NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today the initiation of a Phase 3
program for its 20-Valent pneumococcal conjugate vaccine (20vPnC)
candidate, PF-06482077, for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae serotypes in the
vaccine in adults aged 18 years and older.
“While the full extent of Prevenar 13 protection of adults is still
being realized, we anticipate our 20vPnC vaccine candidate will be the
next important step to help protect adults from a substantial invasive
pneumococcal disease and pneumonia burden, including disease caused by
serotypes not yet covered by any available conjugate vaccine,” said
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine
Research & Development, Pfizer. “As the industry leader in pneumococcal
conjugate vaccination, we are proud to start the Phase 3 trials of our
third generation pneumococcal vaccine, which received Breakthrough
Therapy Designation by the FDA in September 2018.”
About the 20vPnC Phase 3 Program
This first Phase 3 trial will enroll an estimated 3,880 adults and is
designed to compare immune responses after 20vPnC administration to
responses in control subjects ≥60 years old receiving 13-valent
pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide
vaccine; evaluate the immunogenicity of 20vPnC in adults 18-59 years of
age; and describe the 20vPnC safety profile in adults ≥18 years old.
More on the study can be found on www.clinicaltrials.gov
under the identifier NCT03760146.
About 20vPnC
On September 20, 2018, Pfizer announced the FDA granted Breakthrough
Therapy Designation for 20vPnC for the prevention of invasive disease
and pneumonia in adults age 18 years and older. Breakthrough Therapy
Designation is designed to expedite the development and review of drugs
and vaccines that are intended to treat or prevent serious conditions
and preliminary clinical evidence indicates that the drug or vaccine may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s).1 Drugs and vaccines that
receive Breakthrough Therapy Designation are eligible for all features
of the FDA’s Fast Track designation, which may include more frequent
communication with the FDA about the drug’s development plan and
eligibility for Accelerated Approval and Priority Review, if relevant
criteria are met.2
The FDA previously granted Fast Track designation for 20vPnC in October
2017 for use in adults aged 18 years and older.3 The FDA’s
Fast Track approach is a process designed to facilitate the development
and expedite the review of new drugs and vaccines intended to treat or
prevent serious conditions and address an unmet medical need.2
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, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com
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DISCLOSURE NOTICE: The information contained in this release is as of
December 14, 2018. 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 Pfizer’s
20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate,
PF-06482077, and a potential indication to prevent invasive disease and
pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and
older, including its potential benefits, and plans to initiate Phase 3
trials in the coming months, 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, 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, including unfavorable
new clinical data or additional analyses of existing clinical data; the
risk that clinical trial data are subject to differing interpretations,
and, even when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may not
share our views and may require additional data or may deny approval
altogether; whether regulatory authorities will be satisfied with the
design of and results from our clinical studies; whether and when any
biologics license applications may be filed in any jurisdictions for
20vPnC for any indications; whether and when any such applications may
be approved by regulatory authorities, 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 and, if approved, whether 20vPnC will be commercially
successful; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of 20vPnC; uncertainties regarding the ability to obtain recommendations
from vaccine technical committees and other public health authorities
regarding 20vPnC and uncertainties regarding the commercial impact of
any such recommendations; 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, 2017 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 U.S. Food and Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
2 U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
3 Data on file. Pfizer Inc., New York, NY.
View source version on businesswire.com:
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Media:
Jessica Smith
(212) 733-6213
jessica.m.smith@pfizer.com
or
Investors:
Ryan
Crowe
(212) 733-8160
ryan.crowe@pfizer.com
Source: Pfizer Inc.