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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
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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

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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
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Thomas Kudsk Larsen+44 203 749 5712
Craig MarksFinance, Fixed Income, M&A+44 7881 615 764
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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
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

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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AstraZeneca provides update on phase III trial of selumetinib in non-small cell lung cancer

Pressmeddelanden   •   Aug 09, 2016 12:12 CEST


Selumetinib did not meet trial endpoint of progression-free survival in KRASm NSCLC patients.

AstraZeneca today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC).

The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “A randomised Phase II trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation-positive lung cancer. It is disappointing for patients that these results have not been confirmed in Phase III. We expect to present data at a forthcoming medical meeting. We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments.”

SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m2, on day one of every 21-day cycle).

Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.1

– ENDS –

NOTES TO EDITORS

About KRASm non-small cell lung cancer

KRAS is one of the most common genetic mutations in NSCLC, and is found in 30% of patients.2 Adenocarcinomas make up the majority of cases with KRAS mutations, which are less common in squamous cell NSCLC.2,3

KRAS mutations are associated with activation of the RAS-ERK signalling pathway, which drives tumour growth.3

About selumetinib (AZD6244, ARRY-142886)

Selumetinib is an oral, potent and highly selective MEK 1/2 inhibitor. MEK 1/2 are critical components of the RAS-ERK pathway, activation of which is implicated in driving cancer growth and progression, including in patients with KRASm NSCLC.4,5

AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. (NASDAQ: ARRY) in 2003.

In May 2016, selumetinib was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC), and AstraZeneca is committed to exploring its full potential, including in Phase III trials in patients with DTC and in a US National Cancer Institute-sponsored Phase II registration trial in patients with paediatric neurofibromatosis type 1.

About SELECT-1

SELECT-1 (NCT01933932) is a Phase III, double-blind, randomised, placebo-controlled trial. It is designed to assess the efficacy and safety of selumetinib (75 mg twice daily, given orally on a continuous schedule) in combination with docetaxel (75 mg/m2intravenously on day 1 of every 21-day cycle), compared with matched placebo in combination with docetaxel (same schedule) in 510 patients receiving 2nd-line treatment for KRASm locally advanced or metastatic NSCLC (stage IIIB-IV), confirmed by central testing of tumour tissue using the cobas® KRAS Mutation Test (Roche Molecular Systems).3

The primary endpoint is PFS, and secondary endpoints include OS, objective response rate (ORR), duration of response (DoR), and safety and tolerability.3

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 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.

References

1 U.S. National Library of Medicine. Genetics Home Reference: neurofibromatosis type 1. Published 5 July 2016. Available at https://ghr.nlm.nih.gov/condition/neurofibromatosis-type-1. Accessed 6 July 2016.

2Dearden S et al. Mutation incidence and coincidence in non small-celllung cancer: meta-analyses by ethnicity and histology (mutMap). Ann Oncol. 2013 Sep;24(9):2371-6.

3Jänne PAet al. Study design and rationale for a randomized, placebo-controlled, double-blind study to assess the efficacy and safety of selumetinib in combination with docetaxel as second-line treatment in patients with KRAS-mutant advanced non-small cell lung cancer (SELECT-1). Clin Lung Cancer 2016 Mar;17(2):e1-4

4 Davies BR, et al. AZD6244 (ARRY-142886), a potent inhibitor of mitogen-activated protein kinase/extracellular signal-regulated kinase kinase 1/2 kinases: mechanism of action in vivo, pharmacokinetic/pharmacodynamic relationship, and potential for combination in preclinical models. Mol Cancer Ther 2007;6:2209–19.

5 Roberts PJ, Stinchcombe TE. KRAS Mutation: Should We Test for It, and Does It Matter? J Clin Oncol 2013;31(8):1112–21.

CONTACTS

Media Enquiries
Neil BurrowsUK/Global+44 203 749 5637
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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

Selumetinib did not meet trial endpoint of progression-free survival in KRASm NSCLC patients.

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AstraZeneca PLC:s resultatrapport för första halvåret och andra kvartalet 2016

Pressmeddelanden   •   Jul 28, 2016 08:03 CEST

  • De totala intäkterna minskade som förväntat med 3%, vilket återspeglar en minskning i produktförsäljning med 2% och är drivet av patentutgångar, i synnerhet Crestor i USA. Merparten av intäkterna från externa samarbeten förväntas ligga under andra halvåret.
  • Redovisade FoU-kostnader och FoU-kostnader för kärnverksamheten ökade med 6% respektive 9%. Redovisade försäljnings- och administrationskostnader var stabila, försäljnings- och administrationskostnader för kärnverksamheten minskade med 5%, vilket stödjer vårt åtagande för helåret.
  • Rapporterad vinst per aktie minskade med 45% och påverkades negativt av omstruktureringskostnader i samband med det nyligen tillkännagivna besparingsprogrammet. Vinsten per aktie för kärnverksamheten minskade med 20%, vilket avspeglar att merparten av intäkterna från externa samarbeten förväntas ligga under andra halvåret.
  • En oförändrad utdelning för första halvåret på 0,90 USD
  • Oförändrad prognos för helåret 2016

Affärsverksamheten i sammandrag

  • Tillväxtplattformarna ökade med 7% under det första halvåret. Bland de sex plattformarna:
  • Tillväxtmarknader: +7%. Lovande tillväxt i Kina med 11%
  • Diabetes: +18%. Ett bra resultat som bygger på framgångarna med Farxiga
  • Andningsvägar: +1%. Stark försäljning på tillväxtmarknaderna av Symbicort, prispress i USA och Europa
  • Ny onkologi: Försäljning på 251 MUSD speglade den framgångsrika, pågående lanseringen av Tagrisso

Uppnå ledarskap inom forskningen: Framsteg sedan föregående resultatrapport

Myndighetsgodkännanden/villkorade godkännanden

  • Qtern (saxagliptin/dapagliflozin) – diabetes typ 2 (EU)
  • Zavicefta (tidigare CAZ AVI) – allvarliga infektioner (EU)
  • Pandemic Live Attenuated Influenza Vaccine (P/LAIV)– pandemisk influensa (EU)*

Accepterande av ansökningar om registrering

  • saxagliptin/dapagliflozin (USA) förnyad ansökan om registrering

Positiva övergripande resultat från fas III-studier

  • benralizumab – allvarlig astma
  • Faslodex – bröstcancer (första linjens behandling)
  • Tagrisso – lungcancer (andra linjens behandling)

Övriga viktiga framsteg

  • Särläkemedelsstatus: selumetinib – sköldkörtelcancer (USA)
  • Snabbfilsstatus: Lynparza – andra linjens behandling av äggstockscancer (USA)

Pascal Soriot, koncernchef, kommenterade resultatet:

”Våra resultat under det första halvåret ligger i linje med förväntningarna och speglar de förutsedda utmaningarna i närtid kring patentutgångar samt infasningen av intäkterna från externa samarbeten under 2016. Våra tillväxtplattformar fortsatte att öka och utgjorde över 60% av de totala intäkterna. Viktigt är också att vår transformerade forskningsportfölj utvecklas snabbt och levererar ett rikt flöde av nya, differentierade läkemedel, vilket bådar gott för vår återgång till tillväxt.

Vid sidan av uppmuntrande resultat för vårt första potentiella biologiska läkemedel för sjukdomar i andningsvägarna, benralizumab och för Tagrisso i andra linjens behandling av lungcancergynnas vi av den mycket snabba patientrekryteringen till våra program inom immuno-onkologi för kombinationen durvalumab-tremelimumab. Detta starka vetenskapliga momentum kommer att fortsätta, särskilt inom immuno-onkologi där vi förväntar avgörande data”

Prognos för helåret 2016

Prognoserna för helåret 2016 är oförändrade och visas i fasta valutakurser1.

Totala intäkter En låg till medelhög ensiffrig procentuell nedgång
Vinst per aktie för kärnverksamheten En låg till medelhög ensiffrig procentuell nedgång

Ovanstående prognos innefattar effekterna från transaktionerna med Acerta Pharma B.V. (Acerta Pharma) och ZS Pharma, Inc. (ZS Pharma) som tillkännagavs i rapporten för helåret 2015.

Intäkterna från externa samarbeten förväntas öka jämfört med budgetåret 2015, inklusive ett inslag av återkommande intäkter från tidigare avtal. Detta är i linje med företagets långsiktiga affärsmodell som innefattar externa samarbeten som en del i portföljstyrningsstrategin.

Aktiviteter från externa samarbeten, ett resultat av en ökad FoU-produktivitet samt fokus på tre terapiområden, avser specifika strategiska risk- och vinstdelningssamarbeten. De breddar, accelererar och maximerar utvecklings- och kommersialiseringspotentialen för ett antal av företagets läkemedel. Initiala intäkter, intäkter baserade på vissa på förhand bestämda milstolpar samt försäljningsrelaterade intäkter inkluderas i företagets resultatrapport i form av intäkter från externa samarbeten. Intäkterna kommer att redovisas som intäkter från externa samarbeten där AstraZeneca behåller ett betydande löpande intresse i det potentiella eller lanserade läkemedlet.

FoU-kostnader för kärnverksamheten förväntas ligga på en liknande nivå som under helåret 2015. Företaget är inriktat på att avsevärt minska försäljnings- och administrationskostnaderna för kärnverksamheten under helåret 2016 jämfört med föregående år. Dessa åtgärder baseras på fasta valutakurser.

Bolaget presenterar prognos för vinst per aktie för kärnverksamheten. Det går inte att ge en prognos baserad på redovisad/GAAP-basis, eftersom bolaget inte med säkerhet kan förutse väsentliga delar av redovisat/GAAP resultat, inklusive justeringar till verkligt värde av skulder relaterade till förvärv, nedskrivningar av immateriella tillgångar och avsättningar vid juridiska uppgörelser.

Valutakurseffekter helåret 2016

Baserat på genomsnittliga valutakurser under första halvåret och företagets publicerade valutakurskänslighet förväntas det nu bara bli en minimal negativ påverkan på de totala intäkterna för helåret 2016 från valutarörlighet. Vinsten per aktie för kärnverksamheten förväntas nu gynnas av valutarörlighet med en låg till medelhög ensiffrig procentsats jämfört med föregående år. Ytterligare detaljer om valutakänsligheter framgår av Operating and Financial Review i den fullständiga resultatrapporten.

Forskningsportföljen: kommande större nyheter

Innovation är avgörande för att tillgodose stora patientbehov och är något som ligger i centrum för företagets tillväxtstrategi. Vårt fokus på forskning och utveckling är utformat för att ge starka resultat för forskningsportföljen.

Andra halvåret 2016

benralizumab – allvarlig astma: ansökan om registrering (USA, EU)

brodalumab – psoriasis: myndighetsbeslut (USA)

Brilinta – perifer artärsjukdom (PAD): övergripande resultat

  • ZS-9 – hyperkalemi: förnyad ansökan om registrering (USA)
  • roxadustat – anemi: rullande inlämning av ansökan om registrering (Kina)

  • Lynparza – bröstcancer: övergripande resultat
  • Lynparza – äggstockscancer (andra linjens behandling): övergripande resultat
  • Tagrisso – lungcancer: ansökan om registrering (Kina)
  • cediranib – äggstockscancer: myndighetsbeslut (EU)
    selumetinib – lungcancer: övergripande resultat
  • durvalumab – cancer i huvud och hals (HAWK): övergripande resultat (fas II)*
  • acalabrutinib – blodcancer: Övergripande resultat, ansökan om registrering (USA) (fas II)*

Första halvåret 2017

brodalumab: myndighetsbeslut (EU)

Brilinta – perifer artärsjukdom (PAD): ansökan om registrering

saxagliptin/dapagliflozin – diabetes typ 2: myndighetsbeslut (USA)

ZS-9 – hyperkalemi: myndighetsbeslut (EU)

Lynparza – bröstcancer: ansökan om registrering

Lynparza – äggstockscancer (andra linjens behandling): ansökan om registrering

  • selumetinib – lungcancer: ansökan om registrering
  • durvalumab – cancer i huvud och hals (HAWK): ansökan om registrering (USA) (fas II)*

durva + treme – cancer i huvud och hals (CONDOR): övergripande resultat, ansökan om registrering (USA) (fas II)*

durva + treme – lungcancer (MYSTIC): övergripande resultat

durva + treme – lungcancer (ARCTIC): övergripande resultat

Andra halvåret 2017

  • tralokinumab – allvarlig astma: övergripande resultat
  • roxadustat – anemi: övergripande resultat (AstraZeneca-sponsrad studie)
  • Lynparza – äggstockscancer (första linjens behandling): övergripande resultat, ansökan om registrering
  • Tagrisso– lungcancer (första linjens behandling): övergripande resultat
  • durvalumab – lungcancer (PACIFIC) övergripande resultat, ansökan om registrering (USA)
  • durva + treme – lungcancer (MYSTIC): ansökan om registrering
  • durva + treme – lungcancer (ARCTIC): ansökan om registrering
  • durva + treme – cancer i huvud och hals (KESTREL): övergripande resultat
  • moxetumumab – leukemi: övergripande resultat

Termen ”övergripande resultat” i detta avsnitt avser övergripande resultat från fas III, om inget annat anges.

*Potentiell snabb marknadslansering inför randomiserade, kontrollerade studier.

Den fullständig resultatrapporten på engelska finns som bifogad PDF-fil.

Noter

1.Samtliga tillväxttal anges i fasta valutakurser (CER) om inte annat anges.

2.Se Operating and Financial Review i den fullständiga resultatrapporten för en definition av de ekonomiska måtten för kärnverksamheten och en avstämning av de ekonomiska måtten mellan kärnverksamheten och redovisat resultat

Presentation av resultaten

En telefonkonferens för investerare och analytiker, anordnat av ledningen, börjar klockan 13.00 CET idag. Detaljer fås via www.astrazeneca.com/investors.

Rapporteringskalender

Företaget kommer att publicera resultaten för det tredje kvartalet den 10 november 2016.

About 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. Företaget är också aktivt inom inflammation, infektion och neurovetenskap genom ett antal samarbeten. AstraZeneca bedriver verksamhet i över 100 länder och dess innovativa läkemedel används av miljontals patienter över hela världen. För mer information: www.astrazeneca.com.

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Neil Burrows Storbritannien/Globalt +44 203 749 5637
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USA
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771

Adrian Kemp

Company Secretary

AstraZeneca PLC

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

De totala intäkterna minskade som förväntat med 3%, vilket återspeglar en minskning i produktförsäljning med 2% och är drivet av patentutgångar, i synnerhet Crestor i USA. Merparten av intäkterna från externa samarbeten förväntas ligga under andra halvåret.

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AstraZeneca’s antibiotic Zavicefta met primary endpoints in phase III trial for treatment of hospital-acquired pneumonia

Pressmeddelanden   •   Jul 21, 2016 08:14 CEST

AstraZeneca today announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant to current antibiotics commonly used for serious infections, such as carbapenems and polymixins, including colistin.

The REPROVE trial assessed the efficacy of Zavicefta (ceftazidime-avibactam) compared with meropenem in the treatment of adult patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). Zavicefta met the primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). All-cause mortality rate at day 28 from randomisation was also similar in the two groups. Safety observed in the trial was consistent with the known safety profiles of both antibiotics. Full results from REPROVE are expected to be presented at future scientific meetings.

Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit, said: “The positive results from this important Phase III trial validate our science-led approach and confirm the effectiveness of Zavicefta in treating hospital-acquired pneumonia, providing patients and physicians with a much-needed new treatment option in the fight against antibiotic-resistant pathogens.”

On 24 June 2016, Zavicefta was approved by the European Commission for intravenous use in the treatment of adult patients suffering from HAP, including VAP, as well as: Complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.

– ENDS –

NOTES TO EDITORS

About REPROVE

REPROVE is a Phase III, randomised, multi-centre, double-blind, double-dummy, parallel-group, comparative trial to determine the efficacy, safety and tolerability of ceftazidime-avibactam administered intravenously as a two-hour infusion (2000 mg / 500 mg, every 8 hours, compared to meropenem, administered intravenously as a 30 minute infusion (1000 mg every 8 hours). A total of 879 patients were randomised to the REPROVE trial from 23 countries.

The primary endpoint was assessed in the clinically modified intent-to-treat (cMITT) and clinically evaluable (CE) trial populations. The cMITT population consists of all patients dosed who met clinical disease criteria, had microbiologically confirmed Gram-negative respiratory pathogens (with or without concomitant Gram-positive pathogens) and in whom no specific, disease-causing (e.g. etiologic) pathogens were identified. Patients with infections caused by Gram-negative pathogens not expected to respond to either trial drug were excluded from the cMITT analysis. The CE population consists of patients who met the cMITT criteria and also had an evaluable assessment, no important protocol deviations that would affect efficacy, received adequate treatment and received no unacceptable prior/concomitant antibiotics.

The non-inferiority margin was 12.5%.

About Zavicefta

Zavicefta (ceftazidime-avibactam) 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 is a first-in-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D β-lactamases.

Zavicefta offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range Enterobacteriaceae species, including those that produce ESBL and KPC, together with activity against difficult-to-treat P. aeruginosa.

Zavicefta has previously demonstrated non-inferiority to comparators in Phase III trials in hospitalised adult patients with cIAI (RECLAIM 1 and 2) and cUTI (RECAPTURE 1 and 2). In addition, Zavicefta demonstrated statistically significant superior efficacy compared to doripenem for the European Medicines Agency-specified primary endpoint in the RECAPTURE trials. In the REPRISE trial, which evaluated the efficacy and safety of Zavicefta in patients with cIAI or cUTI infections caused by ceftazidime-resistant Gram-negative pathogens, efficacy was similar to best available treatment, and substantially higher microbiological cure rates were observed in cUTI patients treated with Zavicefta.

Ceftazidime-avibactam is being jointly developed by AstraZeneca and Allergan. AstraZeneca holds the global rights to commercialise Zavicefta, with the exception of North America, where the rights are held by Allergan.

About Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)

Hospital-acquired pneumonia (HAP), also known as nosocomial pneumonia, refers to the development of lung infections after a patient has been hospitalised for a minimum of 48 hours. If, after 48 hours, the infection develops during the use of intubation and mechanical ventilation, the condition is then called ventilator-associated pneumonia (VAP).

VAP is generally a severe illness, with patients requiring treatment in the intensive care unit (ICU). Some non-intubated patients with HAP can have either mild or more severe pneumonia.

Nosocomial pneumonia and HAP have similar clinical characteristics and the terms are often used interchangeably.

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 BurrowsUK/Global+44 203 749 5637
Vanessa RhodesUK/Global+44 203 749 5736
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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

AstraZeneca today announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients.

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ASTRAZENECA RECEIVES APPROVAL IN THE EU FOR QTERN (SAXAGLIPTIN AND DAPAGLIFLOZIN) FOR TREATMENT OF TYPE 2 DIABETES

Pressmeddelanden   •   Jul 19, 2016 15:38 CEST

ASTRAZENECA RECEIVES APPROVAL IN THE EU FOR QTERN (SAXAGLIPTIN AND DAPAGLIFLOZIN) FOR TREATMENT OF TYPE 2 DIABETES

19 July 2016

AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.

Qtern is indicated for adults with type 2 diabetes aged 18 years and older to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Qtern alone do not provide adequate control, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca said: “Nearly half of all people with type 2 diabetes are unable to reach their treatment goal and so risk developing complications due to hyperglycaemia. Qtern is the first combination product of its kind approved in Europe and an important new treatment option to help patients reach their goals through powerful HbA1c reduction.”

The approval is based on data from three trials in type 2 diabetes submitted to the European Medicines Agency. In two trials, the combination of saxagliptin and dapagliflozin with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo. An additional trial showed that the combination of saxagliptin and dapagliflozin added to metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with saxagliptin or dapagliflozin alone added to metformin. In these trials, the safety profile of Qtern was similar to the known safety profiles of saxagliptin and dapagliflozin.

– ENDS –

NOTES TO EDITORS

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. Our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.

As a main 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 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
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

AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.

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Tagrisso met primary endpoint in Phase III 2nd-line lung cancer trial

Pressmeddelanden   •   Jul 18, 2016 08:03 CEST

Tagrisso demonstrated superior progression-free survival compared to standard platinum-based chemotherapy,with a safety profile consistent with previous trials

First randomised trial to evaluate the clinical benefit of an EGFR T790M medicine, and data are consistent with those supporting Tagrisso approvals

AstraZeneca today announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials.

In addition to PFS, the objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) also achieved clinically meaningful improvement versus chemotherapy. A full evaluation of AURA3 data, including an analysis of overall survival (OS), is ongoing, and results will be presented at an upcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer. We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need.”

Tagrisso is one of the fastest development programmes ever, from start of clinical trials to approval in just over two and a half years. It was approved in the US, EU, Japan, Canada, Switzerland, Israel and Mexicoas the first treatment for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also approved in South Korea in the same indication. Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumour.

AstraZeneca is committed to exploring the full potential of Tagrisso as monotherapy and in combination, for patients with lung cancer, including in adjuvant and locally-advanced/ metastatic 1st-line EGFRm settings. In addition, AstraZeneca is exploring Tagrisso in NSCLC patients with and without brain metastases, and has presented encouraging data in a small cohort of patients with leptomeningeal disease.

NOTES TO EDITORS

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined. Patients who have the EGFRm form of NSCLC, which occurs in 10-15% of NSCLC patients in the US and Europeand 30-40% of NSCLC patients in Asia,are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two-thirds of patients treated with approved EGFR-TKIs such as gefitinib and erlotinib, this resistance is caused by the secondary mutation, T790M.

About Tagrisso

Tagrisso (osimertinib, AZD9291) 80mg once-daily tablet is the first medicine indicated for the treatment of adult patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is as an irreversible EGFR inhibitor, born out of scientific exploration and engineered to combat the mechanism of resistance by targeting the T790M resistance mutation.

Tagrisso is also being investigated in the adjuvant and metastatic 1st-line settings, including in patients with and without brain metastases, in leptomeningeal disease, and in combination with other treatments.

About AURA3

AURA3 compared the efficacy and safety of Tagrisso 80mg once daily and platinum-based doublet chemotherapy in 419 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC whose disease had progressed on or after treatment with a previous EGFR-TKI. The trial was carried out in more than 130 locations worldwide, including the USA, Canada, Europe, China, Japan, Korea, Taiwan and Australia.

The primary endpoint of the trial was PFS, and secondary endpoints included OS, ORR, DoR, DCR, safety and measures of health-related quality of life (HRQoL).

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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 and Autoimmunity +44 203 749 5716
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Infection and Neuroscience +44 203 749 5711
US
Lindsey Trickett Cardiovascular and 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

Tagrisso demonstrated superior progression-free survival compared to standard platinum-based chemotherapy,with a safety profile consistent with previous trials First randomised trial to evaluate the clinical benefit of an EGFR T790M medicine, and data are consistent with those supporting Tagrisso approvals

Läs vidare »
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Inbjudan till AstraZeneca och Läkartidningens seminarium i Almedalen om jämlik cancervård 4 juli 14.10-15.00

Pressmeddelanden   •   Jul 01, 2016 17:48 CEST

Inbjudan till seminarium i Almedalen

Hur får vi en jämlik cancerbehandling i Sverige - och hur kan ”ordnat införande” bidra?

Tid: Måndag 4 juli, 2016, 14.10-15.00

Arrangör: AstraZeneca Nordic-Baltic

Plats: Läkartidningens tält, plats 508. Strandvägen 2, i rondellen nära kajen.

Vilka utmaningar och möjligheter finns för introduktion av nya cancerbehandlingar idag? Hur har processen med så kallat nationellt ordnat införande* förändrat vår förmåga att jämlikt kunna erbjuda nya behandlingar, över hela landet? Vilka är lärdomarna kring introduktionen? Hur ser uppföljningen ut, och hur fungerar den? Hur vill vi ha det om 5 år?

Dessa frågeställningar vill vi diskutera i Almedalen med representanter från hälso-och sjukvården,

beslutsfattare, patientrepresentanter och andra intressenter.

Deltagare i panelen:

Moderator: Pär Gunnarsson, Chefredaktör Läkartidningen

Maria Landgren, Läkemedelschef, Region Skåne, medlem i NT rådet

Jonas Andersson, (L) Västra Götalandsregionen, SKL

Katarina Johansson, Ordförande Nätverket mot cancer

Per Karlsson, professor och överläkare i Onkologi, Sahlgrenska Universitetssjukhuset

Karolina Antonov, Läkemedelsindustriföreningen (LIF)

För ytterligare information kontakta: petra.eurenius@astrazeneca.com, mobil: 0709 186562

Varmt välkommen!

AstraZeneca Nordic-Baltic

* Nationellt ordnat införande av läkemedel (definition): Syftet är att åstadkomma en kostnadseffektiv och ändamålsenlig användning av nya läkemedel, för alla patienter, i hela landet.

978.806,011 15,2016 SE

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

Hur får vi en jämlik cancerbehandling i Sverige och hur kan ”ordnat införande” bidra? Vilka utmaningar och möjligheter finns för introduktion av nya cancerbehandlingar idag? Hur har processen med nationellt ordnat införande förändrat vår förmåga att jämlikt kunna erbjuda nya behandlingar, över hela landet? Vilka är lärdomarna? Hur ser uppföljningen ut? Hur vill vi ha det om 5 år?

Läs vidare »

Kontaktpersoner 3 kontaktpersoner

  • Presskontakt
  • Extern kommunikationsdirektör
  • jacob.lund@astrazeneca.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