New Phase 3 Data Continue To Indicate That Wyeth's Investigational 13-valent Vaccine Has The Potenti

< BACK TO HEALTH starstarstarstarstar   Community - Health Press Release
12th June 2009, 12:07am - Views: 735

Community Health Wyeth Pharmaceuticals 1 image


New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the

Potential to Broaden Coverage Against Pneumococcal Disease

COLLEGEVILLE, Pa., June 11 /PRNewswire-AsiaNet/ --

    New data from Phase 3 European clinical trials reinforce that Wyeth's (NYSE: WYE) 

investigational pneumococcal vaccine, Prevenar 13* (Pneumococcal 

Polysaccharide Conjugate Vaccine, 13-valent [Adsorbed]), has the potential to 

provide coverage against the 13 most prevalent serotypes associated with 

pneumococcal disease (PD), the leading cause of vaccine-preventable death in 

children younger than five worldwide.

    The Phase 3 data presented at the 27th Annual Meeting of the European

Society for Pediatric Infectious Diseases (ESPID) come from seven core

studies in the pediatric clinical trial program for Prevenar 13 which were

conducted in France, Italy, Poland, Spain and the UK. Researchers also

presented health economic models which estimated the potential public health

and economic impact of Prevenar 13 -- if approved and incorporated into

national immunization programs -- for the Netherlands, the UK, as well as

Germany and the U.S.

    "Our investigational vaccine, Prevenar 13, builds on the scientific

foundation of Prevenar and is designed to provide more comprehensive

protection against pneumococcal disease," says Emilio A. Emini, Ph.D.,

Executive Vice President, Vaccines Research and Development, Wyeth

Pharmaceuticals. "These new data indicate that Prevenar 13 has the potential

to provide direct coverage of the 13 most common disease-causing serotypes,

including 3, 6A and 19A, which have been increasing in prevalence in many

regions around the world."

    Prevenar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F and

23F) in Prevenar* (Pneumococcal Polysaccharide Conjugated Vaccine,

[Adsorbed]) -- the current global standard in PD prevention in infants and

young children as well as six additional serotypes (1, 3, 5, 6A, 7F and 19A)

associated with the greatest remaining burden of invasive disease. Both

Prevenar 13 and Prevenar use CRM197 -- an immunological carrier protein with

a 20-year history of use in pediatric vaccines.

    Phase 3 Data Results

    Data from the studies presented at ESPID indicate that Prevenar 13 is

immunogenic for all serotypes and showed a safety profile similar to

Prevenar. Among the study findings:

    - In a study conducted in France, 613 children were randomized to receive

      either four doses of Prevenar or Prevenar 13 at 2, 3, 4 and 12 months, 

      or three doses of Prevenar at 2, 3 and 4 months with a booster dose of

      Prevenar 13 or Prevenar at 12 months. Antibody response was measured at 

      month 13. Both of the Prevenar 13 schedules induced a robust immune response 

      for all 13 serotypes.

    - In a study conducted in Italy, 606 healthy infants aged 3 months were

      randomized to receive Prevenar 13 or Prevenar along with Infanrix 

      hexa(R) [GlaxoSmithKline], the combined diphtheria, tetanus, pertussis, 

      hepatitis B, inactivated poliovirus, and Hib vaccine, at 3, 5, and 11 months of age. 

      Assessment of functional antibody levels (serotype 

      specific opsonphagocytic assay) one month after the infant series and       

     after the booster dose showed that a high percentage of infants 

      receiving Prevenar 13 had functional antibodies for all serotypes. 

      Prevenar 13 did not affect responses to the concomitantly administered 

      vaccine and showed a safety profile comparable to Prevenar.

    - A study of 352 children in Poland assessed the safety and

      immunogenicity of Prevenar 13 in older children not previously 

      immunized with Prevenar. Children were vaccinated with one of three       

     different catch-up schedules currently recommended for Prevenar. These 

      treatment schedules included the following: 1) two doses of Prevenar 13 

      at age 7 to <12 months with a booster at age 12-16 months; 2) two doses 

      of Prevenar 13 at age 12 to <24 months; and 3) a single dose of 

      Prevenar 13 at age 24 to <72 months. Each of the 3 regimens was shown       

     to elicit immune response levels against all 13 serotypes that were either 

     comparable to or greater than the IgG antibody concentrations achieved in 

      infants after a 3-dose infant series and to have acceptable tolerability and safety profiles.

    Overall, the most frequently reported adverse events in the Phase 3

trials included injection site reactions, (redness, swelling, and

tenderness), fever (greater than or equal to 38 degrees C/100.4 degrees F),

irritability, drowsiness, restless sleep, decreased appetite, vomiting,

diarrhea and rash.

    Health Economic Models

    Three health economic models presented at ESPID estimated the potential

public health and economic impact of Prevenar 13. The results of the analyses

in the Netherlands, the UK, and Germany and the US suggested that the

introduction of Prevenar 13, if approved, to national immunization programs

has the potential to further reduce PD levels in children who are vaccinated

as well as in the unvaccinated population (through a herd effect). Based on

these economic models, the researchers estimated that routine vaccination

with Prevenar 13 could be cost effective or cost saving.

    Registration Status

    To date, Wyeth has submitted regulatory applications for the pediatric

use of Prevenar 13 in more than 45 countries. In December 2008, Wyeth

submitted a marketing authorization application (MAA) for Prevenar 13 to the

European Medicines Agency (EMEA). In March 2009, Wyeth submitted a Biologic

License Application (BLA) for Prevenar 13 to the U.S. Food and Drug

Administration (FDA). Last month, the FDA granted the BLA priority review --

a designation given to products that, if approved, would be a significant

therapeutic or public health advance. Prevenar 13 is also being studied in

global Phase 3 clinical trials in adults, with regulatory submissions

expected in 2010.

    Pneumococcal Disease

    Pneumococcal disease is complex and describes a group of illnesses, all

caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease

affects both children and adults, and includes invasive infections such as

bacteremia/sepsis and meningitis, as well as pneumonia and otitis media

(middle ear infection).

    Most recently serotype 19A, which is included in the candidate vaccine,

has been increasing in prevalence in many regions of the world and is

frequently resistant to antibiotics.

    Indication for Prevenar

    Prevenar is indicated for active immunization against disease by

Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including

sepsis, meningitis, pneumonia, bacteremia, and acute otitis media) in infants

and children from 2 months up to 5 years of age.

    Important Safety Information for Prevenar

    In clinical studies (n=18,168), 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.

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 non vaccine serotypes. The

decision to administer Prevenar should be based on its efficacy in preventing

invasive pneumococcal disease (IPD).

    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, haemophilia, 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, nutritionals 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


    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. In particular, clinical trial data are subject to

differing interpretations, and the views of regulatory agencies, medical and

scientific experts and others may differ from ours. There can be no assurance

that Prevenar 13 will ever receive regulatory approval or be successfully

developed and commercialized. Other risks and uncertainties that could cause

actual results to differ materially from those expressed or implied by

forward-looking statements include, among others, risks related to our

proposed merger with Pfizer, including satisfaction of the conditions of the

proposed merger on the proposed timeframe or at all, contractual restrictions

on the conduct of our business included in the merger agreement, and the

potential for loss of key personnel, disruption in key business activities or

any impact on our relationships with third parties as a result of the

announcement of the proposed merger; 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; the outcome of

government investigations; 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; global economic conditions; interest and

currency exchange rate fluctuations and volatility in the credit and

financial markets; changes in generally accepted accounting principles; trade

buying patterns; the impact of legislation and regulatory compliance; risks

Community Health Wyeth Pharmaceuticals 2 image

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, 2008, which was filed with the Securities and Exchange Commission on

February 27, 2009. 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.

    * Trademark

SOURCE: Wyeth Pharmaceuticals

    CONTACT:  Media, Lili Gordon, 

              Wyeth Pharmaceuticals, 


              or Douglas Petkus, 



              or  Investors, Justin Victoria, 






To view this and other AsiaNet releases please visit

news articles logo NEWS ARTICLES
Contact News Articles |Remove this article