NEW YORK and INDIANAPOLIS, March 2,
2020 /PRNewswire/ -- Pfizer Inc. (NYSE:PFE) and Eli
Lilly and Company (NYSE:LLY) today announced that the U.S. Food and
Drug Administration (FDA) accepted for review a Biologics License
Application (BLA) for tanezumab 2.5 mg administered subcutaneously
(SC), which is being evaluated for patients with chronic pain due
to moderate-to-severe osteoarthritis (OA) who have experienced
inadequate pain relief with other analgesics. Tanezumab is a
monoclonal antibody that is part of an investigational class of
non-opioid chronic pain medications known as nerve growth factor
(NGF) inhibitors.
More than 27 million Americans are living with OA, 11 million of
whom have moderate-to-severe OA. Currently available treatment
options for moderate-to-severe OA do not meet the needs of all
patients, and many cycle through multiple therapies to find relief
from their pain. The Prescription Drug User Fee Act (PDUFA) goal
date for the FDA to make a decision on the tanezumab application is
in December 2020. In its acceptance
letter, the FDA stated that it is currently planning to hold an
Advisory Committee meeting to discuss this application.
"The FDA acceptance of the tanezumab application represents a
significant milestone, and the breadth of our regulatory submission
reflects the extensive clinical data we have gathered for tanezumab
over the course of its development," said Ken Verburg, tanezumab development team leader,
Pfizer Global Product Development. "There is an urgent need for
innovation in the treatment of osteoarthritis, as there have been
no new classes of medicines available for this debilitating
condition in more than a decade. If approved, tanezumab would be a
first-in-class treatment for patients suffering from chronic pain
due to moderate-to-severe osteoarthritis who have experienced
inadequate pain relief with other analgesics."
"Osteoarthritis patients face a significant burden – due to the
physical pain they experience, nearly every aspect of their lives
can be impacted. This pain can affect their ability to participate
in daily activities, which can have significant psychological,
social and societal consequences," said Patrik Jonsson, president, Lilly Bio-Medicines.
"We look forward to working closely with the FDA to potentially
bring tanezumab to patients living with moderate-to-severe
osteoarthritis."
The tanezumab regulatory submission encompasses data from 39
Phase 1-3 clinical studies evaluating the safety and efficacy of
tanezumab among more than 18,000 patients, including three Phase
3 studies evaluating SC administration of tanezumab in
patients with moderate-to-severe OA.
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.
The Pfizer-Lilly Alliance
In 2013, Pfizer and Lilly
entered into a worldwide collaboration to develop and commercialize
tanezumab, a monoclonal antibody that is part of an investigational
class of non-opioid pain medications known as NGF inhibitors.
Tanezumab has the potential to address significant unmet needs in
moderate-to-severe OA, a condition that can have life-altering
physical, social, psychological and economic impacts. We are driven
by our shared mission to improve the lives of the millions of
people who are suffering from chronic pain. Together, we are
leveraging our deep clinical expertise with the goal of delivering
scientific innovation in chronic pain management and making a
meaningful difference for people around the world.
Pfizer Inc.: 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 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 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. P-LLY
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of March 2, 2020.
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 patients with chronic pain due to
moderate-to-severe osteoarthritis who have experienced inadequate
pain relief with other analgesics, 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;
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, 2019 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 chronic pain due to
moderate-to-severe osteoarthritis and reflects Lilly's current
belief. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. Among other things, there can be no
guarantee that future study results will be consistent with the
results to date or that tanezumab will receive regulatory
approvals. 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.
Pfizer Media Contact:
|
Eli Lilly Media
Contact:
|
Steve
Danehy
|
Jen Dial
|
212-733-1538
|
317-220-1172
|
steven.danehy@pfizer.com
|
dial_jennifer_kay@lilly.com
|
|
|
Pfizer Investor
Contact:
|
Eli Lilly Investor
Contact:
|
Ryan
Crowe
|
Kevin Hern
|
212-733-8160
|
317-277-1838
|
Ryan.Crowe@pfizer.com
|
hern_kevin_r@lilly.com
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/us-fda-accepts-regulatory-submission-for-tanezumab-a-potential-first-in-class-treatment-for-patients-with-chronic-pain-due-to-moderate-to-severe-osteoarthritis-301013995.html
SOURCE Eli Lilly and Company