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AstraZeneca updates on progress of oncology pipeline at ESMO 2014 congress

Pressmeddelanden   •   2014-09-27 12:48 CEST

AstraZeneca will present new data from its pipeline of investigational cancer medicines over the next three days at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid. Together with MedImmune, its global biologics research and development arm, the company will present data from over 40 abstracts, building on results highlighted earlier this year at the American Society for Clinical Oncology (ASCO) congress.

Highlights include:

  • Preliminary results in the ongoing Phase I MEDI4736 (PD-L1) + tremelimumab (CTLA-4) combination study in patients with non-small cell lung cancer (NSCLC) who have already received prior cancer treatments.
  • Updated data from a Phase I monotherapy study of MEDI4736 in patients with metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • Further data from the Phase I/II study of AZD9291 in patients with epidermal growth factor receptor mutation positive (EGFRm) T790M+ advanced NSCLC who had disease progression following treatment with an EGFR tyrosine kinase inhibitor (TKI).

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “At ASCO we presented data demonstrating the strength and rapid progression of our oncology pipeline, which we believe has the potential to redefine the way cancer patients are treated. The data being presented here at the ESMO 2014 Congress further builds our clinical understanding of the key assets across our core areas of focus: immuno-oncology, the genetic drivers of cancer and acquired resistance and DNA damage repair. We are encouraged by the results we are seeing and look forward to providing further updates as we continue to work at pace to get these potentially life-changing medicines to patients.”

Immuno-oncology

MedImmune will present updates on its novel immunotherapy portfolio at the ESMO 2014 Congress through eight abstracts, which reinforce the clinical activity and tolerability of MEDI4736 as monotherapy and highlight the potential of the combination of MEDI4736 and tremelimumab.

Specifically, preliminary data was presented today from the ongoing Phase I study of MEDI4736 in combination with tremelimumab in NSCLC patients who have already received prior cancer treatments (Antonia, abstract #1327P). The data covered anti-tumour activity and the tolerability profile of the combination.

“We are pleased with the results from MEDI4736 in combination with tremelimumab,” said Edward Bradley, Senior Vice President, R&D and Oncology iMED Head, MedImmune. “While it is still early with a limited data set, the tolerability profile is encouraging. We have also seen some evidence of clinical activity in patients who have failed prior lines of therapy and whose tumour does not express PD-L1. This supports our strategy to explore this combination more broadly, particularly in the PD-L1 negative population. This trial will identify the optimal dose to take into our Phase III clinical programme.”

MEDI4736 is an investigational, engineered, human monoclonal antibody directed against an immune system ‘checkpoint’, known as programmed cell death ligand 1 (PD-L1). Tremelimumab targets a separate immune checkpoint, CTLA-4. Several checkpoints such as PD-L1 and CTLA-4, which the body normally uses to dampen the immune response, can be hijacked by tumour cells to escape detection by the immune system and facilitate malignant growth. Immunotherapies are designed to enable the immune system to counteract these tactics employed by cancer cells. By targeting more than one hijacked checkpoint, combination therapies have the potential to be more effective than monotherapy in treating this disease.

MedImmune has initiated additional Phase I immunotherapy combination trials, including MEDI4736 + MEDI0680 (PD-1) and MEDI4736 + MEDI6469 (OX40)*.

Ongoing Phase I data were also presented today, assessing the clinical activity and safety profile of MEDI4736 as a monotherapy in patients with NSCLC (Antonia, abstract #1325P). On Sunday, 28 September, MedImmune will present additional MEDI4736 monotherapy data in a Phase I dose-expansion study of patients with solid tumours. This data set will provide further information on the clinical activity and tolerability profile of MEDI4736 across a range of solid tumours, including pancreatic cancer, gastric cancer and hepatocellular cancer (Segal, abstract #1058PD). A separate analysis of patients with metastatic SCCHN will also be shared (Fury, abstract #988PD). The Phase I data, coupled with the pre-clinical data, support the accelerated development of MEDI4736 into Phase III clinical trials in both NSCLC and SCCHN.

Separately, MedImmune has also recently commenced a Phase I human OX40 agonist (MEDI6383) monotherapy study in cancer patients with recurrent or metastatic solid tumors.

Small molecules

On Sunday, 28 September, AstraZeneca will present updates on key assets in its small molecule portfolio, including the investigational NSCLC medicine AZD9291, a highly selective, irreversible inhibitor of both the activating sensitising EGFR mutation (EGFRm) and the resistance mutation T790M, IRESSA® (gefitinib) and the PARP inhibitor olaparib.

Updated data from the ongoing AURA Phase I/II study (Yang, Abstract #449PD) will provide an update on the activity and safety of AZD9291 in patients with EGFRm T790M+ advanced NSCLC whose disease had progressed following treatment with an EGFR TKI. This builds on data from the AURA study presented earlier in the year at ASCO. AstraZeneca has initiated both Phase II and Phase III studies in this patient population (AURA 2 and AURA 3 respectively).

In addition, a Phase III study evaluating AZD9291 in first line EGFRm advanced NSCLC is scheduled to start later this year.

AstraZeneca is also currently investigating combinations of AZD9291 with MEDI4736, and with other investigational drugs selumetinib (small molecule MEK inhibitor) and AZD6094 (small molecule MET inhibitor) in NSCLC.

Antoine Yver, Head of Oncology, Global Medicines Development, AstraZeneca, said “The updated data we are presenting at the ESMO 2014 Congress reinforce our strategy of moving rapidly into Phase III development with AZD9291 in EGFRm T790M+ advanced non-small cell lung cancer. We have already made significant progress with our accelerated development programme and we anticipate filing for regulatory approval in the US in the second half of 2015.”

AstraZeneca will also present data from the Phase III IMPRESS study for IRESSA, a second line, combination study in patients with EGFRm advanced NSCLC who have acquired resistance to first line IRESSA.

Separately, new data will be presented on the impact of olaparib on the quality of life of patients with BRCA mutated platinum-sensitive relapsed ovarian cancer. The Committee for Medicinal Products for Human Use is expected to provide its opinion on olaparib in the EU on 23 October 2014, and the US FDA Prescription Drug User Fee Act date is set for 3 January 2015.

AstraZeneca will host a briefing for analysts and investors at the ESMO 2014 Congress on the evening of Sunday, 28 September 2014 from 18:30 – 20:00 CEST. Details are available at: astrazeneca.com/investors.

– ENDS –

NOTES TO EDITORS

*MEDI6469 is an in-licensed asset from Agonox.

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

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Om AstraZeneca

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

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

AstraZeneca will present new data from its pipeline of investigational cancer medicines over the next three days at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid.

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MOVENTIG® (naloxegol) receives positive CHMP opinion in the EU for the treatment of adults with opioid-induced constipation

Pressmeddelanden   •   2014-09-26 12:18 CEST

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of MOVENTIG® (naloxegol), an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA), for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

OIC is a condition caused by prescription opioid pain medicines. Opioids 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.

The positive opinion was reached after a review of comprehensive data from the KODIAC clinical programme comprised of four studies assessing the safety and efficacy of MOVENTIG.

The CHMP’s positive opinion on MOVENTIG will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland and Norway. Should the EC approve MOVENTIG, it will be the first once-daily, oral PAMORA available in these markets for the treatment of OIC in adult patients who have had an inadequate response to laxative(s).

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 an investigational 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)
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Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg mob: +44 7557 319729
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of MOVENTIG® (naloxegol), an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA).....

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IRESSA receives CHMP positive opinion to include blood based diagnostic testing in European label

Pressmeddelanden   •   2014-09-26 08:03 CEST

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA® (gefitinib). The label update will help doctors to identify lung cancer patients - based on the specific genetic drivers of their tumour - who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample.

IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the EGFR tyrosine kinase. Therefore, only patients whose tumours are EGFR mutation positive are eligible to receive treatment. Tumour samples gained through biopsy are the primary method for determining a patient’s EGFR mutation status, without which patients are not eligible for treatment with an EGFR TKI such as IRESSA, which is the standard of care in Europe. However, up to 25 percent of patients with locally advanced or metastatic NSCLC do not have an available or evaluable tumour sample for this method of testing.

Following today’s CHMP opinion, IRESSA will be the first EGFR TKI in Europe to have a 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. The update will take effect immediately and will be applicable in all 28 European Union member countries.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumour and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are treated. If doctors are unable to assess the mutation status of a tumour, then patients’ access to potentially life-changing medicines such as IRESSA becomes restricted. Today’s decision by the CHMP to endorse a label update for IRESSA is a significant step forward.”

AstraZeneca has pioneered the use of innovative blood-based diagnostic testing for solid tumours and recently announced a partnership with Qiagen to develop a ctDNA test as a companion diagnostic for IRESSA.

-ENDS-

NOTES TO EDITORS

*The CHMP positive opinion to include blood based testing to determine EGFR mutation status in IRESSA’s European label can be implemented without further approval by the EMA due to the nature of the amendment, which is a Type-II variation.

About IRESSA
IRESSA is a targeted monotherapy for the first line treatment of patients with advanced or metastatic EGFR mutation positive 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 2009 and is now approved in 89 countries worldwide.

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

CONTACTS

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Esra Erkal-Paler +44 20 7604 8030 (UK/Global)
Vanessa Rhodes +44 20 7604 8037 (UK/Global)
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Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg mob: +44 7557 319729
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Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627


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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA® (gefitinib).

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AstraZenecas BioVentureHub växer med ytterligare företag

Pressmeddelanden   •   2014-09-25 08:00 CEST


Nystartade Antaros Medical, som är specialister på avancerad avbildningsteknik för kliniska studier inom kardiovaskulära och metabola sjukdomar, flyttar in i AstraZenecas BioVentureHub i Mölndal.

Kontraktet är påskrivet, och bolaget blir det femte som tar plats i lokalerna mitt i AstraZenecas forskningsanläggning i Mölndal. Magnus Björsne, chef för AZ BioVentureHub säger: "Jag är glad för att Antaros Medical har valt att lokalisera sig hos oss. I bolaget finns kompetens som är strategiskt viktig för läkemedelsutveckling inom kardiovaskulära och metabola sjukdomar, och deras ambitioner och affärsidé är helt i linje med vår plan för biohuben”.

AZ BioVentureHub Mölndal kom till som ett resultat av AstraZenecas ökande satsning på öppen innovation och flera externa samarbeten. De första hyresgästerna flyttade in på siten i januari 2014 och intresset har varit stort från akademiska grupper och biotech-företag. I dag pågår samtal med flera intressenter.

”Antaros Medical är ett intressant tillskott i det Life Science ekosystem som är så viktigt för att göra Norden konkurrenskraftigt. Vi ser att det finns möjligheter till samarbete där vi kan dra nytta av deras expertis, och de kan använda sig av kompetens som finns hos oss. På så sätt bygger vi vidare på en öppen innovationskultur här i Mölndal, säger Elisabeth Björk, chef för AstraZeneca i Mölndal.

Genom att kombinera solid läkemedelsutvecklingserfarenhet med unik kompetens inom avancerad avbildningsteknik är Antaros Medicals ambition att bryta ny mark och öka den patofysiologiska förståelsen av hur läkemedel fungerar på organnivå inom kardiovaskulära och metabola sjukdomar. Detta gäller dels läkemedel som redan finns på marknaden, men också läkemedel under utveckling.

”Många läkemedel utvecklas för närvarande mot våra stora folksjukdomar såsom diabetes och hjärtinfarkt, men en stor utmaning för läkemedelsindustrin är att tidigt förstå vilka substanser som fungerar och vilka som inte gör det. Här kan vår specialistkompetens fungera mycket väl i synergi med den stora kunskap som finns på AstraZeneca. Att sitta i en miljö som AZ BioVentureHub är en fantastisk möjlighet för nystartade och mindre företag inom life science”, säger Johannes Hulthe, CEO för Antaros Medical.

Om AstraZeneca

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

Om AstraZeneca BioVentureHub

AZ BioVentureHub är ett av AstraZenecas bidrag till ett mer dynamiskt och konkurrenskraftigt life science ekosystem i Skandinavien. På vår anläggning i Mölndal öppnar vi upp våra kontor, labbutrymmen och andra faciliteter för akademiska grupper och biotech-bolag som kan dra nytta av AstraZenecas infrastruktur och kompetens inom forskning och utveckling.

Om Antaros Medical

Antaros Medical består i dag av fyra personer med över 30 års erfarenhet av läkemedelsutveckling inom alla faser från preklinik till post-marketing och stor erfarenhet från studier med avancerad avbildningsteknik inom akademin. Genom att använda MR (magnetresonans) och PET (Positron Emissions Tomografi) har forskarna i företaget ensamma eller i samarbete med andra framstående forskare utvecklat metoder för att studera åderförfettning, leverförfettning, utveckling av aneursysm (artärbråck) och hjärtsvikt, såväl som B-cell funktion i bukspottskörteln. Alla dessa verktyg är kritiskt viktiga för att designa högkvalitativa studier när man ska studera effekten av läkemedelskandidater inom kardiovaskulära och metabola sjukdomar. För mer info: www.antarosmedical.com

Kontaktperson media: Jacob Lund: 08-553 260 20/072-560 2157

 

Nystartade Antaros Medical, som är specialister på avancerad avbildningsteknik för kliniska studier inom kardiovaskulära och metabola sjukdomar, flyttar in i AstraZenecas BioVentureHub i Mölndal.

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FDA godkänner MOVANTIK™ i tablettform för behandling av opioidinducerad förstoppning hos vuxna patienter med kronisk icke-cancerrelaterad smärta

Pressmeddelanden   •   2014-09-16 17:40 CEST

AstraZeneca meddelar idag att den amerikanska läkemedelsmyndigheten FDA (US Food and Drug Administration) godkänt MOVANTIK™ (naloxegol) tabletter C-II som den första orala perifert verkande my-opioidreceptorantagonisten (PAMORA). MOVANTIK TM tas som en tablett en gång om dagen för behandling av opioid-inducerad förstoppning (OIC) hos vuxna patienter med kronisk, icke-cancerrelaterad smärta.

”FDAs godkännande av MOVANTIK ger ett nytt behandlingsalternativ för vuxna patienter som lider av kronisk icke-cancerrelaterad smärta på grund av opioid-inducerad förstoppning, en vanlig biverkan hos dessa patienter”, säger dr Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer på AstraZeneca. ”Vi är glada att kunna erbjuda läkare och patienter en oral behandling som tas en gång per dag och som stödjs av ett stabilt kliniskt program.”

Läs den fullständiga pressreleasen på engelska i bifogad pdf

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Investor Enquiries Karl Hård +44 20 7604 8123  mob: +44 7789 654364 Jens Lindberg mob: +44 7557 319729 Anthony Brown +44 20 7604 8067 mob: +44 7585 404943 Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627


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 Lilly announce alliance to develop and commercialise BACE inhibitor AZD3293 for Alzheimer’s disease

Pressmeddelanden   •   2014-09-16 08:02 CEST

AstraZeneca and Eli Lilly and Company (Lilly) today announced an agreement to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.

The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain, which is comprised of peptides called amyloid beta. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials.

Under the terms of the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50 million in the first half of 2015. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch.

AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer’s disease. Lilly will lead clinical development, working with researchers from AstraZeneca’s Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293.

Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca, said: “Alzheimer’s disease is one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression. We are looking forward to working with Lilly, an organisation with a long term commitment to and expertise in treating Alzheimer’s disease. We believe that, by combining the scientific expertise from our two organisations and by sharing the risks and cost of late stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach to support the treatment of Alzheimer’s patients around the world.

"What’s more, this alliance will enable AstraZeneca to further sharpen our strategic focus on core therapeutic areas, while leveraging external collaborations to maximise the potential of the strong science we have in our growing pipeline.”

“Lilly has been committed to research in Alzheimer’s disease for more than 25 years, and we’re dedicated to developing new medicines that can change and modify the course of this devastating disease,” said David Ricks, Lilly Senior Vice President and President, Lilly Bio-Medicines. “Lilly’s pipeline of potential medicines and diagnostic agents targeting the known hallmarks of the disease has been bolstered today by this alliance with AstraZeneca, which shares our passion to bring new medicines to patients suffering from this debilitating illness. This alliance moves us one step closer to achieving our goal of making Alzheimer’s dementia preventable by 2025.”

The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca’s 2014 Core Earnings per Share.

– ENDS –

NOTES TO EDITORS

About AZD3293

AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers.

About Alzheimer’s disease

Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. It is the most common form of dementia, accounting for 60 to 80 percent of dementia cases. According to the Alzheimer’s Association, there are currently an estimated 44 million people living with dementia worldwide. The number of people affected by dementia is expected to be more than 75 million in 2030 and 135 million in 2050.

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 and http://newsroom.lilly.com/social-channels.

About AstraZeneca

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

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Michele Meixell +1 302 885 6351 (US)

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

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

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

AstraZeneca and Eli Lilly and Company (Lilly) today announced an agreement to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease

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AstraZeneca to present research from its innovative diabetes portfolio at the 2014 meeting of the European Association for the Study of Diabetes

Pressmeddelanden   •   2014-09-10 08:05 CEST

AstraZeneca today announced that 29 abstracts covering a range of data from the company’s research and development in diabetes have been accepted for presentation at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria, 15-19 September 2014.

The presentations will include the first study data on an investigational formulation of once-weekly exenatide delivered by a single-use autoinjector, as well as data on a number of approved products, including Forxiga® (dapagliflozin), Bydureon® (once-weekly exenatide extended-release for injectable suspension) and Onglyza® (saxagliptin).

“Our research reinforces our strong commitment to advancing science through rigorous clinical programmes that offer individualised treatment approaches for patients with type 2 diabetes across the disease spectrum,” said Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. “We look forward to presenting a wide range of scientific data at EASD, including studies evaluating combination treatments to help more patients achieve their treatment goals.”

Notable abstracts for AstraZeneca investigational compounds and formulations include:

  • #4 Data evaluating the efficacy and safety of the combination of saxagliptin/dapagliflozin as a dual add-on therapy in adult patients inadequately controlled on metformin
    Oral Presentation: Tuesday 16 September, 11:45 AM CEST
  • #244 Data from the DURATION-NEO-1 trial evaluating the autoinjector formulation of once-weekly exenatide vs. exenatide twice-daily injection (Byetta®) in patients with inadequately controlled type 2 diabetes Oral Presentation: Friday 19 September, 12:15 PM CEST

Notable abstracts for AstraZeneca approved products:

  • #822 An analysis evaluating the effect of dapagliflozin* on blood pressure in hypertensive and non-hypertensive patients with type 2 diabetes *dapagliflozin is not indicated for the treatment of hypertension Poster Presentation: Tuesday 16 September, 2:15 PM CEST
  • #844 An analysis of three-year data from the DURATION-3 study evaluating sustained glycaemic control with exenatide once-weekly vs. insulin glargine Poster Presentation: Wednesday 17 September, 2:15 PM CEST
  • #848 Four-year data from a Phase III study examining the durability of glycaemic response with dapagliflozin as add-on therapy to metformin vs. glipizide in patients with type 2 diabetes inadequately controlled with metformin alone Poster Presentation: Thursday 18 September, 1:00 PM CEST
  • #852 52-week data from a Phase III study evaluating the efficacy and safety of dapagliflozin as add-on therapy to metformin plus sulphonylurea Poster Presentation: Thursday 18 September, 1:00 PM CEST
  • #805 Two-year data from a Phase III trial evaluating the efficacy and safety of dapagliflozin in patients with a history of cardiovascular disease Poster Presentation: Thursday, 18 September, 2:15 PM CEST

The complete list of AstraZeneca data presentations can be accessed on the EASD website here.

– ENDS –

NOTES TO EDITORS

About Type 2 Diabetes Diabetes is estimated to affect 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 adults. Type 2 diabetes is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Over time, this sustained hyperglycaemia contributes to further progression of the disease. Significant unmet needs still exist, as many adult patients remain inadequately controlled on their current glucose-lowering regimen.

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
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg mob: +44 7557 319729
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627


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 29 abstracts covering a range of data from the company’s research and development in diabetes have been accepted for presentation at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria, 15-19 September 2014

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Benralizumab phase II COPD study published in the Lancet Respiratory Medicine

Pressmeddelanden   •   2014-09-08 08:04 CEST

Results are among key AstraZeneca respiratory data being presented at 2014 European Respiratory Society International Congress

AstraZeneca today announced that The Lancet Respiratory Medicine has published encouraging safety and efficacy data from a Phase IIa study evaluating its novel investigational monoclonal antibody benralizumab in patients with chronic obstructive pulmonary disease (COPD).

The study, conducted by MedImmune, the company’s global biologics research and development arm, evaluated the safety and efficacy of benralizumab in 101 adults with moderate-to-severe COPD and experiencing at least one acute exacerbation requiring oral corticosteroids, antibiotics, or hospitalisation in the past year. The overall patient population for the study was selected on the basis of elevated levels of eosinophils in sputum. The primary endpoint in the study was not met, as benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall patient population. However, benralizumab demonstrated clinically significant improvements in lung function in the overall population.

In addition, in the pre-specified analyses, the study indicated that benralizumab reduced COPD exacerbations and improved other symptoms of COPD in certain patient groups. Patients treated with benralizumab who had higher baseline levels of eosinophils in their blood showed greater improvements in COPD symptoms, including exacerbation rate, lung function and disease-specific health status as measured by the Saint George’s Respiratory Questionnaire-COPD (SGRQ-C) versus placebo-treated subjects.

There was a higher incidence of serious treatment-emergent adverse events (TEAEs) in the benralizumab group compared with placebo (14 vs 9). Overall, TEAEs were similar across treatment and placebo groups.

These data will be presented in a poster session at the 2014 European Respiratory Society (ERS) International Congress in Munich, Germany, on 8 September 2014, along with key data from AstraZeneca’s broad respiratory portfolio.

Benralizumab is an anti-interleukin-5 receptor alpha monoclonal antibody that depletes blood and sputum eosinophils, a type of white blood cell. Elevated levels of eosinophils are associated with the cause and severity of COPD attacks, as well as asthma and asthma exacerbations. Eosinophilic airway inflammation is believed to be present in between 20 and 30 percent of the 210 million people who suffer from COPD worldwide.

“Benralizumab is the first biological agent to show marked reduction in eosinophilic inflammation and beneficial effects in COPD, indicating a potential new way to treat patients with severe COPD symptoms,” said lead investigator Professor Christopher Brightling, University of Leicester, Glenfield Hospital, Department of Respiratory Medicine. “The strength of these results reinforces the further development of this molecule for COPD.”

“COPD is a highly heterogeneous disease and we are working to better understand patient subtypes, identify potential biomarkers and tailor therapies to achieve the best outcomes for patients,” said Bing Yao, Senior Vice President and Head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit. “Respiratory disease is a core therapeutic area for AstraZeneca and we are encouraged by these results indicating benralizumab’s potential to help certain groups of patients. We look forward to the further development of this promising new biologic as we progress our Phase III programmes in both COPD and severe asthma.”

Detailed results and safety data from the trial were published in The Lancet Respiratory Medicine and can be viewed here. These are believed to be the first clinical data published on a potential biologics treatment for eosinophilic COPD.

AstraZeneca announced the start of the Phase III programme for benralizumab in COPD at the company’s second quarter and half year results on 31 July 2014.

Key AstraZeneca Data to be Presented at ERS

In addition, over 20 scientific abstracts from AstraZeneca and MedImmune are being presented at ERS. Other accepted abstracts of note include:

  • #P2818 LATE-BREAKING ABSTRACT: Phase IIa study showed that benralizumab did not reduce the exacerbation rate in subjects with COPD and elevated airway eosinophils, but significantly improved lung function with an acceptable safety profile Thematic Poster Session: Latest insights in airway diseases, Monday 8 September, 12:50-14:40 CEST
  • #2909 LATE-BREAKING ABSTRACT: Benralizumab reduced asthma exacerbations and improved lung function, and asthma control in adults with uncontrolled eosinophilic asthma and has promise as a novel therapy in this patient population Oral Presentation: The future has started: emerging potentials for personalised asthma treatment, Monday 8 September, 15:30 – 15:45 CEST
  • #1891 Pearl's PT010 triple combination provides comparable budesonide exposure to Symbicort and comparable glycopyrronium and formoterol exposure to PT003 Oral Presentation: Bronchodilators for asthma and COPD, Monday 8 September, 10:45-12:45 CEST
  • #4672 AMG 157 (MEDI9929) showed a reduction in sputum eosinophils, blood eosinophils and FeNO markers of airway and systemic inflammation in AMG 157-treated subjects, which supports a role for TSLP in allergen-induced responses in patients with allergic asthma Oral Presentation: Clinical trials of drugs for respiratory diseases, Wednesday 10 September, 10:00 – 10:15 CEST

-ENDS-

About benralizumab
Benralizumab is a humanised monoclonal antibody directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Scientific literature supports that eosinophil levels are associated with exacerbations and increased eosinophils are associated with frequent exacerbations.

Benralizumab is currently in Phase III development for both COPD and severe asthma.

Benralizumab is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.

About COPD and severe asthma
An estimated 210 million people suffer from Chronic Obstructive Pulmonary Disease (COPD) worldwide, and it is predicted to be the third leading cause of death by 2020. Eosinophilic airway inflammation is associated with about 20-30 percent of patients with COPD.

An estimated 5 to 10 percent of the 300 million people worldwide who suffer from asthma have a severe form, and people with eosinophilic airway inflammation represent approximately 40 to 60 percent of the severe asthmatic population.

About MEDI9929/AMG 157
MEDI9929/AMG 157 is a monoclonal immunoglobulin IgG2λ that binds to and inhibits Thymic stromal lymphopoietin (TSLP) from interacting with its receptor. TSLP is a cytokine that is believed to play a critical role in the start of the allergic cascade, specifically the inflammatory response, and is generated by lung tissue when an allergen is introduced.

MEDI9929/AMG 157 is being jointly developed by Amgen and AstraZeneca and is currently in Phase II development for the treatment of asthma

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation 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)
Susannah Budington +1 202 740 4150 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries
Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Jens Lindberg mob: +44 7557 319729
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627


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

Results are among key AstraZeneca respiratory data being presented at 2014 European Respiratory Society International Congress

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HÖG LÅNGTIDSRISK EFTER HJÄRTINFARKT VISAR NY STUDIE

Pressmeddelanden   •   2014-09-02 08:30 CEST

På ESC presenteras idag resultaten från observationsstudien APOLLO, som belyser de långsiktiga riskerna för nya hjärt- och kärlhändelser eller dödsfall bland patienter som överlevt i minst ett år efter en hjärtinfarkt. Med data från Sverige, USA, Storbritannien och Frankrike visade APOLLO-studien att en av fem patienter som varit fria från ytterligare händelser under första året efter sin hjärtinfarkt drabbades av en ny hjärtinfarkt, stroke eller avled under de tre kommande åren.

”APOLLO-studien visar att patienter som överlevt en hjärtinfarkt har en större långsiktig risk att drabbas av en ny hjärtinfarkt, stroke eller annan allvarlig händelse än vi tidigare trott”, säger Tomas Jernberg, forskare i APOLLO-studien och hjärtläkare och vid Karolinska Universitetssjukhuset. ”Dessa resultat belyser vikten av långsiktig förebyggande behandling”.

”Vi bör fokusera under längre tid än idag på de patienter som haft en hjärtinfarkt för att undvika att de får nya hjärtkärlhändelser. Detta kan till exempel ske genom bättre samverkan mellan specialistvård och primärvård”, säger Magnus Janzon, forskare i APOLLO-studien och hjärtläkare vid Universitetssjukhuset i Linköping.

I APOLLO-studien användes observationsdata från nationella register, elektroniska patientjournaler och sjukvårdsregister för att beskriva sjukdomsbörda och de kliniska resultaten för patienter som fått en hjärtinfarkt och som behandlas enligt klinisk rutin i de fyra länderna. APOLLO-studien omfattar data från över 140 880 patienter från Sverige (n = 77 976), USA (n = 53 909), Storbritannien (n = 7 238) och Frankrike (n = 1 757). Jämfört med svenska och engelska patienter (medelålder ~ 70 år), var de franska patienterna yngre (medelålder 66 år) och friskare medan de amerikanska patienterna var äldre (minimiålder 65, medelålder 79) och med fler sjukdomstillstånd.

Resultaten av APOLLO-studien visar att det fanns en fortsatt hög risk för hjärt-kärlhändelser under de tre åren i samtliga fyra länder. APOLLO-studien fokuserar på patienter som överlevt utan ytterligare händelser under minst ett år efter en akut hjärtinfarkt med en eller flera ytterligare riskfaktorer (ålder ≥65, diabetes, med njursjukdom eller med >1 hjärtinfarkt) samt utan tidigare stroke.

Studien är sponsrad av AstraZeneca och presenteras under den årliga kongressen ESC, European Society of Cardiology.

Förfrågningar från media
Petra Eurenius, Kommunikationschef AstraZenecas marknadsbolag, telefon 0709 186 562.

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


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

På ESC presenteras idag resultaten från observationsstudien APOLLO, som belyser de långsiktiga riskerna för nya hjärt- och kärlhändelser eller dödsfall bland patienter som överlevt i minst ett år efter en hjärtinfarkt.

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Nya data indikerar: Brilinta/Brilique™ har flexibiliteten att ges före ankomst till sjukhus eller på sjukhus till patienter med ST-höjningsinfarkt

Pressmeddelanden   •   2014-09-01 09:16 CEST

Resultaten är i linje med nya ESC / EACTS 2014 riktlinjer för revaskularisering som ger en klass I rekommendation att starta dubbel trombocythämmande behandling av STEMI-patienter vid den första medicinska kontakten

AstraZeneca meddelar idag resultaten från fas IV ATLANTIC studien, vilken visar att profilen för Brilinta / Brilique ™ (ticagrelor) är jämförbar oavsett om det getts före ankomst till sjukhus eller på sjukhus till patienter med ST-höjningsinfarkt (STEMI). Uppgifterna kommer att presenteras under European Society of Cardiology congress1 som äger rum mellan den 30 augusti och den 3 september 2014 i Barcelona.

Resultaten från ATLANTIC-studien publicerades också idag i New England Journal of Medicine 

ATLANTIC utformades för att utvärdera effekten av att ge ticagrelor innan ankomst till sjukhus eller på sjukhus gällande primär perkutan koronar intervention (PCI) – vanligen kallad angioplastik - procedurrelateradeffektivitet, blödning vid 24 timmar och 30 dagar och det fördefinierade sammansatta effektmåttet för död, hjärtinfarkt, stroke, akut revaskularisering och definitiv akut stenttrombos vid 30 dagar. Forskning visar att effektiviteten av PCI kan påverkas av förseningar orsakade vid överföring av patienter med akut STEMI till katetriseringslaboratoriet på sjukhus, och att STEMI-patienter har en hög risk för ihållande och total koronar ocklusion (tilltäppning av blodflödet i kransartären) , vilket resulterar i en högre risk för dödlighet på kort sikt 2.

Det fanns ingen statistiskt signifikant skillnad mellan studiearmarna före sjukhus eller på sjukhus avseende de co-primära mätvariablerna om pre PCI procedurrelaterad effektivitet; procentandel av patienterna då man inte uppnådde upplösning av ST-höjning( ≥70 % före PCI (OR 0,93; 95 % CI 0,69, 1,25; p = 0,632) och procentandel av patienterna som inte fick trombolys vid hjärtinfarkt (TIMI) flödesgrad 3 vid infarktrelaterad – eller ”orsakande” – artär vid initial angiografi (OR 0,97; 95 % CI 0,75, 1,25; p = 0,821).

ATLANTIC-studien var inte designad med statistisk styrka att titta på kliniska utfall, men det fanns ingen skillnad mellan de två armarna vad gäller sammansatt mätvariabel. Administreringen av ticagrelor före sjukhus visade en signifikant riskreduktion av stenttrombos efter PCI (sekundär mätvariabel) både efter 24 timmar (0 % mot 0,8 %; nominellt p = 0,0078) och 30 dagar (0,2 % mot 1,2 %; nominellt p = 0,023).

Studieresultaten visade också att det inte fanns någon skillnad på blödningshändelser mellan studiearmarna före sjukhus eller på sjukhus, det primära säkerhetsmåttet för studien. Antalet blödningar som inte var relaterade till kranskärlsbypass var låga under de första 48 timmarna efter den initiala dosen, och från 48 timmar fram till 30 dagar, och antalet skilde sig inte signifikant mellan de två studiegrupperna, vilket indikerar att tidigarelagd behandling med ticagrelor före ankomst till sjukhus av patienter med akut STEMI kan ske utan ökad blödningsrisk.

”ATLANTIC har visat att för STEMI-patienter som genomgår primär PCI har ticagrelor en flexibilitet att användas antingen före sjukhus eller på sjukhus med en potentiell fördel vid tidig förekomst av stenttrombos”, säger doktor Gilles Montalescot, MD, professor i kardiologi vid Pitié-Salpétrière-sjukhuset i Paris, ansvarig forskare för ATLANTIC-studien. ”Dessa resultat är i linje med de nya ESC/EACTS 2014 Riktlinjer för revaskularisering som också presenterades på årets ESC-konferens, och som ger en klass I-rekommendation att starta dubbel trombocythämmande behandling av STEMI-patienter vid den första medicinska kontakten.”

Marc Ditmarsch, Global Product Vice President för Brilinta säger: ”Resultaten från ATLANTIC-studien ger oss möjlighet att bättre förstå vilken roll Brilinta har vid behandling av STEMI-patienter. Data indikerar att Brilinta har flexibiliteten att ges före ankomst till sjukhus eller på sjukhus till STEMI-patienter utan negativ inverkan på blödning. Även om detta inte var det primära målet för studien, är de siffror som indikerar en minska risk på post-PCI stenttrombos hos patienter som fick Brilinta innan de nådde sjukhuset uppmuntrande och motiverar vidare utredning.”

ATLANTIC är en central studie som bygger på resultaten från den viktiga PLATO-studien, som visade att behandling med ticagrelor plus acetylsalicylsyra under 12 månader kunde sättas i samband med en relativ riskreduktion (RRR) i kardiovaskulär död på 21 % (4 % jämfört med 5,1 %; 1,1 % ARR, P = 0,001) och en RRR i hjärtinfarkt (MI) på 16 % jämfört med klopidogrel plus acetylsalicylsyra under 12 månader (5,8 % jämfört med 6,9 %; 1,1 % ARR, P <0,005). PLATO var den första studien att rapportera till AstraZenecas globala life cycle management program för obesvarade frågor inom aterotrombotiska sjukdomar, och för att undersöka effekten av Brilinta för att minska aterotrombotiska händelser. PARTHENON är AstraZenecas största kliniska prövningsprogram någonsin. Detomfattar mer än 80 000 patienter över hela världen, och är en del av företagets satsning för att förstå och främja behandlingar av hjärt-/kärlsjukdomar i en strävan att förbättra patienternas hälsa.

– SLUT –

NOTES TO EDITORS

1Data on file. ATLANTIC data will be presented as part of the European Society of Cardiology congress at 16:48 CEST on Monday, 1 September during the ‘Hotline’ session. It will also be part of the ‘Meet the Trialists’ session at 10:10 CEST on Tuesday, 2 September.

2Chan M, Sun J et al. Long-Term Mortality of Patients Undergoing Cardiac Catheterization for ST-Elevation and Non-ST-Elevation Myocardial Infarction. American Heart Association. 2009; 3112.

3Non-CABG-related and bleeding event according to PLATO criteria (composite of major and minor bleeds):
- ≤ 48 hours after first dose p=0.87 - > 48 hours and ≤ 30 days after first dose p=0.63

About ATLANTIC
ATLANTIC (A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention) was an international, multicentre, randomised, double blind Phase IV study that aimed to determine optimal timing for initiation of antiplatelet therapy by evaluating whether ticagrelor administered pre-hospital, preferably in the ambulance setting during transfer, could improve coronary reperfusion in STEMI patients intended for primary PCI.

Patients (n=1862) were randomised to receive either a loading dose of BRILINTA 180 mg for the pre-hospital administration (n=909) and placebo for in-hospital administration, or a placebo for pre-hospital administration and BRILINTA 180 mg loading dose for in-hospital administration (n=953). The median time difference between pre-hospital and in-hospital administration of BRILINTA loading dose was 31 minutes. After discharge, all patients continued on BRILINTA 90 mg twice daily for 30 days, with a recommendation that treatment be continued for 12 months.

o The co-primary endpoints were the percentage of patients (i) not achieving ≥70% (complete) ST-segment elevation resolution pre-PCI, or (ii) not reaching TIMI flow grade 3 in the infarct-related artery at pre-PCI angiography.

o Pre-specified secondary endpoints included the composite of death, MI, stent thrombosis, stroke, urgent revascularisation at 30 days; definite stent thrombosis alone at 30 days; thrombotic bail-out with GP IIb/IIIa inhibitors; TIMI flow grade 3 at the end of the procedure; and complete ST-segment elevation resolution at 60 minutes post-PCI.

  o Safety endpoints included major, life-threatening or minor bleeding (excluding coronary artery bypass graft-related [CABG] bleeding) within the first 48 hours and over the 30 day treatment period, evaluated using the PLATO, TIMI, STEEPLE, ISTH, GUSTO and BARC bleeding definitions.

About ticagrelor

Ticagrelor is an oral antiplatelet treatment for acute coronary syndromes (ACS). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). Regarding possible interactions and side effects, please see full prescribing information.

On 6 December 2010, the European Commission granted marketing authorisation to ticagrelor, co-administered with acetylsalicylic acid (maintenance dose 75-150mg daily), for the prevention of atherothrombotic events in adult patients with ACS [unstable angina (UA), non—ST-segment elevation myocardial infarction (NSTEMI) or STEMI], including patients managed medically and those who are managed with percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

Ticagrelor is approved in 100 countries, including in the European Union under the trade name BRILIQUE and in the United States, Canada, Brazil, Australia and Russia under the trade name BRILINTA.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. For detailed information regarding ticagrelor in your area, please refer to the local prescribing information.

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

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Om AstraZeneca

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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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