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Message #1
From: Stock News Bot
Date: October 7, 2007 07:02:11 AM

SNY Sanofi-Aventis News

New Prescription Allergy Treatment XYZAL(R) (Levocetirizine Dihydrochloride) Now Available for Fall Allergy Season

ATLANTA and BRIDGEWATER, N.J., Oct. 2 /PRNewswire-FirstCall/ -- UCB and sanofi-aventis announced today that XYZAL(R), a new once-daily medication used to treat indoor and outdoor allergies, as well as chronic idiopathic urticaria, is now available by prescription in the U.S. XYZAL(R) is an oral antihistamine that has been shown to provide powerful allergy symptom relief. XYZAL(R) is approved for use in adults and children 6 years and older.

'Allergy patients need a prescription treatment option that works quickly to relieve their suffering,' said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. 'It is important for people living with allergies to work with their physician to develop an appropriate allergy treatment plan that will effectively reduce their symptoms.'

According to the Asthma and Allergy Foundation of America (AAFA), 60% of adult patients who were using a prescription medication to treat their seasonal allergies were very interested in finding a new prescription allergy treatment.

A recent survey conducted by Harris Interactive(R) of 683 seasonal and year-round allergy sufferers revealed that almost three-quarters (74%) of those diagnosed with allergies agreed that they don't feel like themselves when they are suffering from allergies. In addition, 81% of respondents agreed that they've adjusted their lives to deal with their allergies and more than half (53%) of allergy sufferers surveyed agreed that they avoid various activities like being outside, traveling and being social because of their allergies.

Studies in allergic rhinitis patients demonstrated XYZAL(R) significantly reduced the common symptoms of the disease, including sneezing, itchy nose, runny nose, and itchy eyes. XYZAL(R) has also been shown to significantly reduce the redness, swelling and itching symptoms associated with hives. In studies with patients exposed to pollen, XYZAL(R) was shown to relieve allergy symptoms at 60 minutes of administration and efficacy was demonstrated at the end of 24 hours. In clinical trials, XYZAL(R) was well tolerated.

XYZAL(R) was approved by the U.S. Food and Drug Administration (FDA) in May 2007. In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL(R) in the U.S.

XYZAL(R) is currently marketed in more than 80 countries worldwide, including the European Union. The FDA approval is based primarily upon the results of eight randomized, placebo-controlled clinical trials involving over 2,000 patients.

About Allergic Conditions

Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that allergies affect as many as 40 million people in the United States.

Seasonal allergic rhinitis (SAR), commonly referred to as 'hay fever' or 'outdoor allergies,' is the most common form of allergic rhinitis. By definition, SAR includes allergies to seasonal pollens like grass, trees, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as 'year round' or 'indoor allergies' and is characterized by allergic symptoms that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria (CIU) is most commonly known as 'chronic hives of unknown origin' and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.

About the Harris Interactive(R) Survey

A survey was conducted online within the United States between August 16 and August 20, 2007 among 2,475 U.S. adults ages 18+, of whom, 683 have been diagnosed with seasonal and year-round allergies. Of those diagnosed with allergies surveyed, 34% were male and 66% female.

Results were weighted as needed for age, sex, race/ethnicity, education, region and household income to reflect the composition of the U.S. adult population. Propensity score weighting was also used to adjust for respondents' propensity to be online. All sample surveys and polls, whether or not they use probability sampling, are subject to multiple sources of error which are most often not possible to quantify or estimate, including sampling error, coverage error, error associated with nonresponse, error associated with question wording and response options, and post-survey weighting and adjustments. Therefore, Harris Interactive avoids the words 'margin of error' as they are misleading. All that can be calculated are different possible sampling errors with different probabilities for pure, unweighted, random samples with 100% response rates. These are only theoretical because no published polls come close to this ideal.

Because the sample is based on those who agreed to be invited to participate in the Harris Interactive online research panel, no estimates of theoretical sampling error can be calculated.

    This survey was supported by UCB Inc. and sanofi-aventis.

    About XYZAL(R)
    Indications and Important Safety Information

XYZAL is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

The use of XYZAL is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

In clinical trials, the most common adverse reactions in greater than or equal to 2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg, XYZAL 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.

In clinical trials, the most common adverse reactions in greater than or equal to 2% of pediatric patients (6-12 years of age) taking XYZAL 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo), and epistaxis (2% vs <1% placebo).

Please visit www.XYZAL.com for full prescribing information.

About UCB Stock market investment discussion chat forums

UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext Brussels Exchange and owns approximately 88% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.

 

Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery

BRIDGEWATER, N.J., Oct. 1 /PRNewswire-FirstCall/ -- Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) has approved Taxotere(R) (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck (SCCHN) before patients undergo chemoradiotherapy and surgery.

The FDA based its approval on the results of the phase III randomized, open-label, international trial, TAX 324, which established the efficacy and safety of the Taxotere-based regimen in significantly improving survival.

Approval Based on Clinical Trial Tax 324

Among patients treated with Taxotere-based therapy (TPF, n=251) overall survival was significantly improved compared to patients receiving just cisplatin and 5-fluorouracil (PF, n=243); the relative risk of death was 30% lower (HR 0.70; p=0.0058). Patients treated with TPF had a longer median overall survival of 70.6 months vs. 30.1 months for patients receiving PF only, representing a more than three year improvement in median OS for patients treated with TPF. The probability to survive three years was 62% in the TPF arm compared to 48% in the PF arm.

'The TAX 324 trial found that the addition of Taxotere to standard induction chemotherapy significantly improved patient survival, adding years to patients' lives,' noted clinical investigator Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston. 'The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by chemoradiotherapy and surgery is a significant advancement in treatment for patients with locally advanced head and neck cancer.'

All patients entering TAX 324 had tumors of the oropharynx, larynx, hypopharynx or oral cavity that either could not be removed, were considered potentially operable but unlikely to be cured with surgery, or could not be removed in order to preserve organ function. Participants in the trial had either stage III or IV SCCHN with no distant metastases.

Patients were treated every three weeks for three cycles with either TPF (Taxotere 75 mg/m2 plus cisplatin 100 mg/m2 and 5-fluorouracil 1000 mg/m2 a day for four days) or PF (intravenous cisplatin 100 mg/m2 followed by 5- fluorouracil 1000 mg/m2 a day for five days), the standard therapy. Both groups of patients were then given weekly chemotherapy (carboplatin) together with radiation therapy for seven weeks, followed by surgery for those patients identified as candidates. The study was designed primarily to evaluate overall survival. Secondary endpoint included progression-free survival, response rates, toxicity, quality of life and clinical benefits.

Overall, the incidence of grade 3/4 toxicity was 65% in the Taxotere arm (TPF) compared to 62% in the group receiving cisplatin and fluorouracil (PF). Patients treated with TPF had more febrile neutropenia (12% vs 7%), neutropenic infection (12% vs 8%), and grade 3/4 neutropenia (84% vs. 56%), dizziness (4% vs. 2%), alopecia (4% vs 1%) and diarrhea (7% vs. 3%) than those in the PF group. Patients in the PF group had more grade 3/4 thrombocytopenia (11% vs. 4%), stomatitis (27% vs. 21%), lethargy (10% vs. 5%) and vomiting (10% vs. 8%). The incidence of other grade 3/4 events was similar between the two groups, such as nausea, anorexia and constipation.

Head and Neck Cancer, a Deadly Disease

More than 640,000 people worldwide are diagnosed with head and neck cancer each year, and more than 350,000 die from the disease annually. Head and neck cancer is a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, tongue, tonsils, throat and voicebox. The term encompasses cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, larynx, and lymph nodes in the upper part of the neck.

'Head and neck cancer is particularly hard to treat and if not detected early has low survival rates,' commented Nancy Leupold, survivor, President and Founder of Support for People with Oral and Head and Neck Cancer (SPOHNC). 'The availability of effective therapies that advance treatment and help patients live longer is very welcome news for the cancer community.'

 

FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)

- May Help Increase Appropriate Early Use in Acute Coronary Syndrome Patients -

BRIDGEWATER and PRINCETON, N.J., Sept. 27 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a 300mg tablet of the antiplatelet PLAVIX(R) (clopidogrel bisulfate). The PLAVIX 300mg tablet will facilitate the use of the FDA approved loading dose for appropriate acute coronary syndrome (ACS) patients as soon as possible after hospital admission. Acute ST-segment elevation myocardial infarction (STEMI), along with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI), are the three conditions classified as ACS, a major cause of emergency medical care and hospitalization in the United States.

'The American College of Cardiology-American Heart Association treatment guidelines for UA/NSTEMI and the American Heart Association Cardiopulmonary Resuscitation and Emergency Cardiac Care guidelines for ACS patients (August 2007) recommend a 300mg loading dose of clopidogrel in conjunction with ASA (aspirin), yet many appropriate ACS patients do not receive a loading dose of clopidogrel,' said Dr. Marc Cohen, F.A.C.C., Chief of the Division of Cardiology, and Director of the Cardiology fellowship at the Newark Beth Israel Medical Center and Professor of Medicine at the Mount Sinai School of Medicine.

'The 300mg loading dose has been proven effective in a broad ACS patient population,' said Cohen. 'A broad ACS population includes not only UA and NSTEMI, but also STEMI as supported by CURE, CLARITY and COMMIT trials.'

The 300mg tablet is bioequivalent to four 75mg FDA approved tablets of PLAVIX. The 300mg tablet of clopidogrel will be available in the U.S. later this year and is also currently under European Medicines Evaluation Agency (EMEA) review.

About PLAVIX

PLAVIX is a prescription antiplatelet medicine taken once a day that helps keep platelets in the blood from sticking together and forming clots. Since its initial approval on November 17, 1997, by the U.S. Food and Drug Administration, PLAVIX has been prescribed to more than 52 million patients worldwide. The new 300mg loading dose tablet reinforces the strong commitment of two research and development pharmaceutical companies dedicated to improving patient health.

The efficacy and safety of PLAVIX have been established through four landmark clinical trials involving more than 81,000 patients. Plavix is the only widely available prescription antiplatelet that provides proven protection against a future heart attack or stroke for patients with ACS (UA, NSTEMI, STEMI) and recent MI, recent Stroke, or established peripheral artery disease.

PLAVIX has demonstrated early and long-term risk reduction for patients at risk for atherothrombotic events in important clinical trials. In the CURE trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) receiving PLAVIX with aspirin were followed for up to one year, and in the CAPRIE trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease receiving PLAVIX alone were followed for up to three years.

PLAVIX is marketed worldwide by sanofi-aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) as Plavix(R) and Iscover(R).

If you have a stomach ulcer or other condition that causes bleeding, you should not use Plavix. When taking Plavix alone or with some other medicines including aspirin, the risk of bleeding may increase so tell your doctor before planning surgery. And, always talk to your doctor before taking aspirin or other medicines with Plavix, especially if you've had a stroke. If you develop fever, unexplained weakness or confusion, tell your doctor promptly as these may be signs of a rare but potentially life-threatening condition called TTP, which has been reported rarely, sometimes in less than 2 weeks after starting therapy. Other rare but serious side effects may occur.

    For more information on PLAVIX visit www.plavix.com.

    WHO SHOULD RECEIVE Plavix (clopidogrel bisulfate)?

PLAVIX is indicated for the reduction of atherothrombotic events as follows:

    -- Recent Myocardial Infarction (MI), Recent Stroke, or Established
       Peripheral Arterial Disease (PAD)
       For patients with a history of recent MI, recent stroke, or established
       PAD, PLAVIX has been shown to reduce the rate of a combined end point
       of new ischemic stroke (fatal or not), new MI (fatal or not), and other
       vascular death.

    -- Acute Coronary Syndrome (ACS)
       For patients with non-ST-segment elevation ACS (unstable angina/non-Q-
       wave MI), including patients who are to be managed medically and those
       who are to be managed with percutaneous coronary intervention (with or
       without stent) or coronary artery bypass graft surgery (CABG), PLAVIX
       has been shown to decrease the rate of a combined end point of
       cardiovascular death, MI, or stroke as well as the rate of a combined
       end point of cardiovascular death, MI, stroke, or refractory ischemia.

For patients with ST-segment elevation acute myocardial infarction, PLAVIX has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

    Important Risk Information

    -- PLAVIX is contraindicated in patients with active pathologic bleeding
       such as peptic ulcer or intracranial hemorrhage.  PLAVIX should be used
       with caution in patients who may be at risk of increased bleeding from
       trauma, surgery, or coadministration with NSAIDs or warfarin. (See
       CONTRAINDICATIONS and PRECAUTIONS.*)

    -- The rates of major and minor bleeding were higher in patients treated
       with PLAVIX plus aspirin compared with placebo plus aspirin in clinical
       trials. (See ADVERSE REACTIONS.*)

    -- As part of the worldwide post marketing experience with PLAVIX, there
       have been cases of reported thrombotic thrombocytopenic purpura (TTP),
       some with fatal outcome.  TTP has been reported rarely following use of
       PLAVIX, sometimes after a short exposure (<2 weeks).  TTP is a serious
       condition that can be fatal and requires urgent treatment including
       plasmapheresis (plasma exchange).  (See WARNINGS.*)

    -- In clinical trials, the most common clinically important side effects
       were pruritus, purpura, diarrhea, and rash; infrequent events included
       intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See
       ADVERSE REACTIONS.*)

Sanofi-aventis enters the Dow Jones Sustainability World Indexes (DJSI World)

PARIS, Sept. 24 /CNW Telbec/ - Sanofi-aventis enters the Dow Jones Sustainability World Indexes (DJSI World), the leading global index tracking the financial performance of the leading sustainability-driven companies worldwide. The DJSI World covers the top 10% of the biggest 2,500 companies in the Dow Jones World Index in terms of economic, environmental and social criteria.

This listing on the index recognizes the Group's commitment to making sustainable development a powerful ongoing element in its business activities.

Sanofi-aventis thus ranks among the 8 pharmaceutical leaders in terms of sustainability according the DJSI World.

The 2006 sanofi-aventis Sustainable Development report is available on the Group's sustainability website: http://sustainabledevelopment.sanofi-aventis.com

 

New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis

HONOLULU, Sept. 19 /PRNewswire-FirstCall/ -- Results from a Phase III clinical trial evaluating the efficacy and safety of risedronate 150 mg once monthly for the treatment of postmenopausal osteoporosis were presented at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting. In the non-inferiority study comparing risedronate 150 mg once monthly to risedronate 5 mg daily [Actonel(R) (risedronate sodium tablets)] increases in bone mineral density (BMD) were similar for patients taking either the monthly or daily dosing regimens.

In the study, BMD was measured at the lumbar spine, total hip, femoral neck, and femoral trochanter. There were no statistically significant differences in BMD increases between the risedronate 150 mg once monthly and the 5 mg daily dose groups at 12 months. In the study, the tolerability and safety profiles were also similar for the monthly and daily dosing regimens of risedronate.

'Risedronate is already approved to reduce the risk of both spinal and nonspinal fractures,' said Michael McClung, M.D., Founding Director of the Oregon Osteoporosis Center in Portland, Oregon. 'For patients who prefer less frequent dosing, risedronate 150 mg, if approved, would provide the convenience of a once monthly dosing option.'

About the Study

The MERIT-OP (Monthly Evaluation of Risedronate Trial in Osteoporosis) study is a 2-year, randomized, double-blind, active-control (5 mg daily risedronate) clinical trial which evaluated 1,292 postmenopausal women (94% Caucasian) between 50 and 88 years old, mean age 64.9, from 47 clinical centers in 13 countries. The participants had osteoporosis, defined as a lumbar spine (LS) BMD T-score less than -2.5 or a LS BMD T-score less than - 2.0 and at least one prevalent vertebral fracture. Patients were randomized to dosing regimens of either risedronate 150 mg monthly or risedronate 5 mg daily and received daily supplements of calcium (1,000 mg) and vitamin D (400-1000 IU). The primary efficacy endpoint of the study was to demonstrate non- inferiority of the risedronate 150 mg monthly regimen to the risedronate 5 mg daily regimen as assessed by percent change from baseline in LS BMD at 12 months. The 24 month results will be reported at a later time. At 12 months, the mean LS BMD increases were 3.54% and 3.43% for the monthly and daily regimens, respectively. The most common adverse events for risedronate 5 mg and risedronate 150 mg, respectively, were upper abdominal pain (6.1% vs. 8.2%), influenza (4.2% vs. 8.9%) and constipation (7.3% vs. 5.8%).

The trial was sponsored by The Alliance for Better Bone Health.

About Actonel(R) (risedronate sodium tablets)

Actonel is approved for the prevention and treatment of osteoporosis in postmenopausal women. Actonel has been proven to reduce the incidence of vertebral fractures, and nonvertebral fractures at a composite endpoint of leg, hip, pelvis, clavicle, humerus and wrist. The following doses are approved: Actonel 5 mg daily, Actonel 35 mg once-a-week, and Actonel 75 mg two consecutive days per month.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint and/or muscle pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients receiving bisphosphonates. Most ONJ cases have occurred in cancer patients undergoing dental procedures. In the majority of cases reported, patients had received intravenous bisphosphonate therapy.

In clinical trials of up to 3-years duration, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).

In a clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).

In a clinical trial comparing Actonel 75 mg two consecutive days/month and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were arthralgia (Actonel 75 mg 10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain (8.8% vs 10.8%).

Please see full prescribing information for Actonel(R) (risedronate sodium tablets) for additional safety information. For a copy of the full prescribing information for Actonel visit the Actonel Web site at http://www.actonel.com.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.

About Procter & Gamble (NYSE: PG)

Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Gain(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella(R), Gillette(R), and Braun(R). The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.

 

Sanofi Pasteur's Investigational H5N1 Influenza Vaccine Achieves High Immune Response at low Dosage

LYON, France, September 18 /PRNewswire-FirstCall/ --

- Clinical Study Demonstrates Breakthrough Dose-Sparing Formulation That Increases Stockpile Capacities and Expands Potential Production Capacities to Billions of Doses in a Pandemic Situation

Sanofi pasteur, the vaccines division of sanofi-aventis Group, today announced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

The vaccine containing only 1.9 micrograms of antigen generated a high level of seroprotective immune response in over 70 percent of the participants in a clinical trial and, in the same clinical trial, vaccine containing 3.75 micrograms of antigen generated a high level of seroprotective immune response in over 80 percent of the participants.

Once fully developed, this vaccine should give sanofi pasteur the potential to provide billions of doses in a pandemic situation and greatly increases its ability to produce vaccines for stockpiling in advance of a pandemic. This would be a significant achievement for public health and a breakthrough in research and development of pre-pandemic and pandemic vaccines that is fully in line with sanofi pasteur's early commitment to bring answers to the global threat posed by pandemic influenza.

Results are based on analysis of a clinical trial conducted in Belgium. The trial involved 266 healthy adults, 18 to 40 years of age. The vaccine tested was produced from inactivated H5N1 virus and contains a new, proprietary adjuvant aimed at stimulating the immune system to increase the response to the vaccine. Trial participants received two doses of each formulation. Four levels of antigen dose were tested, with 1.9 micrograms being the lowest dose.

Preliminary data also show good cross-reactivity to a more recently circulating H5N1 strain. Further assessment of the ability of this vaccine to provide cross-protection to variants of the H5N1 strains is ongoing.

Sanofi pasteur has committed, in the event of a pandemic being declared by the World Health Organization (WHO), to producing the largest possible number of doses of its most advanced pandemic influenza vaccine in the shortest possible time. In order to increase its capacity, sanofi pasteur initiated clinical trials with a novel adjuvant aimed at dramatically reducing the amount of antigen needed to elicit a protective immune response to the H5N1 strain currently identified by global health authorities and experts as a potential source for the next pandemic.

According to the WHO, the next influenza pandemic could result in 1 million to 2.3 million hospitalizations and 280,000 to 650,000 deaths in industrialized nations alone. Its impact is expected to be even more devastating in developing countries.

With production of 170 million doses of influenza vaccine in 2006, sanofi pasteur confirmed its leadership as the world's largest manufacturer of seasonal influenza vaccine, supplying a large portion of the estimated global production of about 350 million doses(1). Sanofi pasteur's Vaxigrip(R) and Fluzone(R) influenza virus vaccines are licensed in over 100 countries.

Pandemic Influenza Overview

Influenza is a disease caused by a highly infectious virus that spreads easily from person to person, primarily when an infected individual coughs or sneezes. An influenza pandemic is a global epidemic of an especially virulent virus, newly infectious for humans, and for which there is no preexisting immunity. This is why pandemic strains have such potential to cause severe morbidity and mortality. In an attempt to minimize the impact of a pandemic, many countries are developing national and transnational plans against a possible influenza pandemic situation.

Sanofi Pasteur and Pandemic Preparedness

Sanofi pasteur is committed to global pandemic preparedness. As the world leader in research, development and manufacturing of influenza vaccines, sanofi pasteur is actively involved in several pandemic preparedness projects in the U.S. and Europe, with the goal of developing a vaccine to protect against a pandemic influenza virus. Sanofi pasteur is also investing in major expansions of its seasonal influenza vaccine production facilities in the U.S. and France, which could be used to produce pandemic influenza vaccine if the need arises.

For more information please visit http://pandemic.influenza.com

About sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi pasteur, the vaccines division of the sanofi-aventis Group, provided more than a billion doses of vaccine in 2006, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The Company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR1 million in research and development. For more information, please visit: http://www.sanofipasteur.com or http://www.sanofipasteur.us

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'plans' and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

    Reference (1):
http://www.who.int/vaccine_research/diseases/ari/en/print.html

    Sanofi Pasteur
    Pascal Barollier
    International Media Relations
    Tel: +33-(0)4-37-37-51-41
    pascal.barollier@sanofipasteur.com

    Len Lavenda
    U.S. Media Relations
    Tel: +1-570-839-4446
    len.lavenda@sanofipasteur.com

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