Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease & Pneumo...
December 14 2018 - 7:00AM
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 and
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
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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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181214005069/en/
Media:Jessica Smith(212)
733-6213jessica.m.smith@pfizer.comorInvestors:Ryan Crowe(212)
733-8160ryan.crowe@pfizer.com
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