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AstraZeneca provides update on cediranib EU marketing authorisation application

Pressmeddelanden   •   Sep 21, 2016 12:11 CEST

AstraZeneca today announced its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy followed by maintenance monotherapy for the treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal sub types).

Cediranib remains an important part of AstraZeneca’s ovarian cancer medicine pipeline and this decision does not affect the ongoing primary development programme testing cediranib as a combination treatment alongside the Company’s existing and potential medicines.

The decision to withdraw the MAA was based on outstanding questions raised by the European Medicines Agency (EMA) at this late stage of the review process. The MAA for cediranib was supported by data from ICON6, a Phase III trial led by investigators from University College London (UCL) and the Medical Research Council (MRC). AstraZeneca has not made additional regulatory submissions for cediranib in this indication in any other markets.

AstraZeneca is committed to enhancing treatment options for patients with ovarian cancer, including developing chemotherapy-free alternatives to help delay or avoid the use of platinum-based chemotherapies.

- ENDS -

NOTES TO EDITORS

About ICON6

ICON6 was a randomised, three-arm and two-stage double-blind placebo-controlled Phase III trial conducted in UK, Canada, Australia, New Zealand and Spain.It was designed to evaluate the safety and efficacy of platinum-based chemotherapy in combination with cediranib in women with platinum-sensitive relapsed ovarian cancer. The trial was developed by the International Collaboration for Ovarian Neoplasia (ICON) and Gynecologic Cancer InterGroup (GCIG) and led by the MRC Clinical Trials Unit at University College London.1

About cediranib

Cediranib is a novel, orally administered multi-Vascular Endothelial Growth Factor receptor (VEGFR) inhibitor which is currently being tested as a maintenance treatment in patients with platinum-sensitive relapsed (PSR) ovarian cancer. Cediranib inhibits tumour growth by stopping blood flow to the tumour site.

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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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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Neil Burrows UK/Global +44 203 749 5637
Vanessa Rhodes UK/Global +44 203 749 5736
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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
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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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca today announced its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy

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Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes

Pressmeddelanden   •   Sep 16, 2016 13:30 CEST

DURATION-8 trial met primary and secondary endpoints, significantly reducing blood sugar (HbA1c), weight and systolic blood pressure versus either medicine alone

The first trial to assess GLP-1RA/SGLT-2i combination therapy

Positive results from the Phase III DURATION-8 trial demonstrated that Bydureon (exenatide extended-release formulation) 2mg once weekly in combination with Forxiga (dapagliflozin) 10mg once daily significantly reduced blood sugar as measured by HbA1c, versus the individual medicines alone in patients with type-2 diabetes inadequately controlled on metformin.1

This was the first clinical trial to combine these two different anti-diabetes medicines, a GLP-1 receptor agonist and an SGLT-2 inhibitor, as an addition to standard-of-care therapy to evaluate potential benefits for patients with type-2 diabetes with inadequate glycaemic control. The results were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany, and simultaneously published inThe Lancet Diabetes & Endocrinology.1

The trial achieved its primary endpoint with the combination of exenatide and dapagliflozin significantly reducing HbA1c from baseline compared with exenatide or dapagliflozin alone (1.95% versus 1.58% and 1.37% respectively, both P<0.01)1 at 28 weeks. It also confirmed the robust efficacy of dapagliflozin in patients not reaching their treatment goal with metformin.

Serge A. Jabbour, MD, FACP, FACE, Professor of Medicine, Director of the Division of Endocrinology and Director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, said: “Because of the progressive nature of type-2 diabetes, patients often require multiple antidiabetic medicines to achieve and maintain glycaemic control. The results of DURATION-8 show that combining medicines that work in different ways can significantly reduce HbA1c, as well as weight and systolic blood pressure.”

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: “With DURATION-8, AstraZeneca is the first company to highlight the potential benefits of combining a GLP-1 receptor agonist and SGLT-2 inhibitor as a highly-effective treatment alternative to existing non-insulin therapies for patients with severe, uncontrolled type-2 diabetes. Further, it reinforces our commitment to pushing the boundaries of science in the treatment of a disease that affects an estimated 415 million adults worldwide.2

Secondary endpoints for the trial included changes in body weight and systolic blood pressure. Patients receiving the combination of exenatide and dapagliflozin versus either exenatide or dapagliflozin alone experienced:

  • Significantly greater body weight reduction (–3.4 kg versus –1.5 kg and –2.2 kg, respectively; both P<0.01); weight reductions seen with the combination were greater (–4.5 kg) in patients with a baseline HbA1c of 8.0-9.0% versus those with a baseline greater than 9.0% (–2.6 kg)
  • Significantly greater systolic blood pressure reduction (–4.2 mmHg vs –1.3 mmHg and –1.8 mmHg, respectively; both P<0.05)1

The combination of exenatide and dapagliflozin exhibited similar rates of adverse events and serious adverse events to the individual medicine treatment groups. The most common adverse events (≥ 5% of patients in any group) were diarrhoea, injection-site nodules, nausea and urinary tract infections.1

– ENDS –

NOTES TO EDITORS

About DURATION-8

DURATION-8 was a phase III, randomised, multicentre, double-blind, active controlled trial which evaluated the safety and efficacy of simultaneous administration of exenatide once weekly and dapagliflozin once daily compared to treatment with the individual medicines in adult patients with type-2 diabetes who were inadequately controlled on metformin.1

The trial was conducted over a 28-week treatment period, with an extension to two years, and enrolled approximately 700 patients in six countries. Eligible participants included adult patients with type-2 diabetes who had uncontrolled HbA1c (a protein within red blood cells that when bound with glucose is measurable to determine average blood sugar levels during a specific period) levels at baseline ranging from 8.0% to 12.0%. The primary endpoint was change in HbA1c from baseline to week 28. Secondary endpoints included changes in body weight, systolic blood pressure, fasting plasma glucose, two-hour postprandial glucose and the proportion of patients achieving HbA1c <7.0% over the 28-week treatment period.1

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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

# # #

References

  • 1.Frias J, Guja C, Hardy E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol 2016; published online Sept 16. http://dx.doi.org/10.1016/S2213-8587(16)30267-4
  • 2.International Diabetes Federation. IDF Diabetes Atlas, 7th ed. Brussels, Belgium: International Diabetes Federation, 2015.

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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​DURATION-8 trial met primary and secondary endpoints, significantly reducing blood sugar (HbA1c), weight and systolic blood pressure versus either medicine alone The first trial to assess GLP-1RA/SGLT-2i combination therapy

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Stora skillnader i vården av typ-2 diabetes i Danmark, Norge och Sverige enligt ny studie som presenteras på EASD

Pressmeddelanden   •   Sep 14, 2016 14:30 CEST

Kontrollen av blodsocker och kolesterol hos patienter med typ 2-diabetes är bättre i Danmark jämfört med i Norge och i Sverige enligt resultat från studien Nordic DISCOVER. Studien är den första nordiska jämförande långsiktiga studien av primärvårdens omhändertagande av patienter med typ 2-diabetes. Resultat presenteras för första gången på den europeiska diabeteskonferensen EASD, 14 september.

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Fördubblade sjukdomskostnader i Sverige för typ 2-diabetes under åren 2006 – 2014. Följdsjukdomar som stroke och hjärtinfarkt kostar allt mer

Pressmeddelanden   •   Sep 13, 2016 14:30 CEST

Sjukdomskostnaderna för behandling av patienter med typ 2-diabetes fördubblades i Sverige mellan åren 2006 och 2014 samtidigt som kostnaderna för diabetesläkemedel genomgående under perioden endast representerar fyra procent. Det visar resultat från den svenska studien DAISY som presenteras på den europeiska diabeteskonferensen EASD i München, den 13 september. Studien är en nationell så kallad cost-of-illness-studie och är den första i sitt slag som har beräknat de samlade sjukdomskostnaderna för typ 2-diabetes i Sverige under åren 2006-2014 (1).

Den totala kostnaden för behandling av patienter med typ 2-diabetes i Sverige fördubblades under perioden 2006 till 2014, från 5,5 miljarder SEK år 2006 till cirka 11,6 miljarder SEK år 2014, främst till följd av ett ökat antal patienter med typ 2-diabetes och behandling av följdsjukdomar.

Antalet patienter i Sverige som behandlas för typ 2-diabetes ökar och har nyligen rapporterats omfatta 4,4 procent av befolkningen (2), och ökning i förekomst kan innebära ökade kostnader för sjukvården. Över 80 procent av dessa har också övervikt och/eller fetma som bidrar till högt blodsocker, blodfettsrubbningar och högt blodtryck (3).

- Diabetes är ett globalt hälsoekonomiskt problem som belastar sjukvården och samhället i en allt större omfattning. Det är därför oerhört viktigt att arbeta aktivt med tidig diagnos, förebyggande åtgärder som kost och motion samt effektiv behandling och uppföljning för att förebygga komplikationer och för tidig död till följd av diabetes, säger David Nathanson överläkare på Södersjukhuset och medförfattare till studien.

Fler att behandla och ökade kostnader för sluten- och öppenvård

Läkemedel för att behandla diabetes stod endast för en liten del (4procent) av de totala kostnaderna. Denna andel förblev stabil under studieperioden (1). Antalet patienter med typ 2-diabetes som behandlades med glukossänkande läkemedel under studieperioden ökade med 77,8 procent (2006: n=206 183 och 2014: n=366 492). Medelåldern för dessa patienter 2014 var 67 år och 43 procent var kvinnor.

- Resultat från denna studie visar att läkemedel för att behandla diabetes står för en liten del av de totala sjukdomskostnaderna för behandling av patienter med typ 2-diabetes. Trots att vi har en mycket bra diabetesvård i Sverige idag når bara drygt hälften behandlingsmålet för sitt långtidsblodsocker vilket på sikt kan medföra ökad risk för komplikationer och följdsjukdomar som hjärtinfarkt och stroke. Det vi ser i denna studie är att det är sjukhusbehandlingen av komplikationer som driver kostnaderna, säger Almina Kalkan hälsoekonom på AstraZeneca, som arbetat med studien.

DAISY-studien visar att de ökade sjukdomskostnaderna för behandling av patienter med typ 2-diabetes under perioden 2006-2014 främst berodde på ökade kostnader för sluten- och öppenvård.

Mer om studien

DAISY-studien inkluderar alla patienter med typ 2-diabetes behandlade med blodglukossänkande mediciner under åren 2006-2014 i Sverige och har till syfte att beskriva sjukdomsprevalens, patientens sjukdomsbelastning, risker för komplikationer och behandlingsverklighet (2). Cost-of-illness-studien som nu presenteras är en del av DAISY för att utvärdera de totala sjukdomskostnaderna för behandling av patienter med typ 2-diabetes under åren 2006-2014, och orsaker till eventuella förändringar i kostnader under denna period. Patientdata till studien hämtades från de nationella läkemedels-, sjukhus- och dödsorsaks-registren (1).

In- och utskrivning vid sjukvårdsvistelse och öppenvårdsbesök extraherades årligen från det nationella patientregistret med hjälp av diagnos- (ICD) och patientklassificeringskoder (DRG, diagnosrelaterade grupper). En beräkning av de samlade kostnaderna för läkemedel och konsumtion av vård genomfördes där 2014 års prisnivå och växelkurs användes (1 euro = 9,10 SEK).

DAISY-studien har genomförts av AstraZeneca i samarbete med forskare vid Karolinska Institutet, Södersjukhuset, Stockholm och Uppsala universitet, Uppsala.

Om AstraZeneca

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

För mer information, se www.astrazeneca.se och www.astrazeneca.com eller följ oss på twitter. Https:/twitter.com/AstraZenecaSE.

Kontaktpersoner:

Petra Eurenius, Kommunikationschef AstraZeneca Nordic-Baltic, petra.eurenius@astrazeneca.com Mobil 0709 186562

David Nathanson, Överläkare Södersjukhuset, David.Nathanson@ki.se, Mobil 0705 589046

Referenser:

1. Doubled healthcare costs of type 2 diabetes mellitus during 2006-2014: a nationwide cost-of-illness study in Sweden. EASD 2016, Abstract #68. http://www.easdvirtualmeeting.org/resources/doubled-healthcare-costs-of-type-2-diabetes-mellitus-during-years-2006-2014-a-nationwide-cost-of-illness-study-in-sweden

2. Norhammar A et al, Incidence, prevalence and mortality of type 2 diabetes requiring glucose lowering treatment, and associated risks of cardiovascular complications: a nationwide study in Sweden, 2006-2013. Diabetologia, 2016. 59(8): p. 1692-701.

3. Gudbjörnsdottir S et al, Swedish National Diabetes Register Annual report 2013. 2014, Centre of Registers, Västra Götaland.

Approval ID 1007420.011 09/16

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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Sjukdomskostnaderna för behandling av patienter med typ 2-diabetes fördubblades i Sverige mellan åren 2006 och 2014 samtidigt som kostnaderna för diabetesläkemedel genomgående under perioden endast representerar fyra procent. Det visar resultat från den svenska studien DAISY som presenteras på den europeiska diabeteskonferensen EASD, den 13 september.

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AstraZeneca announces two new phase IIIb trials for Forxiga in chronic kidney disease and chronic heart failure

Pressmeddelanden   •   Sep 12, 2016 08:05 CEST

First programme to assess potential cardiovascular and renal benefit of an SGLT-2i beyond diabetes

AstraZeneca today announced two new randomised, placebo-controlled Phase IIIb outcome trials with Forxiga (dapagliflozin), an SGLT-2 inhibitor currently indicated for the treatment of type-2 diabetes. These two large outcome trials will help to define the potential role of dapagliflozin in the management of chronic kidney disease and chronic heart failure respectively, in people with and without type-2 diabetes.

This marks the first time a major outcome trial will be conducted to evaluate the effect of an SGLT-2 inhibitor in chronic kidney disease, for which there are currently few treatment options and a significant unmet medical need.1,2

AstraZeneca today also announced the initiation of a series of new mechanistic trials designed to understand the underlying science behind the potential cardiovascular and renal protective signals seen with the SGLT-2 inhibitor class.

These new trials reinforce AstraZeneca’s commitment to Cardiovascular and Metabolic disease (CVMD) as one of its main therapy areas and to dapagliflozin, for which the body of evidence continues to growwith more than 80 completed and ongoing clinical trials and more than a million patients treated to date.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: “Our transformative clinical research aims to address the multiple risk factors associated with cardiovascular morbidity and mortality, including diabetes, chronic heart failure and chronic kidney disease. By following the science, we are seeking to improve outcomes for millions of patients with cardiovascular disease around the world.”

Professor John McMurray, Professor of Cardiology at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, and a member of the Executive Committee for both the chronic heart failure and chronic kidney disease trials, said: “This partnership between AstraZeneca and the wider clinical community is of great importance in allowing us to investigate the potential benefits of dapagliflozin in chronic heart failure and chronic kidney disease, and potentially to transform the way we view and manage these two conditions which place such a burden on our patients and health care systems.”

There are currently an estimated 200 million people worldwide currently living with chronic kidney disease,1 and 38 million people living with chronic heart failure.2

-ENDS-

NOTES TO EDITORS

About SGLT-2 inhibitors

Dapagliflozin (marketed as Farxiga in the US and Forxiga outside the US) is part of a class of medicines called sodium-glucose cotransporter 2 (SGLT-2) inhibitors used to manage type-2 diabetes, which remove glucose via the kidneys.

About AstraZeneca in Cardiovascular and Metabolic Disease (CVMD)

Cardiovascular, renal and metabolic diseases are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. By collaborating across therapeutic disciplines as part of the CVMD therapy area, we are addressing the multiple risk factors associated with CVMD, with the goal of reducing morbidity, mortality and organ damage through innovative therapies. Recognising the growing unmet need and challenges faced by the millions of people across the world living with these interrelated diseases, we’re determined to understand how they interact and impact one another – and how they can be treated together to save more patients’ lives.

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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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

1Ojo A. “Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translation Research.” Transactions of the American Clinical And Climatological Association. 2014; 125:229-246.

2Eugene Braunwald. The war against heart failure: the Lancet lecture. The Lancet. 2015; 385: 812–24.

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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

First programme to assess potential cardiovascular and renal benefit of an SGLT-2i beyond diabetes​

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Benralizumab Phase III trials show positive results in severe asthma

Pressmeddelanden   •   Sep 05, 2016 07:05 CEST

AstraZeneca’s first biologic respiratory medicine met primary and key secondary endpoints in pivotal trials for severe asthma

Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.

The SIROCCO and CALIMA trials evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens as add-on therapy to standard-of-care medicine across primary and key secondary endpoints. Results showed:

  • Reductions in the annual rate of asthma exacerbations (up to 51%)
  • Improvement in lung function (change in FEV1 of up to 159 mL), which was seen at 4 weeks after the first benralizumab dose and sustained throughout the treatment period
  • Improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath

The outcomes were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. In addition, post-hoc analysis showed greater improvements in exacerbation rate reduction, FEV1 and total asthma symptom scores in patients with a history of more frequent asthma exacerbations (≥ 3 in the previous year). Detailed results were published today in The Lancet for the Phase III SIROCCO and CALIMA trials.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “Severe asthma affects the lives of millions of patients around the world and can be life threatening. The SIROCCO and CALIMA Phase III trials have shown that benralizumab can offer a meaningful treatment option for patients as evidenced by reductions in exacerbations, improvement in lung function and symptoms, with the promise of fewer doses a year. Benralizumab has a unique way of working in patients with severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.”

The adverse event frequency was similar between benralizumab-treated patients versus placebo-treated patients for both SIROCCO and CALIMA (72% and 74% for all benralizumab treated patients vs. 76% and 78% for placebo-treated patients observed in SIROCCO and CALIMA, respectively). The most common (≥5%) adverse events in benralizumab-treated patients observed in SIROCCO were asthma, nasopharyngitis, upper respiratory infection, headache, bronchitis, sinusitis, influenza and pharyngitis; and in CALIMA were nasopharyngitis, asthma, bronchitis, upper respiratory tract infection, headache and sinusitis.

Severe uncontrolled asthma is a debilitating and potentially fatal form of the disease, where patients experience frequent exacerbations every year and have significant limitations on lung function and quality of life. Uncontrolled asthma can lead to a dependence on oral corticosteroids (OCS), with systemic steroid exposure leading to serious and irreversible adverse effects.

Benralizumab is an anti-eosinophil monoclonal antibody that induces direct, rapid and near-complete depletion of eosinophils, with an onset of action within 24 hours as confirmed in early phase I/II trials. Eosinophils are the biological effector cells that drive inflammation and airway hyper-responsiveness in approximately 50% of asthma patients, leading to frequent exacerbations, impaired lung function and asthma symptoms.

The data from the SIROCCO and CALIMA trials will be included in regulatory submissions for benralizumab that are planned for the US and EU later in 2016.

– ENDS –

NOTES TO EDITORS

About Severe Asthma

Asthma currently affects the health and day-to-day lifestyles of 315 million individuals worldwide, and by 2020 will likely increase in numbers to as many as 400 million people. Up to 10% of asthma cases are severe, of which approximately 40% remain uncontrolled on current standard of care medicine. Severe, uncontrolled asthma has an eight times higher risk of mortality than severe asthma. Uncontrolled asthma can lead to a dependence on OCS. Systemic steroid exposure can lead to serious and irreversible adverse effects, including osteoporosis, anxiety, depression, weight gain, glaucoma and diabetes. There is also a significant physical and socio-economic burden of severe asthma with these patients accounting for 50% of asthma-related costs.

About the WINDWARD Programme

The WINDWARD programme in asthma is made up of six Phase III trials, including SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE. WINDWARD, the largest Phase III development programme for a biologic medicine in respiratory disease, evaluated a total of 3,068 patients in 798 sites across 26 countries.

The two pivotal trials, SIROCCO and CALIMA, are randomised, double-blind, parallel-group, placebo-controlled trials designed to evaluate the efficacy and safety of a regular, subcutaneous administration of benralizumab (fixed 30mg dose) for up to 56 weeks in exacerbation-prone adult and adolescent patients 12 years of age and older.

A total of 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA) currently receiving standard of care medicine (including high-dosage inhaled corticosteroids and long-acting beta 2 agonists [ICS/LABA]) were randomised globally and received either benralizumab 30mg every 4 weeks; benralizumab 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks; or placebo. All benralizumab doses were administered via subcutaneous injection using an accessorized pre-filled syringe.

In addition to WINDWARD, the Phase III VOYAGER programme is currently underway, which is evaluating the efficacy and safety of benralizumab in patients with severe chronic obstructive pulmonary disease (COPD).

About Benralizumab

Benralizumab was developed by MedImmune, AstraZeneca’s global biologics research and development arm and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-SuspensionTM Delivery Technology. Our research is focused on three key biological pathways: eosinophilic disease, Th2-driven disease and epithelial-driven pathobiology.

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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca’s first biologic respiratory medicine met primary and key secondary endpoints in pivotal trials for severe asthma

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AstraZeneca to present new data highlighting its growing respiratory portfolio and pipeline at European Respiratory Society 2016

Pressmeddelanden   •   Aug 30, 2016 08:03 CEST

New evidence to be presented includes pivotal Phase III data on benralizumab

AstraZeneca will present new data from its growing respiratory portfolio and pipeline at the annual meeting of the European Respiratory Society (ERS) International Congress, 3-7 September 2016 in London, UK.

The breadth and depth of science behind the portfolio and pipeline are reflected in the 38 accepted abstracts including nine oral presentations focused on unmet medical needs in asthma and chronic obstructive pulmonary disease (COPD). Highlights will include full Phase III data for benralizumab, AstraZeneca’s first respiratory biologic, as well as new evidence for dual bronchodilation in COPD and for Symbicort in both COPD and asthma.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said:“The data presented at ERS reflect the breadth of our scientific research in chronic respiratory disease and our progress in delivering the next generation of respiratory therapies. We are particularly excited to share the full Phase III data from the SIROCCO and CALIMA trials on benralizumab in severe asthma, where it is critical to improve outcomes for patients.”

Phase III data on benralizumab

Data from two pivotal Phase III trials of benralizumab in severe asthma will be presented for the first time (abstracts #OA4832 and #OA1969).

Achieving maximum bronchodilation for COPD patients

New data will be presented on:

  • A Duaklir (aclidinium/formoterol) study showing reduced deterioration in COPD compared to monotherapies and placebo (abstract #PA301)
  • The benefit of Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) over a 24-hour period versus tiotropium bromide inhalation spray and placebo
    (abstract #PA994)
  • The effect of dual bronchodilation in all the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (abstracts #PA310 and #PA992)


Symbicort as maintenance and reliever therapy

Ten abstracts including new data on the benefit of Symbicort maintenance and reliever therapy in adolescents (abstract #PA4903) and real-world evidence of the disease burden in mild asthma (abstract #PA4590).

- ENDS -

NOTES TO EDITORS

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-SuspensionTM Delivery Technology. Our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

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 centres, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: http://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 Enquiries
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
Dial / 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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

New evidence to be presented includes pivotal Phase III data on benralizumab

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AstraZeneca to sell small molecule antibiotics business to Pfizer

Pressmeddelanden   •   Aug 24, 2016 08:03 CEST

Value-creating divestment supports AstraZeneca’s focus on three main therapy areas

Pfizer’s dedicated focus on infectious diseases will extend the reach of the antibiotics to more patients globally and maximise the potential of the late-stage, small molecule antibiotics business

AstraZeneca today announced that it has entered into an agreement with Pfizer Inc. (Pfizer) to sell the commercialisation and development rights to its late-stage small molecule antibiotics business in most markets globally outside the US*. The agreement reinforces AstraZeneca’s focus on developing transformational medicines in its three main therapy areas, while realising value from the strong portfolio of established and late-stage small molecule antibiotics through Pfizer’s dedicated commercialisation and development capabilities in anti-infectives. The portfolio comprises the approved antibiotics Merrem, Zinforo and Zavicefta, and ATM-AVI and CXL, which are in clinical development.

Under the terms of the agreement, Pfizer will make an upfront payment to AstraZeneca of $550 million upon completion and a further unconditional payment of $175 million in January 2019 for the commercialisation and development rights to the late-stage antibiotics business in all markets where AstraZeneca holds the rights. In addition, Pfizer will pay up to $250 million in commercial, manufacturing and regulatory milestones, up to $600 million in sales-related payments as well as recurring, double-digit royalties on future sales of Zavicefta and ATM-AVI in certain markets.

Luke Miels, Executive Vice President for Europe and Head of the Antibiotics Business Unit at AstraZeneca, said: “This agreement reinforces our strategic focus to invest in our three main therapy areas where we can make the greatest difference to patients’ lives. We’re pleased that our strong science in antibiotics will continue to serve a critical public health need through Pfizer’s dedicated focus on infectious diseases, ensuring these important medicines reach greater numbers of patients around the world.”

John Young, Group President, Pfizer Essential Health, said: “As we continue to reshape our Essential Health portfolio, we are focusing on areas that further address global public health needs and that complement our core capabilities and experience in therapeutic areas, including anti-infectives. We are committed to looking for ways to enhance our portfolio around the world where we offer patients and healthcare professionals access to more than 60 anti-infective and anti-fungal medicines. The addition of AstraZeneca’s complementary small molecule anti-infectives portfolio will help expand patient access to these important medicines and enhance our global expertise and offerings in this increasingly important area of therapeutics, in addition to providing the opportunity for near-term revenue growth.”

MedImmune’s portfolio of biologics, on-market products such asFluMist/Fluenz and Synagis, and AstraZeneca’s stake in Entasis Therapeutics, spun-off from AstraZeneca in 2015 and now operating as a stand-alone company focused on the development of innovative small-molecule anti-infectives, are not included as part of the agreement.

Financial considerations

The agreement with Pfizer is expected to close in the fourth quarter of 2016, subject to customary closing conditions. As AstraZeneca will de-recognise an intangible product asset and does not maintain a significant future interest in the late-stage small molecule antibiotics business all payments will be reported as Other Operating Income in the Company’s financial statements. This includes the upfront payment of $550 million and unconditional payment of $175 million in 2019 (both to be recognised net of the aforementioned product intangible in 2016), the milestones of up to $250 million, the sales-related payments of up to $600 million and the recurring double-digit royalties on sales of Zavicefta and ATM-AVI.

AstraZeneca’s established antibiotic medicines Merrem and Zinforo are available in more than 100 countries and generated Product Sales in 2015 of $250 million. The agreement does not impact AstraZeneca’s financial guidance for 2016.

-ENDS-

NOTES TO EDITORS

About AstraZeneca’s small molecule anti-infective business

MedicineIndication
Merrem/Meronem (meropenem)Merrem/Meronemis a carbapenem anti-bacterial used for the treatment of serious infections in hospitalised patients. Meropenem is a broad-spectrum agent, originally created by Sumitomo Dainippon Pharma Co., Ltd. and indicated for the treatment of a wide variety of serious bacterial infections in adults and children, including pneumonia, community-acquired pneumonia and nosocomial pneumonia; broncho-pulmonary infections in cystic fibrosis; complicated urinary tract infections; complicated intra-abdominal infections; intra- and post-partum infections; complicated skin and soft tissue infections; and acute bacterial meningitis in adults and children over 3 months of age. In the US, Merrem is indicated as single-agent therapy for the treatment of intra-abdominal infections and bacterial meningitis when caused by susceptible strains of the designated microorganisms in adult and paediatric patients.*AstraZeneca holds the global rights to commercialise Merrem, with the exception of Japan, China, Taiwan and Korea, where the rights are held by Sumitomo Dainippon Pharma Co., Ltd. In addition, Sumitomo Dainippon Pharma has an option to commercialise the product in Thailand, Singapore, Vietnam, Malaysia, Philippines, Indonesia and Hong Kong.

Zinforo (ceftaroline fosamil)Zinforo waslaunched in October 2012 and is an intravenous cephalosporin antibiotic intended for use as a monotherapy in the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP). Zinforo is bactericidal and works by binding to and inhibiting penicillin-binding proteins (PBPs). Zinforo has been designed with a specific and novel mode of action which contributes to its bactericidal activity against the common causative pathogens of cSSTI, and CAP and unlike other cephalosporins, shows a high affinity for particular PBPs in MRSA. Zinforo has now been approved in 52 markets and launched in 32 markets. *AstraZeneca holds the global rights to commercialise Zinforo, with the exception of North America and Japan, where the rights are held by Allergan Pharmaceutical Industries Limited and Takeda Pharmaceutical Company Limited Respectively.
Zavicefta (ceftazidime-avibactam)Zavicefta is a combination antibiotic that has been developed to treat serious Gram-negative bacterial infections. It consists of a combination of avibactam and ceftazidime - a third-generation antipseudomonal cephalosporin with a well-established efficacy and safety profile. Avibactam (AVI, NXL104) is a first-in-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D, β-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by β-lactamases. Zavicefta offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of Enterobacteriaceae including those that produce extended-spectrum beta-lactamase and Klebsiella pneumoniae carbapenemase, together with activity against difficult-to-treat P. aeruginosa.*AstraZeneca holds the global rights to commercialise Zavicefta, with the exception of North America, where the rights are held by Allergan Pharmaceutical Industries Limited.
ATM-AVIATM-AVIis a bactericidal, injectable combination of aztreonam (ATM) and a β-lactamase inhibitor, Avibactam (AVI, NXL104), which is in development for the treatment of life-threatening Gram-negative bacterial infections caused by multi-drug resistant (MDR) strains, including infections caused by metallo-beta-lactamase (MBL)-producing pathogens. ATM-AVI has the potential to be a replacement for, or alternative to, existing antibacterial agents, including colistin and tigecycline. ATM-AVI has completed its Phase I studies and is currently in Phase II development. *AstraZeneca holds the global rights to commercialise ATM-AVI, with the exception of North America, where the rights are held by Allergan Pharmaceutical Industries Limited.
CXLCXLis a novel, injectable bactericidal β-lactam/β-lactamase inhibitor combination of ceftaroline fosamil (marketed as Zinforo in AstraZeneca markets), a next-generation cephalosporin with activity against multidrug-resistant Gram-positive and common enteric Gram-negative pathogens, and Avibactam (AVI, NXL104), a potent β-lactamase inhibitor that inhibits Ambler Class A (including ESBL producers and KPC carbapenemases), Class C (Amp C) β-lactamase enzymes, and some Class D β-lactamase enzymes. CXL has completed a Phase II study and is ready for progression into Phase III.*AstraZeneca holds the global rights to commercialise CXL, with the exception of North America, where the rights are held by Allergan Pharmaceutical Industries Limited.

About Pfizer Inc.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, and like us on Facebook at Facebook.com/Pfizer.

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 - Respiratory & Autoimmunity, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Esra Erkal-PalerUK/Global+44 203 749 5638
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Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+1 302 885 2677
Investor Relations
UK
Thomas Kudsk Larsen+44 203 749 5712
Craig MarksFinance, Fixed Income, M&A+44 7881 615 764
Nick StoneRespiratory & Autoimmunity+44 203 749 5716
Henry WheelerOncology+44 203 749 5797
Christer GruvrisInfection & Neuroscience+44 203 749 5711
US
Lindsey TrickettCardiovascular & Metabolic Diseases+1 240 543 7970
Mitchell ChanOncology+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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Value-creating divestment supports AstraZeneca’s focus on three main therapy areas Pfizer’s dedicated focus on infectious diseases will extend the reach of the antibiotics to more patients globally and maximise the potential of the late-stage, small molecule antibiotics business

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AstraZeneca and Lilly receive FDA Fast Track designation for AZD3293, an investigational treatment for early Alzheimer’s disease

Pressmeddelanden   •   Aug 22, 2016 12:03 CEST

AZD3293 is an oral potent small molecule BACE inhibitor in Phase III development

AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. The FDA’s Fast Track programme is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca, said: “The Fast Track Designation in the US for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE Alliance to advance science for patients and their families managing this devastating illness. BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”

Phyllis Ferrell, Vice President and Global Development Leader for Alzheimer’s disease at Lilly, said: “We are pleased the FDA places a high priority on the development of drugs that target Alzheimer’s disease, one of the most critical health issues of our time. Most importantly, this is a positive step forward for the millions of patients, families, caregivers, advocates and healthcare providers who fight every day for progress.”

In addition to the continuing AMARANTH Phase II/III study, AstraZeneca and Lilly have also announced the planned initiation of a second Phase III trial for AZD3293. The trial, called DAYBREAK-ALZ, studies the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia, and began enrolling participants in the third quarter of 2016.

AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer’s 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 amyloid beta.Inhibiting BACE is expected to prevent the formation and build-up of amyloid plaque which in turn may help slow the progression of the disease.

– ENDS –

NOTES TO EDITORS

About the AstraZeneca and Lilly BACE Alliance

AstraZeneca and Lilly announced an alliance in 2014 for the development and commercialisation of AZD3293. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca’s Neuroscience Research and Development Team, 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.

About Alzheimer's disease

Alzheimer's disease is a fatal illness and is the most common form of dementia, accounting for 60 to 80 percent of cases.[1] There are currently an estimated 46 million people living with dementia worldwide, and this number is expected to exceed than 74 million in 2030 and 131 million in 2050.[2] Only 50 percent of people with dementia ever receive a formal diagnosis,[3] and Alzheimer's disease continues to be one of the most significant health challenges facing the world. The total estimated worldwide cost of dementia in 2015 was $818 billion.2 By 2018, dementia will become a trillion dollar disease, rising to $2 trillion by 2030.2

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 newsroom.lilly.com/social-channels.

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 and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. 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

[1] Alzheimer's Association. 2016 Alzheimer's Disease Facts and Figures. Alzheimer's & Dementia. 2016; 12(4).

[2] Prince M, et al. World Alzheimer Report 2015: The Global Impact of Dementia, An Analysis of Prevalence, Incidence, Cost and Trends. Alzheimer's Disease International. August 2015.

[3] Department of Health. Dementia – a state of the nation report on dementia care and support in England. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/262139/Dementia.pdf [Last accessed July 2015]

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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. The FDA’s Fast Track programme is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

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AstraZeneca announces investment in Moderna

Pressmeddelanden   •   Aug 10, 2016 16:30 CEST

This announcement contains inside information, 10 August 2016 14:35

AstraZeneca today announced that it has increased its equity interest in Moderna Therapeutics (Moderna) with a $140 million investment as part of Moderna’s preferred-stock financing.

AstraZeneca previously acquired an equity stake in Moderna following a collaboration agreement, announced in March 2013, to develop messenger RNA medicines for the potential treatment of selected areas of cardiovascular, metabolic and renal diseases as well as oncology. AstraZeneca and Moderna also entered into a further collaboration agreement in January 2016, to discover, co-develop and co-commercialise medicine candidates for the treatment of a range of cancers.

As a result of today’s investment, AstraZeneca’s ownership of Moderna will be approximately 9% on a fully diluted basis. The additional contribution will be recorded as an equity securities investment.

About Moderna Therapeutics

Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of diseases and conditions. Moderna is developing and plans to commercialize its innovative mRNA drugs through its own ventures and its strategic relationships with established pharmaceutical and biotech companies. Its current ventures are: Onkaido, focused on oncology, Valera, focused on infectious diseases, Elpidera, focused on rare diseases, and Caperna, focused on personalized cancer vaccines. Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca, Alexion Pharmaceuticals, Merck and Vertex Pharmaceuticals. To learn more, visit www.modernatx.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 & Autoimmunity, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. 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 BurrowsUK/Global+44 203 749 5637
Vanessa RhodesUK/Global+44 203 749 5736
Karen BirminghamUK/Global+44 203 749 5634
Rob SkeldingUK/Global+44 203 749 5821
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+1 302 885 2677
Investor Relations
UK
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Adrian Kemp

Company Secretary

AstraZeneca PLC

-ENDS-

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/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca today announced that it has increased its equity interest in Moderna Therapeutics (Moderna) with a $140 million investment as part of Moderna’s preferred-stock financing.

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Kontaktpersoner 3 kontaktpersoner

  • Presskontakt
  • Extern kommunikationsdirektör
  • jamyzgcob.rhlayurjluyynd@awrjnstrazeneca.com
  • 08 553 260 20 Mobil: 072 560 21 57

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 huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se