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AstraZeneca’s BioVentureHub expanding with leading science

Pressmeddelanden   •   2016-02-11 08:00 CET

Two new companies have moved into the BioVentureHub at AstraZeneca Gothenburg, bringing the total to 17 companies and 1 academic group.

The newcomers are: Promimic, developers of an innovative implant surface that mimics living bone tissue, and TATAA Biocenter, experts in nucleic acid and protein analyses.

Magnus Björsne, AstraZeneca’s Executive Director for the BioVentureHub (BVH), is excited to welcome the new companies to the Gothenburg site: “Promimic and TATAA Biocenter are terrific additions to the BioVentureHub. They lead scientific innovation in their respective fields and add new capabilities, ideas and perspectives into the hub mix.”

AstraZeneca established the BVH in 2014 to stimulate open and collaborative innovation and to strengthen competitiveness in the Scandinavian life sciences. Supporting the AstraZeneca Gothenburg site vision to be one of the best R&D sites in the world, the BVH gives emerging biotech/medtech companies and academic groups a unique opportunity to co-locate and interact with AstraZeneca’s scientists and state-of-the-art lab facilities and infrastructure, and with each other.

Promimic has moved into the BVH to further develop its innovative HAnano Surface, which represents a new generation of implant surfaces based on synthetic bone minerals.


“We started our journey of growth last year. To ensure that we can continue to satisfy our customers and to stay at the forefront of product innovation, we needed to upgrade our facilities. Moving into the BioVentureHub and having access to the AstraZeneca labs and infrastructure provides us with the ideal foundation on which we can build the future growth and success of our company,” says Ulf Brogren, CEO of Promimic.


TATAA Biocenter, located in Göteborg (Sweden), Prague (Czech Republic) and Saarbrucken, (Germany), has opened an R&D unit in the BioVentureHub. The unit is led by Dr Robert Sjöback, and will develop TATAA’s novel technology for exceedingly sensitive and specific analysis of microRNAs, as well as quality control products for molecular analyses.


”As we develop innovative methods and products, it is extremely valuable for our R&D team to be embedded amongst interested and knowledgeable potential users that provide input during the development stage and then support our testing and validation”, says Mikael Kubista, CEO and founder of TATAA Biocenter.


About AstraZeneca BioVentureHub

AstraZeneca established the BioVentureHub in 2014 as an open innovation ecosystem to further strengthen competitiveness and dynamism in the Scandinavian life science industry. Based on an innovative public-private partnership model and located at the heart of AstraZeneca Gothenburg, the BioVenturehub gives emerging biotech/medtech companies and academic groups from Sweden and abroad a unique opportunity to co-locate with - and tap into - the power of AstraZeneca’s world-class scientists and state-of-the-art lab facilities and infrastructure, and with each other. www.azbioventurehub.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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. 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


About Promimic

Promimic has developed a process that makes it possible to modify all types of implant materials and geometries with a nanometer-thin surface of synthetic bone minerals; HAnano Surface. It is based on the substance hydroxyapatite (HA)., which by size, shape, structure and chemistry mimics the living bone tissue. The HAnanoSurface is licensed to dental and orthopaedic implants companies. Promimic is a spin-off company based on research from Chalmers University of Technology. For more information about the company, please visit the web page: www.promimic.com


About TATAA Biocenter

TATAA Biocenter is the world’s largest organizer of hands-on training in molecular analyses, Europe’s leading provider of nucleic acid analysis services, and Scandinavia’s most comprehensive distributor of products for nucleic acids analyses. Through its laboratories in Göteborg, Sweden, and Prague, Czech Republic, and sales office in Saarbrucken, Germany, TATAA Biocenter supports its clients with products for full range of nucleic acid and protein analyses and services in compliance with ISO17025 standard. In 2013, TATAA Biocenter was presented the Frost & Sullivan Award for Customer Value Leadership as Best-in-Class Services for Analyzing Genetic Material. In 2015, TATAA separated its consumer diagnostic service business into Life Genomics AB. For more information visit www.tataa.com


Contact

Jacob Lund, AstraZeneca Sweden: +46 8-553 260 20/+ 46 72-560 2157

= = =


952354.011

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

Two new companies have moved into the BioVentureHub at AstraZeneca Gothenburg, bringing the total to 17 companies and 1 academic group.

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AstraZeneca PLC’s resultatrapport för helåret och fjärde kvartalet 2015

Pressmeddelanden   •   2016-02-04 08:02 CET

Pascal Soriot, koncernchef, kommenterar resultatet: "Vi stärkte vår forskningsportfölj och levererade ett starkt finansiellt resultat under 2015 samtidigt som vi påbörjade nästa fas av vår strategiska resa. .....

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TAGRISSO™ (osimertinib) har godkänts i EU som den första behandlingen för patienter med EGFR T790M mutationspositiv metastaserad icke-småcellig lungcancer

Pressmeddelanden   •   2016-02-03 12:29 CET

Det första nya läkemedlet som godkänts inom ramen för Europeiska kommissionens accelererade process

Godkännandet baseras på studier som visar på en objektiv responsfrekvens av 66 % och en progressionsfri överlevnad med en median på 9,7 månader.

Tumörprov eller blodprov kan fastställa vilka patienter som sannolikt kan dra nytta av osimertinib

3 februari 2016

AstraZeneca meddelade idag att Europeiska kommissionen (EU) har beviljat marknadsgodkännande för TAGRISSO™ (AZD9291, osimertinib) med tabletter en gång dagligen för behandling av vuxna patienter med lokalt avancerad eller metastaserad epidermal tillväxtfaktorreceptor (EGFR) T790Mmutationspositiv icke-småcellig lungcancer (NSCLC).

Osimertinib är godkänt för patienter med T790M mutationspositiv icke-småcellig lungcancer, oberoende av tidigare behandling med en EGFR-tyrosinkinashämmare (TKI). Möjligheten att behandla med osimertinib kommer vara beroende av mutationsstatus, vilken fastställs genom ett validerat diagnostiskt test baserat på prov av tumörvävnad eller plasma. Tillgång till ett blodbaserat test för cirkulerande tumör-DNA (ctDNA) innebär att läkare och patienter har flera alternativ för provtagning när man söker efter en T790M-mutation.

"Genom godkännandet av Tagrisso har vi kommit till ytterligare en milstolpe i behandlingen av lungcancer med målriktade läkemedel. För en majoritet av de patienter, vars sjukdom utvecklat resistens genom T790M mutation mot de tidigare generationerna av målriktade läkemedel, är läkemedlet ett mycket värdefullt tillskott som visat på förlängd progressionsfri överlevnad med cirka 10 månader i flera studier. Som kliniker gläds jag med patienterna och ser stora möjligheter för ytterligare förbättrad överlevnad för lungcancerpatienter kommande år genom den positiva utvecklingen vi nu ser, säger Martin Sandelin, Läkare och Medicine doktor, Lungkliniken, Akademiska Sjukhuset i Uppsala."

Sean Bohen, Executive Vice President, Global Medicines Development och Chief Medical Officer på AstraZeneca, säger:”Osimertinib definierar en ny generation målriktade EGFR-TKI-behandlingar, och EU-kommissionens accelererade godkännande speglar vikten av detta innovativa läkemedel för att tillgodose behoven hos patienter med lungcancer med T790M-mutationen. Vi bygger nu vidare på vår förståelse av den kliniska aktiviteten av osimertinib för att undersöka läkemedlets fulla potential hos patienter med EGFR muterad lungcancer i flera behandlingssituationer.”

Dr Matthew Peters, ordförande för Global Lung Cancer Coalition, tillade: ”Det är en spännande tid i behadlingen av patienter med lungcancer. Möjligheten att exakt karaktärisera patienter utifrån typ av lungcancer baserat på genetiska gmutationer, samt att kunna förutsäga hur de kommer svarar på målriktade läkemedel, ger en mer exakt och effektiv hantering av behandlingen av lungcancer patienter. Hittills har patienter med aktiverande EGFR-mutationer samt den specifikaT790M mutationen visat på nedslående respons på standardbehandlingar. Att undersöka lungcancerpatienters T790M-status med hjälp av antingen ett tumörprov eller ett enkelt blodprov, samt att styra patienterna mot ett läkemedel som osimertinib vilket är speciellt utformat för deras mutationsmönster, ger större möjligheter till varaktiga behandlingsresultat.”

Mutationer i EGFR-receptorn kan leda till okontrollerad celltillväxt och tumörtillväxt. Osimertinib riktar sig mot både EGFR-mutation, som utlöser cancertillväxten, och mot T790M, en mutation som gör tumörerna resistenta mot befintlig behandling med EGFR-TKI:er. Nästan två av tre patienter med icke-småcellig lungcancer vars sjukdom progedierar efter behandling med en EGFR-hämmare utvecklar T790M-mutationen, för vilka behandlingsalternativen är begränsade. Ett litet antal patienter (ca 3–5 %) har T790M-mutationen vid diagnosen av icke-småcellig lungcancer.

EU-godkännandet för osimertinib baseras på data från två fas II-studier (AURA-extension och AURA2) samt expansionsstudien AURA fas I, som påvisat effekt hos 474 patienter med EGFRm T790M icke-småcellig lungcancer som hade spridits i samband med eller efter en EGFR-TKI. I de kombinerade fas II-studierna låg den objektiva responsfrekvensen (ORR, ett mått på tumörkrympning) på 66 %, medan den i fas I-studien låg på 62 %. Progressionsfri överlevnad (PFS) låg på 9,7 månader i de kombinerade fas II-studierna och på 11 månader i fas I-studien. Medianvaraktigheten av respons (DOR) i fas I-studien låg på 9,7 månader, medan median-DOR inte uppnåddes i de kombinerade fas II-studierna.

De vanligaste oönskade händelserna (AE) baserade på data från de båda AURA fas II-studierna var generellt milda till måttliga och omfattade diarré (42 % alla grader; 1,0 % grad 3/4), hudutslag (41 % alla grader; 0,5 % grad 3/4), torr hud (31 % alla grader; 0 % grad 3/4) samt nagelförändringar (25 % alla grader; 0 % grad 3/4). Varningar och försiktighetsåtgärder innefattar interstitiell lungsjukdom (ILD) och förlängning av QT-tid.

EU:s marknadsgodkännande erhölls genom det accelererade prövningsförfarandet hos den europeiska läkemedelsmyndigheten (EMA). Detta godkännande följer USA:s accelererade godkännande i november 2015 och tillgänglighet i Storbritannien enligt Early Access to Medicines Scheme (EAMS) i december 2015. I Japan beviljades osimertinib prioriterad granskning av myndigheten för läkemedel och medicintekniska produkter (PMDA). Kommunikation med tillsynsmyndigheter i övriga världen pågår.

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 eller följ oss på twitter. Https:/twitter.com/AstraZenecaSE.

Kontakt för media:

Petra Eurenius, Kommunikationschef AstraZeneca Nordic-Baltic, 0709 186562

Jacob Lund, Kommunikationschef AstraZeneca Sverige, 08 553 260 20

NOTES TO EDITORS

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, and more than breast, prostate and colorectal cancers combined. Patients who have the EGFRm form of NSCLC, which occurs in 10-15%of NSCLC patients in Europeand 30-40%of NSCLC patients in Asia,are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two-thirds of

patients treated with the approved EGFR-TKIs, gefitinib, erlotinib or afatinib, this resistance is caused by the secondary mutation, T790M.

About osimertinib

Osimertinib 80mg once-daily tablet is the first medicine indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC. Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines with significantly less activity against EGFR in wild-type cell lines.

Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with brain metastases, and in combination with other compounds.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death

951202.011 02,2016.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

Det första nya läkemedlet som godkänts inom ramen för Europeiska kommissionens accelererade process Godkännandet baseras på studier som visar på en objektiv responsfrekvens av 66 % och en progressionsfri överlevnad med en median på 9,7 månader. Tumörprov eller blodprov kan fastställa vilka patienter som sannolikt kan dra nytta av osimertinib

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Tagrisso™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790m mutation-positive metastatic non-small cell lung cancer

Pressmeddelanden   •   2016-02-03 08:04 CET

TAGRISSO is the first new medicine to be approved under the European Commission’s expedited process

Approval based on studies showing objective response rate of 66% and median progression-free survival of 9.7 months

Tumour sample or blood test can determine patients likely to benefit from osimertinib

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI). Eligibility for treatment with osimertinib will be dependent on mutation status, to be determined through a validated diagnostic test based on a tumour tissue sample or plasma. Availability of a blood-based test for circulating tumour DNA (ctDNA) means that physicians and patients have multiple options to test for a T790M mutation.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said:“Osimertinib defines a new generation of targeted EGFR-TKI treatments, and the European Commission’s expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation. We are now building on our understanding of the clinical activity of osimertinib to explore its full potential in patients with EGFRm lung cancer in multiple treatment settings.”

Dr Matthew Peters, Chair of the Global Lung Cancer Coalition, added: “It is an exciting time in the care of patients with lung cancer. The ability to precisely characterise patients who have different types of lung cancer based on genetic mutations, and predict their response to targeted treatments, offers a more accurate and efficient approach to lung cancer care. Patients with common sensitising EGFR mutations and the separate T790M have disappointing responses to standard treatments. Testing for the T790M status of lung cancer patients, using either a tumour sample or a simple blood test, and directing patients towards a medication such as osimertinib that is specifically designed for their pattern of mutations, offers greater prospects for durable treatment outcomes.”

Mutations in the EGFR receptor can lead to uncontrolled cell growth and tumour formation. Osimertinib targets both the EGFR mutation that triggers cancer development and T790M, a mutation that makes tumours resistant to existing treatment with EGFR-TKIs. Nearly two out of three patients with NSCLC whose disease progresses after treatment with an EGFR inhibitor develop the T790M mutation, for which treatment options are limited. A small number of patients (approximately 3-5%) have the T790M mutation at NSCLC diagnosis.

The EU approval for osimertinib is based on data from two Phase II studies (AURA extension and AURA2) and the AURA Phase I expansion study, which demonstrated efficacy in 474 patients with EGFRm T790M NSCLC who had progressed on or after an EGFR-TKI. In the combined Phase II studies, the objective response rate (ORR, a measurement of tumour shrinkage) was 66%, and in the Phase I study it was 62%. Progression-free survival (PFS) was 9.7 months in the combined Phase II studies and 11 months in the Phase I trial. Median duration of response (DOR) in the Phase I study was 9.7 months, and in the combined Phase II studies, median DOR was not reached.

The most common adverse events based on data from the two AURA Phase II studies were generally mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4) and nail toxicity (25% all grades; 0% Grade 3/4). Warnings and precautions include interstitial lung disease and QT interval prolongation.

The EU marketing authorisation was received through the Accelerated Assessment procedure of the European Medicines Agency (EMA). This approval follows US Accelerated Approval granted in November 2015 and availability in the UK under the Early Access to Medicines Scheme in December 2015. In Japan, osimertinib was granted Priority Review by the Pharmaceuticals and Medical Devices Agency (PMDA). Interactions with regulatory authorities in the rest of the world are ongoing.

NOTES TO EDITORS

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, and more than breast, prostate and colorectal cancers combined. Patients who have the EGFRm form of NSCLC, which occurs in 10-15%of NSCLC patients in Europeand 30-40%of NSCLC patients in Asia,are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two-thirds of patients treated with the approved EGFR-TKIs, gefitinib, erlotinib or afatinib, this resistance is caused by the secondary mutation, T790M.

About osimertinib

Osimertinib 80mg once-daily tablet is the first medicine indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC. Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines with significantly less activity against EGFR in wild-type cell lines.

Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with brain metastases, and in combination with other compounds.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. 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
Neil BurrowsUK/Global+44 20 7604 8032
Vanessa RhodesUK/Global+44 20 7604 8037
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 LarsenOncology +44 7818 524185
Eugenia LitzRIA+44 7884 735627
Nick StoneCVMD+44 7717 618834
Craig MarksFinance+44 7881 615764
Christer GruvrisConsensus Forecasts+44 7827 836825
US
Lindsey TrickettOncology, ING+1 240 543 7970
Mitch ChanOncology+1 240 477 3771
Dial / Toll-Free+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

Läs vidare »
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Lynparza™ (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer

Pressmeddelanden   •   2016-01-28 08:03 CET

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).

The FDA criteria for BTD require preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically significant endpoint over available therapy. The decision to assign a BTD for Lynparza is based on the results of the TOPARP-A Phase II trial, which found that Lynparza (olaparib) monotherapy in mCPRPC may offer substantial improvement over available therapies for the treatment of the biomarker-selected population with this serious and life-threatening condition. The TOPARP-A Phase II trial was presented at AACR 2015 and published in the New England Journal of Medicine in October 2015[i]. It showed that men with prostate cancer with defective DNA damage repair mechanisms responded to Lynparza (olaparib).

The Breakthrough Therapy designation for Lynparza in this patient population means the FDA will expedite review of submission data within 60 days of receipt.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “More than 27,000 men died of prostate cancer last year in the US alone. The Breakthrough Therapy designation forLynparzais encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic Castration Resistant Prostate Cancer. We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible.”

Once prostate cancer has progressed to mCPRPC, treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. Overall survival time for patients treated with chemotherapy and newer hormonal agents is 10 months[ii]. There are also no approved therapies for third line and above (3L+) mCRPC patients, and no targeted therapies are available for mCRPC patients with somatic or germline mutations in BRCA1, BRCA2 or ATM.

  • Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies.

Lynparza has been approved by regulatory authorities in 40 countries for the maintenance treatment of women with BRCA-mutated ovarian cancer.AstraZeneca is investigating the potential of olaparib in other PARP dependent tumours. Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers are underway, with further studies planned.

NOTES TO EDITORS

About prostate cancer

In 2015, 27,540 US men died of prostate cancer[iii]. Based on the Global Burden of Disease Cancer Collaboration, there were 1.4 million incidents of prostate cancer and 293,000 deaths worldwide for the year 2013. Prostate cancer caused 4.8 million disability-adjusted life-years globally in 2013, with 57% occurring in developed countries and 43% occurring in developing countries[iv].

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates – with a strong focus on combinations. Our recently announced investment in Acerta Pharma also adds the potentially transformational BTK inhibitor class of treatments to our portfolio, subject to closure in the first quarter of 2016, strengthening further our focus on targeted therapies.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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
Neil   BurrowsUK/Global+44 20 7604 8032
Vanessa   RhodesUK/Global+44 20 7604 8037
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 LarsenOncology +44 7818 524185
Eugenia   LitzRIA+44 7884 735627
Nick StoneCVMD+44 7717 618834
Craig   MarksFinance+44 7881   615764
Christer   GruvrisConsensus   Forecasts+44   7827 836825
US
Lindsey   TrickettOncology, ING+1   240 543 7970
Mitch   ChanOncology+1 240 477 3771
Dial /   Toll-Free+1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

-ENDS-

[i] Mateo J, et al. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancerhttp://www.nejm.org/doi/full/10.1056/NEJMoa1506859?af=R&rss=currentIssue&

[ii] Smith MR, DeBono JS, Sternberg CN, Le Moulec S, Oudard S, De Giorgi U et al. Final analysis of COMET-1: Cabozantinib (Cabo) versus prednisone (Pred) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) previously treated with docetaxel (D) and abiraterone (A) and/or enzalutamide (E).ASCO GU 2015. J Clin Oncol 2015;33(7):abstr 139.

[iii]National Cancer Institute 2015. http://www.cancer.gov/types/common-cancers accessed September 2015

[iv] Global Burden of Cancer Coalition. The Global Burden of Cancer 2013. JAMA Oncol. 2015;1(4):505-527. doi:10.1001/jamaoncol.2015.0735. http://oncology.jamanetwork.com/article.aspx?articleid=2294966#ArticleInformation

Om AstraZeneca

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

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

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib),

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AstraZeneca and Incyte announce new lung cancer clinical trial collaboration

Pressmeddelanden   •   2016-01-11 13:03 CET

AstraZeneca and Incyte Corporation today announced a new collaboration to evaluate the efficacy and safety of Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca’s next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso® (osimertinib). The combination will be assessed as a second line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation.

There is increasing evidence that signalling through the JAK-STAT (signal transducer and activator of transcription) pathway could be a contributing factor in resistance to EGFR TKI treatment in patients with EGFR mutation NSCLC. Blocking both JAK and EGFR activity may therefore offer an improved targeted treatment benefit in some patients.

Under the terms of the agreement, AstraZeneca and Incyte will collaborate on a Phase I/II study, to be conducted by Incyte. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination of INCB39110 and Tagrisso, while the Phase II part of the study will assess the safety and efficacy profile. Results from the study will be used to determine whether further clinical development of this combination is warranted.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: “We are pleased to be building on our existing relationship with Incyte and exploring a potentially exciting combination for lung cancer patients who have developed a resistance to first generation EGFR inhibitor treatment. This collaboration allows us to explore further ways in which Tagrisso, our first in class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need, following its accelerated approval in the US and the recent positive CHMP opinion, recommending approval in Europe.”

Rich Levy, MD, Chief Drug Development Officer of Incyte said: “The expansion of our research collaboration with AstraZeneca will allow us to further our understanding of these two compounds and explore their potential synergies which support our goal of delivering innovative medicines that will benefit patients with cancer or other diseases. We look forward to adding to our ongoing clinical research for INCB39110 and exploring the potential of this combination.”

This agreement builds on an existing collaboration between the two companies, announced in May 2014, to explore AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).

– ENDS –

NOTES TO EDITORS

About Tagrisso (osimertinib)

Tagrisso (osimertinib) is the only approved medicine indicated for adult patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR). Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced, or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with brain metastases, and in combination with other compounds.

Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines, with significantly less activity against EGFR in wild-type cell lines.

AboutINCB39110

INCB39110 is an orally bioavailable, isoform-selective inhibitor of Janus-associated kinase 1 (JAK1). JAK1 activity is believed to play an important role in both autoimmune and oncologic diseases. JAK1 forms heterodimeric complexes with JAK2, JAK3 or TYK2 and functions as an immunomodulatory and inflammatory signalling kinase.Selective JAK1 inhibition prevents STAT signalling downstream of a number of cytokines, including IL-6, IL-10 and interferon-gamma. Consistent with the dominant role for JAK1 in mediating heterodimeric JAK/STAT signalling, JAK1 inhibition has been shown to result in equivalent efficacy compared to balanced JAK1/JAK2 modulation in a variety of preclinical solid and liquid tumor models. INCB39110 will be investigated in clinical trials as monotherapy in graft versus host disease (GvHD) and in several combination-based therapeutic regimens, including with PI3Kδ (INCB50465), IDO1 (epacadostat) and EGFR (Tagrisso) inhibitors.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology. For additional information on Incyte, please visit the Company's website at www.incyte.com.

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates – with a strong focus on combinations. Our recently announced investment in Acerta Pharma also adds the potentially transformational BTK inhibitor class of treatments to our portfolio, subject to closure in the first quarter of 2016, strengthening further our focus on targeted therapies.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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
Neil BurrowsUK/Global+44 20 7604 8032
Vanessa RhodesUK/Global+44 20 7604 8037
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 LarsenOncology +44 7818 524185
Eugenia LitzRIA+44 7884 735627
Nick StoneCVMD+44 7717 618834
Craig MarksFinance+44 7881 615764
Christer GruvrisConsensus Forecasts+44 7827 836825
US
Lindsey TrickettOncology, ING+1 240 543 7970
Mitch ChanOncology+1 240 477 3771
Dial / Toll-Free+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 and Moderna Therapeutics announce new collaboration to co-develop and co-commercialise Immuno-Oncology mRNA Therapeutics™

Pressmeddelanden   •   2016-01-11 13:01 CET

Moderna to lead preclinical development; AstraZeneca to lead clinical development; Moderna to co-commercialise and share profits on resulting products in the US

AstraZeneca, along with its global biologics research and development arm, MedImmune, and Moderna Therapeutics today announced a new collaboration to discover, co-develop and co-commercialise messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. The collaboration is in addition to the agreement announced by the companies in 2013 to develop mRNA Therapeutics™ for the treatment of cardiovascular, metabolic and renal diseases as well as selected targets in oncology.

The collaboration will combine MedImmune’s protein engineering and cancer biology expertise with Moderna’s mRNA platform.mRNA-based therapies are an innovative treatment approach that enables the body to produce therapeutic protein in vivo, opening up new treatment options for a wide range of diseases that cannot be addressed today using existing technologies.

Under the terms of the new agreement, AstraZeneca and Moderna, a pioneer of mRNA Therapeutics™, have agreed to collaborate on two specific immuno-oncology programmes, based on promising pre-clinical data, including pharmacology in tumour models. Moderna will fund and be responsible for discovery and preclinical development of product candidates, with the aim of delivering one Investigational New Drug (IND) application-ready molecule for each of the two programmes. Moderna’s efforts will be led by its oncology-focused venture, Onkaido.AstraZenecawill be responsible for early clinical development, led by MedImmune, and Moderna and AstraZeneca will share the costs of late-stage clinical development. The two companies will co-commercialise resulting products in the US under a 50:50 profit sharing arrangement. AstraZeneca will lead ex-US commercialisation efforts, with Moderna receiving tiered royalties up to substantial double digits on ex-US sales.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “We’re pleased to be expanding our relationship with Moderna with this new collaboration, to advance the potential of pioneering messenger RNA technology in developing game-changing new treatments for cancer patients.”

“Since our companies’ original strategic agreement in March 2013, Moderna’s relationship with AstraZeneca has been very fruitful. This new agreement with AstraZeneca demonstrates the effectiveness of our existing relationship and the power of our mRNA technology,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We’re gratified to deepen our relationship with AstraZeneca and MedImmune with this major initiative, and we look forward to getting underway immediately with our new joint immuno-oncology programmes.”

Under the companies’ original strategic agreement, AstraZeneca holds exclusive access to select any target of its choice in cardiometabolic diseases, as well as select targets in oncology, over a period of up to five years for subsequent development in mRNA. Several projects are progressing towards clinical development under the arrangement, and a first-in-human study is expected to commence in late 2016.

– ENDS –

NOTES TO EDITORS

About Moderna Therapeutics

Moderna is a pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna plans to develop and commercialize its innovative mRNA drugs through its own ventures and its strategic relationships with established pharmaceutical and biotech companies. Its current ventures are: Onkaido, focused on oncology, Valera, focused on infectious diseases, Elpidera, focused on rare diseases, and Caperna, focused on personalized cancer vaccines. Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca, Alexion Pharmaceuticals and Merck.

With its novel technology to enable mRNA as a drug, Moderna is building a fully scaled drug discovery and development platform centered on the rapid and low-cost design, delivery and production of mRNA drug candidates. Moderna is also advancing an innovative business model built on the decentralization of drug development activities. With an ecosystem of in-house concept development, ventures focused on therapeutic areas and a cluster of major pharma and biotech partners, Moderna is enabling more than 90 discovery and preclinical programmes today across oncology, infectious diseases, rare diseases and cardiovascular diseases. Moderna’s pipeline also covers a broad expanse of novel drug modalities, each representing a distinct approach to using the company’s novel mRNA expression platform to encode proteins that achieve a therapeutic benefit.

For more information, visit www.modernatx.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 centers, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates – with a strong focus on combinations. Our recently announced investment in Acerta Pharma also adds the potentially transformational BTK inhibitor class of treatments to our portfolio, subject to closure in the first quarter of 2016, strengthening further our focus on targeted therapies.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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
Neil   BurrowsUK/Global+44 20 7604 8032
Vanessa   RhodesUK/Global+44 20 7604 8037
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 LarsenOncology +44 7818   524185
Eugenia   LitzRIA+44 7884   735627
Nick StoneCVMD+44 7717 618834
Craig   MarksFinance+44   7881 615764
Christer   GruvrisConsensus Forecasts+44 7827 836825
US
Lindsey   TrickettOncology, ING+1 240 543 7970
Mitch   ChanOncology+1 240 477 3771
Dial /   Toll-Free+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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ZURAMPIC® (lesinurad) approved by US FDA for patients with gout

Pressmeddelanden   •   2015-12-23 08:01 CET

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC®(lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone.

ZURAMPIC inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, ZURAMPIC increases uric acid excretion and thereby lowers sUA.

In combination with the current standard of care, XOIs allopurinol or febuxostat, ZURAMPIC provides a dual mechanism of action to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to achieve target treatment goals.

Sean Bohen, Executive Vice President of Global Medicines Development and Chief Medical Officer, AstraZeneca, said: “With the FDA approval of ZURAMPIC, we are pleased to offer a new treatment option for the many patients who are suffering from the effects of gout and who are not reaching the recommended serum uric acid treatment targets with the current standard of care.”

The FDA approval is based on data from three pivotal Phase III studies, CLEAR1, CLEAR2 and CRYSTAL, which represent the largest clinical trial data set of gout patients (n=1,537 total) treated with combination urate lowering therapy.

Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia (elevated sUA). It affects millions of people around the globe, many of whom do not reach recommended sUA treatment goals on XOIs, which decrease production of uric acid.For those inadequately controlled patients, the addition of a urate-lowering therapy to increase excretion of uric acid may help them achieve treatment goals.

Dr. Lawrence Edwards, Chairman and Chief Executive Officer of the Gout and Uric Acid Education Society (GUAES), said: “A new approach to treating gout is long overdue given there has been limited therapy innovation over the last 50 years. Combination therapy with ZURAMPIC is an important addition to the medicines available to physicians that will help more gout patients reach their serum uric acid treatment targets, which may ultimately relieve their suffering from this painful disease.”

ZURAMPIC is also under regulatory review in the European Union and other territories.On 18 December 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorisation of ZURAMPIC 200mg tablets. ZURAMPIC, in combination with an XOI, is recommended for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target sUA levels with an adequate dose of an XOI alone.

– ENDS –

NOTES TO EDITORS

About ZURAMPIC®(lesinurad) 200mg tablets

ZURAMPIC®(lesinurad) 200mg tablets inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, ZURAMPIC increases uric acid excretion and thereby lowers serum uric acid (sUA). ZURAMPIC also inhibits organic anion transporter (OAT) 4 a uric acid transporter involved in diuretic-induced hyperuricemia. In addition, in people, ZURAMPIC does not inhibit OAT1 and OAT3, which are drug transporters in the kidney associated with drug-drug interactions.

About the ZURAMPIC Development Programme

CLEAR1 and CLEAR2 (see prior release on this topic here) were pivotal Phase III studies that evaluated the efficacy and safety of a once daily dose of ZURAMPIC in combination with allopurinol compared to allopurinol alone. In CLEAR1 and CLEAR2, ZURAMPIC when used in combination with allopurinol, met the primary endpoint in both studies with approximately twice as many patients achieving the serum uric acid (sUA) goal of <6.0mg/dL (360 µmol/L) by month 6, compared to those treated with allopurinol alone.

CRYSTAL (see prior release on this topic here) was a pivotal Phase III study that evaluated the efficacy and safety of a once daily dose of ZURAMPIC in combination with febuxostat 80mg compared to febuxostat 80mg alone in gout patients with tophi (visible deposits of urate crystals in joints and skin). Patients were administered febuxostat 80mg orally once daily for 3 weeks before randomisation. In CRYSTAL, results showed ZURAMPIC 200mg in combination with febuxostat demonstrated greater (nominal p<0.05) sUA lowering to the target for tophaceous gout of <5.0mg/dL (300 µmol/L) compared to febuxostat alone at all months except at the time of the primary endpoint, month 6 (56.6% vs. 46.8%, non significant). In the subgroup of patients with baseline sUA ≥5.0mg/dL (300 µmol/L) (i.e. those above recommended sUA treatment target for tophaceous gout on febuxostat alone), ZURAMPIC 200mg in combination with febuxostat resulted in more subjects reaching target sUA of <5.0mg/dL (300 µmol/L) compared to febuxostat alone at month 6.

In a pooled analysis of the three clinical trials, the safety profile was similar for ZURAMPIC 200mg in combination with an XOI to that of an XOI alone, with the exception of an increased incidence of predominantly reversible serum creatinine (sCr) elevations.

About Hyperuricemia and Gout

Gout is a serious, chronic, progressive, and debilitating form of inflammatory arthritis that affects more than 15.8 million people in major markets.* The underlying cause of gout is hyperuricemia (elevated sUA),which leads to the deposition of crystals primarily in the joints and in other tissues. This can result in recurrent attacks of inflammatory arthritis and, if left uncontrolled, could lead to chronic, progressive arthritis, and tophus (visible deposits of urate crystals) formation.

The goal of sUA lowering treatment is to reduce sUA levels to the target level of <6.0mg/dL (360 µmol/L) as recommended by both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). In those with greater disease severity and urate burden, such as those with tophi, guidelines recommend lowering sUA to <5.0mg/dL (300 µmol/L) to achieve better disease control.

Among patients treated in clinical trials, less than 50% of patients on allopurinol 300mg reached sUA target levels <6.0mg/dL (360 µmol/L). For patients who cannot reach target on an XOI alone, the current ACR and EULAR guidelines recommend adding an agent that increases uric acid excretion.

*Major markets include the United States, France, Germany, Italy, Spain, the United Kingdom and Japan

About Ardea Biosciences

Ardea Biosciences is a member of the AstraZeneca Group, located in San Diego, California. Ardea is leading the development of AstraZeneca’s gout portfolio, including ZURAMPIC and RDEA3170. RDEA3170 is a potent selective uric acid reabsorption inhibitor (SURI), also intended for use as a combination urate lowering therapy with xanthine oxidase inhibitors (XOIs). RDEA3170 is our lead investigational urate lowering therapy (ULT) in Asia and is currently entering a Phase IIb trial worldwide.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. 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 UK/Global +44 20 7604 8030
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen Oncology +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +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 today announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC®(lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout

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TAGRISSO™ (OSIMERTINIB) , LESINURAD OCH BRILIQUE (TICAGRELOR) FÅR POSITIVT UTLÅTANDE FRÅN CHMP I EU

Pressmeddelanden   •   2015-12-18 15:43 CET

AstraZeneca meddelar idag att den europeiska läkemedelsmyndigheten EMA:s rådgivande kommitté CHMP ger positivt besked och rekommenderar godkännande av TAGRISSO™ (AZD9291, osimertinib) och lesinurad, samt ny indikation för BRILIQUE (ticagrelor) 60mg för behandling av patienter som har en historia av hjärtinfarkt och hög risk att få en ytterligare aterotrombotisk händelse.

De positiva utlåtanden från CHMP kommer nu att granskas av EU-kommissionen, som har befogenhet att godkänna läkemedel för Europeiska unionen. Det slutliga beslutet kommer att tillämpas på alla 28 EU-medlemsländer samt Island, Norge och Liechtenstein.

Dagens besked är i linje med vårt strategiska mål om att uppnå ledarskap inom forskningen och en bekräftelse på hur vi fortsätter att fokusera på genomförandet av våra planer för våra tillväxtplattformer och vår forskningsportfölj.

För detaljer rörande de olika rekommendationerna, vänligen se bifogade pressmeddelanden på engelska.

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområdena andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se eller följ oss på twitter. Https:/twitter.com/AstraZenecaSE.

Kontaktperson media:

Jacob Lund, Extern kommunikationsdirektör tel: 08-553 26020, mob: 072 560 21 57

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 den europeiska läkemedelsmyndigheten EMA:s rådgivande kommitté CHMP ger positivt besked och rekommenderar godkännande av TAGRISSO™ (AZD9291, osimertinib) och lesinurad, samt ny indikation för BRILIQUE (ticagrelor) 60mg för behandling av patienter som har en historia av hjärtinfarkt och hög risk att få en ytterligare aterotrombotisk händelse.

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Durvalumab ATLANTIC trial supports clinical activity and AstraZeneca’s overall immuno-oncology strategy

Pressmeddelanden   •   2015-12-18 08:03 CET

Durvalumab demonstrated clinical activity and durable responses in 3rd-line or later stage NSCLC patients; full data to be presented at a scientific congress in 2016

Durvalumab monotherapy and combination trials on track in multiple cancers, including 1st-line therapy for NSCLC, head & neck and bladder cancers

AstraZeneca today provided an update on preliminary findings from the ATLANTIC trial of durvalumab as 3rd-line or later stage therapy in patients with locally advanced or metastatic programmed death ligand-1 (PD-L1) positive non-small cell lung cancer (NSCLC) that lacks epidermal growth factor receptor (EGFR) or ALK alterations. An initial analysis supports durvalumab’s clinical activity, with durable responses and an established safety profile in these difficult-to-treat patients.

ATLANTIC investigated the efficacy and tolerability of durvalumab in patients who received at least two prior systemic treatment regimens including platinum-based chemotherapy, and who have limited options for further therapy. A full evaluation of the data is ongoing and the results will be presented at a scientific congress in 2016.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “As we have seen in other studies, durvalumab has demonstrated expected clinical activity and durable response in these heavily pre-treated patients. As previously communicated, the treatment and regulatory landscape in lung cancer is evolving. We now believe it is unlikely that ATLANTIC can be used for regulatory submission as a monotherapy, but we will make that determination following a full analysis of the data. Durvalumab is a cornerstone of our immuno-oncology portfolio with a fast advancing development programme focused primarily on novel combinations.”

A comprehensive durvalumab registration programme is underway across multiple tumour types, stages of disease, and lines of therapy both as monotherapy and in combination. This forms part of AstraZeneca’s late-stage immuno-oncology programme and includes more than 9,000 patients in 16 clinical trials in lung, bladder, head & neck, and other cancers, summarised below.

DURVALUMAB   DEVELOPMENT PROGRAMME
Status as of Year-To-Date and Q3 2015 Financial results on 5 November 2015
Next update with FY 2015 Results on 4 February 2016

LUNG CANCER

Name

PhaseLine of treatmentPopulationDesignTimelinesStatus
Early diseaseMonotherapy
ADJUVANTIIIN/AStage Ib-IIIa NSCLCdurvalumab vs placeboData expected 2020Recruiting
PACIFICIIIN/AStage III unresect-able NSCLCdurvalumab vs placeboData expected 2017Recruiting
Advanced/metastatic     diseaseMonotherapy
ATLANTICII3rd linePD-L1 pos. NSCLCdurvalumab (single arm)Full data 2016-
Combination therapy
ARCTICIII3rd lineNSCLCdurvalumab vs SoC (PD-L1 pos.) or durvalumab     vs tremelimumab vs durva + treme vs SoC (PD-L1 neg.)Data expected 2017Recruiting
MYSTICIII1st lineNSCLC (PFS endpoint)durvalumab vs durva + treme vs SoCData expected 2017First patient dosed
NEPTUNEIII1st lineNSCLC (OS endpoint)durva + treme vs SoCData expected 2018Awaiting first patient dosed
-III1st lineNSCLCdurvalumab + chemotherapy +/- tremelimumabIn preparation
CAURALIII2nd lineT790M+ NSCLCosimertinib vs osimertinib + durvalumabData expected 2018Initiated enrolment; currently on partial     clinical hold to characterise incidence of interstitial lung disease

METASTATIC HEAD AND NECK CANCER

NamePhaseLine of treatmentPopulationDesignTimelinesStatus
Monotherapy
HAWKII2nd linePD-L1 pos. SCCHNdurvalumab (single arm)Data expected H2 2016RecruitingIndication granted FDA Fast Track     designation
Combination therapy
CONDORII2nd linePD-L1 neg. SCCHNdurvalumab vs tremelimumab vs durva +     tremeData expected 2017Recruiting
EAGLEIII2nd lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation
KESTRELIII1st lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation
METASTATIC Bladder   CANCER
NamePhaseLine of treatmentPopulationDesignTimelinesStatus
DANUBEIII1st lineCisplatin chemo-therapy-eligible/ineligibledurvalumab vs durva + treme vs SoCData expected 2018First patient dosed
OTHER TUMOUR TYPES
NamePhaseLine of treatmentIndicationDesignTimelinesStatus
-II2nd/3rd line Metastatic gastric cancerdurvalumab vs tremelimumab vs durva +     treme In preparation
-II 2nd lineUnresect-able liver cancerdurvalumab vs tremelimumab vs durva +     tremeIn preparation
ALPSII2nd lineMetastatic pancreatic cancerdurva + treme (single arm)In preparation

SoC = Standard of Care, PFS = Progression Free Survival, OS = Overall Survival

– ENDS –

NOTES TO EDITORS

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against 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. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, gastric, pancreatic, bladder and blood cancers.

About the ATLANTIC trial

ATLANTIC is a Phase II, non-comparative, open-label, multi-centre, international trial of durvalumab in patients with locally advanced or metastatic NSCLC (Stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum-based chemotherapy regimen.

About AstraZeneca in Oncology

Oncology is a therapy area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as 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 – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About AstraZeneca

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

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Om AstraZeneca

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Durvalumab demonstrated clinical activity and durable responses in 3rd-line or later stage NSCLC patients; full data to be presented at a scientific congress in 2016

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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