Press release archive 2003

Tuesday, 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
Tuesday, 23 December 2003
EXANTA™ (XIMELAGATRAN) RECEIVES FIRST APPROVAL 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.
Friday, 19 December 2003
ASTRAZENECA AND ARRAY BIOPHARMA ANNOUNCE ONCOLOGY COLLABORATION 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.
Friday, 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.
Thursday, 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.
Tuesday, 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
Tuesday, 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
Wednesday, 3 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.
Wednesday, 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
Friday, 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.’