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Lynparza™ har godkänts av amerikanska läkemedelsmyndigheten FDA för behandling av avancerad äggstockscancer hos patienter med ärftliga BRCA-mutationer

Pressmeddelanden   •   2014-12-19 19:10 CET

AstraZeneca meddelar idag att den amerikanska läkemedelsmyndigheten FDA (US Food and Drug Administration) har godkänt LYNPARZA™ (olaparib) i kapslar (400 mg två gånger dagligen) som den första monoterapi för patienter med en, ärftlig BRCA-muterad (gBRCAm) avancerad äggstockscancer, som har behandlats med minst tre tidigare cytostatikalinjer. Olaparib har godkänts enligt FDA:s accelererade godkännandeprogram baserat på befintlig objektiv svarsfrekvens och tidsperioden för dessa svarsdata.  Ett fortsatt godkännande för denna indikation är kopplat till verifiering av klinisk nytta i pågående bekräftande fas III-studier.

Olaparib är en poly ADP-ribose polymerase (PARP) hämmare som utnyttjar defekter i DNA-reparationsvägar för att döda cancerceller. Det är den första PARP-hämmaren som godkänts för patienter med ärftlig BRCA-muterad avancerad äggstockscancer, vilka upptäckts genom ett av FDA godkänt produktrelaterat diagnostiskt test, BRACAnalysis CDx™. 

Dr Briggs Morrison, Executive Vice President, Global Medicines Development och Chief Medical Officer på AstraZeneca, säger ”LYNPARZA är ett utmärkt exempel på hur framsteg i förståelsen av cancerbiologi kan användas för att utveckla nästa generation av riktade läkemedel. Det är ett välbehövligt nytt behandlingsalternativ för patienter med ärftlig BRCA-muterad avancerad äggstockscancer. Dagens godkännande markerar också den första av vad vi hoppas kommer att bli ett antal indikationer där detta läkemedel har potential att förbättra livet för cancerpatienter.”

AstraZeneca inlämnade en registreringsansökan i USA för olaparib i februari 2014 baserad på data från en underhållsstudie i fas II1 med olaparib jämfört med placebo hos patienter med platinakänslig recidiverande höggradig serös äggstockscancer. Efter rekommendation från FDA:s rådgivande kommitté för onkologiska läkemedel den 25 juni 2014, och som svar på en FDA-begäran om kompletterande uppgifter, lämnade AstraZeneca in en större omarbetning av registreringsansökan för olaparib den 24 juli 2014. FDA-godkännandet bygger därför på effektdata från en enarmad, öppen fas II-studie2 av olaparib hos patienter med, ärftlig BRCA-muterad avancerad cancer, samt säkerhetsdata från flera andra olaparib-studier, inklusive den placebokontrollerade studien.

Effektstudien av olaparib bygger på analys av 137 patienter med mätbar, ärftlig BRCA-muterad avancerad äggstockscancer som behandlats med minst tre tidigare cytostatikalinjer. Försöksresultaten visade på en total svarsfrekvens på 34 % (95 % konfidensintervall: 26 %, 42 %). Mediansvarstiden var 7,9 månader (95 % konfidensintervall: 5,6, 9,6 månader). De vanligaste biverkningarna som hittills har förknippats med olaparib monoterapi har i allmänhet varit milda till måttliga och inkluderar illamående, kräkningar, trötthet och anemi.

Dr Ursula Matulonis, Associate Professor, Department of Medicine på Harvard Medical School säger: ”Äggstockscancer diagnostiseras på nästan 22.000 kvinnor per år. Den långsiktiga överlevnaden hos patienter med framskriden äggstockscancer är 10% till 30%. FDA’s  godkännande av LYNPARZA är en viktig milstolpe för våra patienter eftersom det för närvarande bara finns  begränsade behandlingsalternativ  för kvinnor med äggstockscancer som bär BRCA mutation.

En fullständig översyn av data från endera av två pågående studier under det kliniska SOLO fas III-programmet krävs för att det accelererade godkännandet av olaparib för BRCA-muterad avancerad äggstockscancer ska omvandlas till ett fullständigt godkännande: SOLO2 utvärderar olaparib jämfört med placebo som underhållsbehandling och SOLO3 utvärderar olaparib jämfört med standardbehandling med cellgifter vid recidiverande sjukdom. Data från SOLO2 studien väntas under 2015 och data från SOLO3 väntas under 2019.

FDA:s godkännande följer tillkännagivandet den 18 december med godkännandet av olaparib i EU som den första terapin för underhållsbehandling av vuxna patienter med platinakänslig recidiverande BRCA-muterad serös äggstockscancer.

– SLUT –

1 Ledermann J et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncology. 2014. http://dx.doi.org/10.1016/S1470-2045(14)70228-1

2 Kaufman B, Shapira-Frommer R, Schmultzler RK et al. Olaparib Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2Mutation. Journal of Clinical Oncology 2014. http://jco.ascopubs.org/content/early/2014/10/30/JCO.2014.56.2728 

NOTES TO EDITORS

A US press release, including important safety information on LYNPARZA, will be available here.

About ovarian cancer

Ovarian cancer is the fifth leading cause of cancer death among women in the United States, mainly because it is often diagnosed late and has an extremely poor prognosis. For the 61% of ovarian cancer patients whose cancer has metastasised by the time of diagnosis, the five-year survival rate is only 27%.

  • Up to 15% of women with ovarian cancer have a BRCA mutation, which is the most common cause of homologous repair deficiency. In BRCA-mutated tumour cells, homologous recombination is defective and DNA double-strand break repair is forced to occur via error-prone pathways, which can lead to genomic instability and cell death.

About LYNPARZA™ (olaparib)

Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathways 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.

Concurrent with the approval of olaparib, the FDA has approved the BRACAnalysis CDx™ (Myriad Genetic Laboratories) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes.

About the Phase III SOLO programme

AstraZeneca initiated the Phase III SOLO programme in September 2013. The programme consists of three studies:

  •   SOLO1: designed to evaluate olaparib as a maintenance monotherapy for ovarian cancer in patients who have a germline BRCA mutation and who demonstrated a complete or partial response following first-line platinum-based chemotherapy
  •   SOLO2: designed to evaluate olaparib as a maintenance monotherapy for relapsed ovarian cancer in patients who have a germline BRCA mutation and who demonstrated a complete or partial response following platinum-based chemotherapy
  •   SOLO3: designed to evaluate olaparib versus non-platinum chemotherapy as third-line or later treatment for relapsed ovarian cancer in patients who have a  germline BRCA mutation

For further information, please visit: www.ovariancancertrials.com

In addition to ovarian cancer, AstraZeneca is committed to investigating the potential of olaparib in multiple tumour types, with Phase III studies in adjuvant and metastatic BRCA-mutated breast cancers, BRCA-mutated pancreatic cancer and second line gastric cancer underway.

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 8123 mob: +44 7789 654364

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

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

Om AstraZeneca

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

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

AstraZeneca meddelar idag att den amerikanska läkemedelsmyndigheten FDA (US Food and Drug Administration) har godkänt LYNPARZA™ (olaparib) i kapslar (400 mg två gånger dagligen) som den första monoterapi för patienter med en, ärftlig BRCA-muterad (gBRCAm) avancerad äggstockscancer, som har behandlats med minst tre tidigare cytostatikalinjer.

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Lynparza™ godkänd inom EU som ”first-in-class” -behandling av avancerad BRCA muterad äggstockscancer

Pressmeddelanden   •   2014-12-18 08:02 CET

AstraZeneca meddelar idag att Europakommissionen (EU-kommissionen) har godkänt Lynparza ™ (olaparib) kapslar (400 mg två gånger dagligen) som första terapi för underhållsbehandling av vuxna patienter med platinakänslig, recidiverande BRCA-muterad (nedärvd och/eller somatisk) höggradig, serös äggstocks-, äggledar-, eller primär peritoneal cancer som svarar fullständigt eller delvis på platinabaserad kemoterapi.

Olaparib är en poly ADP-ribose polymerase (PARP) hämmare som utnyttjar defekter i DNA-reparationsvägar för att döda cancerceller. Det är den första PARP-hämmaren som godkänns för patienter med platinakänslig recidiverande BRCA-muterad äggstockscancer. Patienterna kommer att identifieras genom ett validerat diagnostiskt test.

"Vi är glada över att kunna tillhandahålla denna välbehövliga behandling till patienter med BRCA-muterad äggstockscancer vars behandlingsalternativ för närvarande är mycket begränsade. Dagens godkännande markerar en viktig milstolpe i utvecklingen av nästa generation av målinriktade läkemedel ", säger Briggs Morrison, Executive Vice President, Global Medicines Development och Chief Medical Officer på AstraZeneca. "Vi är fast beslutna att tillhandahålla dessa nya behandlingar till de patienter som behöver dem mest och detta godkännande är det första av vad vi hoppas kommer att bli ett antal indikationer där Lynparza har potential att förändra livet för cancerpatienter, inklusive de med bröstcancer, cancer i bukspottskörteln och magcancer."

EU-kommissionens beslut gäller samtliga 28 EU-länder, samt Norge, Island och Liechtenstein. Godkännandet av olaparib baserades på data från Studie 191, en fas II-studie som utvärderade effekt och säkerhet jämfört med placebo hos patienter med serös, platinakänslig, recidiverande, höggradig äggstockscancer. Studien visade att underhållsbehandling med olaparib signifikant förlängde sjukdomsfri överlevnad (PFS) jämfört med placebo hos patienter med BRCA-muterad äggstockscancer: median PFS 11,2 månader vs 4,3 månader (PFS Hazard Ratio = 0,18; 95% konfidensintervall 0,10-0,31; p <0,0001). De vanligaste biverkningarna som hittills har förknippats med olaparib monoterapi har i allmänhet varit milda till måttliga och inkluderar illamående, kräkningar, trötthet och anemi.

Professor Steve Jackson, forskare vid University of Cambridge, vars forskning etablerade grunden för olaparib och dess kliniska potential säger: "Det är underbart att höra att olaparib har blivit ett licensierat läkemedel och därför snart kommer att finnas tillgängligt för drabbade patienter med avancerad äggstockscancer. Jag ser också fram emot att ta del av resultaten av pågående prövningar för att utforska olaparibs potential för behandling av andra cancerformer. Dagens tillkännagivande belyser hur grundläggande akademisk forskning, som den som utförs av forskargruppen vid University of Cambridge, genom att samarbeta med en partner som AstraZeneca, kan leda till stor medicinsk utveckling."

"Det är fantastiska nyheter att Lynparza nu kommer att finnas tillgängligt för kvinnor med avancerad, recidiverande BRCA-muterad äggstockscancer", säger Dr John Green, Senior Lecturer, Institute of Translational Medicine, University of Liverpool and Chair, European Network of Gynaecological Cancer Advocacy Groups (ENGAGe). "Detta är en förödande sjukdom som har en djupgående inverkan på patienterna och deras familjer. Kvinnor med en BRCA-mutation är särskilt i riskzonen och det har funnits ett stort behov av nya behandlingsalternativ med nya verkningsmekanismer. Utvecklingen av en målinriktad behandling som Lynparza är ett utmärkt exempel på banbrytande forskning som översatts till en behandling som har potential att förändra livet för patienterna."

- ENDS -

1 Ledermann J et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncology. 2014. 15:852-861.

Additional commentary

Harpal Kumar, chief executive of Cancer Research UK, said: “It’s great news that the European Commission has approved the use of olaparib within the European Union, especially when Cancer Research UK scientists played a crucial role in discovering and developing this new generation of cancer drugs. This drug offers new hope to women with advanced ovarian cancer by targeting the weaknesses cancer cells have in repairing damaged DNA. With clinical trial results showing this treatment has potential in other types of cancer, we hope there will be more good news in the future. Our partnerships with AstraZeneca are helping us to bring more new treatments to patients, accelerating our efforts to beat cancer sooner."

About Lynparza™ (olaparib)

Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathways 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.

In addition to ovarian cancer, AstraZeneca will investigate the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.

About ovarian cancer

In Europe, ovarian cancer is the fifth most commonly diagnosed cancer in women and the sixth leading cause of cancer death among women, mainly because it is often diagnosed late by which time the patient has an extremely poor prognosis. For the 61% of ovarian cancer patients whose cancer has metastasised by the time of diagnosis, the five-year survival rate is only 27%.

  • Up to 15% of women with ovarian cancer have a BRCA mutation, which is the most common cause of homologous repair deficiency. In BRCA-mutated tumour cells, homologous recombination is defective and DNA double-strand break repair is forced to occur via error-prone pathways, which can lead to genomic instability and cell 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 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)

Investor Enquiries

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

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

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

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

Om AstraZeneca

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

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

AstraZeneca meddelar idag att Europakommissionen (EU-kommissionen) har godkänt Lynparza ™ (olaparib) kapslar (400 mg två gånger dagligen) som första terapi för underhållsbehandling av vuxna patienter med platinakänslig, recidiverande BRCA-muterad (nedärvd och/eller somatisk) höggradig, serös äggstocks-, äggledar-, eller primär peritoneal cancer

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MOVENTIG (naloxegol) GODKÄNT FÖR BEHANDLING AV OPIOIDORSAKAD FÖRSTOPPNING

Pressmeddelanden   •   2014-12-10 12:03 CET

AstraZeneca meddelar att Moventig (naloxegol) har beviljats marknadsföringstillstånd av Europeiska Kommissionen (EC) för behandling av opiodinducerad förstoppning av vuxna patienter som har haft otillräcklig respons på laxermedel. Läkemedlet är den första orala, perifert verkande mu-opioidreceptorantagonisten med en gång om dagen-dosering (PAMORA) som godkänns inom EU.

Opioider spelar en viktig roll i kronisk smärtlindring och fungerar genom att binda sig till mu-receptorer i det centrala nervsystemet. Men opioiderna binder också till mu-receptorer i mag-tarmkanalen och stör tarmens funktion, vilket kan medföra att patienten drabbas av opioidorsakad förstoppning.

”Opioidorsakad förstoppning är en vanlig biverkan hos många patienter som får smärtstillande läkemedel innehållande opioider, detta kan vara mycket besvärligt för patienten och leda till försämrad livskvalitet. Det är därför värdefullt att få tillgång till nya behandlingsalternativ som lindrar opioidorsakad förstoppning och därmed möjliggöra god smärtlindring,” säger Sylvia Augustini, Överläkare, Smärtmottagningen, Akademiska sjukhuset i Uppsala.

Naloxegol förväntas att bli tillgängligt för patienter i Sverige under 2015.

Godkännandet av naloxegol i EU baseras på data från det kliniska prövningsprogrammet KODIAC, som omfattade fyra studier; KODIAC-4, -5, -7 och -8. KODIAC-4 och -5 var båda placebokontrollerade, dubbelblinda 12-veckors effekt- och säkerhetsstudier medan KODIAC-7 var en 12-veckors säkerhetsuppföljning av KODIAC-4 och KODIAC-8 var en 52-veckors öppen långtidsstudie av säkerheten.

Det beviljade marknadsföringstillståndet gäller för EU:s alla medlemsländer samt Island, Norge och Lichtenstein. Tidigare i år, den 16 september 2014, godkändes MOVANTIKTM (naloxegol) av den amerikanska läkemedelsmyndigheten FDA för behandling av opioidorsakad förstoppning hos vuxna patienter med kronisk, icke-cancerrelaterad smärta.

Kontaktpersoner

Petra Eurenius, Kommunikationschef, AstraZeneca Nordic-Baltic
Mobil: 070 – 918 65 62

Martin Ungerstedt, Nordisk Medicinsk Rådgivare, AstraZeneca Nordic-Baltic
Mobil: 073- 354 20 99

Om AstraZenecaAstraZeneca 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

612013.011 20141210 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

AstraZeneca meddelar att Moventig (naloxegol) har beviljats marknadsföringstillstånd av Europeiska Kommissionen (EC) för behandling av opiodinducerad förstoppning av vuxna patienter som har haft otillräcklig respons på laxermedel. Läkemedlet är den första orala, perifert verkande mu-opioidreceptorantagonisten med en gång om dagen-dosering (PAMORA) som godkänns inom EU.

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Moventig® approved in the European Union for opioid-induced constipation

Pressmeddelanden   •   2014-12-09 08:02 CET

First in class treatment approved for adult patients with opioid-induced constipation who have had an inadequate response to laxatives

AstraZeneca today announced that MOVENTIG® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU).

Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.

Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “Constipation is one of the most common side effects for those using opioid pain medication. We’re very pleased to have received marketing authorisation for MOVENTIG, as it allows us to offer a new treatment option for the millions of patients across Europe who suffer from opioid-induced constipation and haven’t responded to laxatives.”

The approval of MOVENTIG was based on data from the KODIAC clinical programme, which was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week open label, long-term safety study.

The EC marketing authorisation applies to all member states of the EU, Iceland, Norway and Lichtenstein. Today’s announcement follows the approval on 16 September 2014 of MOVANTIKTM (naloxegol) tablets by the US Food and Drug Administration, as the first once-daily PAMORA for the treatment of OIC in adult patients with chronic non-cancer pain.

-ENDS-

NOTES TO EDITORS 

About MOVENTIG®(naloxegol)

MOVENTIG is a peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation (OIC) in adult patients on prescription opioid pain medicines. In Phase III clinical studies, MOVENTIG was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.

The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety study. 

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

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)

Investor Enquiries

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

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

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

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

First in class treatment approved for adult patients with opioid-induced constipation who have had an inadequate response to laxatives

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Jury verdict favours AstraZeneca in Nexium antitrust litigation

Pressmeddelanden   •   2014-12-05 18:06 CET

AstraZeneca today announced that a jury in the US District Court for the District of Massachusetts returned a verdict in favour of AstraZeneca in a Multi-District antitrust case filed by various purchaser groups challenging the previous settlement of Nexium patent litigation with Ranbaxy.

AstraZeneca is pleased with the jury’s verdict. The Company has always maintained that the plaintiffs’ allegations were without merit.

All parties have appellate rights.

Two cases making similar allegations were filed by numerous purchasers in the state court in Pennsylvania and are still pending.

– ENDS –

NOTES TO EDITORS

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 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 8123 mob: +44 7789 654364

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

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

Om AstraZeneca

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

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

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New Drug Application for IRESSA accepted by US Food and Drug Administration

Pressmeddelanden   •   2014-12-02 08:03 CET

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test. The Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.

IRESSA is an EGFR tyrosine kinase inhibitor that acts by blocking the transmission of signals involved in the growth and spread of tumours.AstraZeneca’s NDA submission for IRESSA was based on data from the Phase III IFUM1 (IRESSA Follow-Up Measure) clinical trial, providing evidence of IRESSA’s efficacy in Caucasian patients. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial, as well as other collaborative group studies.

IRESSA is already approved in 90 countries for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.

– ENDS –

NOTES TO EDITORS

1 Douillard JY, et al.  Efficacy, safety and tolerability results from a phase IV, open-label, single arm study of 1st-line gefitinib in Caucasian patients with epidermal growth factor receptor mutation-positive non-small-cell lung cancer.  European Multidisciplinary Conference in Thoracic Oncology, Lugano, Switzerland, May 9-11, 2013; abstract 68O.

2 Maemondo M, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-8.

About IRESSA

IRESSA is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia.

IRESSA was launched in 2002 and is now approved in 90 countries worldwide.

In the US, AstraZeneca is working with Qiagen to develop a companion diagnostic test to guide the use of IRESSA in the treatment of patients with advanced NSCLC.

In Europe, the collaboration between AstraZeneca and Qiagen has resulted in IRESSA becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.

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 8123 mob: +44 7789 654364

Eugenia Litz  +44 20 7604

8233  mob: +44 7884 735627

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

Om AstraZeneca

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

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

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AstraZeneca and Eli Lilly and Company initiate pivotal clinical trial for patients with early Alzheimer’s disease

Pressmeddelanden   •   2014-12-01 08:03 CET

Phase II/III trial of AZD3293, an oral potent small molecule inhibitor of BACE,  aims to enrol more than 1,500 patients in 15 countries

AstraZeneca and Eli Lilly and Company (Lilly) today announced enrolment of the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.

AZD3293, also known as LY3314814, has been shown in Phase I studies to reduce levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.

The pivotal study will investigate the safety and efficacy of AZD3293/LY3314814 compared with placebo in the treatment of early Alzheimer’s disease. 

Samantha Budd, Vice President and Head of Translational Science in AstraZeneca’s Neuroscience Innovative Medicines Unit said: “There is a critical need to develop new medicines that can change the course of Alzheimer’s disease. We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease. Together with Lilly, we have unique expertise that will allow us to evaluate the potential of AZD3293 as a treatment for Alzheimer’s patients.”

“We’re excited to take this important next step in Lilly’s continuing efforts to make life better for so many people and families affected by Alzheimer’s disease,” said Phyllis Ferrell, global brand development leader for Alzheimer’s disease at Lilly. “Our AstraZeneca partners share our determination to find answers for this condition that shatters lives. We’re pleased that the first patient enrollment in AMARANTH comes less than three months since we announced our alliance.”

AstraZeneca and Lilly announced an alliance earlier in 2014 for the development and commercialisation of AZD3293/LY3314814. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca’s Neuroscience Innovative Medicines Unit, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch. 

– ENDS –

NOTES TO EDITORS

About the AMARANTH studyAMARANTH is a Phase II/III study that will further investigate the safety of AZD3293/LY3314814 and subsequently test the hypothesis that it is a disease-modifying treatment for patients with early Alzheimer´s disease. Early Alzheimer’s disease is defined as the continuum of patients with mild cognitive impairment (MCI) due to Alzheimer´s disease and patients diagnosed with mild Alzheimer´s dementia. The study, which has a two-year treatment period, aims to enrol more than 1500 patients in 15 countries.

About Alzheimer’s disease

Alzheimer’s disease, a fatal illness, is the most common form of dementia, accounting for 60 to 80 percent of dementia cases1. It continues to be one of the most significant health challenges, with an estimated 5 million Americans over age 65 alone suffering from the disease1. In the absence of significant change, Alzheimer’s disease will cripple not only the families of aging baby boomers, but also the healthcare systems of many developed nations. The US spends approximately $203 billion a year in direct expenses associated with Alzheimer’s disease, and that number will grow to over $1 trillion by 20501 if something is not done to affect the progression of the disease and delay the debilitating associated dementia.

1 Alzheimer’s Association, 2013 Alzheimer’s disease facts and figures, Alzheimer’s Dement. 2013;9(2):208–245

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.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)

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 8123  mob: +44 7789 654364

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

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

Om AstraZeneca

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

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

AstraZeneca and Eli Lilly and Company (Lilly) today announced enrolment of the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.

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Medimmune completes acquisition of Definiens

Pressmeddelanden   •   2014-11-26 08:16 CET

AstraZeneca today announced that MedImmune, its global biologics research and development arm, completed its acquisition of Definiens, a privately-held company that has pioneered a world-leading imaging and data analysis technology, known as Tissue Phenomics™, which dramatically improves the identification of biomarkers in tumour tissue.

As previously announced, the acquisition will help to accelerate further clinical programmes through precise predictive and prognostic biomarker testing. It is believed that using biomarkers to select patients for clinical trials could potentially shorten clinical timelines and increase response rates. As a result, the technology will serve as an important tool in the advancement of the most promising combination therapies across AstraZeneca’s combined small molecule and biologics pipeline, around 80 percent of which currently has a personalised healthcare approach.

Upon completion of the acquisition, MedImmune acquired 100 percent of Definiens’ shares for an initial consideration of $150 million and may make additional predetermined milestone payments.  Definiens will continue to offer services to third-party customers.

– ENDS –

NOTES TO EDITORS

About Definiens

Definiens is the leading provider of image analysis and data mining solutions for tissue diagnostics and clinical digital pathology. Definiens technology provides detailed cell-by-cell readouts from target structures on tissue slides and allows the correlation of this information with data derived from other sources, generating new knowledge and supporting better decisions in research, diagnostics and therapy.  Definiens' Tissue Phenomics approach was awarded the 2013 Frost and Sullivan Company of the Year Award for Global Tissue Diagnostics and Pathology Imaging.  For more information, please visit: www.definiens.com

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca.  MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.  The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D 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)
Tracy Rossin      +1 301 412 8236 (MedImmune)

Jacob Lund    +46 8 553 260 20 (Sweden)

Investor Enquiries

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

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

Anthony Brown  +44 20 7604 8067 mob: +44 7585 404943

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

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

Om AstraZeneca

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

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

AstraZeneca today announced that MedImmune, its global biologics research and development arm, completed its acquisition of Definiens, a privately-held company that has pioneered a world-leading imaging and data analysis technology, known as Tissue Phenomics™, which dramatically improves the identification of biomarkers in tumour tissue.

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Amgen and AstraZeneca announce positive results from third and final pivotal phase III study of brodalumab

Pressmeddelanden   •   2014-11-25 22:09 CET

Study met all primary endpoints against Stelara® (ustekinumab)

and placebo

Three pivotal studies form the basis for global regulatory filings, planned for 2015

AstraZeneca and Amgen today announced that AMAGINE-2TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two weeks and the brodalumab weight-based analysis group were each shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1).

Results showed that 44.4 percent of patients in the brodalumab 210 mg group, 33.6 percent of patients in the brodalumab weight-based group, 25.7 percent of patients in the brodalumab 140 mg group, 21.7 percent of patients in the Stelara group and 0.6 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 86.3 percent of patients in the brodalumab 210 mg group, 77.0 percent of patients in the brodalumab weight-based group, 66.6 percent of patients in the brodalumab 140 mg group, 70.0 percent of patients in the Stelara group and 8.1 percent of patients in the placebo group achieved PASI 75.

“Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75 percent improvement in their disease,” said Sean E. Harper, Executive Vice President of Research and Development at Amgen. “AMAGINE-2 is the third and final pivotal study in our Phase III psoriasis programme and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities.”

All key secondary endpoints comparing brodalumab with placebo were met. The first key secondary endpoint comparing PASI 100 for brodalumab (140 mg) with Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints against Stelara were also numerically greater (all nominal p-values were less than 0.05), but could not be deemed statistically significant due to the sequential testing method.

The most common adverse events that occurred in the brodalumab arms (more than 5 percent of patients in either group) were common cold, upper respiratory tract infection, headache and joint pain. Serious adverse events occurred in 1.0 percent of patients in the 210 mg group, 1.2 percent of patients in the weight-based group, and 2.1 percent of patients in the 140 mg group compared with 1.3 percent for Stelara and 2.6 percent for placebo during the placebo-controlled period. There was one (0.2 percent) fatal event of stroke in the brodalumab 210 mg group during the 12-week placebo-controlled induction phase, deemed by the study investigator as unrelated to treatment.

Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis. 

“These results confirm our belief that targeting the IL-17 receptor to inhibit inflammatory signaling can have significant benefit for psoriasis patients,” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca.  “We look forward to sharing detailed results from the AMAGINE programme in upcoming scientific forums.”

The AMAGINE programme is comprised of three pivotal Phase III studies designed to assess the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis. Top-line results from AMAGINE-1TM, comparing brodalumab with placebo, were released in May 2014. Top-line results from AMAGINE-3TM, comparing brodalumab with Stelara and placebo, were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design.

– ENDS –

NOTES TO EDITORS

Stelara® is a registered trademark of Janssen Biotech, Inc.

AMAGINE-2 Study Design

AMAGINE-2 is a Phase III study that assessed the safety and efficacy of brodalumab given at two doses every two weeks via subcutaneous injection compared with Stelara and placebo in patients with moderate-to-severe plaque psoriasis. The study also assessed the safety and efficacy of four maintenance regimens of brodalumab. The primary endpoint comparing 210 mg of brodalumab as well as a pre-specified weight-based analysis group with Stelara was the proportion of patients achieving total clearance of skin disease, as measured by PASI 100 at week 12. When comparing brodalumab with placebo, the primary endpoints included the proportion of patients achieving at least a 75 percent improvement from baseline in disease severity (PASI 75) at week 12, and the achievement of clear or almost clear skin, according to the sPGA (0 or 1) at week 12.

The study began with a 12-week, double-blind, active comparator- and placebo-controlled induction phase, where patients were randomised in a 2:2:1:1 ratio to receive brodalumab (210 mg or 140 mg), Stelara (per the labeled dose), or placebo. At week 12, patients originally randomised to either brodalumab arm were re-randomised 2:2:2:1 into the maintenance phase to receive brodalumab 210 mg or 140 mg at four different maintenance regimens. Patients originally randomised to Stelara continued to receive the same treatment, and those originally randomised to receive placebo began 210 mg of brodalumab every two weeks.

At week 52, patients entered the long-term extension portion of the study, and those who were originally randomised to receive Stelara began receiving 210 mg of brodalumab every two weeks. All other patients continued on treatment with brodalumab at the same dose they were being treated with at week 52. Patients may be enrolled in the study for up to 271 weeks (approximately five years). Amgen will continue to collect efficacy and safety data during this long-term exposure period.

A PASI score is a measure of psoriatic plaque redness, scaling and thickness and the extent of involvement in each region of the body. Treatment efficacy is often measured by the reduction of PASI from baseline (e.g., a 75 percent reduction is known as PASI 75, a 90 percent reduction is known as PASI 90 and PASI 100 is total clearance of skin disease).

sPGA is a physician’s rating of psoriasis severity at a given point in time based on plaque, scaling and redness. A physician can rate a patient’s psoriasis as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).

About Psoriasis

Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.1,2 Approximately 125 million people worldwide have psoriasis and 80 percent of those patients have plaque psoriasis.3,4

About Brodalumab (AMG 827)

Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.5 In addition to moderate-to-severe plaque psoriasis (Phase III), brodalumab is currently being investigated for the treatment of psoriatic arthritis (Phase III) and asthma (Phase II).

About the Amgen and AstraZeneca Collaboration

In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialisation for brodalumab (Phase III for moderate-to-severe plaque psoriasis and psoriatic arthritis, Phase II for asthma) and AMG 557/MEDI5872 (Phase Ib for autoimmune diseases, such as systemic lupus erythematosus). AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialisation for MEDI7183/AMG 181 (Phase II for ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase II for Crohn’s disease) and MEDI9929/AMG 157 (Phase II for asthma).

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

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 8123 mob: +44 7789 654364

Anthony Brown  +44 20 7604 8067 mob: +44 7585 404943

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

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

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen, we or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, we are providing this information as of 25 November 2014, and expressly disclaim any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for our and their products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners' competitors and there can be no guarantee of our or our partners' ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. Cost savings initiatives may result in us incurring impairment or other related charges on our assets.  We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans.  Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

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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Duaklir® Genuair® approved in the European Union for chronic obstructive pulmonary disease

Pressmeddelanden   •   2014-11-24 08:03 CET

AstraZeneca today announced that Duaklir® Genuair® (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Approximately 300 million people1 around the world live with COPD, a progressive and chronic disease where people find breathing difficult due to limited airflow. Improving the lung function and managing daily symptoms such as breathlessness are important to the management of COPD.

Duaklir is a fixed-dose combination of already-approved Eklira® (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair® dry powder inhaler device.

AstraZeneca owns the rights to develop and commercialise Duaklir Genuair in the European Union (EU) following the strategic business combination of Almirall’s respiratory portfolio, which was completed last month. The EU approval of Duaklir Genuair marks an important further step in AstraZeneca's inhaled therapy strategy of providing physicians and patients a choice of products uniquely available in both dry powder and pressurised metered dose devices.

“We are pleased to receive European regulatory approval for Duaklir Genuair as an innovative treatment for patients with COPD. Patients need treatments that can help to improve their lung function and allow them to better manage the daily and debilitating symptoms of their condition, in turn improving their overall quality of life.” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

The EU approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide. Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in the lung function compared to monotherapy, providing a favourable benefit-to-risk profile. 

The EC marketing authorisation applies to all member states of the EU and the European Economic Area. Aclidinium bromide/formoterol fumarate will be marketed in Europe by AstraZeneca under the trade name Duaklir® Genuair®.

-ENDS-

NOTES TO EDITORS

About Duaklir® Genuair®

Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is an anticholinergic or long acting muscarinic antagonist (LAMA) that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates the β2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both aclidinium bromide (Eklira®) and formoterol fumarate are separately approved for the maintenance treatment of COPD in the United States and Europe.

AstraZeneca owns the rights for the development and commercialisation of Almirall’s proprietary respiratory business as well as its pipeline of investigational novel therapies.

About Genuair®

Genuair is a multi-dose, pre-loaded dry powder inhaler with a unique combination of optical and acoustic signals to reassure patients that the dose has been taken correctly. The inhaler’s safety features ensure high levels of reliability while its easy-to-use features and design minimise the potential for misuse and are expected to increase patient acceptance and compliance.

About Phase III Studies AUGMENT and ACLIFORM

The Phase III clinical development programme included approximately 4,000 patients with a clinical diagnosis of COPD. The programme comprised of two 6-month randomised, control- and active-controlled studies, ACLIFORM-COPD (LAC 30) - (ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD) and AUGMENT (LAC 31) - (Aclidinium/formoterol FUmurate Combination for InvestiGative use in the TreatMENT of Moderate to Severe COPD); a 6-month extension of the AUGMENT study (LAC 36); and a further long-term 12-month randomised controlled study comparing aclidinium/formoterol 340/12 to formoterol (LAC 32).

About COPD

Chronic obstructive pulmonary disease (COPD) is a progressive and chronic disease which encompasses a number of lung conditions, including chronic bronchitis, emphysema and chronic obstructive airways disease. People with COPD have difficulty breathing due to persistent airflow limitation.

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

1  Decision Resources 2013 for G7 prevalence: http://www.decisionresources.com/Products-and-Services/Report?r=dbasim0213.

Buist SA, McBurnie MA, et al. International variation in the prevalence of COPD (The BOLD Study), a population-based prevalence study; The Lancet (2007): http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)61377-4/abstract,

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AstraZeneca today announced that Duaklir® Genuair® (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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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