Sanofi Aventis (NYSE: SNY) closed yesterday at $37.68. So far the stock has hit a 52-week low of $23.95 and 52-week high of $40.17. Sanofi Aventis stock has been showing support around 36.98 and resistance in...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)

Market-trouncing returns could be written in these four stars.

The drugmaker slips through an advisory committee unscathed.

Sanofi Aventis (NYSE: SNY) closed yesterday at $38.42. So far the stock has hit a 52-week low of $23.95 and 52-week high of $40.17. Sanofi Aventis stock has been showing support around 37.92 and resistance in ...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)

Sanofi-Aventis To Launch Antimalarial Drug Study

This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.

The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year.

Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk patients, with some 50 million Americans take daily aspirin therapy for secondary prevention of heart attacks and strokes.

However, according to data presented at the American College of Gastroenterology and at the American Heart Association meeting, the use of low-dose aspirin for cardiovascular disease prophylaxis is associated with a 2- to 4-fold increase in gastro-intestinal (GI) complications, including gastric ulcers. Enteric coating is not a sufficient to reduce the risk of GI bleeding, and thus the majority of patients that should be taking 325mg aspirin are non-compliant or taking suboptimal low-dose (81mg) "baby" aspirin instead.

Pozen’s PA-325/40 is designed to provide immediate-release omeprazole as a GI-protectant for patients taking full-dose 325mg daily aspirin therapy. If the phase III trials meet the primary endpoint of reduction in cumulative incidence of gastric ulcers, we expect PA-325/40 to be approved by the U.S. FDA with the full cardiovascular label claims of regular enteric-coated aspirin. This is a significant market opportunity in our view, considering less than 15% of the 50 million Americans on daily aspirin therapy are taking a GI-protectant such as omeprazole.

Recently, data from a retrospective analysis of patients that use Sanofi-Aventis (SNY) / Bristol-Myers’ (BMY) Plavix (clopidogrel) showed an increased risk of major adverse cardiovascular events (MACE) by as much as 50% while taking a proton pump inhibitor (PPI) such as AstraZeneca’s (AZN) omeprazole (Prilosec) or esomeprazole (Nexium). The data included analysis of outcomes from 16,700 patients who underwent percutaneous coronary intervention and continued Plavix for 12 months after the procedure.

Approximately 9,900 were not given a PPI at any time during Plavix treatment and 6,800 were given overlapping PPI therapy. The analysis showed a 12-month MACE event rate of about 25% among PPI users, compared with 18% of patients who were not given PPI (MACE hazard ratio of 1.50 for PPI users versus nonusers).

The current Plavix label discourages use of a PPI due to this potential limiting effect on the drug’s effectiveness. The majority of Plavix use for secondary prevention of heart attacks and strokes is with enteric-coated aspirin.

Strengthening this label warning by the U.S. FDA could work to greatly limit the potential uptake for Pozen’s PA-325/40 product. However, we note the retrospective analysis that potentially showed a reduced effectiveness for Plavix while on a PPI was with commercially available delayed release PPIs dosed at the same time as taking Plavix. Pozen is currently conducting a drug-drug interaction study with their immediate release omeprazole doses both at the same time and 12 hours apart from Plavix.

The omeprazole used in PA-325/40 is an immediate release formulation, not the commercially available delayed-release found in Prilosec or Nexium. We suspect that dosing an immediate release omeprazole 12 hours apart (say at night) from Plavix (in the morning) will dramatically reduce the potential negative interactions between the two drugs.

We are optimistic on the development plans for PA-325/40. Besides the potential use as a secondary preventative agent for cardiovascular disease, significant literature exists showing a potential reduction in risk for developing precancerous adenomas on high-dose aspirin regimen.

Four separate government-funded randomized controlled trials concluded that aspirin is a benefit in the prevention of adenomas and significantly reduces the risk of colon cancer. However, the dangerous GI tolerability has greatly limited large outcome-based clinical studies or wide-spread use of high-dose aspirin in colon cancer prevention. We believe that Pozen’s PA-325/40, and phase II PA-650/40, have the potential to be a game-changer with respect to colon cancer prevention. This also helps mitigate the potential downside risk to pushing forward with development despite the recent negative Plavix/PPI headlines.
Read the full analyst report on "POZN"
Read the full analyst report on "SNY"
Read the full analyst report on "BMY"
Read the full analyst report on "AZN"
Zacks Investment Research

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

On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the 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, 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 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine[More...]

 

The proposed trade name for ticagrelor is BRILINTA, 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 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The mode of action involves inhibiting the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic (blood clot) events.

On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death. In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the Phase 2 studies.

On 11/19/09, Delcath Systems (NASDAQ: DCTH) provided the following corporate updates. Active negotiations continue with several international entities to provide exclusive geographic market rights for the PHP System. In October, the pivotal Phase 3 Metastatic Melanoma Trial met its goal of 92 patients and was fully enrolled. This clinical study is evaluating the Delcath PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. Enrollment in the Phase 2 clinical study of the Delcath PHP System with melphalan for patients with inoperable liver metastases from neuroendocrine tumors has now reached 25 patients and continues to enroll patients with data expected in the coming months. Established a low cost operations facility in Queensbury, New York in which Delcath plans to locate manufacturing of its PHP System.

DCTH expects to submit the application to the FDA seeking approval of the PHP System with melphalan by the end of 1H10 and is optimistic about its ability to gain CE mark approval in Europe in early 2010 with commercial sales in the European markets starting shortly thereafter. The Company recently closed a public common stock offering for proceeds of about $32.4 million. The Percutaneous Hepatic Perfusion (PHP) System results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of approved anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body.

On 11/19/09, Unilife Medical Solutions (OTC: UNIFF.PK) (ASX: UNI.AX) announced the appointment of Mikron Group as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill ready-to-fill syringe. Unilife is targeting initial annual commercial production of about 60 million units of the Unifill syringe with development expected to begin next month for installation in the Company's Central Pennsylvania manufacturing facility slated for 4Q10 in conjunction with industrialization partner Sanofi-Aventis (NYSE: SNY), which is a major customer for safety syringes to deliver injectable products such as the flu vaccine and blood thinner Lovenox.

Last week Unilife announced a lodgement of an Information Memorandum with respect to its proposed relocation to the US and primary stock listing on the NASDAQ with a shareholder meeting / vote scheduled for 2010. Click here for the ProActive News Room landing pages for Unilife Medical Solutions and Delcath Systems, which contain a compilation of digital media coverage links, videos, news feeds, articles, and report downloads.

The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

Disclosure: No positions

For Immediate Release

Chicago, IL – November 16, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: GlaxoSmithKline plc (GSK), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Friday’s Analyst Blog:

Glaxo H1N1 Vaccine Approved

GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.

The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is a part of the US Government’s intention to secure about 250 million doses to help fight the swine flu pandemic.

The current outbreak of swine flu pandemic can prove to be a big opportunity for vaccine manufacturers. In addition to Glaxo, other major players in this field include Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

In fact, several companies including Sanofi Pasteur, the vaccine division of Sanofi-Aventis, Novartis Vaccines and Diagnostics Limited, the vaccine and diagnostics arm of Novartis, MedImmune LLC, a subsidiary of AstraZeneca and CSL Limited of Australia, have already received approval from the FDA for their swine flu vaccines.

Glaxo intends to start shipping its vaccine in December and expects to provide all the doses by year-end. We expect the company’s vaccine segment to post strong revenues in the fourth quarter of 2009. In addition to strong influenza product sales, the company has made significant progress in expanding its vaccine product portfolio. The approval of cervical cancer vaccine Cervarix in the US and Japan, H1N1 vaccine Pandemrix in Europe, and the H1N1 vaccine in the US should all help drive vaccine segment revenue.

Want more from Zacks Equity Research? Subscribe to the free Profit from the Pros newsletter: http://at.zacks.com/?id=5515.

About Zacks Equity Research

Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.

Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.

Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today: http://at.zacks.com/?id=5517

About Zacks

Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1978 by Leonard Zacks. As a PhD in mathematics Len knew he could find patterns in stock market data that would lead to superior investment results. Amongst his many accomplishments was the formation of his proprietary stock picking system; the Zacks Rank, which continues to outperform the market by nearly a 3 to 1 margin. The best way to unlock the profitable stock recommendations and market insights of Zacks Investment Research is through our free daily email newsletter; Profit from the Pros. In short, it's your steady flow of Profitable ideas GUARANTEED to be worth your time! Register for your free subscription to Profit from the Pros at http://at.zacks.com/?id=5518.

Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.

Follow us on Twitter: http://twitter.com/zacksresearch

Join us on Facebook: http://www.facebook.com/home.php#/pages/Zacks-Investment-Research/57553657748?ref=ts

Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.

Contact:
Mark Vickery
Web Content Editor
312-265-9380
Visit: www.zacks.com

 

 

Zacks Investment Research

Companies featured in this segment: Fluor Corporation (NYSE:FLR), American Electric Power (NYSE:AEP), Southern Company (NYSE:SO), ReneSola Limited (NYSE:SOL), POSCO (NYSE:PKX), Suntech Power Holdings Company Limited (NYSE:STP), Ormat Technologies Incorporated (NYSE:ORA), Sanofi-Aventis (NYSE:SNY), GlaxoSmithKline plc (NYSE:GSK), Novartis AG (NYSE:NVS), AstraZeneca plc’s (NYSE:AZN), Mitsubishi Corporation (OTC:MSBHY), Sharp Corporation (OTC:SHCAY), CSL Limited (ASX:CSL), Mumias Sugar Company Limited (NBO:MSCL), Athi River Mining Limited (NBO:ARM), Kenya Power & Lighting Company Limited (NBO:KPLA), Daewoo Engineering & Construction Company Limited (SEO:047040)

(IHSI)(ABT)(MRK)(SNY)

INNOVATIVE HEALTH SC
IHSI
Last Trade: 0.55
Change: 0.30 (120.00%)

Innovative Health Sciences to Hold Teleconference Call August 20, 2008 to Update Shareholders

PALM HARBOR, Fla., Aug. 13 /PRNewswire-FirstCall/ -- Innovative Health Sciences, Inc. (Pink Sheets: IHSI - News) today announced that a teleconference call for shareholders has been scheduled for Wednesday, August 20th. The conference call will start at 3:30PM EDT.

Chris Winter, CEO of Innovative Health Sciences and Michael Ivezic, former CEO of HealthSonix, will provide the most recent update and information to the shareholders and answer questions. To participate live in the call, please dial 605-475-6000 and enter security code 728652.

Shareholders are encouraged to submit their questions prior to 5:00PM EDT on August 18th via email, fax or telephone as follows:
1. email: info@innovativeHS.com
2. Fax: [727] 865-5208
3. Telephone: [727] 490-4370 x 112


Innovative Health Sciences, Inc. (Pink Sheets: IHSI - News) is a Medical Technology Holding company that invests in new, unique Medical Technology companies. The common denominator of the investments is that the companies and their products must show the potential to have a major global impact and present significant growth opportunities.

For more information, please visit http://www.innovativehs.com/



CEO Interview Recorded July 15th, 2008

Companies featured in this segment: Aventine Renewable Energy Holdings Incorporated (NYSE:AVR), CHS Incorporated (NASDAQ:CHSCP), Valero (NYSE:VLO), Xstrata (LON:XTA), BHP Billiton (NYSE:BHP), Petrobras (NYSE:PBR), sanofi-aventis (NYSE:SNY), Reliance Industries Limited (BOM:500325), Reliance Power Limited (BOM:532939), Sasol Limited (NYSE:SSL)

(ABT)(MRK)(HSXI)(SNY)(JNJ)

HealthSonix and Abbott Laboratories Launch Innovative Combination Therapy Program for Patients With Advanced Rheumatoid Arthritis
Wednesday September 26, 11:08 am ET

Significant Development in the Fight Against Advanced Rheumatoid Arthritis

IRVINE, CA--(MARKET WIRE)--Sep 26, 2007 -- HealthSonix, Inc. HSXI announced today that the joint marketing program with Abbott Laboratories ABT has commenced in Southern Ontario, Canada. The program is the first of its kind and offers Rheumatologists the option of prescribing "combination therapy" for patients with advanced rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

"The guidelines published by the American College of Rheumatology [ACR] for rheumatoid arthritis state that 'the ultimate goals in managing RA are to prevent or control joint damage, prevent loss of function, and decrease pain,'" said Dieter D. Doederlein, Vice President Corporate Development of HealthSonix. "To maintain joint function, the guidelines suggest that 'regular participation in dynamic and even aerobic conditioning exercise programs improves joint mobility, muscle strength, aerobic fitness and function, and psychological well being without increasing fatigue or joint symptoms.' That is why the combination therapy now offered by Abbott Laboratories and HealthSonix is a significant new development for both rheumatologists and their patients," said Doederlein.

Abbott's biologic therapy works against the inflammatory process like other TNF blockers and has been shown to be effective in controlling symptoms of the disease. The product is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

The benefits of AquaSonix Therapy for the patient with immunological disorders include provision of a reduced weight-bearing environment in which to exercise; improvement in Range Of Motion; reduction in joint and muscle stiffness; improvement in the willingness to move; improvement in functional strength and functional mobility; improvement in social and psychological factors.

"This new program represents a significant development in the fight against arthritis because the ACR guidelines stress that the combination of medications and non-pharmacological therapies is the optimal way to treat the patients," said Doederlein.

HealthSonix, Inc. HSXI is a publicly traded medical technology company. The Company's core products are based on proprietary, patent pending medical technologies that use sound pulses to stimulate soft tissue, muscles and sensory and mechanoreceptors in the human body to relieve pain. All pain relief treatments and products are safe, non-invasive, and have no known side effects.

More information regarding HealthSonix, Inc. and its products and services can be found on the World Wide Web at: http://www.healthsonix.com/ or by calling the company at 1-877-622-2121.

Note: A number of statements contained in this news release are forward-looking statements, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, competitive market conditions, successful integration of acquisitions, the ability to secure additional sources of financing, the ability to reduce operating expenses and other factors not set forth herein. The actual results that the Company may achieve may differ materially from any forward-looking statements due to such risks and uncertainties.

Contact: Contact:
Dieter D. Doederlein
1-877-622-2121
Email Contact

Editors Note:
In a recent press release and interview, CEO Michael Ivezic stated that HealthSonix was preparing for a move to a senior exchange by the end of 2007. At that time we offered the opinion that in order to meet the minimum stock price of the AMEX which is $2.00/share, the company would need to announce a major development. It is our opinion that today's news could well be that event. HealthSonix has flown below Wall Street's radar until today. Once institutions and retail investors who hold Abbot Labs ABT stock become aware of this partnership, it may be seen as an opportunity to strengthen the Health Care sector of their portfolios for pennies on the dollar. We will continue to monitor this situation closely.

(AZMN)(PAAS)(RGLD)(GSS)(AEM)(ABX)(GFI)(GG)(CDE)(HMY)(HL)(SFEG)(GOLD)(AUY)(ABT)(MRK)(RHHBY)(SNY)(BMY)(PFE)(BAY)(NVS)(JNJ)(HSXI)