Total : 124 View more »
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
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
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®) plus aspirin.
http://www.biospace.com/news_story.aspx?StoryID=163389&full=1
Palatin Technologies (PTN)F1Q10 Earnings CallNovember 16, 2009 11:00 am ET<a
Total : 105 View more »
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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Tags: cardiovascular drugs fda health investment investment opinion market market share medicine patent population research sales trial
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
Tags: arizona business cardiovascular clinical disease dollar england fda healthcare heart disease index manufacturing marketing medicine nervous system nyse pharmaceuticals respiratory sales surgery trade trial
Companies: AstraZeneca PLC (AZN)
CRANBURY, N.J., Nov 16, 2009 /PRNewswire-FirstCall via COMTEX/ --
Palatin Technologies, Inc. (NYSE Amex: PTN) today announced results for its quarter ended September 30, 2009. Palatin reported a net loss of $37,000, or $(0.00) per basic and diluted share, for the quarter ended September 30, 2009, compared to a net loss of $4.3 million, or $(0.05) per basic and diluted share, for the same period in 2008. Total revenues in the quarter ended September 30, 2009 were $3.7 million, compared to $754,000 for the same period in 2008.
The decrease in net loss for the quarter ended September 30, 2009, compared to the same period last fiscal year, was primarily due to an increase in revenue recognized under Palatin's license and clinical trial agreements with AstraZeneca AB (AstraZeneca) and a net decrease in operating expenses resulting from strategic restructuring and refocusing of Palatin's clinical-stage development programs in 2008.
In September 2009, Palatin and AstraZeneca signed an amendment to their exclusive research collaboration and license agreement to discover, develop and commercialize compounds that target melanocortin receptors for treatment of obesity and related indications. Under the terms of the amendment to the parties' collaboration agreement, AstraZeneca has agreed to make a $2.5 million payment (received October 2009) and, subject to completion of certain tasks relating to the program, $2.5 million in the first quarter of calendar year 2010. Under the amendment, the terms of the original collaboration and license agreement signed in January 2007 relating to milestone payments and royalty rates were restructured.
As of September 30, 2009, Palatin's cash, cash equivalents and investments totaled $7.7 million, compared to $7.8 million at June 30, 2009.
LICENSE AND CONTRACTS
For the quarter ended September 30, 2009, Palatin recognized $3.7 million of contract revenue under its collaboration agreement with AstraZeneca, compared to $746,000 for the same period in 2008. Based on the September 2009 amendment, Palatin will provide research services to AstraZeneca through January 2010. Accordingly, contract revenue is being recognized over the estimated remaining performance period.
COSTS AND EXPENSES
Total operating expenses for the quarter ended September 30, 2009 were $3.8 million compared to $5.1 million for the comparable quarter of 2008, primarily due to a strategic restructuring and refocusing of Palatin's clinical-stage development programs.
Palatin Technologies' management will discuss the first quarter financial results for the fiscal year ending June 30, 2010 and provide an update on corporate developments during a conference call and webcast on November 16, 2009 at 11:00 a.m. ET.
Conference Call / Webcast
Palatin will host a conference call and webcast on November 16, 2009 at 11:00 a.m. Eastern Time to discuss its first quarter of fiscal year 2010 financial results. Individuals interested in listening to the conference call live can dial 888-801-6504 (domestic) or 913-312-4376 (international), passcode 8561334. The webcast and replay can be accessed by logging on to the "Investor/Media Center-Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 888-203-1112 (domestic) or 719-457-0820 (international), passcode 8561334. The webcast and telephone replay will be available through November 23, 2009.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin Technologies' website at http://www.palatin.com.
Forward-looking Statements
Statements about future expectations of Palatin Technologies, Inc., including statements about its development programs, proposed indications for its product candidates, pre-clinical activities, marketing collaborations, and all other statements in this document other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Palatin's actual results may differ materially from those discussed in the forward-looking statements for various reasons, including, but not limited to Palatin's ability to fund development of its technology, ability to establish and successfully complete clinical trials and pre-clinical studies and the results of those trials and studies, dependence on its partners for certain development activities, need for regulatory approvals and commercial acceptance of its products, ability to protect its intellectual property, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
Three Months Ended September 30,
-------------------------------
2009 2008
---- ----
REVENUES $3,662,619 $753,846
---------- --------
OPERATING EXPENSES:
Research and development 2,669,564 3,657,999
General and administrative 1,153,731 1,456,848
--------- ---------
Total operating expenses 3,823,295 5,114,847
--------- ---------
Loss from operations (160,676) (4,361,001)
-------- ----------
OTHER INCOME (EXPENSE):
Investment income 33,312 82,980
Interest expense (4,701) (4,494)
Gain on sale of supplies 95,000 -
------ ------
Total other income, net 123,611 78,486
------- ------
NET LOSS $(37,065) $(4,282,515)
======== ===========
Basic and diluted net loss
per common share $(0.00) $(0.05)
======= =======
Weighted average number of
common shares outstanding
used in computing basic
and diluted net loss
per common share 91,306,223 85,524,316
========== ==========
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)
September 30, June 30,
2009 2009
------------- ------------
ASSETS
Current assets:
Cash and cash equivalents $4,188,173 $4,378,662
Available-for-sale investments 3,466,673 3,439,650
Accounts receivable 3,233,278 508,528
Prepaid expenses and other
current assets 364,239 492,824
------- -------
Total current assets 11,252,363 8,819,664
Property and equipment, net 3,338,705 3,650,783
Restricted cash 475,000 475,000
Other assets 250,022 254,364
------- -------
Total assets $15,316,090 $13,199,811
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Capital lease obligations $45,154 $87,675
Accounts payable 410,984 206,363
Accrued expenses 1,048,974 1,420,741
Deferred revenue 6,311,416 6,955,553
--------- ---------
Total current liabilities 7,816,528 8,670,332
Capital lease obligations 29,224 33,954
Deferred rent 1,056,673 1,182,026
--------- ---------
Total liabilities 8,902,425 9,886,312
--------- ---------
Stockholders' equity:
Preferred stock of $.01 par value
- authorized 10,000,000 shares;
Series A Convertible; issued and
outstanding 4,997 shares as of
September 30, 2009 and June 30,
2009, respectively 50 50
Common stock of $.01 par value -
authorized 150,000,000 shares;
issued and outstanding
96,155,249 and 86,662,901 shares
as of September 30, 2009 and
June 30, 2009, respectively 961,552 866,629
Additional paid-in capital 212,727,664 209,712,379
Accumulated other comprehensive
income 143,134 116,111
Accumulated deficit (207,418,735) (207,381,670)
------------ -------------
Total stockholders' equity 6,413,665 3,313,499
--------- ---------
Total liabilities and
stockholders' equity $15,316,090 $13,199,811
=========== ===========
SOURCE Palatin Technologies, Inc.
http://www.palatin.com
Tags: amex clinical commercial conference contract corporate deficit equity financial results investment marketing media nyse obesity products property rates research research and development restructuring revenue securities technology trial
Companies: Palatin Technologies, Inc. (PTN)
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Health,... ... ...WILMINGTON Del. Sept. 17 /- AstraZeneca (NYSE... ...,AstraZeneca,Accepts,Secretary,of,Defense,Award,for,Supporting,Employees,Serving,in,National,Guard,and,Reserve,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Welcome to AstraZeneca's international website. As 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 areas of healthcare.
ScienceDirect - the world's leading platform offers over 2,000 high quality peer-reviewed full-text journals and books on science, technology and medicine.
This list simply identifies approved active moieties with sponsors to which FDA has granted exclusivity for pediatric studies. Only applications held by the identified sponsor were granted pediatric exclusivity.
Total : 1,720,000 View more »
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 ...
http://www.corporateinformation.com/Company-Snapshot.aspx?cusip=C82652560
Develops new medicines, includes news releases and careers section for new college graduates. Headquarters and main research centres are located around the UK.
Navigation [accesskey 1] Content [accesskey 2] Site Search [accesskey 3] Job Seekers Login [accesskey 4] top of page [accesskey 5] PharmiWeb.com, From PharmiWeb Solutions PharmiWeb.com from PharmiWeb Solutions PharmiWeb.com Home Page 19 June 2008 Select a company 1st Pharma People 20:20 Selection
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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
Oncology RD is currently booming with pharmaceuticals on a quest to develop effective cancer drugs. The established standard of care – surgery, radiotherapy and chemotherapy is fast giving way to a high-tech array of targeted therapies.
http://www.pharmiweb.com/events/event.asp?eventId=4023§ion=howto