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AstraZeneca PLC: Delårsrapport för första kvartalet 2015 - sammanfattning. Bifogat finns den fullständiga rapporten

Pressmeddelanden   •   2015-04-24 08:06 CEST

Det finansiella resultatet för kvartal 1 2015 ger stöd åt upprepad helårsprognos för 2015.

oTotala intäkter (definierat som produktförsäljning och intäkter från externa samarbeten1) ökade med 1% i fasta valutakurser 2 (CER) till 6 057 MUSD (Q1 2014: 6 460 MUSD)

oVinst per aktie för kärnverksamheten (Core EPS) minskade med 3% till1,08 USD i takt med att vi fortsätter att investera i att uppnå ledarskap inom forskningen.

oDet redovisade rörelseresultatet ökade med 15% till 933 MUSD (Q1 2014: 836 MUSD)

Uppnå ledarskap inom forskningen: vår fokuserade, accelererade och forskningsbaserade portfölj fortsätter att leverera ett starkt nyhetsflöde; ansökningar om 7–8 potentiella NME:er under 2015–16 fortskrider enligt plan.

  • o13 NME:er finns i fas III eller är under registrering.
  • oUSA-ansökan för godkännande av lesinurad mot gikt och saxagliptin/dapagliflozin mot diabetes
  • oPositiva fas III-data för PT003 mot KOL.
  • oPositiva fas IIb-data för anifrolumab mot lupus och investeringsbeslut för fas III.
  • oPositiva fas III-data för Brilinta för patienter med tidigare hjärtinfarkt, samt registreringsansökningar i USA och EU.
  • oSenaste resultat för AZD9291 mot icke-småcellig lungcancer visade på stark klinisk nytta med 13,5 månaders progressionsfri överlevnad.
  • oSärläkemedelsstatus beviljas av amerikanska FDA för tremelimumab mot mesteliom och selumetinib mot uveal melanom.
  • oFast-track status beviljades av amerikanska FDA för MEDI4736 mot icke-småcellig lungcancer och MEDI8897 för behandling av luftvägsinfektion orsakad av RSV-viruset hos små barn.

Tillbaka till tillväxt: tillväxtplattformarna ökade med 13% under kvartalet, vilket motsvarar 56% av de totala intäkterna.

oBrilinta/Brilique: 45% tillväxt under kvartalet, vilket understöddes av publiceringen av positiva PEGASUS-resultat på ACC-konferensen i mars.

oDiabetes: ökade med 47%, understött av en särskilt god tillväxt för Farxiga/Forxiga.

oSjukdomar i andningsvägarna: vår växande verksamhet inom sjukdomar i andningsvägarna ökade med 7%, med stabil försäljning av Symbicort och starkt resultat för Pulmicort.

oTillväxtmarknaderna: växte med 18% under kvartalet, med stöd av en tillväxt på 28% i Kina, där försäljningen inom sjukdomar i andningsvägarna ökade med 35%.

oJapan: försäljningen minskade 2% under kvartalet på grund av de slutliga effekterna av de föreskrivna prissänkningarna som görs vart annat år.

Vårt fokus på externa samarbeten accelererar i linje med vår affärsmodell och skapar ytterligare värde för patienter och aktieägare tack vare den starka forskningsportföljen.

Samarbetsavtal med Daiichi Sankyo i USA avseende marknadsföring av Movantik, som lanserades i mars mot opioid-inducerad förstoppning; överenskommelsen innefattade 200 MUSD i förskott som extern samarbetsintäkt, vilket ingår i de totala intäkterna för Q1 2015.

Strategiskt samarbete med Celgene Corporation för att utveckla vår immunonkologi-portfölj mot blodcancer.

Pascal Soriot, koncernchef, kommenterar resultatet:

”Våra lovande resultat under kvartalet ger stöd åt vår helårsprognos. De totala intäkterna ökade med 1%, där tillväxtplattformarna står för 56%, efter särskilt starka resultat på tillväxtmarknaderna och för Brilinta/Brilique. Vårt samarbetsavtal för Movantik i USA är ett bra exempel på hur vi kommer att föra ut viktiga läkemedel till patienter och hur detta kan ge ett värde för externa samarbeten till våra aktieägare.

”Vår portfölj har utvecklats väl inom alla våra terapiområden. Höjdpunkter innefattar de positiva första resultaten från PINNACLE-programmet i fas III för vårt läkemedel PT003 mot sjukdomar i andningsvägarna samt data från PEGASUS-studien för Brilinta/Brilique mot hjärt-/kärlsjukdomar. Vi fick två godkända ansökningar för nya läkemedel, samt två särläkemedel och två godkännanden om fast-track status av FDA. Vi ser fram emot att presentera närmare uppgifter under året.

”Vi har också fortsatt att stärka vår cancer-verksamhet och har nu 72 prövningar på gång, bland annat 31 inom immunonkologi. De senaste resultaten för AZD9291, som visade på stark klinisk nytta, med 13,5 månaders progressionsfri överlevnad och fast-track status av FDA för MEDI4736, vilka båda är avsedda för patienter med lungcancer, visar på vilka snabba framsteg vi gör på det här området. Vår strategiska allians med Celgene, ledande inom hematologi, kommer att maximera potentialen av våra immunonkologitillgångar för de mycket viktiga hematologi-indikationerna, och vårt samarbete med Innate Pharma kommer att ytterligare stärka vår verksamhet inom immunonkologi.”

Vi räknar med fortsatt starkt nyhetsflöde kring forskningsportföljen under året, bland annat:

oKommande registreringsansökningar för AZD9291 mot icke-småcellig lungcancer och cediranib mot äggstockscancer och brodalumab mot psoriasis.

oKommande regulatoriska beslut för Iressa mot icke-småcellig lungcancer,Brilinta/Brilique för patienter med tidigare hjärtinfarkt, lesinurad mot gikt, saxagliptin/dapagliflozin vid diabetes typ II.

Prognos för 2015:

Bolaget upprepar den prognosen som gavs den 6 mars 2015

  • oHelår 2015 Totala intäkter förväntas minska med medelhög ensiffrig procentuell siffra (mid single-digit)
  • oVinst per aktie (Core EPS ) väntas öka med en låg ensiffrig procentuell siffra (low single digit percent) .

1Ytterligare detaljer om presentationen av de totala intäkterna finns i tillkännagivandet som offentliggjordes av Företaget den 6 mars 2015.

2Alla tillväxtsiffror är i fasta valutakurser

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Den fullständiga pressreleasen på engelska hittar du som bifogad pdf.

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Användbar information:

Full Year 2014 Financial Results Statement

First Quarter 2014 Financial Results Statement

AstraZeneca’s strategy update on 18th November 2014

Photography of AstraZeneca senior management, sites and logo

Kontaktpersoner:

Esra Erkal-Paler+44 20 7604 8030 (Storbritannien/Globalt)

Vanessa Rhodes+44 20 7604 8037 (Storbritannien/Globalt)

Ayesha Bharmal+44 20 7604 8034 (Storbritannien/Globalt)

Jacob Lund+46 8 553 260 20 (Sverige)

Michele Meixell+1 302 885 6351(USA)

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 enters strategic immuno-oncology collaboration with Celgene Corporation to develop PD-L1 inhibitor programme for patients with serious blood cancers

Pressmeddelanden   •   2015-04-24 07:05 CEST

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, today announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. Within the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and existing cancer medicines. Over time, the collaboration could expand to include other assets.

Under the terms of the agreement, Celgene will make an upfront payment of $450 million to AstraZeneca, in relation to MEDI4736. Celgene will lead on development across all clinical trials within the collaboration and will take on all research and development costs until the end of 2016, after which they will take on 75 percent of these costs. Celgene will also be responsible for global commercialisation of approved treatments. AstraZeneca will continue to manufacture and book all sales of MEDI4736 and will pay a royalty to Celgene on worldwide sales in haematological indications. The royalty rate will start at 70 percent and will decrease to approximately half of the sales of MEDI4736 in haematological indications over a period of four years.

Dr. Bahija Jallal, Executive Vice President at MedImmune, said: “We are excited about our strategic collaboration with Celgene, a globally recognised leader in treatments for haematological cancers. This agreement is a great example of how we are accelerating the development of medical innovation in our portfolio in collaboration with other experts, in order to bring life-enhancing new medicines to patients faster. Together with Celgene, we are designing a programme for our anti-PD-L1 that will explore its full potential as a game-changing treatment that could activate the patients’ immune system to fight and change the course of blood cancers in this area of high unmet need.”

“The potential of rationally combining immunotherapies such as MEDI4736 with existing and novel hematology compounds creates new opportunities for patients with blood cancers to live longer, better lives,” said Jacqualyn A. Fouse, Ph.D., President, Global Hematology and Oncology for Celgene. “This strategic collaboration leverages the deep expertise of AstraZeneca/MedImmune in immuno-oncology along with the experience of Celgene in the study and treatment of blood cancers. This collaboration advances Celgene’s already deep, diverse scientific platform to include checkpoint inhibitors, an area of significant promise in hematology.”

The collaboration agreement will become effective upon the expiration or termination of applicable waiting periods under all applicable antitrust laws, if any, and is expected to become effective in the second quarter of 2015. AstraZeneca’s 2015 financial guidance is unaffected by today’s announcement.

– ENDS –

NOTES TO EDITORS

About MEDI4736

MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.

MEDI4736 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 MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas - 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 Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. Follow Celgene on Twitter @Celgene, and on Pinterest and LinkedIn.

About MedImmune

MedImmune is the worldwide 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. 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-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

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

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, today announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736

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AstraZeneca and Innate Pharma announce global co-development and commercialisation collaboration for IPH2201 in immuno-oncology

Pressmeddelanden   •   2015-04-24 07:00 CEST

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, today announced that they have entered into a collaboration to accelerate and broaden the development of Innate Pharma SA’s proprietary anti-NKG2A antibody, IPH2201, including in combination with MEDI4736, an anti-PD-L1 immune checkpoint inhibitor developed by MedImmune. Currently in Phase II development, IPH2201 is a potential first-in-class humanised IgG4 antibody. NKG2A is a checkpoint receptor that inhibits the anti-cancer functions of Natural Killer (NK) and cytotoxic T-cells.

The initial development plan includes: Phase II combination clinical trials with MEDI4736 in solid tumours; multiple Phase II trials planned by Innate to study IPH2201 both as monotherapy and in combination with currently approved treatments across a range of cancers; and the development of associated biomarkers.

The combination of IPH2201 with MEDI4736 adds to the broad programme of immuno-oncology combination trials that AstraZeneca and MedImmune have planned and underway. The studies aim to address multiple immune pathways, harnessing AstraZeneca’s own extensive pipeline and working in partnership to explore the significant potential of immunotherapies in transforming the way cancer patients are treated.

Under the terms of the agreements, AstraZeneca will make an initial payment to Innate of $250 million, which includes the consideration for exclusive global rights to co-develop and commercialise IPH2201 in combination with MEDI4736, as well as access to IPH2201 in monotherapy and other combinations in certain treatment areas. AstraZeneca will pay a further $100 million prior to initiation of Phase III development, as well as additional regulatory and sales-related milestones. AstraZeneca will book all sales and will pay Innate double-digit royalties on net sales. The arrangement includes the right for Innate to co-promote in Europe for a 50% profit share in the territory.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “We are pleased to collaborate with Innate Pharma to bring this prospective first-in-class treatment to cancer patients, further strengthening our broad immuno-oncology pipeline. We believe that combination therapy in immuno-oncology has the potential to be one of the most effective ways of treating cancer and that by targeting both innate and acquired immunity we have the opportunity to deliver important clinical benefit to patients across a range of cancers.”

Hervé Brailly, CEO and co-founder of Innate Pharma, said: “This agreement allows Innate Pharma to broaden and accelerate the development of anti-NKG2A while preserving our innovative development plan. It provides Innate Pharma with the capabilities and resources to transform the company towards late stage development and potential commercial stage with co-promotion rights. We look forward to partnering with AstraZeneca and MedImmune, leaders in immuno–oncology, in this transforming transaction for Innate Pharma.”

The transaction is subject to customary terms and conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to become effective in the second quarter of 2015. AstraZeneca’s 2015 financial guidance is unaffected by today’s announcement.

– ENDS –

NOTES TO EDITORS

About Innate Pharma’s anti-NKG2A

IPH2201 is a first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic NK and CD8 T lymphocytes.

NKG2A is an inhibitory receptor binding HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently up-regulated on cancer cells of many solid tumors or hematological malignancies. IPH2201, a humanized IgG4, blocks the binding of NKG2A to HLA-E allowing activation of NK and cytotoxic T cell responses.Hence, IPH2201 may re-establish a broad anti-tumor response mediated by NK and T cells. IPH2201 may also enhance the cytotoxic potential of other therapeutic antibodies.

About MEDI4736

MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.

MEDI4736 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 MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

About Innate Pharma

Innate Pharma S.A. is a biopharmaceutical company discovering and developing first-in-class therapeutic antibodies for the treatment of cancer and inflammatory diseases. Its innovative approach has translated into major alliances with leaders in the biopharmaceutical industry such as Bristol-Myers Squibb and Novo Nordisk A/S. The Company has two clinical-stage programs in immuno-oncology, a new therapeutic field that is changing cancer treatment by enhancing the capability of the body’s own immune cells to recognize and kill cancer cells. Innate Pharma’s science also has potential in chronic inflammatory diseases.

Listed on Euronext-Paris, Innate Pharma is based in Marseille, France, and had 99 employees as at December 31, 2014. Learn more about Innate Pharma atwww.innate-pharma.com.

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas - 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

AstraZeneca Media Enquiries

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

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 2677 (US)

AstraZeneca Investor Enquiries

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

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

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

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

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

Innate Pharma Media Enquiries

Judith Aziza, Mob.:+33 (0)6 70 07 77 51

Marielle Bricman, Mob.:+33 (0)6 26 94 18 53

presse@atcg-partners.com

Innate Pharma Investor Enquiries

Laure-Hélène Mercier

Director, Investor Relations

Tel.: +33 (0)4 30 30 30 87

investors@innate-pharma.com

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 MedImmune, the Company’s global biologics research and development arm, today announced that they have entered into a collaboration to accelerate and broaden the development of Innate Pharma SA’s proprietary anti-NKG2A antibody

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Insatser för svensk kardiolgi uppmärksammas: Berglind Libungans får 2015 års stipendium inom akuta koronara syndrom utlyst av Svenska Kardiologföreningen och AstraZeneca

Pressmeddelanden   •   2015-04-23 13:30 CEST

Idag tilldelas Berglind Libungans, verksam vid enheten för kardiologi, Sahlgrenska Universitetssjukhuset i Göteborg ett forskningsstipendium på 120 000 kr. Berglind Libungans forskning fokuserar på behandling av akut koronart syndrom hos äldre patienter över 80 år och projektet förväntas ge värdefull ny information som kan leda till en bättre förståelse av sjukdomsmekanismer och behandlingsmöjligheter hos äldre patienter med akut hjärtinfarkt.

Stipendiet har instiftats av Svenska Kardiologföreningen. För femte året i rad har Svenska Kardiologföreningen utsett en mottagare. Syftet är att stimulera klinisk forskning inom området akut omhändertagande och uppföljning av patienter med akuta koronara syndrom.

-Berglind Libungans forskning fokuserar på behandling av akut koronart syndrom hos äldre. Hon kommer att studera nyttan och riskerna med invasiv behandling vid icke ST-höjningsinfarkt hos patienter över 80 år. Det är ett viktigt forskningsområde då andelen äldre med akut koronart syndrom ökar och valet av behandling ofta påverkas av patientens övriga sjuklighet. Berglind Libungans forskningsresultat kommer att bidra till en ökad kunskap inom området, säger Christina Christersson, vetenskaplig sekreterare i Svenska Kardiologföreningen och överläkare vid Akademiska Sjukhuset i Uppsala.
 
-Den äldre patientgruppen är snabbt växande inom sjukvården. Hur de skall behandlas är ofta ett kliniskt dilemma då denna patientgrupp är dåligt studerad och såväl kvaliteten som kvantiteten av underliggande vetenskapliga bevis är begränsad. Forskning har visat att äldre patienter får mindre behandling både vad gäller invasiv och medicinsk behandling vid akut krankärlssjukdom. Att äldre patienter i lägre grad får evidensbaserad behandling kan sannolikt förklaras att  man värderar att risken ofta överväger nyttan för denna patientgrupp, även om detta inte är verifierat i studier. Vi är oerhört tacksamma att Svenska Kardiologföreningen och AstraZeneca uppmärksammar och stödjer vår kliniska forskning, som handlar om äldre patienter (>80 år) med akut kranskärlssjukdom, säger Berglind Libungans, verksam vid enheten för kardiologi, Sahlgrenska Universitetssjukhuset i Göteborg.

Stipendiet delas ut i samband med Svenska Kardiologföreningens årsmöte i Örebro, den 23 april 2015.

Svenska Cardiologföreningen

Föreningen utgör en sammanslutning av svenska kardiologer, andra kardiologiintresserade svenska läkare och vetenskapsmän, blivande läkare samt företrädare för kardiologi närstående verksamheter. Föreningen fungerar som Svenska Läkarsällskapets sektion för kardiologi och som specialistförening i Sveriges Läkarförbund. Föreningens ändamål är att främja den svenska kardiologins utveckling.

Kort om hjärt-kärlsjukdom i Sverige

Hjärt-kärlsjukdomar såsom hjärtinfarkt och stroke orsakas vanligen av åderförkalkning. Trots stora framsteg i prevention och behandling av dessa tillstånd utgör hjärt-kärlsjukdomar fortfarande den vanligaste dödsorsaken i Sverige.

Om AstraZeneca

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

För mer information

Christina Christersson, vetenskaplig sekreterare, Svenska Kardiologföreningen, e-post christina.christersson@ucr.uu.se

Petra Eurenius, Kommunikationschef, AstraZeneca Nordic-Baltic, tel 08-553 513 96, mobil 0709-186 562, e-post petra.eurenius@astrazeneca.com

744625.011 04.2015/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

Idag tilldelas Berglind Libungans, verksam vid enheten för kardiologi, Sahlgrenska Universitetssjukhuset i Göteborg ett forskningsstipendium på 120 000 kr.

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AstraZeneca and Bina collaborate to deploy genomic management solution in R&D

Pressmeddelanden   •   2015-04-21 13:08 CEST

AstraZeneca and Bina Technologies, Inc., a member of the Roche Group, today announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Programme and to further develop the Bina Genomic Management Solution (GMS)[i]. AstraZeneca will utilise the Bina GMS to support its development work across its main therapeutic areas of respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and oncology.

Bina’s proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximise the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support genomic data analysis and management. Bina will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.

Dr. Carl Barrett, Vice President, Translational Oncology, at AstraZeneca, said: “Bina GMS is a powerful data analysis platform that will help AstraZeneca leverage more effectively genomic data across all phases of our research globally as we develop personalised therapies to treat complex diseases.”

Justin Johnson, Principal Translational Genomic Scientist at AstraZeneca, added: “In working with Bina, we can not only significantly accelerate the speed in which we incorporate genomic data into areas like target discovery and patient selection, but we can do this on top of a flexible, scalable and validated analysis infrastructure that our bench scientists can work with.” Johnson will be presenting early results of the collaboration during the Cambridge Healthtech Institute’s 14th Annual Bio-IT World Conference and Expo (Bio-IT) in Boston, MA on Thursday 23 April.

“We are very excited about the work we are doing with the AstraZeneca team,” said Dr. Narges Bani Asadi, CEO and Founder of Bina. “In this collaboration, our multidisciplinary team of scientists and engineers will try to push the boundaries of genomics research. We are very fortunate to be able to contribute to the research at AstraZeneca. Through this collaboration we both hope to define a new standard for the pharmaceutical research industry in how to effectively leverage the genomic information for discovery and development.”

[1]Bina products are for research use only and not for use in diagnostic procedures

– ENDS –

NOTES TO EDITORS

About Bina Technologies

Bina Technologies builds next-generation technologies for scalable, accurate processing and management of genomic information. Bina’s Genomic Management Solution is a comprehensive analysis platform used by clinical and translational researchers to gain insight from their genomic data sets. Bina’s Genomic Management Solution dramatically decreases the complexity, time, and cost of genomic analysis, accelerating the science of personalised medicine. Bina Technologies was acquired by Roche in December, 2014. Learn more about Bina’s product, technologies, and team at www.bina.com

About Roche

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

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

About AstraZeneca

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

CONTACTS

AstraZeneca Media Enquiries

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

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Bina Technologies Media EnquiriesKena Hudson or Rachel Wallace

Chempetitive Group for Bina

(510) 908-0966

BinaTeam@Chempetitive.com

Roche Sequencing Media EnquiriesRoche Sequencing Media Relations
Jacquie Bucher
Phone: +1 520.468.9145
Email: jacquie.bucher@ventana.roche.com

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 Bina Technologies, Inc., a member of the Roche Group, today announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Programme

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AstraZeneca tillkännager uppdaterade data om progressionsfri överlevnad för forskningssubstansen AZD9291 mot icke småcellig lungcancer

Pressmeddelanden   •   2015-04-17 09:03 CEST

Uppdaterade data som presenterades vid European Lung Cancer Conference 2015 visar en fördröjning av tumörprogression på över ett år

AstraZeneca meddelar i dag senaste data från den pågående AURA-studien av AZD9291 på patienter med avancerad icke småcellig lungcancer med mutationspositiv epidermal tillväxtfaktorreceptor (EGFRm) som också har den T790M-resistenta mutationen. Dessa data visade på en progressionsfri medianöverlevnad (PFS) på 13,5 månader (95 % konfidensintervall (CI) 8,3 månader till ej beräkningsbart (NC))1.PFS-fynden avser oberoende granskade data från 63 patienter med T790M-tumörer som har behandlats med AZD9291 i en dos på 80 mg per dag, och bygger på att enbart 38 % av patienterna hade tumörprogression.

Uppdaterade data visar också en total responsfrekvens på AZD9291 80 mg på 54 % (95 % CI 41 % till 67 %) och i median en bibehållen responsfrekvens i upp till 12,4 månader (95 % CI 8,3 månader till NC).

Dr Pasi A. Jänne MD, PhD, huvudprövare för AURA-studien och chef för Lowe Center for Thoracic Oncology Dana-Farber Cancer Institute samt professor i medicin vid Harvard Medical School, presenterade den senaste analysen vid European Lung Cancer Conference (ELCC) 2015 i Genève, Schweiz. Han betonade den tydliga aktiviteten hos AZD9291 manifesterad i avgörande kliniska parametrar. ”Det finns för närvarande få behandlingsalternativ tillgängliga för patienter med avancerad icke småcellig lungcancer och EGFRm som får tumörprogression på grund av en andra mutation som kallas T790M. Dagens behandlingsalternativ är vanligtvis begränsad till kemoterapi eller upprepad behandling med EGFR-tyrosinkinashämmare. I takt med att kliniska data från AURA fortsätter genereras, och att trenden för den progressionsfria överlevnaden, samt att varaktig klinisk respons bibehålls, ökar möjligheterna för att AZD9291 kan komma att övervägas som ett framtida behandlingsalternativ för patienter med icke småcellig lungcancer och EGFRm i långt framskridet stadium.”

AZD9291 är en selektiv, irreversibel EGFR-tyrosinkinashämmare (TKI) som tas en gång per dag. Den är avsedd att rikta in sig på både de aktiverande mutationerna, EGFRm samt T790M mutationen, det vill säga den genetiska mutation som svarar för TKI-behandlingsresistens hos EGFRm i upp till cirka två tredjedelar av fallen av avancerad icke småcellig lungcancer. Det finns för närvarande inga behandlingar som är specifikt godkända för patienter som har avancerad icke småcellig lungcancer med EGFRm och T790M-mutationer.

Antoine Yver, Head of Oncology, Global Medicines Development, AstraZeneca, säger: ”Vi arbetar intensivt med att utveckla nya läkemedel som är inriktade på att fylla de betydande behov inom lungcancervården som för närvarande inte är tillgodosedda genom att fokusera på de genetiska faktorer som ligger bakom sjukdomen. Vi siktar på en registreringsansökan för AZD9291 i USA under årets andra kvartal. Inom vårt omfattande kliniska forskningsprogram undersöks också möjligheterna att sätta in AZD9291 vid tidigare stadier av sjukdom och i kombination med andra läkemedel som är under utveckling, däribland immunonkologimolekyler. Med hjälp av denna övergripande strategi är vårt mål att utveckla ett brett spektrum av möjliga behandlingsalternativ för patienter med EGFR-mutationspositiv icke småcellig lungcancer.”

Under den pågående AURA-studien i fas I/II undersöks AZD9291 hos patienter med avancerad icke småcellig lungcancer och sjukdomsprogression efter behandling med EGFR-TKI. Den 2 december 2014 fanns 283 patienter med EGFR-muterad avancerad icke småcellig lungcancer och förvärvad resistens mot EGFR-TKI:er med i programmet – 31 patienter med dosökning och 252 patienter i utvidgade kohorter. Av dessa patienter hade 163 T790M-muterade tumörer, bekräftat av centrala tester1. De resultat som presenterades vid ELCC är uppdateringar av tidigare inrapporterade data som presenteras vid European Society for Medical Oncology 20142.

Hos patienter som behandlas med AZD9291 80 mg är den vanligaste av alla biverkningar av någon grad hudutslag, 38 % (0 % grad ≥3) och diarré, 36 % (1 % grad ≥3). Prövarbedömda behandlingsrelaterade biverkningar av grad ≥3 uppträdde hos 14 % av patienterna.

Per den 19 mars 2015, med över 1 000 patienter som fått AZD9291 i alla studier, rapporterades grupperade händelser av interstitiell lungsjukdom (ILS) hos cirka 2,7 % av patienterna (27 incidenter): tolv oönskade händelser (CTCAE) grad 1-2, 13 grad ≥3; två för närvarande ej klassificerade. Av dessa var det totalt tre patienter som rapporteras ha dött på grund av ILS (grad 5).

AstraZeneca undersöker för närvarande också AZD9291 som primärbehandling för patienter som har icke småcellig lungcancer med EGFRm, och i kombination med MEDI4736 (anti-PDL1-immunoterapi), selumetinib (MEK-hämmare) och AZD6094 (MET-hämmare) på icke småcellig lungcancer. Preliminära data kommer att presenteras vid ASCO:s (American Society of Clinical Oncology) årsmöte 2015.

– ENDS –

NOTES TO EDITORS

[1] Jänne PA,et al. A Phase I study of AZD9291 in patients with EGFR-TKI-resistant advanced NSCLC – updated progression-free survival and duration of response data. Presented at the European Lung Cancer Conference (ELCC) Annual Meeting, Geneva; 15-18 April 2015.

2 Yang, J,et al. Updated safety and efficacy from a Phase 1 study of AZD9291 in patients (pts) with EGFR-TKI-resistant non-small cell lung cancer (NSCLC). Presented at the European Society for Medical Oncology (ESMO) Annual Meeting, Madrid; 26-30 September 2014. Abstract available at: https://www.webges.com/cslide/library/esmo/browse/search/bjy#9f9C033w.Accessed March 2015.

About AZD9291

AZD9291 is an investigational, highly selective, irreversible inhibitor of both activating sensitising EGFRm and the resistance mutation, T790M, while sparing the activity of wild type EGFR.2 AZD9291 is also designed to achieve minimal or no activity against two biological receptors, known as the insulin receptor and insulin-like growth factor receptor (IFGR), in order to avoid the potential for hyperglycaemia. Hyperglycaemia (high blood sugar) can lead to patients requiring treatment with additional medications.

Patients who have the EGFRm form of NSCLC, which occurs in 10-15 percent of NSCLC patients in Europe and 30-40 percent 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, tumour cells almost always develop resistance to treatment, leading to disease progression. In up to approximately two-thirds of patients with EGFRm advanced NSCLC, this resistance is caused by a secondary mutation known as T790M. There are currently no treatments specifically approved specifically for EGFRm T790M advanced NSCLC.

AZD9291 has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US Food and Drug Administration (FDA).

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas - 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-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

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

Uppdaterade data som presenterades vid European Lung Cancer Conference 2015 visar en fördröjning av tumörprogression på över ett år

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Selumetinib granted Orphan Drug Designation by US FDA for treatment of uveal melanoma

Pressmeddelanden   •   2015-04-17 08:01 CEST

AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.

Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas1,2.

“Uveal melanoma is a rare and devastating disease for which there are currently no effective treatment options once it spreads beyond the tissues of the eye. Selumetinib could potentially become the first effective treatment for these patients. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma,” said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca.

The Orphan Drug Designation programmeprovides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US3.

Selumetinib, originally licensed from Array BioPharma Inc., inhibits the MEK pathway in cancer cells to prevent the tumour from growing. Data from a phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type 1.

Initial data from a combination study of selumetinib with other AstraZeneca pipeline molecules including AZD9291 (T790M-directed EGFR inhibitor) and MEDI4736 (anti-PD-L1)in non-small cell lung cancer will be presented at the American Society of Clinical Oncology (ASCO) annual meeting 2015.

– ENDS –

NOTES TO EDITORS

1Egan KM, et al. Surv Ophthalmol 1988; 32: 239–51

2.Ramaiya KJ, Harbour JW. Expert Rev Ophthalmol 2007; 2: 939–46

3US Food and Drug Administration. Developing Products for Rare Diseases & Conditions http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm Accessed on 31 March 2015

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas - 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-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

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

AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.

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Medimmune and Immunocore announce new collaboration to conduct immuno-oncology combination trials in melanoma

Pressmeddelanden   •   2015-04-16 08:02 CEST

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a collaboration to conduct clinical trials in immuno-oncology with Immunocore Limited, a privately-held UK-based biotechnology company.

Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune’s investigational checkpoint inhibitors MEDI4736 (anti-PD-L1) and/or tremelimumab (anti-CTLA-4) with IMCgp100, Immunocore’s lead T-cell receptor-based investigational therapeutic, for the potential treatment of patients with metastatic melanoma. MedImmune has an exclusive relationship with Immunocore for the development of IMCgp100 in combination with MEDI4736 and/or tremelimumab, and will have first right of negotiation for the future commercial development of these combinations for tumours expressing glycoprotein 100 (gp100), a tumour-associated antigen.

Immunocore and MedImmune will collaborate to establish a dosing regimen for IMCgp100 combined with MEDI4736 and/or tremelimumab within the Phase Ib study. The Phase II study will assess the safety and efficacy of the different combinations.

The companies have a pre-existing research collaboration and licensing agreement, announced in January 2014, to develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology.

“We are pleased to expand our partnership with Immunocore, a leader in the discovery and development of novel T-cell receptor-based drugs, to include this combination clinical trial in melanoma,” said Dr. Ed Bradley, Senior Vice President and Head of the Oncology Innovative Medicines unit at MedImmune. “Immuno-oncology is a priority area for us and by employing combinations with biological synergies, we believe we have the potential to enhance treatment effectiveness and ultimately to see improved overall survival rates. Our partnership with Immunocore is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer.”

“We are excited to deepen our relationship with MedImmune through this combination study agreement. We look forward to a successful partnership in the development of novel combination treatments in metastatic melanoma, which we believe have the potential to be best-in-class treatments,” said Eliot Forster, Chief Executive Officer of Immunocore.

MEDI4736, tremelimumab and IMCgp100 are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body’s own immune system in fighting cancer.

AstraZeneca and MedImmune have a broad programme of immuno-oncology combination trials underway and planned to address multiple immune pathways, harnessing the company’s own extensive pipeline and working in partnership to explore the significant potential of immunotherapies in transforming the way cancer patients are treated.

– ENDS –

About IMCgp100 and ImmTACs

Immunocore’s proprietary technology is focused on small protein molecules called ImmTACs (Immune Mobilising mTCR Against Cancer) that enable the immune system to recognise and kill cancerous cells.

ImmTACs have ultra-high affinity for intracellular cancer targets, are synthetic, soluble T cell receptors (TCRs) that recognise diseased cells containing disease specific targets. The ImmTACs enable circulating T-cells to selectively identify and kill diseased cells.The ImmTAC platform is unique and has very high specificity and potency as well as broad applicability to a wide range of intracellular targets.ImmTACs can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies.

The most advanced ImmTAC, IMCgp100, is currently in Phase IIa clinical trials for the treatment of late stage melanoma. Following completion of a Phase I study at the end of 2013, which showed promising results with an encouraging safety profile and early signs of efficacy, Immunocore initiated a Phase IIa study to optimize the dosing regimen of IMCgp100. Immunocore has a growing internal pipeline of ImmTACs addressing many different cancer types and has developed a broad database of intracellular cancer targets.

About MEDI4736

MEDI4736 is an investigationalhuman monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.

MEDI4736 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 MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

About tremelimumab

Tremelimumab is a fully human monoclonal IgG2 antibody, which stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.

Tremelimumab has been granted Orphan Drug Designation by the US FDA for the treatment of patients with malignant mesothelioma. It is also currently being studied in combination with AstraZeneca’s anti -PD-L1 investigational immunotherapy, MEDI4736, in tumour types including non-small cell lung cancer and head and neck cancer. It is also being studied in combination with Iressa (gefitinib) in EGFR mutated non-small cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.

About Immunocore

Immunocore is one of the world’s leading immuno-oncology biotechnology companies. Immunocore has a pipeline of wholly-owned and partnered ImmTAC programmes with robust clinical data, based on decades of world-leading scientific innovation in the discovery of HLA targets and T cell receptor technology and validated by collaborations with world-leading pharmaceutical companies.Immunocore aims to leverage the utility of its platform across a wide range of indications to become a Premier Biotech company and world-leader in its field.

Immunocore’s world-leading science and strong IP position has attracted major pharmaceutical companies including Genentech, GlaxoSmithKline, MedImmune, the biologics division of AstraZeneca, via discovery collaborations, as well as a co-discovery and co-development partnership with Lilly.Founded in 2008 originally out of Oxford University and headquartered outside Oxford, Immunocore now has more than 140 staff. For more information, please visit www.immunocore.com

About MedImmune

MedImmune is the worldwide 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. 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-Paler+44 20 7604 8030 (UK/Global)

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

Jacob Lund+46 8 553 260 20 (Sweden)

Susannah Budington+301 398 6717 (US - MedImmune)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

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

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a collaboration to conduct clinical trials in immuno-oncology with Immunocore Limited, a privately-held UK-based biotechnology company.

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Tremelimumab har beviljats särläkemedelsstatus av FDA för behandling av malignt mesoteliom

Pressmeddelanden   •   2015-04-15 08:04 CEST

AstraZeneca meddelar i dag att den amerikanska läkemedelsmyndigheten (Food and Drug Administration, FDA) har beviljat särläkemedelsstatus åt den monoklonala anti-CTLA-4-antikroppen tremelimumab för behandling av malignt mesoteliom.

Mesoteliom är en sällsynt, aggressiv cancerform som oftast drabbar vävnad som omsluterlungorna och buken. De tillgängliga behandlingarna mot mesoteliom är mycket begränsade, i synnerhet för patienter med långt framskriden sjukdom.

”Det finns ett stort behov av nya behandlingsalternativ för patienter med mesoteliom, eftersom färre än fem procent av patienterna för närvarande överlever längre än fem år, även om de får snabb diagnos och vård. Vårt mål är att skynda på utvecklingen av tremelimumab som ett potentiellt nytt behandlingsalternativ för de här patienterna”, säger Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development vid AstraZeneca.

Programmet för klassificering av särläkemedelger särläkemedelsstatus åt läkemedel och bioläkemedel som enligt definition är avsedda för en säker och effektiv behandling, diagnostisering eller prevention av sällsynta sjukdomstillstånd som drabbar färre än 200 000 personer i USA1.

Tremelimumab ingår i den breda arsenal med immunonkologiska preparat som utvecklas av AstraZeneca och dess forskningsenhet för biologiska läkemedel, MedImmune. De här preparaten utformas i syfte att utnyttja kroppens eget immunförsvar för att bekämpa cancer. Tremelimumab är en helt human monoklonal antikropp som stimulerar immunsystemet att förstöra cancerceller genom att binda till proteinet CTLA-4, som uttrycks på ytan av aktiverade T-lymfocyter.

Förutom att tremelimumab utreds som en monoterapibehandling för patienter med mesoteliom studeras det för närvarande också i kombination med AstraZenecas anti-PD-L1-försöksimmunterapi, MEDI4736, på olika tumörtyper, däribland icke-småcellig lungcancer, samt huvud- och halscancer. Det studeras även i kombination med Iressa (gefitinib) på EGFR-muterad icke-småcellig lungcancer, samt med MEDI6469 (en OX40-agonist från mus) i solida tumörer.

– ENDS –

NOTES TO EDITORS

1US Food and Drug Administration. Developing Products for Rare Diseases & Conditions http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm Accessed on 31 March 2015

About AstraZeneca in Oncology

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

Our broad pipeline of next-generation medicines is focused on four main disease areas - 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-Paler  +44 20 7604 8030 (UK/Global)

Vanessa Rhodes  +44 20 7604 8037 (UK/Global)

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

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

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

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

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

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

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

Om AstraZeneca

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

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

​AstraZeneca meddelar i dag att den amerikanska läkemedelsmyndigheten (Food and Drug Administration, FDA) har beviljat särläkemedelsstatus åt den monoklonala anti-CTLA-4-antikroppen tremelimumab för behandling av malignt mesoteliom.

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FDA Advisory Committee reviews SAVOR outcomes study results for ONGLYZA® and KOMBIGLYZE® XR

Pressmeddelanden   •   2015-04-15 08:03 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13to 1(1 abstained; 15 total votes) that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study demonstrated that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile. In addition, 14 out of 15 Committee members recommended that the FDA supplement the products’ labeling to add new safety information, with one vote to withdraw saxagliptin from the market.

AstraZeneca will also conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results.

The Advisory Committee was asked to consider data from SAVOR, a large, randomised, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of ONGLYZA when added to current type 2 diabetes background therapy in adult patients with type 2 diabetes mellitus at risk for cardiovascular disease.

SAVOR met the primary safety objective, demonstrating that ONGLYZA did not increase the risk for cardiovascular death, nonfatal myocardial infarction and nonfatal ischemic stroke when added to a patient’s current standard of care, with or without other antidiabetic therapies, as compared to placebo. The supplemental New Drug Applications (sNDAs) based on the SAVOR results, if approved, will provide prescribers and patients important additional information about the benefit-risk profile of ONGLYZA and KOMBIGLYZEXR.

The Advisory Committee was convened to discuss previously submitted sNDAs to the FDA for ONGLYZA and KOMBIGLYZEXR. The FDA is not bound by the Advisory Committee's recommendation but takes its advice into consideration when reviewing these sNDAs. AstraZeneca remains committed to working closely with the FDA to support further review of these sNDAs.

– ENDS –

NOTES TO EDITORS

About SAVOR

The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of ONGLYZA (saxagliptin) was a large, randomised, double-blind, placebo-controlled Phase IV study in patients with type 2 diabetes at high risk of cardiovascular disease, designed and conducted in accordance with the 2008 FDA guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The primary objective of this trial was to determine that the addition of saxagliptin to standard of care in this patient population did not significantly increase the incidence of major cardiovascular events as compared to placebo.

SAVOR met the primary safety objective, demonstrating that ONGLYZA did not increase the risk for cardiovascular death, nonfatal MI and nonfatal ischaemic stroke when added to a patient’s current standard of care (with or without other antidiabetic therapies), as compared to placebo (613 patients [3.7 per 100 person-years] in the ONGLYZA group compared with 609 patients [3.7 per 100 person-years] in the placebo group (Hazard Ratio [HR]: 1.00; 95% Confidence Interval [CI]: 0.89, 1.12; non-inferiority p-value < 0.001; superiority p-value = 0.99]). ONGLYZA did not meet the primary efficacy objective of superiority to placebo for the same composite endpoint. For the secondary endpoint of nonfatal MI, nonfatal stroke, cardiovascular death, hospitalisation for heart failure (hHF), hospitalisation for unstable angina, or hospitalisation for coronary revascularization, no statistically significant treatment differences were observed between ONGLYZA and placebo (HR 1.02 [95% CI 0.94, 1.11]; nominal p=0.66 for a difference between the 2 treatment groups). However, an increased risk for hHF, a component of the balanced secondary endpoint, was observed with ONGLYZA treatment. The analysis showed a numerical imbalance with more events on ONGLYZA (HR 1.11 [95% CI 0.96, 1.27]; nominal p=0.154). This finding was most relevant for patients at increased risk for heart failure (HF), such as those with a history of HF or renal impairment, and is manageable in the context of the routine care of patients at risk for HF. The other secondary endpoint of the SAVOR study was all-cause mortality. The analysis showed a numerical imbalance with more events on ONGLYZA (HR 1.11 [95% CI 0.96, 1.27]; nominal p=0.154). The results of the evaluation of all-cause mortality indicate that there was no excess mortality attributable to saxagliptin in the SAVOR study.

About DPP-4 inhibitors

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

About Type 2 Diabetes

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

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science to create life-changing medicines to reduce the burden and complications of diabetes. Our comprehensive diabetes portfolio provides treatment options to patients throughout the different stage of their disease, supporting them to reach treatment goals with a mono or combination therapies.As a core strategic area for the company, we are focusing our research and development efforts indiverse populations and patients with significant co-morbidities, such as cardiovascular disease, heart failure, obesity, NASH, and chronic kidney disease. Our research efforts are also targeting the regeneration of pancreatic cells aiming to address the underlying cause of the disease. In partnership with diabetes professional and patient societies and associations, AstraZeneca is contributing to solutions supporting prevention, awareness, diagnosis, professional education and advance care for diabetic patients.

About AstraZeneca

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

CONTACTS

Media Enquiries

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

Michele Meixell+1 302 885 6351 (US)

Investor Enquiries

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

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

Om AstraZeneca

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

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

AstraZeneca today announced that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13to 1(1 abstained; 15 total votes) that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with

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Kontaktpersoner 3 kontaktpersoner

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

Om AstraZeneca

Om AstraZeneca

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