- Data presented at the joint annual meeting of ICAAC and IDSA
- Results suggest candidate vaccine may be as effective as Prevnar for
the seven shared serotypes, and provide expanded coverage for six additional
- Wyeth on track to complete U.S. filing for pediatric use in the first
quarter of 2009, with other pediatric global filings expected at the same
time, or possibly earlier
WASHINGTON, Oct. 27 /PRNewswire-FirstCall/ -- Data from a pivotal trial
and three other Phase 3 studies presented today indicate that Wyeth's (NYSE:
WYE) investigational 13-valent pneumococcal conjugate vaccine (PCV13) may
offer broader protection against pneumococcal disease (PD) in infants and
young children compared to Prevnar(R), Pneumococcal 7-valent Conjugate Vaccine
(Diphtheria CRM197 Protein).
Specifically, the data indicate that PCV13 may be as effective as Prevnar
(also referred to as PCV7) in helping to prevent invasive pneumococcal disease
(IPD) due to the seven serotypes shared by the vaccines, and may provide
expanded coverage for six additional serotypes found worldwide. The data were
presented at the joint annual meeting of the Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases
Society of America (IDSA) in Washington, D.C.
The candidate vaccine includes the 13 most common pneumococcal serotypes
associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F)
are included in Prevnar -- 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 the greatest burden of residual, or remaining,
invasive disease. Both vaccines contain CRM197 -- an immunological carrier
protein with a 20-year history of use in pediatric vaccines.
"These new data suggest that the 13-valent pneumococcal vaccine has the
potential to address a critical unmet need," says Emilio A. Emini, Ph.D.,
Executive Vice President, Vaccine Research and Development, Wyeth
Pharmaceuticals. "Based on the known prevalence of pneumococcal serotypes, it
is estimated that the candidate vaccine has the potential to cover up to 92
percent of invasive pneumococcal disease in infants and young children
worldwide. Given the global burden of serious pneumococcal disease, this
candidate vaccine is designed to provide more comprehensive protection."
The Company expects to complete its U.S. filing for pediatric use of the
vaccine in the first quarter of 2009, with other pediatric global filings
expected at the same time, or possibly earlier. The 13-valent candidate
vaccine is also being studied in global Phase 3 clinical trials in adults,
with regulatory filings expected in 2010.
Pneumococcal disease affects both children and adults, and is a leading
cause of illness and death worldwide. Pneumococcal disease describes a group
of illnesses, all caused by the bacterium Streptococcus pneumoniae, that
include invasive infections such as bacteremia/sepsis and meningitis, as well
as pneumonia and otitis media. Most recently, the pneumococcal 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.
Phase 3 Data Results
The data presented today represent four of 13 core Phase 3 studies in the
pediatric clinical trial program intended to support regulatory filings for
licensure of the 13-valent vaccine.
European Pivotal Data
The pivotal Phase 3 trial (#G-2117), conducted in Germany with 604
infants, compared the candidate PCV13 to Prevnar. The immunogenicity
assessments were conducted at one month after completion of the infant
vaccination series (using a vaccination schedule of 2, 3 and 4 months). The
immunogenicity objectives of the study were to:
-- Compare the immune responses elicited by PCV13 and Prevnar against
of the seven pneumococcal serotypes common to the two vaccines.
-- Evaluate the immune response elicited by the six additional
pneumococcal serotypes included in the 13-valent vaccine.
On the basis of a prospectively defined set of immunogenicity criteria,
the results of the study indicated that the responses elicited by PCV13 for
all 13 serotypes were comparable (scientifically referred to as
"non-inferior") to those of Prevnar. Additionally, PCV13 elicited functional
(biologically active) antibodies for all 13 serotypes. The results of this
study also indicated that the safety and tolerability of PCV13 and Prevnar
Finally, the study evaluated the immune responses elicited against
several components (hepatitis B, Haemophilus influenzae type B and diphtheria)
of the concomitantly administered Infanrix(R) hexa (GlaxoSmithKline) pediatric
vaccine. Immune responses to these vaccine antigens were comparable when
co-administered with either PCV13 or Prevnar.
Overall, the results of this pivotal study suggest that PCV13 may be as
effective as Prevnar in helping to prevent pneumococcal disease caused by the
serotypes currently in Prevnar, and that PCV13 may provide expanded coverage
in helping to prevent PD caused by the six additional serotypes.
Additional Phase 3 Data Presented at ICAAC/IDSA
Data from three additional Phase 3 European trials (France, Poland and
the U.K.) presented at the conference support the pivotal study conclusion
that PCV13 is well tolerated, immunogenic and has the potential to provide
direct protection against the 13 serotypes included in the vaccine.
-- In the study conducted in France (n=613, #G-2119), three doses of
investigational PCV13 administered to infants elicited a significant
immune response to all 13 vaccine serotypes. In addition, immune
responses to antigens contained in the concomitantly administered
pediatric vaccine, Pentavac(TM) (Sanofi-Pasteur), were generally
comparable, whether given with PCV13 or Prevnar. Safety and
tolerability between the two vaccine groups were also comparable.
-- In the U.K. study (n=278, #G-2118), two doses of the candidate vaccine
given at 2 and 4 months were immunogenic for all serotypes.
Tolerability was comparable to Prevnar, and antibody responses were
comparable to concomitantly administered vaccines (Pediacel(R)
[Sanofi-Pasteur], NeisVac-C(R) [Baxster] and Menitorix(TM)
-- In the Poland study (n=269, #G-2116), the results indicated that the
immunogenicity and tolerability of PCV13 produced at manufacturing
scale were similar to that of the candidate vaccine produced at the
pilot scale, which was the type used in most of the Phase 3 clinical
Safety and tolerability of PCV13 and Prevnar were comparable in all four
studies and the most frequently reported adverse events included injection
site reactions, (redness [erythema], swelling [induration], 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.
"Wyeth's 13-valent pneumococcal conjugate vaccine represents an important
scientific achievement, and demonstrates Wyeth's continuing commitment to
advance health care through pioneering science," adds Dr. Emini. "The
candidate vaccine builds on the scientific foundation of Prevnar and has the
potential to provide direct protection against pneumococcal disease caused by
the 13 most prevalent pneumococcal serotypes worldwide."
According to the World Health Organization (WHO), pneumococcal disease is
the number one vaccine-preventable cause of death in children younger than
five years of age. Due to the significant burden of pneumococcal disease and
demonstrated vaccine efficacy, WHO recommends the priority inclusion of PCV7
in national childhood immunization programs worldwide. WHO notes that if
other pneumococcal vaccines that offer expanded protection become available,
countries should assess whether it would be helpful to switch to these
Prevnar is indicated for active immunization of infants and toddlers
against invasive disease caused by Streptococcus pneumoniae, including
bacteremia (bloodstream infection) and meningitis (infection of the membranes
surrounding the brain and spinal cord) caused by the seven serotypes in the
vaccine. The seven serotypes (strains) of S. pneumoniae included in the
vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly
cause these serious diseases in children. The routine schedule is 2, 4, 6,
and 12 to 15 months of age.
Prevnar is also indicated for immunization of infants and toddlers
against otitis media (ear infections) caused by the seven serotypes included
in the vaccine. Protection against ear infections is expected to be less than
that for invasive disease.
As with any vaccine, Prevnar may not protect all individuals receiving
the vaccine from serious invasive disease cause by S. pneumoniae. This
vaccine should not be used for treatment of active infection.
Important Safety Information for Prevnar
In clinical trials, 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 Prevnar.
Hypersensitivity to any vaccine component, including diphtheria toxoid, is a
contraindication to its use. Prevnar does not protect 100% of children
vaccinated. Immunization with Prevnar does not substitute routine diphtheria
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, hemophilia, 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. As noted above, the
clinical trial data presented at the meeting reflect only four of 13 core
Phase 3 studies of PCV13 in the pediatric population and, accordingly, do not
represent the totality of data and other information that may affect
regulatory review and commercialization of PCV13. There can be no assurance
that PCV13 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, without limitation, 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; 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; economic
conditions including interest and currency exchange rate fluctuations; 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, 2007, which was filed with the
Securities and Exchange Commission on February 29, 2008. 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.
For further information:
For further information: Media, Lili Gordon of Wyeth Pharmaceuticals,
+1-484-865-6671, or Douglas Petkus of Wyeth, +1-973-660-5218; or Investors,
Justin Victoria of Wyeth, +1-973-660-5340