astrazeneca plc-spons adr (AZN) Key Developments
AstraZeneca Presents Positive Phase III Results Ceftazidime-Avibactam
Apr 27 15
AstraZeneca presented positive Phase III data demonstrating the efficacy and safety of ceftazidime-avibactam (CAZ-AVI), an investigational antibiotic being developed to treat serious Gram-negative bacterial infections including complicated intra-abdominal infections. New Phase III data was also presented for ZINFORO (ceftaroline fosamil), an antibiotic approved for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP). AstraZeneca held a symposium at the congress, which highlighted the need for new treatment strategies to address antibiotic resistant infections, which remains a rapidly accelerating global concern. Epidemiological data was presented at the symposium which demonstrated the high clinical burden associated with Gram-positive and Gram-negative infections, including those caused by multidrug-resistant (MDR) pathogens. Full Phase III results for the global RECLAIM-1 and RECLAIM-2 studies were presented at ECCMID. Both studies evaluated the safety and efficacy of CAZ-AVI, administered intravenously (IV) as a two hour infusion (2000 mg /500 mg) every eight hours plus metronidazole 500 mg IV as a one hour infusion every eight hours, compared to meropenem, administered intravenously as a 30 minute infusion (1 g) every eight hours, in hospitalised adult patients with presumed or definite diagnosis of complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Results showed CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The number of patients randomised to CAZ-AVI plus metronidazole was 532, with 534 randomised to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). Findings also showed CAZ-AVI treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem. The adverse event rate for CAZ-AVI in combination with metronidazole was similar to meropenem (45.9% vs 42.9% with serious adverse event rates of 7.9% and 7.6% respectively). The most commonly reported adverse events for CAZ-AVI in combination with metronidazole were diarrhoea, nausea, vomiting and fever, which were not unexpected based on the known safety profiles of ceftazidime and metronidazole. Full Phase III results from the global REPRISE study were also presented at ECCMID. This study evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg /500 mg) in patients with complicated intra-abdominal or complicated urinary tract ceftazidime-resistant gram-negative infection. Patients with complicated intra-abdominal infection also received metronidazole. CAZ-AVI was compared to best available therapy. Results showed that efficacy for CAZ-AVI and Best Available Treatment was similar as reflected by the primary endpoint of clinical response at Test of Cure (TOC) visit. CAZ-AVI showed that in patients with complicated urinary tract infection (cUTI), microbiological cure rates at TOC (and beyond) were substantially higher in patients treated with CAZ-AVI. The Phase III COVERS trial evaluated the safety and efficacy of ceftaroline fosamil for cSSTI patients with evidence of systemic inflammatory response or underlying comorbidities, administered via a 600 mg IV infusion over 120 minutes every eight hours, rather than the currently approved 600 mg every 12 hours dosing regimen. The study included patients from Asia, Europe, North and South America who were randomised 2:1 to receive ceftaroline fosamil 600 mg every eight hours, or to vancomycin 15 mg/kg every 12 hours plus aztreonam 1 g every eight hours for five to 14 days. Results demonstrated that ceftaroline fosamil was effective and well-tolerated for these patients at the adjusted dose, demonstrating non-inferiority versus vancomycin plus aztreonam. Ceftaroline fosamil was well tolerated with 45.6% and 45.5% patients treated with ceftaroline fosamil and vancomycin plus aztreonam respectively, experiencing =1 adverse event. The qualitative safety profile of ceftaroline fosamil 600 mg every eight hours was similar to previous trials with the 12 hour dosing, with no new safety signals identified.
AstraZeneca PLC Approves Adoption of New Articles of Association
Apr 24 15
AstraZeneca PLC at its Annual General Meeting on April 24, 2015, approved adoption of new articles of association of the company.
AstraZeneca PLC Elects Cori Bargmann as Director
Apr 24 15
AstraZeneca PLC has elected Cori Bargmann as a Director at the AGM held on 24 April 2015.
AstraZeneca PLC Announces Unaudited Consolidated Financial Results for the First Quarter Ended March 31, 2015; Reiterates Earnings Guidance for the Year 2015
Apr 24 15
AstraZeneca PLC announced unaudited consolidated financial results for the first quarter ended March 31, 2015. For the quarter, the company reported revenue of $6,057 million against $6,460 million a year ago. Operating profit was $933 million against $836 million a year ago. Profit before tax was $678 million against $638 million a year ago. Profit attributable to owners of the parent was $550 million against $504 million a year ago. Earnings per share basic and diluted were $0.44 against $0.40 a year ago. Net cash used in operating activities was $72 million compared with net cash from operating activities of $1,187 million a year ago. Purchase of property, plant and equipment was $227 million compared to $183 million a year ago. Purchase of intangible assets was $848 million compared to $545 million a year ago. Net debt as at March 31, 2015 was $6,373 million compared to $4,833 million as of March 31, 2014. Core operating profit was down 4% to $1,805 million.
The Company reiterates the guidance for the year 2015. For the year 2015, the company’s total revenue is expected to decline by mid-single-digit percent at CER and core EPS is expected to increase by low single-digit percent at CER.
AstraZeneca and MedImmune Enter into an Exclusive Collaboration with Celgene Corporation for the Development and Commercialisation of MEDI4736
Apr 24 15
AstraZeneca and MedImmune announced that they have entered into an exclusive collaboration agreement with Celgene Corporation,
for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin's lymphoma, myelodysplastic syndromes and multiple myeloma. Under the terms of the agreement, Celgene will make an upfront payment of $450 million to AstraZeneca in relation to MEDI4736. Celgene will lead on development across all clinical trials within the collaboration and will take on all research and development costs until the end of 2016, after which they will take on 75% of these costs. Celgene will also be responsible for global commercialisation of approved treatments. AstraZeneca will continue to manufacture and book all sales of MEDI4736 and will pay a royalty to Celgene on worldwide sales in haematological indications. The royalty rate will start at 70% and will decrease to approximately half of the sales of MEDI4736 in haematological indications over a period of four years. MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour's immune-evading tactics. Within
the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and
existing cancer medicines. Over time, the collaboration could expand to include other assets.