Whether the vaccine is effective in preventing the onset of community acquired

Tag : Saccharide

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), todayannounced the initiation of the Community Acquired PneumoniaImmunization Trial in Adults a major study in adults of aninvestigational 13-valent conjugate vaccine designed to helpprevent pneumococcal pneumonia -- the leading cause of bacterialpneumonia in adults.

In Europe and the United States, pneumococcal pneumonia is the mostcommon community-acquired bacterial pneumonia, for which the adultmortality rate averages between 10 to 20 percent. That rate mayexceed 50 percent in high-risk groups worldwide.

The results from this trial are not intended or required forinclusion in Wyeth's currently planned regulatory filings for theuse of the 13-valent pneumococcal conjugate candidate vaccine inadults. Rather, this study is being initiated proactively as partof a Phase 4 commitment, and in agreement with the U.S. Food andDrug Administration (FDA).

The Community Acquired Pneumonia Immunization Trial in Adults is adouble-blind, placebo-controlled study expected to enrollapproximately 85,000 participants 65 years of age and older. Thestudy is being conducted by the Julius Center for Health Sciencesand Primary Care at the University Medical Center Utrecht in theNetherlands. Participants in the trial will receive either Wyeth'sinvestigational 13-valent pneumococcal conjugate vaccine orplacebo.

"We are very excited to conduct this major trial addressing theimportant disease of adult pneumonia," says Marc Bonten, M.D.,principal investigator of the trial and Professor of MolecularEpidemiology of Infectious Diseases, Department of MedicalMicrobiology, Julius Center for Health Sciences and Primary Care,University Medical Center Utrecht. "The primary goal of the trialis to evaluate whether the vaccine is effective in preventing theonset of community acquired pneumonia caused by the serotypesincluded in the vaccine. The trial will also evaluate whether thevaccine is effective in preventing all-cause pneumonia and invasivepneumococcal disease."

The investigational 13-valent vaccine being evaluated in this trialin adults uses Wyeth-pioneered conjugation technology, and is basedon the science of PREVENAR(TM) (Pneumococcal Saccharide ConjugatedVaccine, Adsorbed). PREVENAR is indicated for active immunizationof infants and children from 6 weeks through 9 years of age againstinvasive disease, pneumonia and otitis media caused byStreptococcus 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. The13-valent pneumococcal conjugate vaccine is currently being studiedin 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, WyethPharmaceuticals. "This will be an important trial to evaluate ourconjugate vaccine's potential to address this medical need."

About Pneumonia and Pneumococcal Disease
Pneumonia is a leading cause of death and hospitalization, costinghealth care systems billions of dollars and an estimated 600,000adult deaths worldwide each year. Pneumococcal disease is caused bythe bacterium Streptococcus pneumoniae and the term describes agroup of illnesses, including invasive infections, such asbacteremia/sepsis and meningitis, as well as pneumonia and upperrespiratory tract infections. Although all age groups may beaffected, the highest rate of pneumococcal disease occurs in youngchildren and older adults. In addition, persons suffering from awide range of chronic conditions (eg, diabetes, cardiovasculardisease) and immune deficiencies are at increased risk.

Important Safety Information for PREVENAR
In clinical studies (n=18,168) in children, the most frequentlyreported 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 PREVENARHypersensitivity to any vaccine component, including diphtheriatoxoid, is a contraindication to its use. PREVENAR does not provide100% protection against vaccine serotypes or protect againstnonvaccine serotypes.

As many pathogens other than the pneumococcal serotypes representedin the vaccine may contribute to the burden of pneumonia,protection against all clinical pneumonia is expected to be lowerthan for invasive pneumococcal disease.

PREVENAR is not indicated for use in adults or in infants youngerthan 6 weeks of age.

About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products inthe areas of women's health care, infectious disease,gastrointestinal health, central nervous system, inflammation,transplantation, hemophilia, oncology, vaccines and nutritionalproducts. Wyeth is one of the world's largest research-drivenpharmaceutical and health care products companies. It is a leaderin the discovery, development, manufacturing and marketing ofpharmaceuticals, vaccines, biotechnology products andnon-prescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge AnimalHealth.

The statements in this press release that are not historical factsare forward-looking statements that are subject to risks anduncertainties that could cause actual results to differ materiallyfrom those expressed or implied by such statements. These risks anduncertainties include, without limitation, the inherent uncertaintyof the timing and success of, and expense associated with,research, development, regulatory approval and commercialization ofour products and pipeline products; government cost-containmentinitiatives; restrictions on third-party payments for our products;substantial competition in our industry, including from branded andgeneric products; emerging data on our products and pipelineproducts; the importance of strong performance from our principalproducts and our anticipated new product introductions; the highlyregulated nature of our business; product liability, intellectualproperty and other litigation risks and environmental liabilities;uncertainty regarding our intellectual property rights and those ofothers; difficulties associated with, and regulatory compliancewith respect to, manufacturing of our products; risks associatedwith our strategic relationships; economic conditions includinginterest and currency exchange rate fluctuations; changes ingenerally accepted accounting principles; trade buying patterns;the impact of legislation and regulatory compliance; risks anduncertainties associated with global operations and sales; andother risks and uncertainties, including those detailed from timeto time in our periodic reports filed with the Securities andExchange 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, RISKFACTORS" in our Annual Report on Form 10-K for the year endedDecember 31, 2007, which was filed with the Securities and ExchangeCommission on February 29, 2008. The forward-looking statements inthis press release are qualified by these risk factors. We assumeno obligation to publicly update any forward-looking statements,whether as a result of new information, future developments orotherwise.

SOURCE Wyeth Pharmaceuticals

CONTACT: Media, Lili Gordon, Wyeth Pharmaceuticals,+1-484-865-6671, or Douglas Petkus, Wyeth, +1-973-660-5218, orInvestors, Justin Victoria, Wyeth, +1-973-660-5340
(WYE)

COPYRIGHT © 2008 Terms of Use

Print Version Send to Friend Write a Comment





Previous Stories Babylon presents Babylon 2008 MAC Cincom debuts Program Management software enhancements USINPAC chair available for interviews on US-India Civilian NukeAgreement