Pfizer Inc. (NYSE: PFE) today announced that it has entered into an
agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent
meningitis ACWY vaccines, Nimenrix and Mencevax, for a total
consideration of approximately $130 million (€115 million). This
transaction will add two high-quality and complementary vaccines to
Pfizer’s portfolio, allowing the company to reach a broader global
population.
Nimenrix (meningococcal serogroups A, C, W-135 and Y conjugate vaccine)
is a single dose meningococcal ACWY-TT (tetanus toxoid) conjugated
vaccine designed to protect against Neisseria meningitidis, an uncommon
but highly contagious disease that can lead to disability and death.
Launched three years ago, it is indicated for all age groups above one
year of age. Nimenrix is currently registered and approved for sale in
61 countries across the European Economic Area (EEA 30), Canada,
Australia and Emerging Markets, with registrations under review in
another 18 countries across Africa, Asia, Eastern Europe and the Middle
East.
Mencevax (meningococcal polysaccharide serogroups A, C, Y and W-135
vaccine) is a single-dose meningococcal ACWY unconjugated polysaccharide
vaccine used to control outbreaks of meningococcal infection and for
travelers to countries where the disease is endemic or highly epidemic.
Mencevax is indicated for use across all age groups from two years of
age, and is currently registered and approved in 79 countries across
Africa, Asia, Australia, Europe, Latin America, Middle East and New
Zealand.
Pfizer is committed to identifying opportunities that make a difference
in public health and benefit more patients across the globe. With the
approval in 2014 of Trumenba® (Meningococcal Group B Vaccine)
in the U.S. for protection against serogroup B meningococcal disease in
individuals 10 through 25 years of age, the acquisition of NeisVac-C for
protection against serogroup C meningococcal disease from Baxter last
year, and the addition of these two quadrivalent meningitis vaccines,
the company is creating a broad portfolio that is focused on helping
prevent meningococcal disease as well as used for outbreak control.
“The addition of Nimenrix and Mencevax is an important milestone for
Pfizer Vaccines. Adding these two innovative and complementary vaccines
to our current portfolio will allow us to more completely respond to
meningococcal disease outbreaks as well as proactively address a
critical public health need – the prevention of meningococcal disease
across all ages,” said Susan Silbermann, President, Pfizer Vaccines.
“Acquiring these quadrivalent vaccines will broaden our ability to
address the burden of meningococcal meningitis – an uncommon but serious
and sometimes fatal disease. This helps us to further fulfill our vision
to protect lives with innovative vaccines to fight serious diseases
worldwide and gives us even greater capability to meet the needs of the
global community we serve.”
Pfizer’s focus for the past several years has been on strengthening its
innovative core so that it can bring to patients new therapies that
significantly improve their lives. Pfizer Vaccines’ strategy includes
growing its core business, advancing its pipeline and enhancing its
portfolio through targeted external opportunities that complement our
existing products and future pipeline.
Pfizer does not expect this transaction to have any significant impact
on its 2015 financial performance. The transaction is subject to
customary closing conditions as well as regulatory approvals in several
markets, and is expected to occur in the second half of 2015.
Pfizer’s legal advisors for the transaction were Ropes & Gray and
Clifford Chance.
About Nimenrix and Mencevax
Nimenrix is indicated for active immunization of individuals from the
age of 12 months and above against invasive meningococcal diseases
caused by Neisseria meningitidis group A, C, W-135 and Y.
Mencevax is indicated for active immunization of children older than two
years, adolescents and adults against invasive meningococcal disease
caused by meningococci of groups A, C, W135 and Y.
U.S. Indication for Trumenba® (Meningococcal
Group B Vaccine)
Trumenba is indicated for active immunization to prevent invasive
disease caused by Neisseria meningitidis serogroup B in individuals 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.
You are encouraged to report negative side effects of vaccines to the
U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC). Visit www.vaers.hhs.gov
or call 1-800-822-7967.
For the full prescribing information for Trumenba, please visit www.trumenba.com.
About NeisVac-C
NeisVac-C is indicated for active immunization in children from 2 months
of age, adolescents and adults, for the prevention of invasive disease
caused by Neisseria meningitidis serogroup C.
About Pfizer Inc.
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. To learn more, please visit us at www.pfizer.com.
DISCLOSURE NOTICE
The information contained in this release is as of June 22, 2015.
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 an agreement
by Pfizer to acquire GSK’s quadrivalent meningitis ACWY vaccines,
Nimenrix and Mencevax, and the potential benefits thereof, as well as
about the anticipated timing of the closing of the transaction and its
expected impact on Pfizer’s 2015 financial performance, 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, risks relating to
the satisfaction of conditions to closing the transaction in the
anticipated timeframe or at all; the ability to realize the anticipated
benefits of the acquisition; other business effects, including the
effects of industry, market, economic, political or regulatory
conditions; future exchange or interest rates; the uncertainties
inherent in research and development; whether and when regulatory
authorities in jurisdictions in which applications are pending will
approve such applications, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted; decisions by
regulatory authorities regarding labeling and other matters that could
affect the availability or commercial potential of the vaccines; 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, 2014, 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 10-Q and Form
8-K, all of which are filed with the SEC and available at www.sec.gov
and www.pfizer.com.
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