Sanofi Pasteur related Press Releases

Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients

Maureen Martino — Thu, 18 Sep 2008 08:57:30 -0400

Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients

PARIS, and TORONTO, Sept 17, 2008 -- PARIS, and TORONTO, Sept. 17 /PRNewswire/ -- Sanofi pasteur, the vaccines division of the sanofi-aventis Group, announced today that it is sponsoring a Phase II clinical study exploring a multi-pronged treatment approach to high risk and advanced-stage melanoma -- an often fatal form of cancer for which there are limited treatment options. Patients are being enrolled in the United States and Canada. The trial, called MEL11, will investigate the safety and efficacy of a therapeutic cancer vaccine regimen aimed at stimulating the body's immune system to fight melanoma.

"The MEL11 study uses an entirely new treatment approach to advanced-stage melanoma," said Teresa Petrella, MD, Medical Oncologist and Clinical Researcher at the Odette Cancer Centre at the Sunnybrook Health Sciences Centre in Toronto and the lead investigator of the trial. "The study protocol combines the use of a vaccine with more traditional anti-cancer agents to bolster the effectiveness of the immune system. Melanoma is an increasing concern in the cancer community; its incidence is on the rise and there are very few available treatment options."

The vaccine candidate is uniquely designed to stimulate the body's own defenses -- the immune system -- to find and fight cancer cells. It makes use of a modified canarypox virus, ALVAC(2), which has been shown in an extensive body of research to promote immune responses in humans. The ALVAC(2) virus contains the genes for five antigens -- molecules that induce an immune response -- that are commonly found in melanoma tumors. These antigens stimulate T-cells within the immune system to hone in on melanoma cells, and are expected to halt or slow cancer progression. The vaccine also contains the genes for three proteins called co-stimulatory molecules, which increase the immune response of T-cells to the antigens. In addition to the vaccine, patients in this trial will be treated with two other agents that augment the immune response: GM-CSF and interferon-alpha-2b.

About the Clinical Trial

The randomized, open-label trial involves 120 participants at 23 centers across the United States and Canada. Stage IIIc, IVa and IVb melanoma patients with at least one measurable lesion and a life expectancy of at least six months will be included in the study. Participants will be randomized to one of two study groups. The first group will receive vaccine treatment consisting of a series of ALVAC and GM-CSF injections, followed by administration of interferon. The second group will receive administration of interferon alone.

The study is designed with the primary objective of progression-free survival (tumor stabilization) and the secondary objective of evaluation of safety, other efficacy endpoints (response rates), and the ability of the treatment regimen to induce an immune response.

The first cycle of vaccine treatment is conducted for a period of 16-weeks. If there is no evidence of disease progression during the first cycle, vaccine treatment is extended to a second 16 week cycle of treatment. In the study, patients in Group 2 whose disease has progressed during the first treatment cycle may be offered the vaccine regimen as the next cycle of treatment.

About Melanoma

Melanoma is the most serious form of skin cancer, accounting for 80 percent of all skin cancer deaths. Incidence and mortality rates for melanoma are rising faster than those for any other cancer. According to the American Cancer Society and Canadian Cancer Society, this year nearly 65,000 people in North America will be diagnosed with melanoma and more than 9,000 will die from the disease. By the year 2010, it is estimated that one in 50 people will have been diagnosed with melanoma. Standard treatments have minimal effect on survival, and sometimes cause significant toxicity.

About Therapeutic Cancer Vaccines

Therapeutic cancer vaccines represent an emerging, experimental type of immunotherapy, which are being used in combination with standard cancer treatments. They are different from preventive or prophylactic vaccines, which are used to prevent initial infection and disease. Researchers believe therapeutic cancer vaccines may help inhibit the progression of existing cancers, prevent recurrence of cancers, or destroy remaining cancer cells not killed by prior treatments.

For more information on this program visit www.cancervaccines.com.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York .
Sanofi pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2007, 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: www.sanofipasteur.com.

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, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Crucell Enters Agreement with Sanofi Pasteur for Next-generation Biologicals against Rabies

Maureen Martino — Thu, 03 Jan 2008 08:40:07 -0500

Crucell Enters Agreement with Sanofi Pasteur for Next-generation Biologicals against Rabies

Exclusive agreement for rabies monoclonal antibodies to fight fatal disease

Leiden, The Netherlands, 3 January 2008 - Dutch biotechnology company Crucell N.V. today announced that it has signed an exclusive collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

Under the terms of the agreement, Crucell will continue to perform the development activities. Crucell will be responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF. Crucell will receive a payment of € 10 million following the execution of the agreement and will be eligible for milestone payments of up to € 66.5 million.

Crucell has developed a combination of two rabies monoclonal antibodies that has shown favorable results comparable to current immunoglobulin products. Phase I clinical trials demonstrated that the antibody product is well tolerated, provides the expected immediate passive neutralizing activity and that it can be safely administered in combination with a rabies vaccine without interfering with the vaccine's ability to induce an active immunity. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. Crucell expects to enter phase II clinical trials in the first half of 2008. Peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.

Sanofi pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur's rabies products.

"Sanofi pasteur is the global leader in providing rabies vaccine and immunoglobulin, and the only international company to offer a full range of rabies biologicals. Adding a next generation rabies treatment to our well-established rabies product range will further position the company as a leading force to help prevent this fatal disease," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "Louis Pasteur's first human rabies immunization in 1885 was a founding milestone for modern vaccination and we are proud to build on his legacy with innovative treatments."

"We are pleased that sanofi pasteur selected our rabies antibodies to be used in combination with their rabies vaccine," said Ronald H.P. Brus, Crucell's Chief Executive Officer. "Today, millions of people are exposed to rabies and often no life-saving treatment is available for this fatal disease. This agreement further validates our PER.C6® production technology and our MAbstract® technology for generating monoclonal antibodies."

About rabies
Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure. There is no proven treatment for rabies once symptoms of the disease have appeared. Lethal rabies is prevented by post-exposure prophylaxis (PEP) via the combined administration of a rabies vaccine and RIG (rabies immunoglobulin) following the bite of a rabid animal.

Rabies is prevalent in Europe, Asia, North and South America as well as Africa. Every year, approximately 10 million people are vaccinated worldwide. An estimated 40,000 to 70,000 people die of the disease each year, mainly in Asia.

About Crucell's rabies antibody cocktail program
Crucell develops the antibody cocktail using its PER.C6® technology, which offers large-scale manufacturing capabilities and production under serum-free culture conditions. Crucell's rabies monoclonal antibody cocktail offers the potential for replacing the traditional serum-derived products that are currently still used for the treatment of rabies.

Crucell's cocktail is a combination of two human monoclonal antibodies, generated with the use of Crucell's MAbstract® technology and produced with the use of Crucell's PER.C6® technology. Phase I clinical studies (conducted in the US and India) recently showed that the antibody cocktail can be safely co-administered with rabies vaccine in line with standard therapy and that it provides the expected immediate passive neutralizing activity. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. The Fast Track program facilitates the development and expedites the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. Peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.

About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. Compared to conventional production technologies, the strengths of the PER.C6® technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.

About MAbstract® technology
Crucell's proprietary MAbstract® technology can be used to discover drug targets, such as cancer markers or proteins from infectious agents including bacteria and viruses, and identify human antibodies against those drug targets.

About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases, and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminium-free hepatitis A vaccine on the market. The Company has a broad pipeline, with several products based on its unique PER.C6® production technology in development. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the US. The Company employs over a 1000 people. For more information, please visit www.crucell.com

About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of 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: www.sanofipasteur.com or www.sanofipasteur.us

Forward-looking statements
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on June 13, 2007, and the section entitled "Risk Factors". The Company prepares its financial statements under International Financial Reporting Standards (IFRS) with reconciliation to the generally accepted accounting principles in the United States (US GAAP).

PRESS RELEASE: Acambis Joins Forces With Sanofi Pasteur to Develop West Nile Virus Vaccine

Maureen Martino — Tue, 13 Nov 2007 12:17:42 -0500

Acambis Joins Forces With Sanofi Pasteur to Develop West Nile Virus Vaccine

CAMBRIDGE, England and CAMBRIDGE, Massachusetts, November 1 - No Human Vaccine Currently Exists Against the West Nile Virus, Which has Caused 3,265 Cases and 92 Deaths in the US so far in 2007; Collaboration Aims to Bring Leading West Nile Virus Vaccine Candidate to Market as Rapidly as Possible

Acambis plc (Acambis) , a leading vaccine development company, announced today that it has signed an exclusive global collaboration agreement with Sanofi Pasteur, the vaccines division of sanofi-aventis Group, for the development and marketing of Acambis' ChimeriVax(TM)-West Nile vaccine, which is the leading West Nile vaccine in development.
"Since 1999 when it was first detected in the US, the West Nile virus has spread across the entire continental United States, causing 27,240 cases and 1,054 deaths," commented Ian Garland, Chief Executive Officer of Acambis. "Vaccination is the ideal approach to tackling this disease and, through this unique collaboration, we aim to bring this vaccine to market as rapidly as possible."

"Providing a vaccine against West Nile disease may now be within reach. This vaccine candidate is the most promising in the industry and would help meet a growing public health need," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur.

Acambis started developing a West Nile vaccine in 1999, shortly after the virus was first identified in the US. Under the terms of the agreement, Acambis will continue to perform ChimeriVax(TM)-West Nile development activities, up to and including the filing of a license application in the US.

Acambis will receive an upfront payment of $10m in 2007 from Sanofi Pasteur, and would be eligible for pre- and post-marketing milestone payments of up to $70m based on product approval and sales in the US market. It would also be entitled to receive development funding and royalties on net sales of the vaccine. In addition, if the vaccine were registered in other countries, Acambis would be entitled to further post-marketing milestone payments and royalties.
There is currently no human vaccine for the prevention of West Nile virus-related disease and no specific treatment. As of 6 November 2007, 3,265 cases of disease and 92 deaths had been recorded in 42 US States by the US Centers for Disease Control and Prevention (CDC) this year. The CDC has identified those aged 50 and above as being most at risk of severe West Nile virus-related disease. In the US, this population totals more than 87 million people.

Acambis is currently conducting a Phase 2 safety, tolerability and immunogenicity trial of ChimeriVax-West Nile in the US in adults aged 41-64 years and 65 years and above. Preliminary data from a previous Phase 2 dose-ranging trial in healthy adults have shown that over 98% of subjects seroconverted 28 days after a single vaccination. The safety profile of the vaccine has been shown to be satisfactory. Acambis' West Nile vaccine candidate uses its proprietary ChimeriVax(TM) technology, which was developed in association with St Louis University.

About West Nile virus
West Nile virus is a potentially serious illness. Experts believe it is established as a seasonal epidemic in North America that flares up in the summer and continues into the fall. About one in 150 people infected with West Nile virus will develop severe illness. The severe symptoms can include high fever, headache, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, vision loss, numbness and paralysis. These symptoms may last several weeks, and neurological effects may be permanent. Up to 20% of the people who become infected have symptoms such as fever, headache, body aches, nausea, vomiting, and sometimes swollen lymph glands or a skin rash on the chest, stomach and back. Symptoms can last for as short as a few days, though even healthy people have become sick for several weeks. Approximately 80% of people who are infected with West Nile virus will not show any symptoms at all.

About Acambis
Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax(TM)-JE, Acambis' most advanced product in its non-biodefence pipeline, has to date shown an excellent safety and efficacy profile following pivotal Phase 3 trials. It is currently undergoing paediatric trials in India and is partnered with Sanofi Pasteur and Bharat Biotech. Acambis' proprietary ChimeriVax(TM) technology, developed in association with St Louis University, has also been used to develop ChimeriVax(TM)-West Nile, which is undergoing Phase 2 clinical testing, making it the most advanced investigational vaccine against the West Nile virus. Acambis has established a global collaboration with Sanofi Pasteur for further development and commercialization of the vaccine. ChimeriVax(TM) has also been applied to development of Sanofi Pasteur's tetravalent dengue vaccine, which has successfully demonstrated proof-of-concept in a Phase 2 trial by generating 100% seroconversion to all four dengue virus serotypes.

Acambis also has the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. C. difficile is estimated to cause at least 350,000 cases of C. difficile-associated disease in the US alone with annual costs to the healthcare system of $1.1bn. Acambis' influenza program aims to develop a universal vaccine against influenza, for which a universal 'A' strain vaccine, ACAM-FLU-A, is currently being tested in a Phase 1 trial, and also includes various further vaccine candidates in the research and pre-clinical stages.

Acambis is recognised internationally as the leading producer of smallpox vaccines. Acambis' ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection was licensed by the US Food and Drug Administration in August 2007. Acambis has manufactured doses of ACAM2000 for emergency-use stockpiles held by the US Government and several other governments around the world. For safety and prescribing information, please refer to http://www.acambis.com/ACAM2000.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at http://www.acambis.com/.

"Safe Harbor" statement
Statements contained within this news release may contain forward-looking comments, which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this news release are subject to the satisfactory progress of research which is, by its very nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.