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AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada

Pressmeddelanden   •   Feb 20, 2017 08:16 CET

AstraZeneca to receive upfront payment and sustainable and ongoingsales-based income

Agreement expands the commercial potential of Zoladex in US and Canada

AstraZeneca today announced that it has entered into an agreement with TerSera Therapeutics LLC (TerSera) for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989.

TerSera will pay AstraZeneca $250 million upon completion. AstraZeneca will also receive sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of Product Sales. AstraZeneca will also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada.

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca said: “This agreement allows us to retain a significant share of the value of Zoladex in the US and Canada, while concentrating our resources on our innovative New Oncology medicines. It also ensures patients have continued access to Zoladex, with TerSera’s dedicated focus helping to expand the potential of this important medicine.”

Ed Fiorentino, Chairman and CEO of TerSera Therapeutics, said: “We are very pleased to be partnering with AstraZeneca, and investing in the future growth of Zoladex, which continues to be a mainstay of treatment for its indicated uses.”

Financial considerations

In 2016, Product Sales for Zoladex were $69 million in the US and Canada, and $816 million globally. AstraZeneca will continue to commercialise Zoladex in all markets outside the US and Canada. The transaction is expected to complete in the first quarter of 2017, subject to customary closing conditions. AstraZeneca will maintain a significant ongoing interest in Zoladex in the US and Canada through the sustainable and ongoing income from the upfront, milestone, quarterly sales-based and supply payments received from TerSera. The $250 million upfront, $70 million milestone payments and double-digit percentage quarterly sales-based payments received from TerSera will be reported as Externalisation Revenue in the Company’s financial statements.

The agreement does not include the transfer of any AstraZeneca employees or facilities and does not impact AstraZeneca’s financial guidance for 2017.

– ENDS –

NOTES TO EDITORS

About TerSera Therapeutics LLC

TerSera Therapeutics LLC acquires, develops and markets specialty pharmaceutical products with a focus on select therapeutic areas. Its mission is to provide products which truly make a difference for patients. For more information about TerSera Therapeutics, please visit www.tersera.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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Om AstraZeneca

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

​AstraZeneca to receive upfront payment and sustainable and ongoingsales-based income Agreement expands the commercial potential of Zoladex in US and Canada

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Updated durvalumab monotherapy data confirm results in urothelial bladder cancer

Pressmeddelanden   •   Feb 17, 2017 18:17 CET

AstraZeneca and its global biologics research and development arm, MedImmune, today announced updated efficacy and safety data for durvalumab in patients with locally-advanced or metastatic urothelial cancer (UC).

Updated results from the Phase I/II trial, presented at the 2017 ASCO Genitourinary Cancers Symposium, showed an objective response rate (ORR) of 20.4% in all evaluable patients (n=103) (95% confidence interval (CI): 13.1%, 29.5%) and 31.1% (95% CI: 19.9%, 44.3%) in patients whose tumours express PD-L1*. At the time of data cut-off, median overall survival (OS) was 14.1 months (95% CI: 4.7, not estimable).

David Berman, Senior Vice President, Head of Oncology Innovative Medicines at MedImmune, said: “The durable responses observed in this larger data set from Study 1108 confirm the promising efficacy we’ve already seen for durvalumab in patients with advanced bladder cancer. We are continuing to test durvalumab in combination with tremelimumab and as monotherapy in the bladder cancer 1st-line setting in our ongoing Phase III DANUBE trial.”

Durvalumab 10mg/kg was administered intravenously every two weeks for up to 12 months, and demonstrated a manageable safety profile among all patients (n=191). The most common adverse events (AEs) reported in 5% or more of patients were fatigue (19.4%), decreased appetite (9.4%), diarrhoea (8.4%), rash (7.3%), nausea (6.8%), arthralgia (5.8%), pyrexia (5.8%) and pruritus (5.2%). Grade 3 or 4 adverse events occurred in 6.8% of patients, and three patients discontinued treatment due to AEs.

Professor Thomas Powles, Director of Barts Cancer Centre, London, UK, said: “The clinical efficacy of durvalumab in patients with advanced UC is particularly encouraging. For the past three decades we’ve seen limited progress in therapy for bladder cancer patients, and there remains significant unmet need for new treatment options.”

In December 2016, AstraZeneca received FDA acceptance of review of the Biologics License Application (BLA) for durvalumab in patients with locally-advanced or metastatic urothelial carcinoma, whose disease has progressed during or after one standard platinum-based regimen and was granted Priority Review. The urothelial cancer cohort from Study 1108 formed the basis for the BLA submission, which follows the FDA’s Breakthrough Therapy Designation for durvalumab for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.

The combination of durvalumab and tremelimumab is also being studied in non-small cell lung cancer, head and neck squamous cell carcinoma, gastric cancer, pancreatic cancer, hepatocellular carcinoma and haematological malignancies. AstraZeneca currently has more than 30 ongoing durvalumab clinical trials in combination with other IO agents and targeted therapies.

– ENDS –

NOTES TO EDITORS

*PD-L1 expression was defined as 25% or more PD-L1 staining in tumour cells (TCs) or immune cells (ICs) as assessed through use of the Ventana® SP263 PD-L1 Assay.

About durvalumab

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.

Durvalumab is also being studied in the first line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which enrolled its first patient during the final quarter of 2015. Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in non-small cell lung cancer, head and neck squamous cell carcinoma, bladder, gastric, pancreatic, hepatocellular carcinoma and blood cancers.

AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments across multiple tumour types.

We are pursuing a comprehensive clinical trial programme that includes durvalumab (PD-L1) monotherapy and durvalumab in combination with tremelimumab (CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

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 six 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 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 Oncology; Respiratory, Cardiovascular & Metabolic Diseases; 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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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UK/Global

+44 203 749 5821

Jacob Lund

Sweden

+46 8 553 260 20

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Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
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Finance, Fixed Income, M&A

+44 7881 615 764

Henry Wheeler

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Mitchell Chan

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+1 240 477 3771

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+1 240 543 7970

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Om AstraZeneca

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

Updated Study 1108 data presented at ASCO GU demonstrate compelling clinical activity in patients that had previously progressed during or after one line of standard platinum-based chemotherapy

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Lynparza meets primary endpoint in phase III trial in BRCA-mutated metastatic breast cancer

Pressmeddelanden   •   Feb 17, 2017 08:03 CET

​Lynparza provided a statistically-significant improvement in progression-free survival compared to chemotherapy First positive randomised trial to evaluate the efficacy and safety of a PARP inhibitor beyond ovarian cancer

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Siliq (brodalumab) approved by the US FDA for adult patients with moderate-to-severe plaque psoriasis

Pressmeddelanden   •   Feb 16, 2017 13:05 CET

​Approval triggers $130 million milestone payment to AstraZeneca from US Partner Valeant Pharmaceuticals

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AstraZeneca leder nytt industriforskningscentrum för utveckling av målsökande biologiska läkemedel

Pressmeddelanden   •   Feb 07, 2017 17:41 CET

​Stiftelsen för strategisk forskning (SSF) satsar minst 75 miljoner kronor i ett AstraZeneca-samarbete om att paketera biologiska läkemedel i nanokapslar för att nå in i kroppens celler och bota svåra sjukdomar.

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AstraZeneca PLC:s resultatrapport för helåret och fjärde kvartalet 2016

Pressmeddelanden   •   Feb 02, 2017 08:04 CET

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Symbicort granted paediatric exclusivity in the US

Pressmeddelanden   •   Jan 26, 2017 11:03 CET

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AstraZeneca expands 1st-line lung cancer immuno-oncology programme opportunities

Pressmeddelanden   •   Jan 17, 2017 08:07 CET

Refined endpoints and statistical analysis plan in the Phase III MYSTIC trial China regulatory submission opportunity strengthened with the expansion of the Phase III NEPTUNE trial and the initiation of the new Asia-focused Phase III PEARL trial

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US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer

Pressmeddelanden   •   Dec 09, 2016 16:10 CET

​FDA grants priority review status with PDUFA set for Q2 2017

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

Pressmeddelanden   •   Dec 06, 2016 10:32 CET

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

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Om AstraZeneca

Om AstraZeneca

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