US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine
Phase III clinical study data presented at IDWeek in Philadelphia
October 20, 2014 – WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). If approved, it would be the first pediatric combination vaccine in the United States designed to help protect against six important diseases – diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B.
“We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases,” said Robin Isaacs, M.D., Vice President, Vaccine Clinical Research, Merck Vaccines.
“Leading organizations – the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians – generally recommend the use of combination vaccines instead of individual injections,” said John Shiver, Ph.D., Senior Vice President, Research and Development, Sanofi Pasteur.
Phase III Clinical Study Data Presented at IDWeek
Data from a Phase III study for the investigational pediatric hexavalent vaccine were recently presented at IDWeek in Philadelphia. This Phase III study, a randomized, open-label, active-comparator controlled clinical trial with more than 1,400 infants at multiple centers across the United States, evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines. The investigational and comparator vaccines were given at two, four, and six months of age.
In the study, healthy infants were randomized in a 2:1 ratio to receive either the investigational pediatric hexavalent vaccine (Group 1) or Sanofi Pasteur’s Pentacel® 2 plus Merck’s Recombivax HB® 3(Group 2). Antibody levels after the third infant doses were measured, and from these measurements 19 primary comparisons between Groups 1 and 2 were evaluated. For 18 of these 19 comparisons (all but one pertussis comparison), the antibodies in the Group 1 infants were non-inferior to those in the Group 2 infants. After the toddler dose of licensed vaccines, antibodies were again measured; the Group 1 antibodies were non-inferior to those in Group 2 for all 8 pertussis comparisons.
The most common, solicited, systemic adverse events following any dose of the investigational hexavalent vaccine were irritability (83%), crying (75%), and drowsiness (74%). Solicited systemic adverse event rates after any dose were similar following administration of the investigational pediatric hexavalent vaccine versus control with the exception of increased rates of fever, which was mostly mild to moderate in intensity and two days or fewer in duration.
“We are encouraged by the results of this Phase III trial,” said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine, and lead investigator of the study. “This investigational combination vaccine against six important diseases showed similar immune responses against the antigens covered by licensed vaccines.”
The partnership between Merck and Sanofi Pasteur draws upon both companies’ experience in the development, manufacturing and marketing of individual and combination vaccines. This pediatric hexavalent vaccine includes antigens for diphtheria, tetanus, pertussis (whooping cough), and polio (poliovirus types 1, 2, and 3) from Sanofi Pasteur and antigens for Haemophilus influenzae type b and hepatitis B from Merck.
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 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 and connect with us on Twitter, Facebook and YouTube.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).
Sanofi Pasteur, the vaccines division of Sanofi, 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 a broad 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.
Merck Forward-Looking Statement
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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the exposure to litigation, including patent 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 2013 Annual Report on Form 10-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).
Sanofi 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 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’s 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, 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 product candidates, the absence of guarantee that the product 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, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
1 Known as V419 on the Merck pipeline chart and DTaP-HepB-Polio-Hib (PR5I) Pediatric hexavalent vaccine on the Sanofi and Sanofi-Pasteur pipeline charts. Also referred to as PR5I at clinicaltrials.gov.
2 Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) is a registered trademark of Sanofi Pasteur, the vaccines division of Sanofi, Paris, France.
3 Recombivax HB (Hepatitis B Vaccine [Recombinant]) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.