Lyon, 25th April 2013 – Sanofi Pasteur MSD,  the joint venture between MSD and Sanofi Pasteur in Europe, announced today that the European Commission has granted a community marketing authorisation for Hexyon^TM, an innovative new 6-in-1 paediatric vaccine.

Hexyon^TM is the only fully liquid, ready-to-use 6-in-1 vaccine to protect infants against six World Health Organization (WHO) priority diseases: diphtheria, tetanus, whooping cough, Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Hexyon^TM has a unique advantage for healthcare professionals in that it is fully liquid (with all components in one syringe) and does not require any reconstitution, so making administration simple and limits the risk of error. The vaccine is indicated for primary and booster vaccination of infants from six weeks to 24 months of age in accordance with official recommendations in each European nation.

“We are very pleased that Hexyon is now approved for use in Europe. It clearly demonstrates Sanofi Pasteur MSD’s  commitment to provide innovative advances in vaccines to enhance public health in Europe.” said Jean-Paul Kress, President of Sanofi Pasteur MSD. “With this approval we can now give healthcare professionals an effective vaccine for infants with a unique ready-to-use formulation that will make administration simpler and  more secure.”

The EU Commission’s decision follows the recent recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), and is supported by the results of multi-center clinical studies involving approximately 5,000 infants. These studies compared Hexyon^TM with other licensed combination vaccines and  demonstrated that Hexyon^TM has a good safety profile and induces a robust immune response against all six targeted diseases.

The new hexavalent vaccine, developed by Sanofi Pasteur, will be commercialised in Europe under two brands names – in Western Europe* by Sanofi Pasteur MSD under the brand name Hexyon^TM and in Eastern Europe by Sanofi Pasteur under the brand name Hexacima^®.

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* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal,  Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines to improve disease prevention across Europe.

For further information please contact: 

Caroline Ashe
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

 Hexyon 6-in-1 Paediatric Vaccine Approved in Europe

Lyon, 11 April 2013 – Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, announced today that it has submitted a decentralized marketing authorization application in Europe for a ‘Quadrivalent’ influenza vaccine, a new advanced seasonal flu vaccine.

The ‘Quadrivalent’ vaccine, developed by Sanofi Pasteur, is expected to help protect people from four different strains of seasonal influenza viruses. Currently available flu vaccines protect against three strains of flu viruses. By including a fourth influenza strain, the new seasonal flu vaccine could help further reduce influenza disease and influenza-related complications, hospitalizations and deaths.

“This filing clearly demonstrates our commitment to providing advanced vaccine solutions to help improve disease prevention in Europe,” said Jean Paul Kress, President of Sanofi Pasteur MSD. “We believe that quadrivalent flu vaccines will become the new standard for the prevention of seasonal flu.”

The new flu vaccine has been submitted for licences in Europe under the decentralized approval process, with France acting as the “Reference Member State” for the review of the licence dossier.

Once approved, the new quadrivalent vaccine will be commercialized in Western European countries by Sanofi Pasteur MSD and in Eastern European countries by Sanofi Pasteur, the vaccine division of Sanofi.

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About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline Ashe
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

 Sanofi Pasteur MSD Submits Quadrivalent Influenza Vaccine for European Licenses 

Lyon, 22 February 2013 – Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur in Europe, announced today that their innovative 6-in-1 paediatric vaccine Hexyon has been recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The new hexavalent vaccine, developed by Sanofi Pasteur, will be commercialised in Europe under two brands names – in Western Europe* by Sanofi Pasteur MSD under the brand name Hexyon and in Eastern Europe by Sanofi Pasteur under the brand name Hexacima.

Hexyon is the only fully liquid, ready-to-use 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

“We welcome the CHMP’s positive recommendation,” said Jean-Paul Kress, President of Sanofi Pasteur MSD.  “It validates the clinical data supporting the vaccine’s effective and safe use for infants.  Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process.”

Hexyon’s formulation does not require reconstitution prior to administration, so improving convenience.  Hexyon will be indicated for primary and booster vaccination of infants from six weeks to 24 months of age in accordance with official recommendations.

-END-

* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal, Switzerland, Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline ASHE

Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel :   +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

European Medicines Agency Recommends Approval of Hexyon 6-in-1 Paediatric Vaccine

Lyon, 14th January 2013 – Andrea Rappagliosi, Vice President of Market Access, Health Policy & Medical Affairs at Sanofi Pasteur MSD has been appointed President of Vaccines Europe* as of  1^st January 2013.

Vaccines Europe is the group representing vaccine manufacturers within the European Federation of Pharmaceutical Industries and Associations (EFPIA), the professional association of the European pharmaceutical industry.  Its members include established vaccine companies such as Sanofi Pasteur MSD, AstraZeneca, Sanofi Pasteur, Novartis, GlaxoSmithKline Biologicals, Pfizer, Crucell, Abbott, Baxter and MSD.

Sanofi Pasteur MSD is one of the largest vaccines companies in Europe and Andrea Rappagliosi’s appointment highlights the calibre and expertise of the new management team that has been brought in by Jean Paul Kress, President of Sanofi Pasteur MSD, since he took over the company in 2011.

“I am strongly supportive of Andrea’s Presidency as it reflects our commitment to maintain and strengthen healthcare excellence in Europe for the benefit of people’s health and wellbeing” said Jean-Paul Kress, President of Sanofi Pasteur MSD. “Andrea’s expertise will boost Vaccines Europe’s advocacy focus whilst highlighting Sanofi Pasteur MSD’s profile as a clear leader in vaccines in Europe.” 

With twenty years of experience in the pharmaceutical industry and a number of years within the Italian Institutions, Rappagliosi joined Sanofi Pasteur MSD from GlaxoSmithKline in 2012 as Vice President of Market Access, Health Policy & Medical Affairs.

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About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

*About Vaccines Europe

Vaccines Europe (VE) is a specialized group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), the professional association of the European pharmaceutical industry. Formed in 1991 under the name European Vaccines Manufacturers (EVM), the association set out to improve public health through immunization and promoting R&D of innovative vaccines, Vaccines Europe member companies are major manufacturers of vaccines worldwide, producing the majority of vaccine doses in Europe. VE members are: Abbott Biologicals, AstraZeneca, Baxter, Crucell, GlaxoSmithKline Biologicals, MSD, Novartis Vaccines, Pfizer, Sanofi Pasteur and Sanofi Pasteur MSD.

Visit Vaccines Europe Website

For further information please contact:

Caroline ASHE

Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel :   +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in pdf format here:

Andrea Rappagliosi President of Vaccines Europe

Lyon, 11^th Jan

The new appointment is part of the re-shaping of the organisation that has been led by Jean-Paul Kress, President of Sanofi Pasteur MSD, over the last 18 months. Dr Kress’s re-organisation of his senior management and business operations has resulted in a healthy sales growth in Europe and he now aims to provide a strong platform for the successful introduction of two major new vaccines.
“I’m pleased that Serge has agreed to take on this important role in our company,” said Jean-Paul Kress, President of Sanofi Pasteur MSD. “Serge can apply his unique experience of diverse European markets to anticipate and respond to the dynamic evolution of the healthcare system in France, to best meet the needs of patients and citizens in this country.”
Serge Montero previously held the post of Vice President & General Manager of European Midsized Countries at Sanofi Pasteur MSD. These countries included Austria, Belgium, Denmark, Finland, Greece, Iceland, Ireland, Liechtenstein, Luxemburg, the Netherlands, Norway, Portugal, Sweden and Switzerland.

Montero has extensive experience of the vaccine business from over twenty years with Sanofi Pasteur MSD and its family of companies. During this time, he has held leadership positions in Sales, Marketing, Business Management, Supply and Information Systems. His industry experience is underpinned by a strong academic record including a PhD in Computer Sciences from the Institut National des Sciences Appliquées, a Master in Finance and Banking from the Université de Lyon II, a Master in Applied Mathematics and a Master in Technological Sciences from the Université de Lyon I.

Serge Montero replaces Eric LeCocq, who stepped down from the role of General Manager, France this month to pursue external opportunities.

- END-

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline ASHE

Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel :   +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Lyon, 6^th December 2012 – Data from two large, long term follow-up studies continue to show that vaccination with Gardasil offers a long duration of protection from human papillomavirus (HPV) diseases related to HPV types 6, 11, 16 and 18.   HPV-related diseases include cervical cancer and genital warts.

The interim data, presented at the 28^th International Papillomavirus Conference (IPV) in Puerto Rico, showed that young women¹ and adolescent girls and boys² vaccinated with Gardasil were protected from HPV-related diseases for up to eight years following vaccination. Furthermore, data on immunogenicity³ (the degree to which an immune response is induced) showed that immune levels remained high for nine years following vaccination.

“These latest data show an encouraging trend of continued protection with Gardasil against HPV-related cervical, vaginal and vulvar disease in women through eight years,” said Professor Susanne Krüger Kjær, Danish Cancer Society.  “These studies provide further evidence for the ongoing efficacy, immunogenicity, and safety of Gardasil.”

The European studies were conducted in Sweden, Denmark, Norway and Iceland. One study followed young women aged between 16-23 years and the second study followed adolescent boys and girls between 9-15 years.  The studies will continue tracking the study participants for at least 14 years.

Benoit Soubeyrand, Executive Director, Medical Affairs for Sanofi Pasteur MSD stated:  “These data tell us that Gardasil can in effect help protect people from HPV diseases during the entire period when they are most at risk – from adolescence into early adulthood.   That’s nearly a decade of protection that could save many lives over time.”

More than 100 million doses of Gardasil® have been distributed worldwide since 2006.

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Notes to Editors

About the studies

The Scandinavian study¹ among young women is an extension of the pivotal Phase III FUTURE II clinical trial of Gardasil. The study is being conducted through the national health registry systems in four Nordic countries: Denmark, Iceland, Norway and Sweden. Because of the extensive nationwide registers in these countries, it is possible to conduct follow-up studies that can track the health of the study participants well into the future, beyond the original study’s timeframe.  The Long Term Follow-Up (LTFU) study evaluated effectiveness against the early stages of cervical cancer, vulvar cancer and vaginal cancer related to HPV types 6/11/16/18.   Data from this Scandinavian study showed a trend of continued protection, with no breakthrough cases of disease, through eight years.  Analysis and observation of the study participants will be followed for 10 years, for a total of 14 years post vaccination.

The study among adolescent girls and boys² aged 10-15 years followed a randomized, double-blind trial of 1,781 participants.  Safety, immunogenicity and effectiveness of Gardasil were assessed following vaccination in this population as they got older and as some became sexually active.  Results also showed persistence of high immune response to HPV types 6, 11, 16 or 18 over 8 years in study participants.  In this follow up period there were no cases of disease related to vaccine HPV types 6, 11, 16 or 18 through 8 years.  This study will continue to follow participants through at least 10 years of post-vaccination follow-up.

References:

1. Krüger Kjær S et al. Long-term effectiveness of Gardasil™ in the Nordic countries. Poster and abstract presented at the 28^th International Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.

2, 6 Saah A et al. Long-term extension study of Gardasil in adolescents; results through month 96.  Poster and abstract presented at the 28^th International Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.

3. Nygård M et al.A long term follow-up study of the immunogenicity of the quadrivalent HPV (qHPV) vaccine in Scandinavia and Iceland. Poster and abstract presented at the 28^th International Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline ASHE

Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel :   +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

 Studies demonstrate Gardasil® has long duration of protection from HPV disease

Vaccine submitted to European Medicines Agency for licence review

Lyon, 19th October 2012 – Sanofi Pasteur MSD plans to licence and commercialise an innovative 6-in-1 paediatr
ic vaccine in its European territories.

The new hexavalent vaccine, developed by Sanofi Pasteur, is the only fully liquid, ready to use 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

“This is a landmark for our company as we hope to provide healthcare professionals in Europe with a ready-to-use hexavalent vaccine that will raise the standard of care in vaccination for millions of infants,” said Jean-Paul Kress, MD, President of Sanofi Pasteur MSD.

“This clearly reflects our commitment to bring innovative new vaccines to the European market and it shows the benefits of being able to draw upon the collective expertise of our joint venture. With this new 6-in-1 vaccine, Sanofi Pasteur MSD will then have a broad paediatric vaccine portfolio that will allow us to provide a wide range of vaccine solutions for our customers.”

Sanofi Pasteur MSD is a joint venture in Europe between Sanofi Pasteur, the vaccines division of Sanofi, and Merck, known as MSD outside the United States and Canada.

The vaccine has been submitted by Sanofi Pasteur MSD to the European Medicines Agency (EMA) for licence within the European Union and upon approval the company will commercialise it in its European territories under its own brand name.

Download the press release in pdf format here:

Sanofi Pasteur MSD To Commercialise New 6-in-1 Paediatric Vaccine in European Markets

Reduction in Genital Warts Seen with Gardasil, New Studies are Early Markers of Impact

These clinical data add to those demonstrating robust immune response in adolescents aged 9 to 15 years. The European Commission followed the advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA).Gardasil® is the only vaccine that allows HPV vaccination of girls and women as well as boys and men. “Gardasil® can help boys and young men to prevent HPV-related diseases such as genital warts,” says Benoît Soubeyrand, Medical Affairs Director Europe at Sanofi Pasteur MSD. “In addition to this direct benefit, HPV vaccination of boys could help to further decrease the circulation of HPV in the population and improve the adoption of this vaccination among girls.” Genital warts are common and can occur at young ages, and the frequency is increasing further.

They can reduce self-esteem and create embarrassment and anxiety. The removal of  genital warts can be painful, and recurrence rates can be high as the infection persists. Genital warts represent also an economic burden for society. The product information has also been updated to include clinical efficacy in the prevention of  anal pre-cancerous lesions due to HPV types 16 or 18, demonstrated in a sub-study with men who self-identified as having sex with men.The sub-study focused on these men because they are at a relatively high risk of HPV-related anal pre-cancerous lesions (facilitating demonstration of efficacy). Anal pre-cancerous lesions were used in the study as a marker of anal cancer the prevention of which itself cannot be studied for ethical reasons. Gardasil® is the only HPV vaccine that directly targets the four HPV types 6, 11, 16 and 18 which together cause the vast majority of HPV-related genital diseases.