Key Developments: AstraZeneca PLC (AZN)
52.17USD
24 May 2013
$0.09 (+0.17%)
$52.08
$51.69
$52.27
$51.60
1,324,055
2,032,859
$52.72
$39.72
Latest Key Developments (Source: Significant Developments)
AstraZeneca PLC Reaffirms FY 2013 Guidance-Conference Call
AstraZeneca PLC announced that for fiscal 2013, it continues to expect a mid to high single-digit decline in revenue in constant currency and core earnings per share (EPS) to decline at a rate significantly higher than the decline in revenue. The Company reported revenue of $27.973 billion and EPS of $6.41 in fiscal 2012. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenues of $26.397 billion and EPS of $5.83 for fiscal 2013. Full Article
AstraZeneca PLC Announces Top-Line Results From OSKIRA-1 Phase 3 Study Of Fostamatinib In Rheumatoid Arthritis
AstraZeneca PLC announced top-line results of OSKIRA-1, a Phase 3 study to assess efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). OSKIRA-1 had two primary endpoints assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified Total Sharp Score). In the OSKIRA-1 study, fostamatinib achieved statisticall improvement in ACR20 response rate at 24 weeks in both 100 mg twice daily group and group that received 100 mg twice daily for four weeks followed by 150 mg once daily (49%, p <0.001 and 44%, p=0.006 respectively) compared to placebo (34%). Fostamatinib did not demonstrate a statisticall difference in mTSS compared to placebo at 24 weeks for either dose (p=0.252 and p=0.170, respectively). The safety and tolerability findings for fostamatinib observed in OSKIRA-1 study were generally consistent with those previously reported for the TASKi Phase 2 program. OSKIRA-1 randomized 923 patients who had experienced an inadequate response to methotrexate (MTX) and, over a 24-week period, evaluated the effectiveness of two dosing regimens of fostamatinib (100 mg twice daily or fostamatinib 100 mg twice daily for four weeks followed by 150 mg once daily) in combination with MTX versus placebo in combination with MTX. Full Article
AstraZeneca PLC Buys Early-Stage U.S. Biotech Firm-Reuters
Reuters reported that AstraZeneca PLC has bought privately held U.S. biotechnology company AlphaCore Pharma, which is developing a new type of cholesterol medicine. Financial details of the acquisition by the British drugmaker's MedImmune unit were not disclosed. Full Article
US District Court Rules AstraZeneca PLC's One Pulmicort Respules Patent Invalid
AstraZeneca PLC announced that the United States District Court for the District of New Jersey ruled that AstraZeneca's US Patent No. 6,598,603 (the '603 patent), protecting PULMICORT RESPULES in the United States, is invalid. The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834. The decision is limited to the US and has no impact on the validity of patents related to PULMICORT RESPULES in other countries. The Company announced that it disagrees with the Court's decision and is considering next steps, including an appeal of the Court's decision. The patents protecting PULMICORT RESPULES expire in 2018, with paediatric exclusivity extending into 2019. Full Article
AstraZeneca PLC and Bristol-Myers Squibb Co Complete Acquisition of Rights for Byetta and Bydureon from Eli Lilly And Co
AstraZeneca PLC and Bristol-Myers Squibb Co announced that they completed the acquisition of rights to Byetta (exenatide) and Bydureon (exenatide) from Eli Lilly And Co. AstraZeneca and Bristol-Myers Squibb started in January 2007 a diabetes alliance and a cooperation on research, development and sale for certain products for type 2 diabetes. Full Article
AstraZeneca PLC Enters Settlement Agreement In US Patent Infringement Litigation Against Watson Laboratories Inc, Actavis Inc
AstraZeneca PLC announced that it has entered into a settlement agreement in its US patent infringement litigation against Watson Laboratories Inc., Actavis Inc. (formerly known as Watson Pharmaceuticals, Inc.), and EGIS Pharmaceuticals regarding Watson's proposed rosuvastatin zinc product. Watson, a successor of Cobalt, also agreed not to further appeal a decision by the U.S. Court of Appeals for the Federal Circuit that upheld the validity and enforceability of the CRESTOR (rosuvastatin calcium) substance patent. Shionogi is also a party to the settlement agreement. Under the agreement, Watson and EGIS concede that the CRESTOR substance patent is valid, enforceable and would be infringed by Watson's rosuvastatin zinc product and its rosuvastatin calcium product. The settlement agreement permits Watson to begin selling its generic version of CRESTOR and its rosuvastatin zinc product beginning May 2, 2016, at a fee to AstraZeneca of 39% of net sales of Watson's products until the end of pediatric exclusivity on July 8, 2016. Full Article
AstraZeneca PLC and Karolinska Institute to Create Integrated Translational Research Center
AstraZeneca PLC announced that the Company and Swedish medical university Karolinska Institutet announced intention to create an Integrated Translational Research Center for cardiovascular and metabolic disease and regenerative medicine located at Karolinska Institutet’s site in Stockholm, Sweden. The Center will be set up to conduct preclinical and clinical studies aimed at advancing the understanding of cardiovascular and metabolic disease pathophysiology and assessing new drug targets for AstraZeneca’s two biotech units, AstraZeneca Innovative Medicines and Early Development (iMed) and MedImmune. Building on the organizations’ longstanding collaboration, the Center will initially run for a period of five years and will be made up of between 20 and 30 scientists, including a number of AstraZeneca scientists. In addition, AstraZeneca will contribute up to USD 20 million per annum, and Karolinska Institutet will contribute knowledge and facilities. The Center is expected to be operational by mid-2013. Karolinska Institutet has a long history of scientific collaboration with AstraZeneca. In the field of cardiovascular and metabolic disease a three-year research partnership has recently been established, focusing on advancements in cardiac regenerative therapy. This work and the new Integrated Translational Research Center will also feed into a collaboration between AstraZeneca and Moderna Therapeutics, focused on the discovery and development of messenger RNA therapeutics. Full Article
AstraZeneca PLC Announces Agreement with Moderna Therapeutics to Develop Messenger RNA Therapeutics
AstraZeneca PLC announced that it has signed an exclusive agreement with Moderna Therapeutics to discover, develop and commercialize messenger RNA therapeutics for the treatment of serious cardiovascular, metabolic and renal diseases as well as cancer. Under the terms of the agreement, AstraZeneca will make an upfront payment of USD 240 million. AstraZeneca will have exclusive access to select any target of its choice in cardiometabolic diseases, as well as selected targets in oncology, over a period of up to five years for subsequent development of messenger RNA. In addition, Moderna is entitled to an additional USD 180 million for the achievement of three technical milestones. Through this agreement, AstraZeneca has the option to select up to 40 drug products for clinical development and Moderna will be entitled to development and commercial payments as well as royalties on drug sales ranging from high single digits to low double digits for each product. AstraZeneca will lead the preclinical, clinical development and commercialization of therapeutics resulting from the agreement and Moderna will be responsible for designing and manufacturing the messenger RNA against selected targets. Effectiveness of the agreement is contingent on expiration or termination of the waiting period under the Hart Scott-Rodino Antitrust Improvements Act. Full Article
AstraZeneca PLC to Cut Jobs as Part of Restructuring
AstraZeneca PLC announced a restructuring of its SG&A activities that will result in a global reduction in headcount of approximately 2,300. The majority of this headcount impact is related to programs under way or already communicated to affected employees. The Company is combining this SG&A restructuring with two previously announced programs. These comprise the headcount reduction of 1,600 related to the proposed Research & Development footprint changes announced on March 18, 2013, and the balance of the Phase 3 restructuring program announced in February 2012, which amounts to 1,150 roles. The total combined Phase 4 program entails an estimated global headcount reduction of approximately 5,050 over the period between 2013 and 2016. Full Article
AstraZeneca PLC To Cut 2,300 Jobs-Business Line
Business Line reported that AstraZeneca PLC will cut some 2,300 jobs worldwide as part of a restructuring plan. The Company said that the cuts are in addition to a previously announced programme cutting 1,600 positions related to research and development announced March 18 and the elimination of 1,150 positions announced last year. A Company statement indicates the elimination of these positions will result in a one-time $2.3 billion restructuring charge. The Company anticipates the cuts will produce benefits of about $800 million per year by 2016. Full Article
AstraZeneca closes in on site for new home in Cambridge
LONDON - AstraZeneca is closing in on a site for its new $500 million home in Cambridge, with a biomedical park just south of the English city the most likely site, property industry sources said.
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