Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)
today announced the outcome of the U.S. Food and Drug
Administration (FDA) Joint Arthritis Advisory Committee and Drug
Safety and Risk Management Advisory Committee on tanezumab. There
was a single voting question focused on whether the proposed risk
evaluation and mitigation strategy (REMS) for tanezumab will ensure
its benefits outweigh its risks, and the Committee voted 1 in favor
and 19 against. Tanezumab 2.5 mg administered subcutaneously (SC)
every eight weeks is being evaluated for the treatment of
moderate-to-severe osteoarthritis (OA) pain in adult patients for
whom use of other analgesics is ineffective or not appropriate.
Tanezumab is an investigational monoclonal antibody in a new class
of medicines called nerve growth factor (NGF) inhibitors, which
work in a different manner than currently available treatments such
as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) and other
analgesics. In studies to date, tanezumab has not demonstrated a
risk of addiction, misuse or dependence.
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“While we are disappointed with today’s outcome, we continue to
believe that tanezumab has a positive benefit-risk profile for
patients with moderate-to-severe osteoarthritis pain for whom
current treatments are ineffective or not appropriate. Many of
these patients have exhausted available therapies, have not had a
new class of medications available to them in more than a decade
and are eager for new, non-opioid options,” said Ken Verburg,
tanezumab development team leader, Pfizer Global Product
Development. “We will continue to work with the FDA as the agency
continues its review of our application.”
The Advisory Committee’s discussions were based on the Biologics
License Application (BLA) currently under review by the FDA. The
BLA includes data from 20 Phase 1-3 clinical studies evaluating the
safety and efficacy of tanezumab administered intravenously or SC
in patients with OA, including three pivotal Phase 3 SC studies
involving more than 4,500 patients with moderate-to-severe OA.
“The dialogue during the open public forum of this week’s
Advisory Committee meeting reinforced the urgent need for
innovation for people living with moderate-to-severe osteoarthritis
pain – many of whom cycle through three to four therapies each year
without adequate relief. The unresolved pain can impact all aspects
of their lives, creating physical, emotional, social and financial
hardships,” said Ilya Yuffa, president, Lilly Bio-Medicines.
Advisory Committees provide the FDA with independent opinions
and recommendations from outside medical experts during the
regulatory review process; however, the recommendations are not
binding.
“Osteoarthritis is the most common type of arthritis and poses
unique challenges for patients,” said Steven Taylor, executive vice
president, mission & strategic initiatives for the Arthritis
Foundation. “Despite its far-reaching impact, many patients still
live with debilitating pain and have exhausted or are unable to
take or tolerate currently available therapies. That is why the
Arthritis Foundation advocates for innovative treatment solutions
and a patient-centered approach to managing chronic pain for those
with osteoarthritis.”
About Tanezumab
Tanezumab is an investigational monoclonal antibody that works
by selectively targeting, binding to and inhibiting NGF. NGF levels
increase in the body as a result of injury, inflammation or in
chronic pain states. By inhibiting NGF, tanezumab may help to keep
pain signals produced by muscles, skin and organs from reaching the
spinal cord and brain. Tanezumab has a novel mechanism that acts in
the periphery in a different manner than opioids and other
analgesics, including nonsteroidal anti-inflammatory drugs
(NSAIDs), and in studies to date, tanezumab has not demonstrated a
risk of addiction, misuse or dependence.
About Osteoarthritis
OA is a chronic, progressive and disabling disease of the joint
that is a leading cause of chronic pain. In the United States, OA
impacts an estimated 31 million people, 11 million of whom have
moderate-to-severe OA and have been living with the condition for
an average of nine years. OA places a significant burden on these
patients – the pain can limit their ability to function, which can
force compromises in everyday life, negatively impacting their
roles and relationships and causing feelings of isolation,
frustration and anxiety. OA can also impact their ability to
function in the workplace. There is a need for innovation, as
currently available treatment options for moderate-to-severe OA do
not meet the needs of all patients.
About the Pfizer-Lilly Alliance
In 2013, Pfizer and Lilly entered into a collaboration to
develop and commercialize tanezumab. If approved, the companies
will jointly commercialize tanezumab in the U.S. and Pfizer will be
responsible for commercialization activities outside of the U.S.
Pfizer and Lilly are driven by our shared mission to improve the
lives of the millions of people who are suffering from
moderate-to-severe OA pain, and together, we are leveraging our
deep clinical expertise to make a meaningful difference for
patients.
About Pfizer: Breakthroughs That Change Patients’
Lives
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, including innovative medicines and vaccines. 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 170 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 and like us
on Facebook at Facebook.com/Pfizer.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.com and lilly.com/newsroom.
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of March 25, 2021. 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 a
product candidate, tanezumab and a potential indication in the U.S.
for the treatment of moderate-to-severe OA pain in adult patients
for whom use of other analgesics is ineffective or not appropriate,
including its 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, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when drug applications for any potential indications
for tanezumab may be filed in any other jurisdictions; whether and
when the FDA may approve the pending application for the potential
indication and whether and when regulatory authorities in any
jurisdictions may approve any such other applications that may be
filed for tanezumab, which will depend on myriad factors, including
making a determination as to whether the product’s benefits
outweigh its known risks and determination of the product’s
efficacy and, if approved, whether tanezumab will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of tanezumab;
uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; 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, 2020 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.
LILLY DISCLOSURE NOTICE: This press release contains
forward-looking statements (as that term is defined in the Private
Securities Litigation Reform Act of 1995) about tanezumab as a
potential treatment for patients with moderate-to-severe OA pain
for whom the use of other analgesics is ineffective or
inappropriate and reflects Lilly's current beliefs and
expectations. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of research,
development, and commercialization. Among other things, there can
be no guarantee that future study results will be consistent with
the results to date, that tanezumab will receive regulatory
approvals or be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's most recent
Form 10-K and Form 10-Q filings with the United States Securities
and Exchange Commission. Except as required by law, Lilly
undertakes no duty to update forward-looking statements to reflect
events after the date of this release.
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Pfizer Media Relations: Steve
Danehy 212-733-1538 steven.danehy@pfizer.com Pfizer Investor Relations: Bryan Dunn 212-733-
8917 bryan.dunn@pfizer.com Lilly Media
Relations: Jen Dial 317-220-1172 dial_jennifer_kay@lilly.com
Lilly Investor Relations: Kevin Hern
317-277-1838 hern_kevin_r@lilly.com
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