- 85,000 Expected to Enroll in Phase 4 Study Initiated Pre-Registration -
COLLEGEVILLE, Pa., Sept. 23 /PRNewswire/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the initiation of the Community Acquired Pneumonia Immunization Trial in Adults a major study in adults of an investigational 13-valent conjugate vaccine designed to help prevent pneumococcal pneumonia -- the leading cause of bacterial pneumonia in adults.
In Europe and the United States, pneumococcal pneumonia is the most common community-acquired bacterial pneumonia, for which the adult mortality rate averages between 10 to 20 percent. That rate may exceed 50 percent in high-risk groups worldwide.
The results from this trial are not intended or required for inclusion in Wyeth's currently planned regulatory filings for the use of the 13-valent pneumococcal conjugate candidate vaccine in adults. Rather, this study is being initiated proactively as part of a Phase 4 commitment, and in agreement with the U.S. Food and Drug Administration (FDA).
The Community Acquired Pneumonia Immunization Trial in Adults is a double-blind, placebo-controlled study expected to enroll approximately 85,000 participants 65 years of age and older. The study is being conducted by the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht in the Netherlands. Participants in the trial will receive either Wyeth's investigational 13-valent pneumococcal conjugate vaccine or placebo.
"We are very excited to conduct this major trial addressing the important disease of adult pneumonia," says Marc Bonten, M.D., principal investigator of the trial and Professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht. "The primary goal of the trial is to evaluate whether the vaccine is effective in preventing the onset of community acquired pneumonia caused by the serotypes included in the vaccine. The trial will also evaluate whether the vaccine is effective in preventing all-cause pneumonia and invasive pneumococcal disease."
The investigational 13-valent vaccine being evaluated in this trial in adults uses Wyeth-pioneered conjugation technology, and is based on the science of PREVENAR(TM) (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). PREVENAR is indicated for active immunization of infants and children from 6 weeks through 9 years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. The study vaccine includes six serotypes (1, 3, 5, 6A, 7F and 19A), in addition to the seven serotypes included in PREVENAR. The 13-valent pneumococcal conjugate vaccine is currently being studied in late-stage global clinical trials in both infants and adults.
"Pneumococcal pneumonia in adults represents a significant burden, both clinically and economically," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "This will be an important trial to evaluate our conjugate vaccine's potential to address this medical need."
About Pneumonia and Pneumococcal Disease
Pneumonia is a leading cause of death and hospitalization, costing health care systems billions of dollars and an estimated 600,000 adult deaths worldwide each year. Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and the term describes a group of illnesses, including invasive infections, such as bacteremia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections. Although all age groups may be affected, the highest rate of pneumococcal disease occurs in young children and older adults. In addition, persons suffering from a wide range of chronic conditions (eg, diabetes, cardiovascular disease) and immune deficiencies are at increased risk.
Important Safety Information for PREVENAR(TM)
In clinical studies (n=18,168) in children, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including PREVENAR(TM). Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. PREVENAR does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
As many pathogens other than the pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
PREVENAR is not indicated for use in adults or in infants younger than 6 weeks of age.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
|SOURCE Wyeth Pharmaceuticals|
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