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27 December 2004
COUNCIL RECOMMENDS APPROVAL OF CRESTOR IN JAPAN
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AstraZeneca announced today that the Pharmaceuticals Affairs Council has recommended that the Japanese Ministry of Health, Labour and Welfare (MHLW) approve CRESTORTM (rosuvastatin) in Japan at a dose range of 2.5-20 mg for the treatment of hypercholesterolaemia. The Council’s recommendation is contingent on final agreement of a post marketing surveillance programme. The recommended starting dose of 2.5 mg is in line with normal clinical practice in Japan where, compared to the western world, lower dose ranges of drugs, including statins, are made available.
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17 December 2004
GEFITINIB (IRESSA™) LUNG CANCER ISEL TRIAL SHOWS NO OVERALL SURVIVAL ADVANTAGE IN A HIGHLY REFRACTORY POPULATION |
AstraZeneca today announced that the initial analysis of the primary endpoint of Study 709, IRESSA Survival Evaluation in Lung cancer (ISEL) with 1692 patients has been conducted, and shows that IRESSA failed to significantly prolong survival in comparison to placebo in the overall population (HR 0.89, p=0.11, Median 5.6 vs 5.1 months), or in patients with adenocarcinoma (HR 0.83, p=0.07, Median 6.3 vs 5.4 months).
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17 December 2004
ASTRAZENECA BOARD ANNOUNCEMENT |
AstraZeneca PLC today confirms the appointment of Louis Schweitzer as non-executive Chairman with effect from 1 January 2005. Percy Barnevik will retire from the Board as Chairman and a Director on 31 December 2004. The appointment of Louis Schweitzer as Chairman was anticipated in the announcement of his appointment as a non-executive Director on 11 March 2004.
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17 December 2004
CLINICAL AND REGULATORY CHANGES AT ASTRAZENECA |
- GUIDANCE FROM SIR TOM McKILLOP, CHIEF EXECUTIVE
AstraZeneca is committed to the development of innovative medicines but Exanta and Iressa, two products based on breakthrough science, have suffered setbacks.
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8 December 2004
NEW DATA ESTABLISH ASTRAZENECA’S ARIMIDEX™ (ANASTROZOLE) AS SUPERIOR TO TAMOXIFEN IN PREVENTING CANCER RECURRENCE |
New data, from the landmark ATAC (‘Arimidex’, Tamoxifen, Alone or in Combination) trial, is presented today at the San Antonio Breast Cancer Symposium, USA.
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6 December 2004
ASTRAZENECA ANNOUNCES COMPLETION OF ENROLMENT IN SAINT I PHASE III TRIAL OF CEROVIVE® (NXY-059) |
AstraZeneca announced today that it has ahead of schedule completed the enrolment of patients in SAINT I, one of two Phase III trials (SAINT I and II) being conducted to determine the effect of CEROVIVE (NXY-059) on disability and neurological recovery in acute ischaemic stroke patients.
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1 December 2004
ASTRAZENECA ANNOUNCES TWO BUSINESS MILESTONES FOR SEROQUEL™ |
AstraZeneca today announces two new business milestones for SEROQUEL (quetiapine), an atypical antipsychotic for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder (manic-depressive illness).
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30 November 2004
ASTRAZENECA STARTS CONSTRUCTION OF $40M MANUFACTURING PLANT IN EGYPT |
A groundbreaking ceremony today marked the start of construction by AstraZeneca of a $40 million tablet manufacturing plant in Egypt.
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29 November 2004
NEXIUM RECEIVES FDA APPROVAL FOR RISK REDUCTION OF NSAID-ASSOCIATED STOMACH ULCERS |
AstraZeneca today announced that a new indication for its prescription proton pump inhibitor Nexium® (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). Nexium is now also indicated for reducing the risk of gastric (stomach) ulcers developing among at risk patients on continuous therapy with non-steroidal anti-inflammatory drugs (NSAIDs). The FDA also issued an approvable letter for the indication of the healing of gastric ulcers associated with NSAIDs therapy.
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29 November 2004
EUROPEAN MUTUAL RECOGNITION PROCEDURE APPROVES ASTRAZENECA’S ATACAND® FOR THE TREATMENT OF CHRONIC HEART FAILURE |
AstraZeneca today announced that the European Mutual Recognition Variation Procedure (MRP) evaluating the use of Atacand® (candesartan cilexetil), a selective angiotensin receptor blocker (ARB) in the treatment of chronic heart failure (CHF) has been completed. Atacand, already a well established antihypertensive therapy, is now indicated for the treatment of patients with heart failure and impaired left ventricle systolic function. The UK was the MRP Reference Member State for marketing approval across a number of EU countries*.
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22 November 2004
ASTRAZENECA AND CAMBRIDGE ANTIBODY TECHNOLOGY ANNOUNCE MAJOR STRATEGIC ALLIANCE TO DISCOVER AND DEVELOP HUMAN ANTIBODY THERAPEUTICS IN INFLAMMATORY DISORDERS
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AstraZeneca makes £75 million upfront equity investment. Complements earlier alliance with Abgenix, Inc. in oncology.
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19 November 2004
CRESTOR™ STOCK EXCHANGE STATEMENT |
During the course of testimony yesterday, to the Committee of Finance of the US Senate Hearing on the worldwide withdrawal of VIOXX, Dr David Graham raised the possibility of safety concerns surrounding five other products including AstraZeneca's lipid lowering medicine 'Crestor'.
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10 November 2004
CRESTOR™ HELPS MORE AFRICAN AMERICAN PATIENTS WITH HYPERCHOLESTEROLAEMIA ACHIEVE CHOLESTEROL GOALS
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Results from the ARIES study presented today at the American Heart Association’s Annual Scientific Sessions demonstrate that CRESTOR 10 and 20mg reduce LDL-cholesterol (LDL-C or “bad” cholesterol) significantly more and raise HDL-cholesterol (HDL-C or “good” cholesterol) more than atorvastatin 10 and 20mg in African Americans with hypercholesterolaemia, and enable more patients to achieve their US NCEP ATP III guideline LDL-C goals.
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3 November 2004
ASTRAZENECA TO ADD RESULTS FROM ONGOING STUDIES IN RESUBMITTED SYMBICORT SINGLE INHALER THERAPY™ FILE IN THE EU
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AstraZeneca announced today that it has withdrawn its Symbicort Single Inhaler Therapy™ file for the EU. As a result of discussions during the Mutual Recognition Process, AstraZeneca expects a file to be submitted in the second half of next year (2005), with additional data from recently completed (COSMOS) and ongoing studies designed to provide further confirmation of this new treatment concept.
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25 October 2004
ASTRAZENECA PREPARES FOR ADOPTION OF IAS/IFRS |
As part of its preparation for the adoption of International Accounting Standards (IAS)/International Financial Reporting Standards (IFRS), AstraZeneca today made available financial information for the full year 2003 and the first half of 2004, together with quarterly information, prepared in accordance with the new standards.
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21 October 2004
THIRD QUARTER AND AND NINE MONTHS RESULTS 2004 |
“A strong third quarter with sales up 7 percent and Earnings per Share up 19 percent.”
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14 October 2004
PHASE III TRIALS FOR CEROVIVE (NXY-059) WILL CONTINUE AS PLANNED FOLLOWING INTERIM DATA ANALYSIS |
AstraZeneca announced today that the Phase III trials (SAINT I and II) to determine the effect of CEROVIVE (NXY-059) on disability and neurological recovery in acute ischemic stroke patients will continue as planned. This decision is based upon a recommendation from the Independent Data and Safety Monitoring Board (IDMB) and the trial Steering Committee.
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11 October 2004
ASTRAZENECA RECEIVES ACTION LETTER FROM FDA FOR EXANTA® (XIMELAGATRAN) |
AstraZeneca announced today that the US Food and Drug Administration (FDA) did not grant approval for the investigational oral anticoagulant EXANTA® (ximelagatran). The company had submitted a New Drug Application (NDA) for EXANTA for the prevention of strokes in patients with atrial fibrillation, for the prevention of blood clots in patients undergoing knee-replacement surgery, and for the long-term secondary prevention of blood clots following standard treatment of a clot.
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6 October 2004
ASTRAZENECA CONFIDENT OF STRONG PERFORMANCE FROM GROWTH PRODUCTS AND DELIVERY OF DEVELOPMENT PIPELINE |
AstraZeneca will today express confidence in its future prospects at its annual business review meeting in London and will update analysts on:
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16 September 2004
NEW INDICATIONS FOR NEXIUM® IN HEALING AND PREVENTION OF NSAID-ASSOCIATED ULCERS |
AstraZeneca today announced that the Mutual Recognition Procedure (MRP) for new indications for Nexium® (esomeprazole) has been successfully finalised. The new indications are for the healing of gastric ulcers and, for patients at risk, the prevention of gastric and duodenal ulcers, associated with non-steroidal anti-inflammatory drug (NSAID) therapy. The company is now awaiting individual national approvals.
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13 September 2004
FDA ADVISORY COMMITTEE RECOMMENDS FURTHER DATA TO SUPPORT APPROVAL OF ASTRAZENECA’S ORAL ANTICOAGULANT EXANTA™ (XIMELAGATRAN) |
AstraZeneca today announced that the Cardiovascular and Renal Drugs Advisory Committee to the US FDA has advised that more data is needed to support the approval of the oral anticoagulant Exanta™ (ximelagatran).
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8 September 2004
CRESTOR™ (ROSUVASTATIN) REACHES 10 MILLION PRESCRIPTION MILESTONE |
AstraZeneca today announced that CRESTOR™ (rosuvastatin), its statin indicated for the treatment of dislipidaemia, has reached the significant milestone of 10 million prescriptions worldwide.
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6 September 2004
CRESTOR™ TAKES LEAD IN INTERNATIONAL STUDY OF STATIN TREATMENT FOR PATIENTS WITH THE METABOLIC SYNDROME |
New data from the first international prospective study of statin treatment in people with the metabolic syndrome show that AstraZeneca’s CRESTOR™ (rosuvastatin) achieves excellent results for this important and growing group of patients. The results presented today at the 40th Annual Meeting of the European Association for the Study of Diabetes (EASD), Munich, Germany, show that CRESTOR lowers LDL-cholesterol (LDL-C, or ‘bad’ cholesterol) and raises HDL-cholesterol (HDL-C, or ‘good’ cholesterol) significantly more than another commonly prescribed statin, atorvastatin, in patients with the metabolic syndrome and high cholesterol.
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22 July 2004
DOUBLE BOOST FOR SEROQUEL™ |
Thursday 22nd July
FDA APPROVES 12-WEEK LABEL IN MANIA
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved additional efficacy labelling information, based on 12-week data for SEROQUEL (quetiapine), a psychotropic medication indicated for the treatment of acute manic episodes associated with bipolar I disorder. SEROQUEL is the first medication in its class to include monotherapy safety and efficacy data for acute manic episodes associated with bipolar disorder extending beyond three weeks in its label. These latest data demonstrate that SEROQUEL treatment alone works early and continues to work through 12 weeks.
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22 July 2004
AstraZeneca PLC Second Quarter and Half Year Results 2004 |
“Strong performance from growth products delivers 11 percent increase in sales for the second quarter. Dividend increased by 15 percent.”
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21 June 2004
FIRST LAUNCH FOR ASTRAZENECA’S EXANTA™ (XIMELAGATRAN): THE FIRST ORAL ANTICOAGULANT IN NEW CLASS OF DIRECT THROMBIN INHIBITORS (DTIS) |
Exanta™ (ximelagatran), a new anticoagulant and the first oral treatment in the new class of direct thrombin inhibitors (DTIs), is launched today in Germany in its first indication: the prevention of venous thromboembolic events (VTE) in elective hip or knee replacement surgery (orthopaedic surgery).
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20 May 2004
ASTRAZENECA MAKES GLOBAL BOND MARKET DEBUT |
AstraZeneca PLC today announced a successful global bond market debut issuing a total of $750 million. The proceeds of the issue will be used for general corporate purposes
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11 May 2004
ASTRAZENECA SELLS INTEREST IN ADVANTA BV |
AstraZeneca PLC and its joint venture partner, (Royal Cosun), announced today that they have reached an agreement to sell Advanta BV to Syngenta AG, for 400 million Euro plus a final net asset value adjustment. Completion will be subject to the necessary regulatory approvals and settlement will be in cash.
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5 May 2004
NEW SEROQUEL DATA SHOWS EFFICACY AND TOLERABLITY IN BIPOLAR DEPRESSION |
AstraZeneca announces important new data from its first large-scale clinical trial to examine SEROQUEL (quetiapine) as a treatment for depressive episodes in patients with bipolar I and II disorders. The results, presented at the 157th American Psychiatric Association (APA) congress, show that SEROQUEL is an effective and well-tolerated agent for the treatment of bipolar depression and improves a broad range of anxiety and mood symptoms associated with bipolar depression.
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4 May 2004
SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR EXANTA™ (XIMELAGATRAN) IN EUROPE |
AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in Europe for Exanta™ (ximelagatran) for short-term use in the prevention of venous thromboembolic events in major elective orthopaedic surgery (hip or knee replacement) – the ‘proof of concept’ indication for this new anticoagulant.
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3 May 2004
ASTRAZENECA ANNOUNCES MAJOR INVESTMENT TO SUPPORT WORLDWIDE GROWTH OF SYMBICORT |
Investment of $114 million will create 150 new jobs
AstraZeneca today announced a major investment in new production facilities to support the further growth of Symbicort, the Company’s key respiratory product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Representing an investment of over $114 million, this latest development will result in the creation of around 150 new manufacturing jobs at AstraZeneca’s production site in Dunkerque, France.
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29 April 2004
AstraZeneca PLC First Quarter Results 2004 |
“First quarter sales exceed $5 billion. Financial targets for the year on track.”
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19 April 2004
NEW STUDIES CONFIRM SUPERIORITY OF CRESTOR™ COMPARED TO ATORVASTATIN IN PATIENTS WITH TYPE 2 DIABETES AND DYSLIPIDAEMIA |
New data released at the European Atherosclerosis Society (EAS) Congress in Seville show that CRESTOR™(rosuvastatin) significantly reduces LDL-cholesterol (LDL-C or ‘bad’ cholesterol) in patients with type 2 diabetes and dyslipidaemia (high cholesterol) more than atorvastatin.
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7 April 2004
ASTRAZENECA SUBMITS REGULATORY APPLICATION IN EUROPE FOR THE USE OF ATACAND® IN THE TREATMENT OF HEART FAILURE |
Results of landmark CHARM study programme form the basis of heart failure submission for leading hypertension therapy, Atacand
AstraZeneca today announced the submission of a regulatory application in the European Union (EU), as part of the Mutual Recognition Variation Procedure to obtain a new indication for Atacand (candesartan cilexetil), its angiotensin II type 1 (AT1) receptor blocker, for use in the treatment of heart failure (CHF). The UK acts as the RMS (Reference Member State). Further filings in the US and other markets are expected in the near future.
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31 March 2004
ASTRAZENECA CEO CALLS FOR INTEGRATED BIOMEDICAL RESEARCH STRATEGY AT AMS LECTURE
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Sir Tom McKillop, Chief Executive AstraZeneca PLC, today will call for an integrated biomedical research strategy and a European Market Place ready to reward innovation to reverse Europe’s relative decline in biomedical research. Sir Tom McKillop will make these remarks when he delivers the Second Annual Forum Lecture to the Academy of Medical Sciences (AMS).
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22 March 2004
SYMBICORT® SINGLE INHALER THERAPY (SYMBICORT® SiT) DEMONSTRATES SUPERIOR ASTHMA CONTROL USING ONLY ONE INHALER |
New data, announced today at the American Academy of Allergy, Asthma and Immunology (AAAAI), San Francisco, highlights the benefits of Symbicort®(budesonide/formoterol) Single inhaler Therapy (Symbicort® SiT), a new approach to asthma management. The research shows that superior asthma control is achieved by using just one inhaler combining both maintenance and reliever medication, compared to traditional asthma treatment with a higher fixed daily dose of an inhaled corticosteroid and a separate rescue inhaler. This new dosing regimen is currently under review by the European Mutual Recognition Procedure as an addition to the currently approved dosing regimen for Symbicort®, where a separate reliever medication is required.
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16 March 2004
ASTRAZENECA ANNOUNCES LATEST PHASE OF UK £1 BILLION INVESTMENT PROGRAMME |
AstraZeneca has announced two major investments in the UK with the imminent opening of major new facilities in Alderley Park, Macclesfield, Cheshire, and additional investment to support the development of its research site in Charnwood, Loughborough, Leicestershire. These latest developments will mean that AstraZeneca’s investment in the UK (from 1999 and planned until 2006), will have approached a potential £1 billion, with the creation of well over 550 new science related jobs.
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12 March 2004
MARKETING APPROVAL GRANTED FOR FASLODEX™ (FULVESTRANT) IN EUROPEAN UNION |
AstraZeneca announced today that it has received European marketing approval for its new breast cancer drug FASLODEX™ (fulvestrant). ‘Faslodex’ is indicated for the treatment of advanced breast cancer in post-menopausal women whose cancer has progressed on previous anti-oestrogen treatments such as tamoxifen. This is the first new type of treatment for hormone receptor positive advanced breast cancer to be approved in the European Union since 1995.
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11 March 2004
ASTRAZENECA BOARD ANNOUNCEMENT |
AstraZeneca PLC today announces the appointment of Louis Schweitzer, presently Chairman and CEO of Renault, as a non-executive Director. It is planned that he will be appointed as non-executive Chairman later this year. Percy Barnevik will then retire from the Board as Chairman and a Director.
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25 February 2004
ASTRAZENECA ISSUES 2003 ANNUAL REPORT
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AstraZeneca today published its Annual Report and Form 20-F for 2003 and its 2003 Annual Review. These documents are available on the company’s website www.astrazeneca.com, (click on Investor Relations - Annual Reports).
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29 January 2004
AstraZeneca PLC Fourth Quarter and Full Year Results 2003 |
“Achievements in 2003 position AstraZeneca for strong sales and profit growth”
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29 January 2004
ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM® IN US AND EUROPE FOR HEALING AND PREVENTION OF NSAID-ASSOCIATED ULCERS |
AstraZeneca today announced the submission of regulatory applications to the United States Food and Drug Administration (FDA), the European Union (EU) and other global markets for two indications related to the Non-steroidal anti-inflammatory drugs (NSAID)-associated gastrointestinal (GI) side effect programme for NEXIUM®. These indications are for the use of NEXIUM® for the healing of NSAID-associated gastric ulcers and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk, in patients requiring continued NSAID therapy.
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14 January 2004
SUCCESSFUL OUTCOME OF EUROPEAN MUTUAL RECOGNITION PROCEDURE FOR ASTRAZENECA’S NEXIUM I.V. |
AstraZeneca today announced that the European Mutual Recognition Procedure (MRP) for the intravenous (i.v.) formulation of Nexium® has been successfully completed.
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13 January 2004
ASTRAZENECA RECEIVES FDA APPROVAL FOR SEROQUEL™ |
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL (quetiapine) as a monotherapy and adjunct therapy for the treatment of mania associated with bipolar disorder (manic-depressive illness).
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