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AstraZeneca Submits US New Drug Application for Ticagrelor (BRILINTA(TM)), an Investigational Antiplatelet Agent.
The product will be manufactured and developed by AstraZeneca and distributed and sold by Astellas Pharma, while promotion will be jointly carried out by both companies.
http://www.pharmaasia.com/article-8045-astrazenecaasthmatreatmentgetsapprovalinjapan-asia.html
Nektar Therapeutics said it licensed a pair of experimental pain treatments to AstraZeneca PLC in a deal valued at about $1.12 billion.
http://www.manufacturing.net/News-AstraZeneca-Could-Pay-Up-To-1B-In-Nektar-Deal-092109.aspx
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with a
http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=11149
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Nov 21, 2009 (Zacks.com via COMTEX) --
Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application. AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or myocardial infarction, stroke) over clopidogrel (Plavix), without an increase in major bleeding. Brilinta is the first investigational antiplatelet that has demonstrated a reduction in CV death versus Plavix in ACS patients. As a reminder, PLATO evaluated the efficacy, safety and tolerability of Brilinta versus Plavix. The trial design prospectively identified 66 subgroups including 33 efficacy and 33 safety subgroups. The findings from 62 of the 66 subgroups were consistent with the results in the overall study population. ACS represents conditions that result from a reduction in blood flow to the heart muscle, including unstable angina and myocardial infarction. According to data from the American Heart Association, approximately 1.4 million people in the United States are affected by ACS annually. We believe that if Brilinta gets FDA approval and enters the approximately $9 billion anticlotting medicine market, it would provide increased competition to Plavix, which is one of the largest selling drugs globally with sales of $5.6 billion in 2008. Plavix already has to contend with a new player in the market, Eli Lilly's (LLY) Effient. Moreover, Plavix will lose patent protection in 2011 resulting in huge loss of revenues for Bristol. If AstraZeneca can get Brilinta on the market before Plavix goes generic, it may help Brilinta maintain its market share and reduce the number of patients switching to generic clopidogrel. Currently, we are Neutral on AstraZeneca.
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WILMINGTON, Del., Nov 20, 2009 /PRNewswire-FirstCall via COMTEX/ --
AstraZeneca (NYSE: AZN) and the Philadelphia Department of Public Health announced today at a press conference at Philadelphia Health Care Center #6 that AstraZeneca will provide free medicines to the city's Health Centers to help uninsured Philadelphians access both the medical care and medications they need.
By participating in the AZ&Me(TM) Prescription Savings program for healthcare facilities, the Philadelphia Department of Public Health will be better equipped to provide medicine to its patients. Eligible patients will be referred by their physician to receive their medications at health center pharmacies.
"I am glad to see companies like AstraZeneca stepping up to support important health needs of Philadelphians. This program will make care at our centers more comprehensive and helps make the city a healthier place to live," said Mayor Michael Nutter.
"During these tough economic times for both patients and government agencies, I am delighted to announce this public-private collaboration between AstraZeneca and the City of Philadelphia to bring free medications to those most in need, who use our health centers," said Donald F. Schwarz, MD, MPH, Health Commissioner, the Philadelphia Department of Public Health. "With the help of companies like AstraZeneca, we can reduce the barriers that often lead to some patients doing without medicines that are critical to their health."
The Philadelphia Department of Public Health operates eight health centers located in neighborhoods throughout the city. It is the mission of the health centers to provide high quality, comprehensive health care to all Philadelphians regardless of their insurance status.
The services provided by the health centers include primary and preventive care for adults and children as well as key public health services. The Philadelphia Department of Public Health aims to protect and promote the health of all Philadelphians through the delivery of services at the health centers.
"At AstraZeneca, we want to go beyond making innovative medicines to making sure that the people who need these medicines can get them," said Jennifer McGovern, Director, Patient Assistance Programs, AstraZeneca Pharmaceuticals LP. "We look forward to partnering with the Philadelphia Department of Public Health to improve the health of our local community."
In 2008, AstraZeneca provided $13.7 million in savings to more than 8,300 patients in Pennsylvania. Nationally, the company helped more than 440,000 patients save $612 million on their medicines.
The AZ&Me(TM) Prescription Savings program for healthcare facilities provides medicines free of charge to community free clinics, community health centers, hospitals and other qualifying facilities that serve the uninsured. The program is available to non-profit organizations that have a licensed outpatient pharmacy or dispensary on site and meet other program criteria. Patients are eligible for AstraZeneca medicines through this program if they do not have prescription drug coverage and have a household income at or below $30,000 for an individual, or $60,000 for a family of four.
"The City's budget crisis has forced us to find creative ways to maintain services to those in greatest need," said Dr. Thomas P. Storey, MD, MPH, Director of the City Health Centers. "We are grateful to AstraZeneca for their prescription savings program which will provide free medications to low income health center patients, many of whom have complex health care needs."
With this program, AstraZeneca builds on its more than 30-year history of helping patients afford the medicines they need.
To learn if your organization qualifies for the AZ&Me(TM) Prescription Savings program for healthcare facilities, please call 1-866-325-8198. Program specialists are available Monday through Friday between the hours of 9:00 AM and 5:00 PM EST.
Prescription savings programs are available regardless of which medications your doctors prescribe. To find out more about the more than 475 savings programs covering 2,500 medications, please visit www.pparx.org or call 1-888-4PPA-NOW (1-888-477-2669).
About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business. For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com .
About the Philadelphia Department of Health
In 1969 the city of Philadelphia opened its first primary care health center in North Philadelphia, which provided comprehensive health care services in addition to the traditional public health services. Since that time 7 other health centers have been established in neighborhoods throughout the city. The health centers provide residents access to comprehensive quality healthcare services, regardless of insurance status. Annually, the health centers deliver services to close to 90,000 Philadelphians and conduct over 349,000 visits. Over half of the patients seen are uninsured, however, annually counselors at the health centers interview approximately 24,000 patients for insurance coverage and successfully enroll 2,500 patients into a health insurance plan. The health centers recognize the diversity of their patient population. Currently, on site interpreters are available at three health centers and dual hand set phones for interpretations are available at all eight health centers. A total of 36 languages are spoken in the health centers. With the increasing demand for services the health centers continue to explore ways to improve the quality and delivery of healthcare services and remain committed to their mission.
The health centers provide services on both an appointment and walk-in basis, however appointments are preferred. New patients are required to submit verification of city residency and income. Insurance information, if applicable should also be submitted.
For general information about available services, or to find out where a Health Care Center in your area is located, contact: (215) 685-6790, Monday - Friday, 8:30 am - 5 pm.
SOURCE AstraZeneca
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Companies: AstraZeneca PLC (AZN)
WILMINGTON, Del., Nov 19, 2009 /PRNewswire-FirstCall via COMTEX/ --
AstraZeneca (NYSE: AZN) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA(TM), pending approval from the FDA.
(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO )
This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix(R)) plus aspirin.
Acute coronary syndrome (ACS) is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle.(1) These conditions range from unstable angina (chest pain) to myocardial infarction (heart attack).(2) According to the American Heart Association, ACS affects an estimated 1.4 million people in the United States, every year.(3) It is estimated that one in three ACS patients will die, have another heart attack or be hospitalized again within six months of the first cardiovascular event.(4)
Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists inhibit the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.
About the PLATO study
PLATO was an international head-to-head outcomes study of ticagrelor versus clopidogrel to establish whether ticagrelor can achieve meaningful cardiovascular and safety endpoints in ACS patients. The phase III study investigated whether the inhibition of platelet aggregation seen with ticagrelor in phase II trials could lead to a reduction of cardiovascular events in the full spectrum of ACS patients, which includes patients hospitalized for unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
PLATO involved 18,624 ACS patients in 43 countries and was designed to provide a comprehensive analysis of efficacy, safety and tolerability of ticagrelor. The study design reflected real world clinical practice by enrolling the full spectrum of ACS patients within 24 hours of their index event, and evaluating their outcomes regardless of whether they were medically managed or underwent invasive procedures such as PCI or coronary artery bypass graft (CABG) surgery.
The PLATO results were presented at the European Society of Cardiology (ESC) annual meeting in August 2009 and simultaneously published in the New England Journal of Medicine.(5) The PLATO study design of was published in the April 2009 edition of the American Heart Journal.(6)
About Ticagrelor (BRILINTA(TM))
Ticagrelor (BRILINTA(TM)) is an investigational oral antiplatelet treatment for ACS and the first in a new chemical class, the CPTPs (cyclo-pentyl-triazolo-pyrimidines). Ticagrelor is chemically distinct from the thienopyridines, such as clopidogrel and prasugrel.
AstraZeneca has proposed the name BRILINTA.(TM) If approved by the FDA, it will serve as the trade name for ticagrelor. BRILINTA is a trademark of the AstraZeneca group of companies.
About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.
For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com.
References
1. American Heart Association:
http://www.americanheart.org/presenter.jhtml?identifier=3010002. Acute
Coronary Syndromes. Paragraph 1, Lines 1 - 5
2. American Heart Association:
http://www.americanheart.org/presenter.jhtml?identifier=4438.
Antiplatelet Agents. Paragraph 2, Lines 1 - 2.
3. American Heart Association:
http://www.americanheart.org/presenter.jhtml?identifier=3010002. Acute
Coronary Syndromes. Paragraph 3, Lines 3 - 5
4. National Institute of Health: Heart Health - Heart Disease: Symptoms,
Diagnosis and Treatment; What is Acute Coronary Syndrome. Paragraph 2,
Line 1;
http://www.nlm.nih.gov/medlineplus/magazine/issues/winter09/articles/wint
er09pg25-27.html
5. Lars Wallentin, M.D., Ph.D., Richard C. Becker, M.D., et al. Ticagrelor
versus Clopidogrel in Patients with Acute Coronary Syndromes N Engl J Med
2009;361
6. James S, Akerblom A, Cannon C et al, Comparison of ticagrelor, the first
reversible oral P2Y12 receptor antagonist, with clopidogrel in patients
with acute coronary syndromes: Rationale, design, and baseline
characteristics of the PLATelet inhibition and patient Outcomes (PLATO)
trial Am Heart J 2009;157:599-605
SOURCE AstraZeneca
http://www.astrazeneca-us.com
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Companies: AstraZeneca PLC (AZN)
Nov 17, 2009 (Fresh Brewed Media via COMTEX) --
AstraZeneca (NYSE: AZN) closed yesterday at $46.20. So far the stock has hit a 52-week low of $29.96 and 52-week high of $47.61. AstraZeneca stock has been showing support around 45.72 and resistance in the 46.60 range. Technical indicators for the stock are Bullish and S&P gives AZN a neutral 3 STAR (out of 5) hold rating. AZN appears on the Investors Observer Hedged Dividend Income list. For a hedged play on this stock, look at a Jan '10 45 covered call (AZN AI) for a net debit in the $43.80 area. That is also the break even stock price for this trade. This covered call has a 60 day duration, provides 5.19% downside protection and a 2.74% assigned return rate for a 16.67% annualized return rate (comparison purposes only). A lower cost hedged play for this stock would use a longer term call option in place of the covered call stock purchase. To use this strategy look at going long the AZN Jan '11 30 Call (OXU AF) and selling the Jan '10 45 call (AZN AI) for a $14.10 debit. The trade has a 60 day life and would provide 4.55% downside protection and a 6.38% assigned return rate for a 39.00% annualized return rate (for comparison purposes only). AstraZeneca has a current annual dividend yield of 4.59%.
ATU-Seven Summits Research Goto www.iotogo.com/18w1 for our free report titled, The 18 Ways To Know When It's Time To Dump A Stock
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Companies: AstraZeneca PLC (AZN)
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Mark E. Haddad, with whom Nitin Reddy, Carter G. Phillips, Sidley Austin LLP, D. Scott Wise, Michael S. Flynn, Kimberley D. Harris, Davis Polk & Wardwell, Donald R. Ware, Sarah Cooleybeck and Foley Hoag LLP, were on brief for appellant. Steve W. Berman, with whom Sean R.
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One of the world's leading pharmaceutical companies, our business is focused on turning good ideas into innovative, effective medicines that make a real difference in important ...
AstraZeneca plc [1] (LSE: AZN, NYSE: AZN, OMX: AZN) is an British-Swedish pharmaceutical company formed on 6 April 1999 by the re merger of Swedish Astra AB and British Zeneca ...
AstraZeneca PLC. The Group's principal activity is discovering, developing, manufacturing and marketing prescription pharmaceuticals and biological products. The Group's operation ...
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Develops new medicines, includes news releases and careers section for new college graduates. Headquarters and main research centres are located around the UK.
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Pictured are some of the attendees of a presentation by the 'father of modern contraception' - Prof John Guillbaud - which took place at the Herbert Park Hotel in Ballsbridge, Dublin
With clinical trials running over budget and with too few participants, this executive briefing in association with Roche and AstraZeneca promises to provide invaluable advice on producing effective marketing strategies to attract and retain patients.
http://www.smi-online.co.uk/event_media/overview.asp?is=4&ref=2642
G-protein-coupled receptors (GPCRs) play a crucial role in transmitting chemical signals from hormones and neurotransmitters across cell membranes and converting them into cellular responses.