Pfizer 2014 Annual Report Download - page 13

PFIZER ANNUAL REVIEW 2014 www.pzer.com/annual 13
ANNUAL REVIEW 2014
Vaccines
Vaccines are an essential tool in the ght against disease, and we continue to build
our strength in vaccines, both to prevent serious illnesses and in the future to perhaps
treat them. In 2014, Trumenba® was approved by the FDA to prevent invasive disease
caused by Group B meningitis in people aged 10 through 25 years. This is both a
serious and unpredictable disease that can occur quickly and without warning in
otherwise healthy individuals. Outbreaks occurred in the U.S. in both 2013 and 2014.
We made progress in other preventive vaccines, including one now in Phase 2
development against Staphylococcus aureus, a leading cause of serious healthcare-
associated infections, resulting in a substantial burden to healthcare systems. To date,
there is no licensed vaccine available to prevent this disease. Our Staphylococcus
aureus vaccine has “Fast Track” status by the FDA, given that this often-aggressive
bacteria is becoming resistant to antibiotic therapies. Fast Track designation is a way
to expedite drug development and review for drugs and vaccines intended to address
unmet needs and treat serious or life-threatening conditions.
In addition to positive internal developments, we also broadened our vaccines portfolio
with two recent acquisitions.
In 2014, we acquired Baxter International’s marketed vaccines, including one that helps
protect against diseases caused by Group C meningitis. This is another virulent strain
of bacteria that is fatal in an estimated 10 percent of patients. The Baxter acquisition
also provides us a second vaccine that helps protect against tick-borne encephalitis, an
infection of the brain that may cause permanent neurological damage, or even death.
Early in 2015, we acquired a controlling interest in Swiss-based Redvax GmbH.
This gives us access to a promising vaccine in early-stage development for human
cytomegalovirus (CMV), a virus present in most people but potentially dangerous if
passed from a newly infected mother to her newborn. Congenital CMV can lead to
serious disabilities in infants, including vision and hearing loss. More children have
disabilities due to congenital CMV than other well-known infections and syndromes,
including Down syndrome, fetal alcohol syndrome, spina bida and pediatric HIV/AIDS.
Along with new vaccines, we continue to invest in clinical studies to expand the value
of our marketed portfolio, including Prevnar 13,® our largest-selling vaccine. Early in
2014, we announced that a landmark study called CAPiTA (for Community-Acquired
Pneumonia Immunization Trial in Adults) demonstrated the value of vaccinating adults
aged 65 and over against pneumococcal disease. As a result, the U.S. Centers for
Disease Control and Prevention’s Advisory Committee on Immunization Practices voted
to recommend Prevnar 13 for this older patient population, one of the fastest-growing
cohorts in the U.S.
Biosimilars
An emerging area of innovation for Pzer, biosimilars are highly similar versions
of approved and authorized biological medicines. We have built one of the leading
biosimilars pipelines in our industry, with a strong focus on cancer treatments and
auto-immune disorders. Right now, we have ve biosimilars in development, with
Phase 3 trials underway in therapies for metastatic breast cancer, follicular lymphoma
and rheumatoid arthritis. We are striving to become one of the world’s leading providers
of biosimilars, a market expected to approach $20 billion in 2020. Pzer is suited to
lead in this business segment as we have the scientic and manufacturing expertise to
engineer and produce these complex, large-molecules in the quantities, needed and to
the quality standards required.
CEO Letter > Letter to Stakeholders
CEO LETTER