|
23 December 2003
EXANTA™ (XIMELAGATRAN) REGULATORY FILINGS SUBMITTED IN UNITED STATES (US) AND EUROPEAN UNION (EU) FOR KEY CHRONIC INDICATIONS |
AstraZeneca has submitted Exanta™ the first oral direct thrombin inhibitor, for regulatory review in the EU and US in key chronic-use indications. In the US, submissions have been made to the Food and Drug Administration (FDA) for Exanta in the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF) and long-term secondary prevention of venous thromboembolism (VTE), after standard treatment for an episode of acute VTE. In Europe, regulatory submissions have been made to the Reference Member State, France, as part of the Mutual Recognition Procedure for use of Exanta in prevention of stroke and other thromboembolic complications associated with AF and the treatment of VTE.
|
 |
23 December 2003
EXANTA™ (XIMELAGATRAN) RECEIVES FIRST APPROVAL |
First indication for prevention of venous thromboembolic events in major orthopaedic surgery
AstraZeneca has received its first regulatory approval for Exanta™ (ximelagatran) in France for the prevention of venous thromboembolic events in major orthopaedic (hip or knee replacement) surgery. France is the Reference Member State for the European Union (EU) Mutual Recognition Procedure for Exanta. Subject to approval, launches of Exanta in this first ‘proof of principle’ indication are expected to take place later in 2004.
|
|
19 December 2003
ASTRAZENECA AND ARRAY BIOPHARMA ANNOUNCE ONCOLOGY COLLABORATION |
Phase I Clinical Trial on Array’s Lead MEK Inhibitor Targeted for 2004
AstraZeneca and Array BioPharma today announced a licensing and collaboration agreement to develop Array’s MEK programme in the field of oncology. The programme includes the clinical development candidate (ARRY-142886) and related intellectual property.
|
|
12 December 2003
ASTRAZENECA PRILOSEC® PATENTS UPHELD BY FEDERAL APPEALS COURT |
AstraZeneca today announced that a three judge panel of the United States Court of Appeals for the Federal Circuit upheld the October 2002 decision by U.S. District Court Judge Barbara S. Jones, finding that Andrx, Genpharm and Cheminor infringed AstraZeneca’s patents for Prilosec® (omeprazole), and that the two formulation patents are not invalid. The Court also upheld the judgment that Kudco’s formulation did not infringe.
|
|
11 December 2003
EUROPEAN COURT JUDGMENT DOES NOT SUPPORT ASTRAZENECA IN OMEPRAZOLE PATENT CASE |
AstraZeneca today announced that the European Court of Justice had ruled against its arguments in a case relating to the duration of patent protection for omeprazole, the active ingredient in Losec, the anti-secretory treatment.
|
|
9 December 2003
FURTHER DATA SUPPORTS SAFETY AND EFFICACY OF ORAL DIRECT THROMBIN INHIBITOR, EXANTA™ (XIMELAGATRAN) IN PREVENTION OF VENOUS THROMBOEMBOLISM |
AstraZeneca today announced further evidence to support the efficacy and safety profile of Exanta™ (ximelagatran), following a presentation at the American Society of Haematology (ASH) Annual Meeting 2003, San Diego, US
|
|
9 December 2003
ASTRAZENECA SUBMITS REGULATORY APPLICATION FOR SYMBICORT® TURBUHALER® FOR THE MANAGEMENT OF ASTHMA WITH ONE SINGLE INHALER (SYMBICORT® SINGLE INHALER THERAPY) |
AstraZeneca announced today the submission of an EU regulatory application for the new asthma treatment concept Symbicort® Single inhaler Therapy (SiT). Symbicort® SiT is the management of persistent asthma with a single inhaler, Symbicort® Turbuhaler®. This new treatment concept is a further development of Symbicort® adjustable maintenance dosing, which has already shown overall better asthma control than treatment with a higher average fixed maintenance dose. Symbicort® Single inhaler Therapy, once approved, will make asthma treatment more effective and simpler for both the physician and the patient.
|
|
3 December 2003
ARIMIDEX™ CHALLENGES TAMOXIFEN AS STANDARD ADJUVANT THERAPY IN POSTMENOPAUSAL WOMEN WITH EARLY BREAST CANCER |
New data, announced today at the San Antonio Breast Cancer Symposium, USA, questions the role of tamoxifen as standard adjuvant therapy for postmenopausal women with hormone-sensitive early breast cancer. The ITA (Intergruppo Tamoxifen Anastrozole) Trial data suggests that patients who change their adjuvant therapy from tamoxifen to ‘ARIMIDEX’™ after two - three years, are less likely to experience a return of breast cancer than those who complete a five year course of tamoxifen. In addition, those patients who change to ‘ARIMIDEX’™, experience significantly fewer serious side effects than those who remain on tamoxifen.
|
|
2 December 2003
ASTRAZENECA COMMITS TO PARTNERING WITH INNOVATIVE EDUCATIONAL PROGRAMME AND SUPPORTING CHINA’S HEALTHCARE REFORM OVER THE LONG TERM |
AstraZeneca today announced a collaboration with Peking University’s (PKU) Guanghua School of Management (GSM) to fund the China Center for Pharmacoeconomics and Outcomes Research (CCPOR) in a series of research and educational programmes aimed at supporting reform of China’s healthcare system.
|
|
21 November 2003
POSITIVE OPINION GIVEN ON APPROVABILITY OF FASLODEX™ (FULVESTRANT) IN EUROPEAN UNION (EU) |
AstraZeneca announced today that it has received a positive opinion on EU marketing approval of its breast cancer therapy Faslodex™ (fulvestrant) from the Committee for Proprietary Medicinal Products (CPMP), scientific advisory body to the European Commission. The CPMP concluded that, on the basis of the quality of safety and efficacy data submitted, ‘there is a favourable risk balance for Faslodex and therefore recommends the granting of the marketing authorisation.’
|
|
17 November 2003
ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR HIGH DOSE RANGE OF SYMBICORT® TURBUHALER® |
AstraZeneca announced today that it has successfully completed the European Union Mutual Recognition Procedure for Symbicort® Turbuhaler®, which permits the use of an increased dose range in some patients with persistent asthma. National licences are expected to be issued throughout the EU over the coming months and will allow patients to use up to four inhalations twice daily of the 80/4.5mg and 160/4.5mg strengths (or two inhalations twice daily of the 320/9mg strength).
|
|
11 November 2003
NEW STUDY CONFIRMS POTENTIAL FOR EXANTA™ (ximelagatran) IN PREVENTION OF STROKE IN ATRIAL FIBRILLATION
|
AstraZeneca today announced the results from the SPORTIF V study at the American Heart Association (AHA) Scientific Sessions 2003, in Orlando, US. The data supports the potential for Exanta™ (ximelagatran), the first oral treatment in a new class of direct thrombin inhibitors (DTIs), to be an effective and predictable replacement for warfarin in the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), without the limitations of warfarin treatment.
|
|
30 October 2003
ASTRAZENECA RECEIVES FDA APPROVABLE LETTER FOR SEROQUEL™ (QUETIAPINE FUMARATE) TABLETS IN TREATMENT OF MANIA |
AstraZeneca today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its Supplemental New Drug Applications (sNDAs) for the use of SEROQUEL as both an adjunct and monotherapy for the treatment of manic episodes associated with bipolar disorder. The company is working closely with the FDA to supply information and to finalize labelling.
|
|
23 October 2003
ASTRAZENECA PLC THIRD QUARTER AND NINE MONTHS RESULTS |
“Strong quarter contributes to a 2 percent increase in nine months sales; Key growth products up 56 percent; Full year earnings expected at or just above top of forecast range."
|
|
16 October 2003
ASTRAZENECA AND ABGENIX ANNOUNCE STRATEGIC ALLIANCE TO DISCOVER AND DEVELOP ANTIBODY THERAPEUTICS FOR CANCER |
AstraZeneca makes $100 million upfront equity investment to broaden oncology research scope. Abgenix to receive milestone, royalty and collaboration payments.
London and Fremont, CA –AstraZeneca and Abgenix, Inc. (Nasdaq: ABGX) announced today that they have entered into a broad collaboration, license and investment alliance to discover, develop and commercialise fully human monoclonal antibodies to treat cancer.
|
|
13 October 2003
ASTRAZENECA RECEIVES EUROPEAN APPROVAL FOR SEROQUEL™ IN BIPOLAR MANIA |
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of SEROQUEL (quetiapine) to the treatment of mania associated with bipolar disorder (manic-depressive illness). SEROQUEL is also under review for bipolar mania in the United States with the Food and Drug Administration (FDA) and in the UK with the Medicines and Healthcare products Regulatory Agency (MHRA).
|
|
2 October 2003
ASTRAZENECA SET TO DELIVER TOP-TIER FINANCIAL PERFORMANCE THROUGH US MARKETING AND R&D SUCCESS |
CRESTOR and IRESSA US Launches Show Early Promise
London – 2 October 2003 – AstraZeneca is well positioned to compete in the dynamic, US marketplace where the demand for new, innovative medicines continues to be strong, the company’s executives reported today at its Annual Business Review.
|
|
11 September 2003
ASTRAZENECA SUBMITS NEXIUM® INTRAVENOUS FORMULATION TO FDA FOR REGULATORY APPROVAL |
AstraZeneca today announced submission of the new Nexium® (esomeprazole sodium) intravenous (i.v.) formulation for regulatory approval by the US Food and Drug Administration (FDA).
|
|
8 September 2003
NEW STUDY SHOWS SYMBICORT® ADJUSTABLE DOSING PROVIDES BETTER ASTHMA CONTROL THAN SERETIDE® FIXED DOSING |
AstraZeneca announced today that new data presented at the World Allergy Organization’s International Congress of Allergology and Clinical Immunology (ICACI) show that the rate of severe exacerbations is 40 per cent lower in asthma patients on Symbicort® adjustable dosing than in patients on Seretide® fixed dosing. These are the first head-to-head data on the two fastest growing brands in asthma treatment.
|
|
2 September 2003
LARGEST-EVER STROKE PREVENTION STUDY IN ATRIAL FIBRILLATION SHOWS POTENTIAL FOR EXANTA™ (XIMELAGATRAN) IN MAJOR INDICATION |
Latest data from the full presentation today of the SPORTIF III study at the European Society of Cardiology (ESC), Vienna, Austria, shows clinical benefit for Exanta (ximelagatran), the first in a new class of oral direct thrombin inhibitors (oral DTIs), compared with the current standard treatment, dose-adjusted warfarin, in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
|
|
1 September 2003
PHASE II STUDY DEMONSTRATES PROMISE FOR EXANTA™ (XIMELAGATRAN) IN REDUCING MAJOR CARDIOVASCULAR EVENTS FOLLOWING MYOCARDIAL INFARCTION (MI) |
ESTEEM* study indicates potential for Exanta in new cardiovascular indication
AstraZeneca announced today from the European Society of Cardiology (ESC) in Vienna, Austria, that data from a phase II dose-guiding study, ESTEEM*, indicate that oral Exanta™ (ximelagatran), provides significant additional benefits compared to the current treatment, aspirin, in prevention of major cardiovascular events in patients following an acute myocardial infarction (heart attack). This is the first time an oral direct thrombin inhibitor (oral DTI) has been evaluated in long-term treatment of patients following heart attack who are at high risk of arterial thrombotic events, such as further heart attack, stroke or cardiovascular death.
|
|
1 September 2003
NEW DATA DEMONSTRATES CLEAR BENEFITS OF ATACAND® IN TREATMENT OF SYMPTOMATIC HEART FAILURE |
Atacand®, the only Angiotensin Receptor Blocker to reduce cardiovascular death and hospitalisation in chronic heart failure when given together with conventional therapy
AstraZeneca announced today that data presented at the European Society of Cardiology annual meeting demonstrated Atacand® (candesartan cilexetil) reduces both cardiovascular deaths as well as hospital admissions for heart failure, across a broad spectrum of patients with chronic heart failure.
|
|
27 August 2003
ASTRAZENECA INTRODUCES INTRAVENOUS FORMULATION OF NEXIUM® (esomeprazole) IN FIRST MARKET - SWEDEN |
Offering New Hope to Patients Unable to Take Oral PPI Therapy
AstraZeneca announced today, after receiving its first approval from the Swedish Medical Products Agency (MPA), that it will launch the new intravenous (i.v.) formulation of the proton pump inhibitor (PPI) Nexium®, providing an opportunity for physicians to treat patients suffering from gastroesophageal reflux disease (GERD) who are unable to take oral therapy. Nexium® administered intravenously demonstrates the same efficacy as oral Nexium® – the first PPI to have shown superior control of gastric acid secretion compared with all other oral PPIs.
|
|
13 August 2003
CRESTOR® RECEIVES FDA APPROVAL |
CRESTOR Significantly Lowers LDL Cholesterol by As Much As 63%
AstraZeneca announced today that its new cholesterol-lowering medication, CRESTOR® (rosuvastatin calcium), which has been shown to lower LDL-cholesterol by up to 63 percent, has received approval from the U.S. Food and Drug Administration (FDA) as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. This follows the successful Advisory Committee Meeting held in the US on 9th July 2003 where the Committee voted unanimously to recommend the approval of CRESTOR.
|
|
8 August 2003
ASTRAZENECA TO SEEK TRIPLE DAMAGES IN PATENT INFRINGEMENT LAWSUIT AGAINST MYLAN PHARMACEUTICALS |
AstraZeneca announced today that it will amend its lawsuit against Mylan Pharmaceuticals to seek triple damages for the wilful and intentional infringement of AstraZeneca’s Prilosec® (omeprazole) formulation patents. In addition, AstraZeneca is filing suit to recover wilful infringement damages against Esteve Quimica, S.A. and Laboratorios Dr. Esteve, S.A., which are formulators of the Mylan omeprazole product. AstraZeneca reaffirms its commitment to vigorously defend its right to patent protection both in the remaining omeprazole patent infringement cases now pending in New York federal court, and in relation to the Schwarz/KUDCo formulation case now under appeal. The company will continue to monitor the situation closely and retains recourse to further legal action.
|
|
31 July 2003
ASTRAZENECA REFUTES PRELIMINARY FINDINGS OF EC OMEPRAZOLE INVESTIGATION |
AstraZeneca confirms that the European Commission has served a ‘Statement of Objections’ on the company, stating that in the Commission’s preliminary view AstraZeneca abused its dominant position with omeprazole (‘Losec’) in a number of European countries and that this would constitute an infringement of Article 82 of the EU Treaty. AstraZeneca intends to respond to the Statement and the company vigorously refutes any wrongdoing. In particular AstraZeneca will deny that it made misrepresentations before national patent offices or that it misused the rules and procedures applied by national medicines agencies.
|
|
24 July 2003
ASTRAZENECA PLC SECOND QUARTER AND HALF YEAR RESULTS 2003 |
“First half results ahead of expectations. Interim dividend increased by 10 percent. EPS targets for the year increased.”
|
|
18 July 2003
ASTRAZENECA DONATES £60,000 FOR MEDICAL TEXT BOOKS IN THE DEVELOPING WORLD |
AstraZeneca announced today that it will provide a £60,000, four-year grant to BookPower, a non-profit organisation which provides medical and nursing text books at a subsidised price to students in Africa. The AstraZeneca grant will be used to fund medical texts covering the subjects of Cardiology, Endocrinology, Gastroenterology, Immunology and Infection.
|
|
14 July 2003
EXANTA™(ximelagatran) SHOWS EFFICACY IN FIRST STUDY FOR TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) – SUPPORTS REGULATORY SUBMISSION |
AstraZeneca announced today that data from the THRIVE Treatment study show that Exanta™ (ximelagatran), the first in a new class of oral anticoagulants called oral direct thrombin inhibitors (oral DTIs), is as effective as the current standard of care treatment regimen, enoxaparin/warfarin, in the treatment of acute venous thromboembolism (VTE; deep vein thrombosis with or without pulmonary embolism) and secondary prevention of recurrent VTE events. Importantly, the six month long study, presented today at the XIX Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Birmingham, UK, also showed a favourable trend for Exanta in bleeding and mortality rates compared with the standard therapy regimen.
|
|
10 July 2003
FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF CRESTOR® (rosuvastatin calcium) |
AstraZeneca announced today that the Endocrinologic and Metabolic Advisory Committee to the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval for CRESTOR® (rosuvastatin calcium) as an adjunct to diet for the treatment of various lipid disorders including hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. The FDA will now review the Committee’s recommendation and make its final decision on granting marketing approval for CRESTOR.
|
|
1 July 2003
ASTRAZENECA PLC APPOINTS TWO NEW NON-EXECUTIVE DIRECTORS |
AstraZeneca PLC today announced that two new Non-Executive Directors are to join the Board of Directors with immediate effect.
|
|
23 June 2003
ASTRAZENECA ANNOUNCES ABSTRACT PUBLISHED ON
EXANTA™ (ximelagatran) IN THE TREATMENT OF VENOUS THROMBOEMBOLISM (VTE)
|
AstraZeneca today announced the publication of an abstract, which details the results from the phase III THRIVE Treatment study (1) for Exanta™ (ximelagatran), the first of a new class of oral direct thrombin inhibitor (oral DTI). The results of the THRIVE Treatment study will be presented at the XIX Congress of the International Society on Thrombosis and Haemostasis, on Monday 14 July 2003. The abstract is available online at: http://www.isth2003.co.uk/
Top line results include:
|
|
20 June 2003
ASTRAZENECA ANNOUNCES SETTLEMENT WITH U.S. GOVERNMENT ON ZOLADEX® INVESTIGATION |
AstraZeneca today announced the settlement of a multi-year investigation into US sales and marketing practices for Zoladex® (goserelin acetate implant), a treatment for prostate cancer.
|
|
16 June 2003
ASTRAZENECA OPENS NEW US$25M (£16M) PHARMACEUTICAL R&D FACILITY FOR INVESTIGATIONAL PRODUCTS AT MACCLESFIELD, CHESHIRE, UK
|
New research and development (R&D) facilities, worth around US$25 million (£16 million), were officially opened today at AstraZeneca’s Macclesfield site by the Company’s Executive VP Global Development, Dr Martin Nicklasson.
|
|
2 June 2003
ASTRAZENECA OPENS MULTI-MILLION DOLLAR INDIAN RESEARCH FACILITY TO FIND NEW TREATMENTS FOR TUBERCULOSIS |
AstraZeneca today opened a new multi-million dollar research facility in Bangalore, India, which will focus principally on finding new treatments for tuberculosis (TB), a disease which is diagnosed in about two million people every year in India and in more than eight million people worldwide, mostly in the developing world (WHO Report 2003). At the opening, Sir Tom McKillop, Chief Executive, AstraZeneca PLC, highlighted AstraZeneca’s unique commitment to India, which combines TB research and manufacturing capabilities, along with a strong presence in the Indian market.
|
|
2 June 2003
IRESSA™ (gefitinib) DEMONSTRATES CLINICAL ACTIVITY IN MULTIPLE TUMOUR TYPES |
AstraZeneca announced today that new data presented at the 39th American Society of Clinical Oncology Annual Meeting in Chicago demonstrate the potential of IRESSA™ (gefitinib, ZD1839) to have anti-tumour activity across a broad range of common cancers. Encouraging data from Phase ll trials in advanced colorectal cancer, non-small cell lung cancer (NSCLC), breast cancer and brain cancer support IRESSA’s current and future role as an efficacious anti-cancer agent that is generally well tolerated across all tumour types.
|
|
22 May 2003
ASTRAZENECA OPENS NEW US$145M (£90M) BULK MANUFACTURING FACILITIES FOR CRESTOR® AT AVLON WORKS, BRISTOL, UK |
New bulk drug manufacturing facilities, worth a total of around US$145 million (£90 million), were officially opened today at AstraZeneca’s Avlon Works near Bristol by the Company’s Deputy Chairman, Dr Håkan Mogren.
|
|
21 May 2003
NEW DATA SHOW SEROQUEL® TO BE AN EFFECTIVE, WELL-TOLERATED AND FAST-ACTING TREATMENT FOR MANIA IN BIPOLAR DISORDER |
AstraZeneca today announced new data, presented at the 156th annual meeting of the American Psychiatric Association (APA) in San Francisco, which indicate that SEROQUEL® (quetiapine) is effective, well tolerated and fast-acting when used as monotherapy for the treatment of mania associated with bipolar disorder.
|
|
21 May 2003
NEW DATA SHOW NEXIUM® RELIEVES NSAID RELATED UPPER GI SYMPTOMS IN PATIENTS WITHOUT ULCERS |
AstraZeneca announced today that new data, presented at the annual Digestive Diseases Week Meeting in Orlando, Florida, show that NEXIUM® (esomeprazole) is the first Proton Pump Inhibitor (PPI) proven to significantly relieve upper gastrointestinal (GI) symptoms in non-steroidal anti-inflammatory drug (NSAID) users without ulcers.
|
|
20 May 2003
CRESTOR® - NEW DATA AND REGULATORY UPDATE |
New Data
|
|
5 May 2003
ASTRAZENECA RECEIVES FDA APPROVAL FOR NEW CANCER DRUG IRESSA™ (gefitinib, ZD1839) |
IRESSA is the First in a New Class of Drugs for the Treatment of Advanced
Non-Small Cell Lung Cancer - Only FDA-Approved Option for Third Line Patients
|
|
1 May 2003
ASTRAZENECA RECEIVES AUSTRALIAN APPROVAL FOR IRESSA™ FOR ADVANCED NON-SMALL CELL LUNG CANCER - Second Approval for Novel Anti-cancer Treatment |
AstraZeneca announced today that the Australian Therapeutic Goods Administration has granted approval of IRESSA™ (gefitinib, ZD1839) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received treatment with chemotherapy. The decision in Australia represents the second approval world-wide for IRESSA— the first in a new class of anti-cancer drugs known as ‘Epidermal Growth Factor Receptor (EGFR) inhibitors’. IRESSA was approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of inoperable or recurrent NSCLC in July 2002 and is under review elsewhere, including the US Food and Drug Administration and the European Medicines Evaluation Agency.
|
|
30 April 2003
AstraZeneca PLC: Håkan Mogren to become Non-Executive Director |
AstraZeneca PLC announced today that Dr Håkan Mogren, currently Executive Deputy Chairman, will cease to be an Executive Director of the Company on 31 August 2003. With effect from that date, he will become Non-Executive Deputy Chairman.
|
|
30 April 2003
First Quarter Results 2003 |
Download the narrative
and the figures.
|
|
30 April 2003
ASTRAZENECA PLC - ANNUAL GENERAL MEETING : 30 APRIL 2003
|
AstraZeneca PLC announced the results of the polls taken at its Annual General Meeting today in respect of Items 5(e), 9 and 10 on the Agenda, as follows:
|
|
3 April 2003
ASTRAZENECA AND ADVENT INTERNATIONAL FORM STRATEGIC PARTNERSHIP |
AstraZeneca UK Limited announced today the initiation of a strategic relationship with Advent International Corporation for the purpose of identifying and evaluating emerging technologies in health care and life sciences. Representatives from AstraZeneca’s Discovery and Business Development groups will work closely with Advent’s Boston-based health care team in evaluating emerging opportunities and transactions with companies in the health care and life sciences industry.
|
|
2 April 2003
NEW CRESTOR® DATA AT ACC MEETING CONFIRM SUPERIOR PRODUCT PROFILE |
AstraZeneca today announced results from two international, large-scale clinical studies which further confirm that CRESTOR® (rosuvastatin) lowers LDL (or ‘bad’) cholesterol, raises HDL (or ‘good’) cholesterol, enabling more patients to achieve their cholesterol goals; better than the same and even some higher doses of other currently available treatments, including atorvastatin. Both studies, which add to the wealth of evidence in favour of CRESTOR, were presented at the American College of Cardiology (ACC) Congress in Chicago.
|
|
2 April 2003
NEW STUDY DEMONSTRATES THE POTENTIAL OF EXANTA™ (ximelagatran) FOR PREVENTION OF STROKE IN ATRIAL FIBRILLATION |
AstraZeneca today announced results from the first phase III stroke prevention data for Exanta™ (ximelagatran), the first of a new class of oral direct thrombin inhibitor (Oral DTI), presented at the 52nd Scientific Session of the American College of Cardiology (ACC), Chicago. The results show that fixed dose twice daily 36mg oral Exanta compares favourably with dose-adjusted warfarin in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), meeting the study’s primary efficacy endpoint.
|
|
1 April 2003
ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM® IN THE FIRST OF FOUR INDICATIONS FOR THE MANAGEMENT OF NSAID*-ASSOCIATED GI SIDE EFFECTS |
AstraZeneca today announced the submission of a regulatory application to the United States Food and Drug Agency (FDA) for the first of four indications within the NSAID-associated gastrointestinal (GI) side effect programme for NEXIUM®. This first indication is for the use of NEXIUM® for the treatment of upper GI symptoms in patients taking NSAIDs. Applications for the indication are also currently being filed in Europe and Canada.
|
|
24 March 2003
NEW DATA BEING PRESENTED ON CRESTOR AND EXANTA: IMPORTANT DIARY DATE
|
Data on two of AstraZeneca’s exciting new products,
Crestor
(rosuvastatin) and
Exanta
(ximelagatran), will be presented during the ACC (American College of Cardiology Congress).
|
|
15 March 2003
ASTRAZENECA LISTED IN BUSINESS IN THE COMMUNITY’S FIRST PUBLISHED CORPORATE RESPONSIBILITY INDEX |
AstraZeneca today announced that it has been listed as one of the top 20 companies in Business in the Community’s new Corporate Responsibility Index. This is the first business-led, voluntary index, publicly benchmarking the responsible business practice of a range of companies in different industry sectors. In addition, AstraZeneca improved its ranking in the Business in the Environment Index.
|
|
10 March 2003
SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR CRESTOR® IN EUROPE |
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in Europe for CRESTOR® (rosuvastatin) 10-40 mg for the management of primary hypercholesterolaemia and mixed dyslipidaemia. The Netherlands acted as the reference member state for the MR procedure, and CRESTOR has been launched in that market. National marketing authorisations in an additional 13 countries will be issued in the coming months.
|
|
3 March 2003
FIRST EUROPEAN LAUNCH FOR CRESTOR® IN THE NETHERLANDS |
AstraZeneca announced today it has launched CRESTOR® (rosuvastatin) 10-40 mg for the management of primary hypercholesterolaemia and mixed dyslipidaemia in the Netherlands, the first European market to launch CRESTOR.
|
|
27 February 2003
ASTRAZENECA ISSUES 2002 ANNUAL REPORT
|
AstraZeneca today published its Annual Report and Form 20-F for 2002. The document is available on our website. Download report
|
|
19 February 2003
ASTRAZENECA’S NEW STATIN, CRESTOR™, RECEIVES APPROVAL IN CANADA - COMPANY INTENDS IMMEDIATE LAUNCH |
AstraZeneca announced today it has received approval for CRESTOR™ (rosuvastatin) 10-40 mg from the Therapeutic Products Directorate of Health Canada for the management of primary hypercholesterolaemia, mixed dyslipidaemia, and familial hypercholesterolaemia in Canada. The company will launch CRESTOR in Canada immediately.
|
|
18 February 2003
ASTRAZENECA RESEARCH UPDATE ON AZD3582 |
AstraZeneca and NicOx today announced that AZD3582, in development for the treatment of acute and chronic nociceptive pain, showed efficacy in a recently completed Phase II clinical study, but did not reach its primary end point with respect to gastro-intestinal ulcers.
|
|
17 February 2003
RESULTS OF EXANTA™ (ximelagatran) TRIAL IN PREVENTION OF STROKE IN ATRIAL FIBRILLATION (SPORTIF III)
TO BE PRESENTED AT ACC MEETING |
AstraZeneca announced today that headline results of the recently completed SPORTIF III (Stroke Prevention Oral Thrombin Inhibitor in Atrial Fibrillation) trial comparing Exanta™ (ximelagatran), with warfarin, the current standard of care, are encouraging. The data support the emerging positive benefit / risk profile for Exanta in this indication and will be presented in the Late-Breaking Clinical Trial section of the American College of Cardiology (ACC) meeting in Chicago on 2 April 2003.
|
|
13 February 2003
ASTRAZENECA SUBMITS INFORMATION AMENDMENT FOR CRESTOR® (ROSUVASTATIN CALCIUM) NDA TO FDA
|
AstraZeneca announced today the submission of an information amendment to its New Drug Application (NDA) for CRESTOR® (rosuvastatin calcium) Tablets in response to the US Food and Drug Administration (FDA) approvable letter of May 2002.
|
|
12 February 2003
ASTRAZENECA ANNOUNCES A FURTHER $85M (£60.9M) INVESTMENT IN NEW CANCER RESEARCH BUILDING |
AstraZeneca today announced an $85m (£60.9m) investment in a new cancer research building - its largest single investment to date at Alderley Park, Cheshire.
|
|
11 February 2003
ASTRAZENECA SUBMITS IRESSA™ (gefitinib, ZD1839) FOR APPROVAL IN EUROPE FOR ADVANCED NON-SMALL CELL LUNG CANCER |
AstraZeneca announced today the submission in Europe of a Marketing Authorisation Application for IRESSA™ (gefitinib, ZD1839) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have failed prior chemotherapy. This follows the submission yesterday (4 February) of the European Marketing Authorisation Application for the use of FASLODEX™ (fulvestrant) in the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following prior endocrine therapy.
|
|
11 February 2003
BROTHERLY LOVE CAN MEND A HEART — IN MORE WAYS THAN ONE |
International Research Consortium—PROCARDIS—To Study Families’ Genes for Future Cardiovascular Therapies
|
|
10 February 2003
ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR SYMBICORT® TURBUHALER® IN COPD IN THE EUROPEAN UNION
|
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in the European Union for the use of the SYMBICORT® TURBUHALER® in the maintenance therapy of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of exacerbations. Sweden acted as the reference member state. SYMBICORT is already a leading therapy in the treatment of asthma, and is now set to gain European approval as a combined ß2-agonist and inhaled corticosteroid treatment for COPD.
|
|
7 February 2003
ASTRAZENECA SEEKS MANIA INDICATION FOR SEROQUEL® (QUETIAPINE) IN EUROPE
|
The application to the European Health Authorities follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AstraZeneca to examine the efficacy and tolerability of SEROQUEL in this important disease area. The programme has delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm SEROQUEL to be an ideal first line agent. The application for a new license for SEROQUEL has been simultaneously submitted to the 14 European Member States participating in the Mutual Recognition Procedure. Further submissions in other markets worldwide are progressing.
|
|
5 February 2003
ASTRAZENECA SUBMITS FASLODEX® (fulvestrant) FOR APPROVAL IN EUROPE |
AstraZeneca announced today the submission in Europe of a Marketing Authorisation Application for the use of FASLODEX® (fulvestrant) in the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following prior endocrine therapy. FASLODEX was approved by the U.S. Food and Drug Administration in April 2002
|
|
30 January 2003
FOURTH QUARTER AND FULL YEAR RESULTS 2002
|
Download the
narrative
and the
figures
.
|
|
9 January 2003
ASTRAZENECA ANNOUNCES FDA REQUIRES MORE TIME FOR PRIORITY REVIEW OF IRESSA® (ZD1839) U.S. APPLICATION - DECISION EXPECTED BY MAY 5, 2003 |
The U.S. Food and Drug Administration (FDA) has notified AstraZeneca that it requires more time to review information requested of the company during the six month priority review of the new drug application (NDA) for IRESSA® (ZD1839/gefitinib). AstraZeneca will work closely with the agency to complete the review in a prompt and effective manner. The extended user fee goal date is May 5th 2003.
|
|
8 January 2003
ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR OXIS® TURBUHALER® IN COPD IN THE EUROPEAN UNION
|
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in the European Union (France excluded) for the treatment of COPD with OXIS® TURBUHALER® as maintenance therapy, with additional doses as required, up to a maximum total daily dose of 36µg. Sweden acted as the reference member state.
|
|
2 January 2003
ASTRAZENECA FILES sNDA FOR SEROQUEL® (QUETIAPINE)
IN BIPOLAR DISEASE |
AstraZeneca today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL® (quetiapine) for the treatment of acute mania associated with bipolar disorder (manic depressive illness).
|
|