Merck and Sanofi Pasteur Initiate Phase III Study in the United States of Pediatric Combination Vaccine to Help Prevent Six Infectious Diseases
Apr 21, 2011
WHITEHOUSE STATION, N.J. and LYON, FRANCE, April 21, 2011 – Merck (NYSE: MRK) (known outside the United States and Canada as MSD) and Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN, NYSE: SNY), announced today the initiation of a Phase III clinical program to evaluate the safety and immunogenicity of an investigational pediatric hexavalent combination vaccine1. This combination vaccine is designed to help protect against six potentially serious diseases: diphtheria, tetanus, whooping cough (Bordetella pertussis), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b, and hepatitis B.
The investigational vaccine is a combination of select components: DTaP5-IPV-Hib- HepB; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine. The vaccine is being developed as part of a partnership between Merck and Sanofi Pasteur that focuses on the development of pediatric combination vaccines.
"Combination vaccines simplify the childhood immunization schedule and may improve coverage, on time vaccination and reduce the number of injections for children,” said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine.
The Phase III clinical program will begin in the United States with a randomized, open-label, active-comparator controlled clinical trial that will involve approximately 1,440 infants at multiple centers. The primary study objectives are to assess the safety and immunogenicity of the investigational hexavalent combination vaccine when given at 2, 4, and 6 months of age concomitantly with Prevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent). The clinical program is expected to begin in Europe this year. For more information on this study, please visit www.clinicaltrials.gov.
The Phase III program was initiated following results from a Phase IIb clinical trial of 459 children that assessed the safety and immunogenicity of the investigational combination vaccine.
"Based on the results of Phase II trials, we are pleased to move this investigational hexavalent combination vaccine to a late-stage clinical program," said Michel DeWilde, Ph.D., senior vice president, Research and Development, Sanofi Pasteur. "We partnered with Merck to draw on the companies' combined leadership, experience and expertise in the development, manufacturing and marketing of pediatric combination vaccines."
In the United States, the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP) generally recommend the use of combination vaccines instead of individual injections, considering the potential for improved vaccination coverage.
“The need to consolidate vaccinations for infants will become increasingly important as the number of diseases that vaccines help prevent continues to increase,” said Tony Ford-Hutchinson, Ph.D., senior vice president, Vaccines Research, Merck. "The development of a hexavalent combination vaccine is complex. The ability to share expertise and capabilities with our partner Sanofi Pasteur is fundamental in reaching our shared goal of developing new combination vaccines that may improve vaccination rates of children."
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
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). For more information, please visit: www.sanofi-aventis.com
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provides more than 1 billion doses of vaccine each year, 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 EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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 projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential 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 among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities as well as 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, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
# # #
Prescribing Information and Patient Product Information for ROTATEQ® are attached and are available at
1 Known as V419 on the Merck pipeline chart and DTP-HepB-Polio-Hib Pediatric hexavalent vaccine on the sanofi-aventis and Sanofi-Pasteur pipeline charts.
ROTATEQ® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA. All other brands are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA
Sanofi Pasteur Contacts: