COLLEGEVILLE, Pa., May 29 Wyeth Pharmaceuticals,a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and DrugAdministration (FDA) has granted Fast Track designation to the Company'sinvestigational 13-valent pneumococcal conjugate vaccine for infants andtoddlers. Wyeth is seeking a pediatric indication for active immunizationagainst invasive pneumococcal disease (IPD) and otitis media caused byserotypes included in the vaccine. The vaccine includes six new serotypes (1,3, 5, 6A, 7F and 19A) in addition to the seven serotypes (4, 6B, 9V, 14, 18C,19F and 23F) included in PREVNAR(R), Pneumococcal 7-valent Conjugate Vaccine(Diphtheria CRM197 Protein), also known as PCV7.
"While the incidence of pneumococcal disease has been substantiallyreduced since our introduction of PREVNAR in the United States, pneumococcaldisease remains a health threat to children, specifically as emerging strains,such as 19A, become more prevalent," says Emilio Emini, Ph.D., Executive VicePresident, Vaccine Research and Development, Wyeth Pharmaceuticals. "Withthat in mind, we are very pleased that the FDA has granted Fast Trackdesignation to our investigational 13-valent vaccine for pediatric use."
Fast Track designation is designed to facilitate review of products thataddress serious or potentially life threatening conditions for which there isan unmet medical need. With Fast Track designation, Wyeth plans to submit thebiologics license application on a rolling basis as sections of theapplication are completed, enabling the FDA to begin review sooner.
The Company expects to complete its U.S. filing for pediatric use of thevaccine in the first quarter of 2009. Wyeth is also exploring opportunitiesto accelerate the timing of pediatric filings of the vaccine in the rest ofthe world from its current target of the first quarter of 2009. Wyeth'sinvestigational 13-valent pneumococcal conjugate vaccine is being studied inPhase 3 global clinical trials in both infants and adults.
Wyeth recently has achieved significant success in bringing new productsto market. In the first quarter of 2008 alone, Wyeth obtained three newproduct approvals in the following therapeutic areas: major depressivedisorder, Hemophilia A and opioid-induced constipation.
According to the World Health Organization (WHO), pneumococcal disease isthe number one vaccine-preventable cause of death in children younger than 5years of age. Due to the significant burden of pneumococcal disease anddemonstrated vaccine efficacy, WHO recommends the priority inclusion of PCV7in national childhood immunization programs worldwide. WHO notes that onceother pneumococcal vaccines offering broader protection become available,countries can assess whether it would be helpful to switch to these vaccines.
Pneumococcal disease affects both children and adults and is a leadingcause of illness and death worldwide. Pneumococcal disease is caused by thebacterium Streptococcus pneumoniae and describes a group of illnesses,including invasive infections, such as bacteremia/sepsis and meningitis, aswell as pneumonia and upper respiratory tract infections, including otitismedia.
Important Safety Information about PREVNAR
In clinical trials (n=18,168), the most frequently reported adverse eventsincluded injection site reactions, fever (greater than or equal to 38 degreesC/100.4 degrees F), irritability, drowsiness, restless sleep, decreasedappetite, vomiting, diarrhea, and rash. Risks are associated with allvaccines, including PREVNAR. Hypersensitivity to any vaccine component,including diphtheria toxoid, is a contraindication to its use. PREVNAR doesnot provide 100 percent protection against vaccine serotypes or protectagainst nonvaccine serotypes.
Wyeth Pharmaceuticals, a division of Wyeth, has leadi