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Tagrisso (osimertinib) visar på förbättrade resultat vid EGFR T790M icke småcellig lungcancer jämfört med cytostatika

Pressmeddelanden   •   Dec 06, 2016 10:32 CET

Den första randomiserade fas 3-studien (AURA3) som jämför osimertinib med dubbel platinumbaserad cytostatikabehandling Osimertinib förbättrade progressionsfri överlevnad med nästan sex månader Patienter med metastaser på centrala nervsystemet visade på liknande resultat som den totala populationen enligt förbestämda subgruppsanalyser

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AstraZeneca takes latest scientific advances in oncology to major US and European congresses

Pressmeddelanden   •   Nov 29, 2016 08:03 CET

​Tagrisso scientific updates include results of AURA3 trial in patients with lung cancer, and Phase II efficacy data on CNS metastases New analyses of Phase III FALCON trial will extend understanding of Faslodex in 1st-line treatment of advanced breast cancer New acalabrutinib safety and efficacy data in patients with difficult-to-treat chronic lymphocytic leukaemia

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AstraZeneca head and neck cancer trials resume new patient enrolment as FDA lifts partial clinical hold

Pressmeddelanden   •   Nov 22, 2016 08:15 CET

AstraZeneca today announced that the US FDA has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.

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AstraZeneca uppmärksammar Världsdiabetesdagen den 14 november

Nyheter   •   Nov 14, 2016 16:47 CET

Korta fakta om diabetes - en växande folksjukdom. AstraZeneca har som mål att förbättra livet för personer med diabetes genom att minska påverkan av sjukdomen och dess komplikationer. Vi forskar inom metabola sjukdomar och har en ambition att vara ledande på området. AstraZeneca erbjuder olika behandlingsmöjligheter inom typ 2-diabetes.

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AstraZeneca PLC:s resultatrapport för de första nio månaderna och tredje kvartalet 2016

Pressmeddelanden   •   Nov 10, 2016 08:18 CET

​Resultatet för tredje kvartalet är i linje med våra förväntningar

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Lynparza Phase III SOLO-2 trial shows significant progression-free survival benefit

Pressmeddelanden   •   Okt 26, 2016 08:02 CEST

Trial studied Lynparza as maintenance treatment for women with BRCA-mutated metastatic ovarian cancer Initial findings show safety profile with Lynparza tablets was consistent with previous studies

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FDA accepts for review New Drug Application for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalaemia

Pressmeddelanden   •   Okt 18, 2016 08:03 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2 response.

Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.

– ENDS –

NOTES TO EDITORS

About sodium zirconium cyclosilicate (ZS-9) for oral suspension

Sodium zirconium cyclosilicate (ZS-9) is an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions. Sodium zirconium cyclosilicate has been studied in three double-blind, placebo controlled trials and in one ongoing 12-month open label clinical trial in patients with hyperkalaemia which represents over 1,600 patients treated. Sodium zirconium cyclosilicate is an investigational medicine that is not currently approved for any indication in any market.

About hyperkalaemia

Hyperkalaemia (potassium levels > 5.0 mEq/L in the blood serum) commonly occurs in patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death. Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia. Current therapeutic options are limited, leaving a high unmet medical need in these patients.

About ZS Pharma ZS Pharma was founded in 2008, became a public company in 2014 and, in December 2015, joined the AstraZeneca Group. ZS Pharma is focused on the development and commercialisation of highly selective, non-absorbed drugs to treat renal, cardiovascular and metabolic disorders. Additional information about ZS Pharma is available at www.zspharma.com.

About AstraZeneca in Cardiovascular & Metabolic Disease (CVMD)

Cardiovascular, metabolic disease and chronic kidney disease are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. Our patient-led strategy is focused on addressing the multiple risk factors facing CVMD and CKD patients at different stages of their disease, with the goal of reducing morbidity and mortality through life changing medicines.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 203 749 5637
Vanessa Rhodes UK/Global +44 203 749 5736
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, neuroscience & infection +44 203 749 5711
US toll free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdenaneurovetenskap och autoimmunitet. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

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AstraZeneca enters agreement with Cilag GmbH International to divest rights to Rhinocort Aqua outside the US

Pressmeddelanden   •   Okt 07, 2016 08:04 CEST

AstraZeneca today announced that it has entered into an agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the US.

Rhinocort Aqua is a nasal spray indicated for allergic and non-allergic rhinitis(inflammation of the inside of the nose), and for the treatment of nasal polyps (swelling of the nasal lining). The active ingredient is the anti-inflammatory medicine budesonide.

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca, said: “This agreement allows us to concentrate our efforts in Respiratory as one of our three strategic therapy areas, on transforming the treatment of asthma and COPD, where budesonide remains a key component of our marketed as well as pipeline medicines.”

Financial considerations

The agreement is subject to customary closing conditions and is expected to complete in the fourth quarter of 2016. As AstraZeneca will not maintain a significant ongoing interest in Rhinocort Aqua, the $330 million payment received from Cilag GmbH International upon completion of the transaction will be recognised as Other Operating Income in the Company’s financial statements. The transaction does not include the transfer of any AstraZeneca employees or facilities and does not impact the Company’s financial guidance for 2016.

-ENDS-

NOTES TO EDITORS

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also selectively active in Neuroscience and Autoimmunity. 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
Neil Burrows UK/Global +44 203 749 5637
Vanessa Rhodes UK/Global +44 203 749 5736
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
UK
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Nick Stone Respiratory +44 203 749 5716
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Neuroscience & Autoimmunity +44 203 749 5711
US
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll-free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena neurovetenskap och autoimmunitet. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced that it has entered into an agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the US.

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AstraZeneca enters agreement with Aralez for beta-blocker medicine Toprol-XL in the US

Pressmeddelanden   •   Okt 04, 2016 08:08 CEST

AstraZeneca today announced that it has entered into an agreement with Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez Pharmaceuticals Inc., for the rights to branded and authorised generic Toprol-XL (metoprolol succinate) in the US. Toprol-XL is a beta-blocker medicine for the control of hypertension (high blood pressure), angina (chest pain) and heart failure. It was first approved in the US in 1992.

Under the terms of the agreement, Aralez will pay AstraZeneca $175 million to acquire the rights to Toprol-XL tablets in the US, and the authorised generic medicine marketed by Par Pharmaceuticals. Aralez will also pay AstraZeneca up to $48 million in milestone and sales-related payments, as well as mid-teen percentage royalties on sales. AstraZeneca will continue to manufacture and supply Toprol-XL and the authorised generic medicine to Aralez.

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca said: “This agreement allows us to focus our resources on our new launches and pipeline of innovative medicines, while working with Aralez, a partner with expertise in cardiovascular disease, to ensure continued patient access to Toprol-XL.

Adrian Adams, Chief Executive Officer of Aralez Pharmaceuticals Inc. said: “We are pleased to be entering into this agreement with AstraZeneca. Toprol-XL represents a strong addition to our growing anchor position in cardiovascular disease. We look forward to helping patients continue to benefit from this important medicine.”

Financial considerations

In 2015, US Product Sales for Toprol-XL and the AstraZeneca share from the sale of the authorised generic medicine totalled $89 million. The transaction is expected to complete in the fourth quarter of 2016, subject to customary closing conditions. As AstraZeneca will retain an ongoing interest in Toprol-XL in the US through the ongoing milestones, royalties and product supply, the upfront payment of $175 million, milestones and sales-related payments of up to $48 million and mid-teen percentage royalties will be reported as Externalisation Revenue in the Company’s financial statements. The agreement does not include the transfer of any AstraZeneca employees or facilities and does not impact AstraZeneca’s financial guidance for 2016.

– ENDS –

NOTES TO EDITORS

AboutAralez Pharmaceuticals Inc.

Aralez Pharmaceuticals Inc.(NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercialising products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in Mississauga, Ontario, Canada, the U.S. Headquarters is planned to be inPrinceton, NJand the Irish Headquarters is inDublin, Ireland. More information about Aralez can be found at www.aralez.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also selectively active in Neuroscience and Autoimmunity. 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
Neil Burrows UK/Global +44 203 749 5637
Vanessa Rhodes UK/Global +44 203 749 5736
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
UK
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Nick Stone Respiratory & Autoimmunity +44 203 749 5716
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Infection & Neuroscience +44 203 749 5711
US
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll-free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt verksamma inom områdena neurovetenskap och autoimmunitet. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced that it has entered into an agreement with Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez Pharmaceuticals Inc., for the rights to branded and authorised generic Toprol-XL (metoprolol succinate) in the US

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AstraZeneca reports top-line results from the Brilinta EUCLID trial in patients with peripheral artery disease

Pressmeddelanden   •   Okt 04, 2016 08:06 CEST

Brilinta did not demonstrate a benefit over clopidogrel in a symptomatic peripheral artery disease patient population

AstraZeneca today announced top-line results from the EUCLID trial. Brilinta (ticagrelor) did not demonstrate a benefit over clopidogrel in a symptomatic peripheral artery disease (PAD) patient population and therefore did not meet the primary endpoint of the trial.

The EUCLID trial included 13,885 patients in 28 countries and is the largest cardiovascular (CV) outcomes trial to date conducted exclusively in symptomatic patients with PAD. It evaluated the treatment of Brilinta 90mg tablets twice daily versus clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of cardiovascular death, heart attack or ischaemic stroke). The primary endpoint of the trial was the time to first occurrence of any such event.

Based on preliminary analyses, safety data is consistent with the known safety profile of Brilinta.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged. We are disappointed that the EUCLID trial results showed Brilinta did not demonstrate a benefit over clopidogrel in this specific symptomatic PAD population.”

Full results from the EUCLID trial are expected to be presented at the American Heart Association Scientific Sessions in New Orleans, Louisiana in November 2016.

– ENDS –

NOTES TO EDITORS

About Peripheral Artery Disease (PAD)

PAD is the third most common cause of cardiovascular complications (largely myocardial infarction and stroke) in the world. PAD is a chronic and progressive clinical manifestation of a systemic atherosclerotic vascular disease and a predictor of future vascular events. However, only a limited number of PAD patients receive the recommended treatment advocated in international guidelines. There is no cure and patients endure a high risk of serious cardiovascular morbidity and mortality.

About EUCLID

EUCLID (Examining Use of tiCagreLor In paD) is a global, event-driven, double-blind, parallel group trial involving approximately 13,800 patients in 28 countries, and was run for AstraZeneca by The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, Durham, North Carolina. The EUCLIDtrial evaluated the efficacy and safety of long-term treatment with Brilinta 90mg twice daily compared to clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of ischaemic stroke, myocardial infarction and CV death) in patients ≥50 years of age with symptomatic PAD, defined by ankle-brachial index (ABI) ≤0.80 (at enrolment) and lower extremity symptoms, or by prior lower extremity revascularisation more than 30 days prior.

About the PARTHENON programme

PARTHENON is the largest-ever AstraZeneca CV outcomes programme, involving nearly 85,000 patients at high risk of CV events (MI, stroke and/or CV death) due to their underlying disease. Through the PARTHENON programme, AstraZeneca aims to address unmet patient needs by enhancing scientific understanding of the potential role of Brilinta in the treatment of atherothrombotic conditions. It includes five key trials covering broad patient populations across varying timescales. The trials encompass a wide range of CV disorders, including coronary artery disease (PEGASUS-TIMI 54), acute coronary syndrome (PLATO), stroke (SOCRATES) and patients with type 2 diabetes at high risk of CV events (THEMIS).

About Brilinta

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

Brilinta 90mg is indicated to reduce the rate of atherothrombotic CV events in patients with ACS [unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI)]. Brilinta 60mg is indicated for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment with Brilinta 60mg may be started as continuation therapy after an initial one-year treatment with Brilinta 90mg and aspirin or other dual anti-platelet therapy.

Brilinta has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention, it also reduces the rate of stent thrombosis.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also selectively active in Neuroscience and Autoimmunity. 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
Neil Burrows UK/Global +44 203 749 5637
Vanessa Rhodes UK/Global +44 203 749 5736
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
UK
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Nick Stone Respiratory & Autoimmunity +44 203 749 5716
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Infection & Neuroscience +44 203 749 5711
US
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll-free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt verksamma inom områdena neurovetenskap och autoimmunitet. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Brilinta did not demonstrate a benefit over clopidogrel in a symptomatic peripheral artery disease patient population

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se