate on immuno-oncology combination clinical trial

Pressmeddelanden   •   2015-08-24 08:07 CEST

AstraZeneca today announced that it has entered into a clinical trial collaboration with Peregrine Pharmaceuticals, Inc. to evaluate the safety and efficacy of Peregrine’s investigational phosphatidylserine (PS)-signalling pathway inhibitor, bavituximab, in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumours.

AstraZeneca and Peregrine will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumours. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination and the Phase Ib part of the trial will assess the safety and efficacy of the investigational combination. The initial trial will be conducted by Peregrine.

Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumour microenvironment. The treatment increases activated T-cells in tumours and fights cancer by reversing the immunosuppressive environment that many tumours establish in order to proliferate.Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Preclinical data have demonstrated that by combining the enhanced T-cell mediated anti-tumour activity of bavituximab with checkpoint inhibitors like PD-L1 antibodies, the ability of tumour-specific T-cells to continue attacking the tumor is prolonged.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said: “We believe that combination therapy in immuno-oncology has the potential to be a novel and highly effective approach to treating cancer. Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers.”

Steven W. King, President and Chief Executive Officer of Peregrine said: "Data generated to date have shown significant potential for combining bavituximab with agents targeting the PD-1/PDL-1 pathway and we’re excited to further explore this approach in studies with durvalumab. AstraZeneca, with its biologics arm MedImmune, is a recognised leader in the immuno-oncology field and this collaboration will play a key role as we continue to fully explore the potential of bavituximab in combination immunotherapies for a variety of clinical applications.”

– ENDS –

NOTES TO EDITORS

About Bavituximab

Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognise and fight tumours. Bavituximab, the lead compound in Peregrine's immuno-oncology development programme, blocks PS to remove this immunosuppressive signal and sends an alternate immune activating signal.  Targeting PS with bavituximab has been shown to shift the functions of immune cells in tumours, resulting in robust anti-tumour immune responses.

About durvalumab (MEDI4736)

Durvalumab 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. Durvalumab blocks these signals, countering the tumour's immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer.

About Peregrine Pharmaceuticals, Inc.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit www.peregrineinc.com.

About AstraZeneca in Oncology

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

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

About 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

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
Michele MeixellUS+1 302   885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRIA+44 20 7604   8233+44 7884 735627
Nick StoneCVMD+44 20 7604 8236+44 7717 618834
Karl HårdOncology+44 20 7604   8123+44 7789 654364
Craig MarksING+44 20 7604   8591+44 7881   615764
Christer Gruvris+44 20 7604   8126+44 7827 836825
US
Dial / Toll-Free+1 301 398 3251+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

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 appoints Dr Sean Bohen as Executive Vice President of Global Medicines Development and Chief Medical Officer

Pressmeddelanden   •   2015-08-24 08:06 CEST

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Medimmune enters into strategic cancer vaccine collaboration and license agreement with Inovio Pharmaceuticals

Pressmeddelanden   •   2015-08-10 09:02 CEST

Agreement includes clinical-stage INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases.

Under the agreement, MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18.INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumours.These HPV types are responsible for more than 70 per cent of cervical pre-cancers and cancers.

MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers.Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumour-specific T-cells.

Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.

Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialise. Inovio will receive development, regulatory and commercialisation milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: “Today’s collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses.The unique combination of our broad immuno-oncology portfolio with Inovio’s T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients.”

J. Joseph Kim, President and CEO, Inovio, said: “Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio’s cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune’s recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration.”

Today’s agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area.Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.

– ENDS –

NOTES TO EDITORS

About INO-3112

Inovio's SynCon® DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio's HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovio’s VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.

Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA immunotherapy.

Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia to early stage or no disease, meeting the study's primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favourable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca in Oncology

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

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

About AstraZeneca

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

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
Michele MeixellUS+1 302   885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen+44 20 7604   8199+44 7818 524185
Eugenia LitzRIA+44 20 7604 8233+44 7884 735627
Nick StoneCVMD+44 20 7604   8236+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksING+44 20 7604 8591+44 7881   615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
US
Dial / Toll-Free+1 301 398   3251+1 866 381 7277

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

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

​Agreement includes clinical-stage INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates

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AstraZeneca and Heptares Therapeutics enter agreement to develop novel immuno-oncology treatments

Pressmeddelanden   •   2015-08-06 08:01 CEST

AstraZeneca and Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation, today announced that they have entered into a licensing agreement under which AstraZeneca will acquire exclusive global rights to develop, manufacture and commercialise the adenosine A2A receptor antagonist, HTL-1071, a small molecule immuno-oncology candidate,andpotential additional A2A receptor-blocking compounds. AstraZeneca will explore the assets across a range of cancers, including in combination with its existing portfolio of immunotherapies.

Tumour cells have developed mechanisms to evade the immune system, including through the production of a natural molecule called adenosine. By stimulating A2A receptors, adenosine stops T-cells within the immune system from proliferating and reduces their ability to destroy cancer cells. Blocking A2A receptors can therefore promote the anti-cancer response of T-cells within in the tumour microenvironment.

Under the terms of the agreement, Heptares will grant AstraZeneca an exclusive license to research, develop, manufacture and commercialise HTL-1071. The companies will also collaborate to discover further A2A receptor-blocking compounds for development in cancer immunotherapy.

Heptares will receive an upfront payment of $10 million and is eligible to receive additional, significant near term milestone payments based on agreed pre-clinical and/or clinical events. Subject to successful completion of development and commercialisation milestones, Heptares is also eligible to receive more than $500 million, as well as up to double-digit tiered royalties on net sales.

Susan Galbraith, Vice President, Head of Oncology in AstraZeneca’s Innovative Medicines and Early Development Unit, said: “We are pleased to expand our successful collaboration with Heptares into the exciting area of immuno-oncology. By combining the pioneering A2A receptor programme with the strength of AstraZeneca’s oncology portfolio, we hope to develop novel treatments with the potential to transform the lives of patients.”

Malcolm Weir, Chief Executive Officer of Heptares, said: “The A2A receptor programme at Heptares has been an outstanding example of our Structure Based Drug Design approach in action, resulting in a novel clinical candidate, HTL-1071, with a highly attractive profile. Heptares is targeting G-protein-coupled receptors that play a key role in cancer biology through the identification of both antibody and small molecule therapeutics.We are delighted to be entering this expanding field by partnering with AstraZeneca, an innovative leader in the field of cancer immunotherapy. This agreement further builds on our successful existing research collaboration.”

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

– ENDS –

NOTES TO EDITORS

About Heptares Therapeutics

Heptares is a clinical-stage company creating transformative medicines targeting G protein-coupled receptors (GPCRs), a superfamily of 375 receptors linked to a wide range of human diseases. Heptares’ proprietary structure-based drug design technology enables us to engineer drugs for highly validated, yet historically undruggable or challenging, GPCRs. Using this approach, we have built an exciting pipeline of new medicines with the potential to transform the treatment of Alzheimer’s disease, schizophrenia ADHD, migraine, addiction, metabolic disease,and other indications. Our pharmaceutical partners include AstraZeneca, MedImmune, Cubist, MorphoSys and Takeda. Heptares is a wholly owned subsidiary of Sosei Group Corporation. For more information, please visit www.heptares.com and www.sosei.com.

About AstraZeneca in Oncology

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

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

About AstraZeneca

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

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
Michele MeixellUS+1 302   885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen+44 20 7604   8199+44 7818 524185
Eugenia LitzRIA+44   20 7604 8233+44 7884 735627
Nick StoneCVMD+44 20 7604   8236+44 7717 618834
Karl HårdOncology+44   20 7604 8123+44 7789 654364
Craig MarksING+44   20 7604 8591+44 7881   615764
Christer Gruvris+44   20 7604 8126+44 7827 836825
US
Dial / Toll-Free+1 301 398   3251+1 866 381 7277

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

Om AstraZeneca

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

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

AstraZeneca and Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation, today announced that they have entered into a licensing agreement.

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Medimmune and Mirati Therapeutics partner on immuno-oncology combination in lung cancer

Pressmeddelanden   •   2015-08-05 08:03 CEST

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into an exclusive clinical trial collaboration with Mirati Therapeutics, Inc., an oncology company focusing on genetic and epigenetic drivers of cancer. The Phase I/II study will evaluate the safety and efficacy of MedImmune’s investigational anti-PDL1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with mocetinostat, Mirati’s investigational spectrum-selective histone deacetylase (HDAC) inhibitor.

This novel combination will initially be evaluated in patients with non-small cell lung cancer (NSCLC), with the potential to explore additional indications in the future.

Durvalumab is designed to counter the tumour’s immune-evading tactics by blocking a signal that helps tumours avoid detection, while mocetinostat selectively inhibits Class I HDAC enzymes, which has the potential to enhance the positive effect of checkpoint inhibitors, such as durvalumab, on tumour immunity.

David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: “The collaboration with Mirati is yet another example of our combination-focused immuno-oncology strategy and our comprehensive approach in lung cancer as a key disease area. We continue to follow the scientific evidence to explore novel combination treatments to meet unmet patient need, with durvalumab as the cornerstone.”

Charles M. Baum, President and CEO, Mirati, said: “There is a growing body of evidence that mocetinostat may enhance the efficacy of immune check-point inhibitors such as PD-L1 antibodies. Mocetinostat selectively targets specific HDACs that may increase the efficacy of durvalumab in patients with non-small cell lung cancer, as well as other tumour types. We look forward to working with MedImmune on this combination to potentially improve future outcomes for patients.”

Under the terms of the agreement, Mirati will conduct and fund the initial Phase I/II clinical trial, which is expected to start in 2016, and MedImmune will supply durvalumab for the trial. The parties have established a Joint Steering Committee to oversee the trial. In the event that the initial clinical trial demonstrates positive results, MedImmune will have an exclusive period of time in which to negotiate a commercial license for the combination in this indication.

– ENDS –

NOTES TO EDITORS

About Mocetinostat

Mocetinostat is an orally-bioavailable, spectrum-selective HDAC inhibitor. Mocetinostat is currently in two single-agent Phase II trials evaluating the treatment of patients that carry inactivating mutations of the histone acetyltransferase genes CREBBP and EP300. One trial is in patients with bladder cancer, the other is an investigator-sponsored study in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to mocetinostat as a treatment for DLBCL. Additionally, there is growing evidence suggesting that Class I spectrum-selective HDAC inhibitors may be able to increase the target patient population and enhance the activity of immune check-point inhibitors when these classes of agents are combined. Based on this strong scientific rationale, mocetinostat is being evaluated in combination with a PD-L1 monoclonal antibody for the treatment of NSCLC. This Phase I/II study is expected to begin in 2016. Mirati retains worldwide rights to mocetinostat with the exception of certain Asian territories where the program is partnered with Taiho Pharmaceutical Co., Ltd.

About Durvalumab

Durvalumab (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. Durvalumab blocks these signals, countering the tumour’s immune-evading tactics.

Durvalumab was accelerated into Phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate durvalumab as monotherapy and in combination with a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody tremelimumab, in lung cancer, across the spectrum of the disease. In head and neck cancer, durvalumab is being investigated in three late stage studies (HAWK, CONDOR and EAGLE) as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

A comprehensive development programme for durvalumab is underway across multiple tumor types, including gastric, pancreatic and bladder cancer, in addition to lung and head and neck cancers.

About Mirati TherapeuticsMirati Therapeutics develops molecularly targeted cancer treatments that are intended to inhibit tumor growth. Mirati's approach combines the three most important factors in oncology drug development, 1) researching and developing drug candidates that target genetic and epigenetic drivers of cancer, 2) designing creative and agile clinical development strategies that select for patients whose tumors are dependent on specific driver alterations, and 3) leveraging a highly accomplished targeted oncology leadership team. The Mirati team uses a blueprint – proven by their prior work – for developing potential breakthrough cancer therapies, with accelerated development paths, in order to improve outcomes for patients. Mirati is advancing three drug candidates through clinical development for multiple oncology indications. More information is available at www.mirati.com.

About AstraZeneca in Oncology

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

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

About 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

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Vanessa RhodesUK/Global+44 20 7604 8037
Ayesha BharmalUK/Global+44 20 7604 8034
Jacob LundSweden+46   8 553 260 20
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Thomas Kudsk Larsen+44 20 7604   8199+44 7818 524185
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Karl HårdOncology+44   20 7604 8123+44 7789 654364
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

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 MedImmune, its global biologics research and development arm, has entered into an exclusive clinical trial collaboration with Mirati Therapeutics, Inc., an oncology company focusing on genetic and epigenetic drivers of cancer.

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

Pressmeddelanden   •   2015-08-03 08:02 CEST

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

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

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

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

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

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

– ENDS –

NOTES TO EDITORS

About Isis Pharmaceuticals, Inc.

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

About AstraZeneca

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

Media Enquiries
Esra Erkal-PalerUK/Global+44 20 7604 8030
Karen BirminghamUK/Global+44 20 7604 8120
Vanessa RhodesUK/Global+44 20 7604 8037
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+1   302 885 2677

Investor   Enquiries
UK
Thomas Kudsk Larsen+44 20 7604 8199+44 7818 524185
Eugenia LitzRIA+44 20 7604 8233+44 7884 735627
Nick StoneCVMD+44   20 7604 8236+44 7717 618834
Karl HårdOncology+44 20 7604 8123+44 7789 654364
Craig MarksING+44 20 7604 8591+44 7881 615764
Christer Gruvris+44 20 7604 8126+44 7827 836825
US
Dial / Toll-Free+1 301   398 3251+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

Isis Pharmaceuticals’ Forward-looking Statement

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

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

Om AstraZeneca

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

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

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Kontaktpersoner 3 kontaktpersoner

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  • Extern kommunikationsdirektör
  • jacob.lund@astrazeneca.com
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Om AstraZeneca

Om AstraZeneca

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