Healthcare Industry News: GARDASIL
News Release - January 4, 2006
In a New Study Published in New England Journal of Medicine, ROTATEQ(R), Merck's Investigational Rotavirus Vaccine, Prevented 98 Percent of Severe Rotavirus GastroenteritisROTATEQ Also Reduced Rotavirus-Related Hospitalizations and Emergency Room (ER) Visits by More Than 90 Percent
WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Jan. 4, 2006--In a new study of nearly 70,000 infants published in this week's New England Journal of Medicine, Merck's investigational vaccine ROTATEQ® (rotavirus vaccine, live, oral, pentavalent) prevented 98 percent of severe cases of rotavirus gastroenteritis caused by serotypes targeted by the vaccine. Rotavirus is the most common cause of severe dehydrating gastroenteritis in infants and young children. The study also showed that ROTATEQ was generally well-tolerated as compared to placebo. ROTATEQ targets the five strains of rotavirus - G1, G2, G3, G4 and P1 - responsible for more than 90 percent of rotavirus disease around the world.
Among children under five years of age in the United States, rotavirus is responsible for up to 70,000 hospitalizations, an estimated 250,000 ER visits and more than 400,000 visits to primary care offices annually. Worldwide, rotavirus causes more than two million hospitalizations and nearly 500,000 deaths each year.
"Merck has devoted more than 15 years of research to developing a vaccine to prevent the potentially serious effects of rotavirus. The results of REST demonstrated the potential benefit of ROTATEQ in the prevention of this common and highly contagious childhood disease that sends hundreds of thousands of children to the doctor's office every year," said Penny Heaton, M.D., senior director of clinical research at Merck Research Laboratories. "Merck has filed for licensure of ROTATEQ in the U.S. and more than 50 other countries, and we plan to initiate clinical studies this year to evaluate the use of ROTATEQ in the developing world."
Nearly 70,000 Infants from 11 Nations Participated in REST
REST was a double-blind, randomized, placebo-controlled study and one of the largest vaccine clinical trials ever conducted. The study began in 2001 and enrolled infants in the age range of six to 12 weeks in 11 countries (the United States, Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Sweden and Taiwan). Infants were randomly assigned to receive three doses of vaccine or placebo, given four to 10 weeks apart. Because intussusception was associated with a previously licensed rotavirus vaccine made by another manufacturer, one of the primary goals of REST was to evaluate the safety of ROTATEQ with respect to intussusception among vaccine and placebo recipients. Intussusception takes place when the bowel folds in on itself, causing an intestinal blockage. Overall, 68,038 infants were vaccinated in REST - 34,035 in the vaccine group and 34,003 in the placebo group. All were monitored for serious adverse events, including intussusception, and all were followed to assess whether ROTATEQ could prevent hospitalizations and emergency room visits due to rotavirus disease. In addition, sub-studies within the large scale study were designed to evaluate the overall safety of ROTATEQ, as well as the efficacy of ROTATEQ against rotavirus gastroenteritis of any severity.
ROTATEQ Prevented Mild, Moderate and Severe Rotavirus Gastroenteritis
Among the 5,673 infants (2,834 in the vaccine group and 2,839 in the placebo group) included in an efficacy sub-study, ROTATEQ demonstrated 98 percent efficacy against severe rotavirus gastroenteritis and 74 percent efficacy against rotavirus gastroenteritis of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) as compared to placebo through the first full rotavirus season after vaccination. Overall, 397 cases of rotavirus gastroenteritis of any severity (82 in the vaccine group and 315 in the placebo group) occurred 14 or more days after the third dose through the first full rotavirus season after vaccination. Only one case of severe rotavirus gastroenteritis occurred in the vaccine group and 51 in the placebo group. In this same sub-study, ROTATEQ also reduced office or clinic visits for rotavirus gastroenteritis by 86 percent.
Among the infants included in the large scale study, ROTATEQ reduced hospitalizations for rotavirus gastroenteritis caused by serotypes targeted by the vaccine by 96 percent and reduced ER visits by 94 percent. Overall, 204 infants went to the ER and 144 were hospitalized for rotavirus caused by specific serotypes targeted by the vaccine (ER: 13 in the vaccine group and 191 in the placebo group; hospitalizations: six in the vaccine group and 138 in the placebo group).
In Study, Incidence of Intussusception in Vaccine Group Similar to Placebo Group
In REST, parents of all infants were to be contacted at least three times following each dose - at one, two and six weeks - and asked about serious adverse events, including intussusception. Additional contacts were made every six weeks thereafter for one year after the first dose. Among the infants evaluated there were six cases of intussusception in the vaccine group and five in the placebo group during the six week period following any dose. Within one year after the first dose, there were 12 cases of intussusception in the vaccine group and 15 in the placebo group. No cases were seen in the vaccine group within six weeks after the first dose. The number and characteristics of cases were similar to that expected with naturally occurring intussusception, which occurs in approximately one in two thousand infants less than two years of age each year.
A detailed safety sub-study was designed to evaluate safety with respect to all adverse events. ROTATEQ was generally well-tolerated as compared to placebo. Among the 9,605 infants included (4,806 in the vaccine group and 4,799 in the placebo group), the rates of fever, vomiting, diarrhea and hematochezia within six weeks after any dose were similar among vaccine recipients and placebo recipients (fever: 40.9% in vaccine group vs. 43.0% in placebo group; vomiting: 12.8% vaccine group vs. 13.4% placebo group; diarrhea: 19.7% vaccine group vs. 19.1% placebo group; hematochezia: 0.6% vaccine group vs. 0.6% placebo group).
Merck submitted a Biologics License Application (BLA) for ROTATEQ on April 5, 2005, and Phase III clinical trial results were reviewed last month at the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee. The Committee unanimously agreed that the clinical data from REST and the other Phase III studies supported the efficacy and safety of ROTATEQ. If approved by FDA, ROTATEQ would be the only vaccine available in the United States to protect against rotavirus. The FDA is not bound by the committee's conclusions but takes its advice into consideration when reviewing investigational vaccines seeking approval.
ROTATEQ is one of three Merck vaccines currently being evaluated by the FDA. The FDA and other regulatory agencies around the world are reviewing applications for ZOSTAVAX, Merck's investigational vaccine to prevent shingles and shingles-associated pain in adults, and GARDASIL, Merck's investigational HPV and cervical cancer vaccine.
About Rotavirus Gastroenteritis
Rotavirus causes approximately one-third of diarrhea-associated hospitalizations and nearly 500,000 deaths worldwide every year in children under five. Although symptoms can vary, those typically associated with rotavirus gastroenteritis include vomiting, fever, abdominal pain and watery diarrhea which can persist for three to nine days. The severity of rotavirus gastroenteritis ranges from asymptomatic infection to dehydrating gastroenteritis that can be fatal. The incidence of rotavirus is similar in developed and developing countries, which suggests that differences in environment (e.g., clean water, hygiene or sanitation) do not prevent this disease.
During the first few years of life, a child typically has several rotavirus infections. The highest rates of gastroenteritis are generally in children under two years of age, who are also at the greatest risk for severe disease. Nearly all children will be infected with rotavirus by age five. There are several different serotypes of rotavirus and the prevalence of these serotypes varies by geographic region and changes from season to season. Children usually develop increased immunity against different strains of the virus after several infections.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com
This press release, including the financial information that follows, contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
ROTATEQ® is a registered trademark of Merck & Co., Inc.
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