MEDIA RELEASE PR35005
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
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
SOURCE: Wyeth Pharmaceuticals
CONTACT: 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
(WYE)
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