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 /CNW/ -- 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 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.  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 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



    




For further information:

For further information: Media, Lili Gordon, Wyeth Pharmaceuticals,
+1-484-865-6671, or Douglas Petkus, Wyeth, +1-973-660-5218, or  Investors,
Justin Victoria, Wyeth, +1-973-660-5340

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