COLLEGEVILLE, Pa., Dec. 3 Wyeth Pharmaceuticals,a division of Wyeth (NYSE: WYE), announced today that it has submitted amarketing authorization application (MAA) to the European Medicines Agency(EMEA) for approval to market its investigational 13-valent pneumococcalconjugate vaccine (PCV13) for infants and young children. Wyeth is seeking anindication for the prevention of pneumococcal disease (PD) caused by the 13serotypes included in the investigational vaccine in infants and children fromtwo months to five years of age. The review of the MAA will be coordinated bythe EMEA for all 27 countries in the European Union, as well as Norway,Iceland and Liechtenstein.
PCV13 includes the 13 most prevalent pneumococcal serotypes associatedwith serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F) areincluded in Prevenar* (Pneumococcal saccharide conjugated vaccine, adsorbed) -- the current global standard in PD prevention in infants and young children.The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with thegreatest burden of remaining invasive disease. Both Prevenar (also known asPCV7) and PCV13 use CRM197 -- an immunological carrier protein with a 20-yearhistory of use in pediatric vaccines.
"Today's submission is an important milestone for Wyeth and underscoresthe company's commitment to help protect current and future generations fromserious pneumococcal disease," says Emilio Emini, Ph.D., Executive VicePresident, Vaccine Research and Development, Wyeth Pharmaceuticals. "Sinceits introduction, Prevenar has had a substantial impact on public health,dramatically reducing the rate of invasive pneumococcal disease where it isroutinely used. Our investigational 13-valent pneumococcal conjugate vaccineis designed to broaden protection, with the potential to cover up to 92percent of invasive pneumococcal disease in infants and young childrenworldwide."
The PCV13 submission to EU regulators includes data from 12 Phase 3studies, involving more than 7,000 infants and young children. Data fromthese studies have demonstrated that, for the pneumococcal serotypes common toboth vaccines, the immunogenicity of PCV13 is comparable to that of Prevenarusing a pre-determined set of immunological criteria. In addition, PCV13elicits antibacterial functional antibodies to the six additional serotypes.These observations indicate that PCV13 may be as effective as Prevenar inhelping to prevent invasive pneumococcal disease (IPD) due to the seven sharedserotypes in the vaccines and may also be effective in helping to prevent IPDdue to the six additional serotypes. The results also showed that the safetyand tolerability of PCV13 and Prevenar are comparable, and that PCV13 can beadministered with other commonly used pediatric vaccines.
Earlier this year, the U.S. Food and Drug Administration (FDA) grantedFast Track designation to PCV13 for infants and toddlers. Fast Trackdesignation is designed to facilitate review of products for serious or life-threatening conditions for which there is an unmet medical need. The Companyexpects to complete its U.S. filing for pediatric use of the vaccine in thefirst quarter of 2009, while initiating other pediatric filings in the nearterm. PCV13 is also being studied in global Phase 3 clinical trials inadults, with regulatory filings expected in 2010.
Pneumococcal disease affects both children and adults, and is a leadingcause of illness and death worldwide. Pneumococcal disease describes a groupof illnesses, all caused by the bacterium Streptococcus pneumoniae, thatinclude invasive infections such as bacteremia/sepsis and meningitis, as wellas pneumonia and otitis media. Most recently, the pneumococcal serotype 19A,which is included in the candidate vaccine, has been increasing in prevalencein many regions of the world and is frequently resistant to antibiotics.
Due to the significant burden of pneumococcal disease and demonstratedvaccine efficacy, the World Health Organization (WHO) recommends the priorityinclusion of PCV7 in national childhood immunization programs worldwide.
Important Safety Information for Prevenar (PCV7)
In clinical studies (n=18,168) in children, the most frequently reportedadverse events included injection site reactions, fever (greater than or equalto 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep,decreased appetite, vomiting, diarrhea, and rash. Risks are associated withall vaccines, including Prevenar. Hypersensitivity to any vaccine component,including diphtheria toxoid, is a contraindication to its use. Prevenar doesnot provide 100% protection against vaccine serotypes or protect againstnonvaccine serotypes. The frequency of pneumococcal serotypes and serogroupscan vary from country to country, which could influence the effectiveness ofthe vaccine in any given country.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in theareas 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 andhealth care products companies. It is a leader in the discovery, development,manufacturing and marketing of pharmaceuticals, vaccines, biotechnologyproducts, nutritionals and non-prescription medicines that improve the qualityof life for people worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts areforward-looking statements that are subject to risks and uncertainties thatcould cause actual results to differ materially from those expressed orimplied by such statements. In particular, clinical trial data are subject todiffering interpretations, and the views of regulatory agencies, medical andscientific experts and others may differ from ours. The Phase 3 clinicaltrial data publicly presented to date reflect only four of the core Phase 3studies of PCV13 in the pediatric population and, accordingly, do notrepresent the totality of data and other information that may affectregulatory review and commercialization of PCV13. There can be no assurancethat our regulatory submissions for PCV13 will be accepted for review byregulatory agencies or that PCV13 will ever receive regulatory approval or besuccessfully developed and commercialized. Other risks and uncertainties thatcould cause actual results to differ materially from those expressed orimplied by forward-looking statements include, without limitation, theinherent uncertainty of the timing and success of, and expense associatedwith, research, development, regulatory approval and commercialization of ourproducts and pipeline products; government cost-containment initiatives;restrictions on third-party payments for our products; substantial competitionin our industry, including from branded and generic products; emerging data onour products and pipeline products; the importance of strong performance fromour principal products and our anticipated new product introductions; thehighly regulated nature of our business; product liability, intellectualproperty and other litigation risks and environmental liabilities; uncertaintyregarding our intellectual property rights and those of others; difficultiesassociated with, and regulatory compliance with respect to, manufacturing ofour products; risks associated with our strategic relationships; economicconditions including interest and currency exchange rate fluctuations; changesin generally accepted accounting principles; trade buying patterns; the impactof legislation and regulatory compliance; risks and uncertainties associatedwith global operations and sales; and other risks and uncertainties, includingthose detailed from time to time in our periodic reports filed with theSecurities and Exchange Commission, including our current reports on Form 8-K,quarterly reports on Form 10-Q and annual report on Form 10-K, particularlythe discussion under the caption "Item 1A, RISK FACTORS" in our Annual Reporton Form 10-K for the year ended December 31, 2007, which was filed with theSecurities and Exchange Commission on February 29, 2008. The forward-lookingstatements in this press release are qualified by these risk factors. Weassume no obligation to publicly update any forward-looking statements,whether as a result of new information, future developments or otherwise.
SOURCE Wyeth Pharmaceuticals