Pfizer Inc. (NYSE:PFE) today announced the European Medicines
Agency (EMA) has accepted the Marketing Authorization Application
(MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review.
TRUMENBA has been developed for the prevention of invasive
meningococcal disease (IMD) caused by Neisseria meningitidis
serogroup B (MnB) in individuals aged 10 years and older. The
acceptance marks the beginning of the regulatory review process for
this vaccine in the EU.
“The EMA’s acceptance of TRUMENBA’s Marketing Authorization
Application brings us one step closer to fighting this uncommon yet
life-threatening disease worldwide, by helping to protect
adolescents and adults who are at risk to contract meningococcal
disease caused by serogroup B,” said Kathrin Jansen, Ph.D., senior
vice president and head of Vaccine Research and Development for
Pfizer Inc. “At Pfizer we are committed to providing innovative
vaccines that help people live the longest, healthiest lives
possible.”
The MAA for TRUMENBA is based upon a clinical trial dataset of
approximately 20,800 adolescents and adults aged 10 years and
older, studied globally. This dataset demonstrates the consistency
of vaccine-induced immune responses to diverse disease-causing MnB
strains and the well-studied safety and tolerability profile.1
Vaccines are one of the greatest public health advances,
demonstrating control, elimination or near-elimination of numerous
infectious and vaccine-preventable diseases. Pfizer’s portfolio is
built with vaccines that help protect against five of the most
common serogroups causing invasive meningococcal disease (A, B, C,
W and Y) – approvals varying by country – which can threaten the
health of people at various points in their lives.
TRUMENBA is currently approved in the U.S.
Indication for TRUMENBA in the U.S.
TRUMENBA (Meningococcal Group B Vaccine) is indicated for active
immunization to prevent invasive disease caused by Neisseria
meningitidis serogroup B in individuals aged 10 through 25 years of
age.
Approval of TRUMENBA is based on the demonstration of immune
response, as measured by serum bactericidal activity against four
serogroup B strains representative of prevalent strains in the
United States. The effectiveness of TRUMENBA against diverse
serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA® should not be given to anyone with a history of a
severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced
immune response.
The most common adverse reactions were pain at the injection
site, fatigue, headache, muscle pain, and chills.
Data are not available on the safety and effectiveness of using
TRUMENBA and other meningococcal group B vaccines interchangeably
to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to
become pregnant.
Ask your healthcare provider about the risks and benefits of
TRUMENBA. Only a healthcare provider can decide if TRUMENBA is
right for you or your child.
For the full prescribing information for TRUMENBA, please visit
www.trumenba.com.
About TRUMENBA® (Meningococcal Group B Vaccine)
TRUMENBA® is a sterile suspension composed of two recombinant
lipidated factor H binding protein (fHBP) variants from N.
meningitidis serogroup B, one from fHBP subfamily A and one from
subfamily B (A05 and B01, respectively). fHBP is one of many
proteins found on the surface of meningococci and contributes to
the ability of the bacterium to avoid host defenses. fHBPs can be
categorized into two immunologically distinct subfamilies, A and B.
The susceptibility of serogroup B meningococci to
complement-mediated, antibody-dependent killing following
vaccination with TRUMENBA is dependent on both the antigenic
similarity of the bacterial and vaccine fHBPs, as well as the
amount of fHBP expressed on the surface of the invading
meningococci.2
As with any vaccine, TRUMENBA may not prevent disease in all
vaccinated individuals. The frequency of meningococcal disease
caused by serogroup B varies geographically, and could influence
the ability to evaluate effectiveness of the vaccine in any given
country. Based on the low incidence of meningococcal disease,
placebo-controlled clinical trials for TRUMENBA were considered
unfeasible due to the size of the study that would be required and
were not performed. Licensure of TRUMENBA was based on
demonstration of immune responses measured using a serum
bactericidal assay with human complement (hSBA).
In 2014, TRUMENBA was reviewed and received Accelerated Approval
under the FDA's Breakthrough Therapy designation and Priority
Review programs.
About Meningococcal Disease
Meningococcal disease can affect any one, at any age.3 The
reported incidence of invasive meningococcal disease (IMD) varies
by region, ranging from less than 0.5 cases per 100,000 in North
America and just under 1 case per 100,000 in Europe, and up to
10-1,000 cases per 100,000 during epidemic years in Africa.4 The
majority of invasive meningococcal disease cases worldwide can be
attributed to six Neisseria meningitidis serogroups (A, B, C, W, X
and Y).4,5
Meningococcal serogroup B disease affects all ages. In Europe,
the majority of meningococcal disease cases are caused by serogroup
B strains.6 Global serogroup distribution patterns vary between
countries, and change over time.4
Serogroup B meningococcal disease may result in life-altering,
significant long-term and permanent medical disabilities.7,8,9
Despite the availability of antibiotic treatment, 1 in 10
adolescents and young adults who contract MnB die and many of those
who survive are afflicted with long-term disabilities, such as
brain damage, hearing loss, learning disabilities or limb
amputations.10
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on
Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of May 20, 2016. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about
TRUMENBA® (Meningococcal Group B Vaccine) and a marketing
authorization application for TRUMENBA filed with the EMA,
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, uncertainties
regarding the commercial success of TRUMENBA; the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical trial completion dates and regulatory
submission dates, as well as the possibility of unfavorable
clinical trial results; whether and when any biologics license
applications may be filed in any other jurisdictions for TRUMENBA;
whether and when the EMA or regulatory authorities in any other
jurisdictions where applications for TRUMENBA may be pending or
filed may approve any such applications, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the immunogenicity and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of TRUMENBA; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
1 Pfizer Data on File
2 TRUMENBA® (Meningococcal Group B Vaccine) Prescribing
Information. Philadelphia, PA: Pfizer, Inc. 2015.
3 World Health Organization. Epidemics of meningococcal disease,
African meningitis belt, 2001. Wkly Epidemiol Rec. 2001; 76(37);
281-288. http://www.who.int/docstore/wer/pdf/2001/wer7637.pdf.
Published 2001. Accessed February 10, 2016.
4 Halperin SA, et al. Vaccine. 2012;30(2):B26–36
5 Pinto VB, Burden R, Wagner A, Moran EE, Lee C. The Development
of an Experimental Multiple Serogroups Vaccine for Neisseria
meningitidis. PLoS ONE. 2013; 8(11):1-10. Available at
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0079304;
Accessed February 1, 2016
6 World Health Organization. Meningococcal vaccines: WHO
position paper, 2011. Wkly Epidemiol Rec. 2011; 86(47); 521-540.
http://www.who.int/wer/2011/wer8647.pdf?ua=1. Published 2011.
Accessed April 25, 2016.
7 Sabatini C, Bosis S, Semino M, Senatore L, Principi N,
Esposito S. Clinical Presentation of Meningococcal Disease in
Childhood. J Prev Med Hyg. 2012; 53: 116-119.
8 Brigham KS, Sandora TJ. Neisseria meningitidis: epidemiology,
treatment and prevention in adolescents. Curr Opin Pediatr. 2009;
21: 437-443.
9 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of
Meningococcal Disease in Adolescence: prospective, matched-cohort
study. Pediatrics. 2009; 123: e502-e509.
10 Granoff D.M. (2013). Meningococcal vaccines. In Vaccine (pp.
388-418). Philadelphia, PA: Saunders.
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Pfizer Inc.Media:Sally Beatty,
347-330-7867sally.beatty@pfizer.comorInvestors:Bryan Dunn,
212-733-8917bryan.dunn@pfizer.com
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