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.
Read the full analyst report on "AZN"
Read the full analyst report on "BMY"
Read the full analyst report on "SNY"
Read the full analyst report on "LLY"
Zacks Investment Research

Are these companies dead -- or just dead-ish?

AstraZeneca (NYSE: AZN) 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.
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.
Acute coronary syndrome (ACS) is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle.
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services.

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

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 [...]

(AZN) AstraZeneca Seeks U.S. Food and Drug Administration Approval

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.
Read the full analyst report on "AZN"
Read the full analyst report on "BMY"
Read the full analyst report on "SNY"
Read the full analyst report on "LLY"
Zacks Investment Research

We are initiating coverage of Affiliated Computer Services Inc. (ACS) with a Neutral rating. Headquartered in Dallas , Texas , ACS delivers IT-based services and solutions globally to commercial and government clients in the U.S. The company is a leading provider of business process outsourcing [BPO], information technology [IT] services and system integration services. With growing revenue, [...]

(ACS) Initiating Coverage of Affiliated Computer Services at Neutral

We are initiating coverage of Affiliated Computer Services Inc. (ACS) with a Neutral rating.

Headquartered in Dallas , Texas , ACS delivers IT-based services and solutions globally to commercial and government clients in the U.S. The company is a leading provider of business process outsourcing (BPO), information technology (IT) services and system integration services.

With growing revenue, increased earnings momentum, strong bookings, cost-control initiatives and substantial free cash flow, we remain positive on the company’s long term prospects. Moreover, we are encouraged by the ramp of new business signings, which were a record for fiscal 2009 at $1 billion of annual recurring revenue (ARR), a substantial increase of 27% from fiscal 2008. Total contract value is estimated at $4.5 billion.

While acquisitions have enabled revenue to grow at a considerable rate, the pace of acquisitions is aggressive and raises the risk of integration.

The company’s cash flow is strong. Operating cash flow of $877.1 million (13.4% of total revenue) in 2009 is an increase of 6.1% from 2008. However, the high level of debt is a threat to the stock.

As of June 2009, Affiliated’s net cash position (cash less debt, including current portion) was a significant deficit of $1.61 billion or about $16.45 per share (long-term debt to total capitalization ratio of 49%). Moreover, the company has $250 million in senior notes due in June 2010, which will further reduce cash.

The company announced its acquisition by Xerox Corporation for a total of $6.4 billion ($63.11 per ACS share). This represents a 33.6% premium to the closing price of ACS following the announcement. We expect the transaction to close soon, which should be accretive to fiscal 2010 earnings. As a subsidiary of Xerox, Affiliated will operate independently. Trading currently below the acquisition price, we believe the deal to be beneficial for Affiliated.

Thus we set a six-month price target of $63.00, close to the acquisition price. Our target price is 15.1x our 2010 EPS estimate, a discount to the industry.
Read the full analyst report on "ACS"
Zacks Investment Research

Companies featured in this segment: Empresas ICA SA (NYSE:ICA), Fluor Corporation (NYSE:FLR), SNC-Lavalin Group Incorporated (TSX:SNC), Carso Infraestructura y Construccion SAB de CV (MXK:CICSAB), Actividades de Construccion y Servicios SA (MCE:ACS), Obrascon Huarte Lain SA (MCE:OHL), Maire Tecnimont Spa (BIT:MT), RWE AG (OTC:RWEOY), Dusseldorf-based E.ON AG (OTC:EONGY), Alliant Energy (NYSE:LNT), Vestas (CPH:VWS) and Macquarie Group Limited (ASX:MQG)

Two Veteran Wall Street Analysts Review the November 23, 2007 Edition of the Value Line Investment Survey

Ian Stansel takes a look at news currently driving the market.

L-3 Communications, Watson Wyatt Worldwide, Target, eCollege.com, Movie Gallery, Rotech Healthcare