NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today
announced positive top-line results from a Phase 3 study evaluating
tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe
osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three
co-primary endpoints at 24 weeks, demonstrating a statistically
significant improvement in pain, physical function and the patients’
overall assessment of their OA compared to those receiving placebo. The
tanezumab 2.5 mg treatment arm met two of the three protocol-defined
co-primary efficacy endpoints compared to placebo, demonstrating a
statistically significant improvement in pain and physical function,
while patients’ overall assessment of their OA was not statistically
different than placebo. Tanezumab is a humanized monoclonal antibody
that is part of an investigational class of non-opioid pain medications
known as nerve growth factor (NGF) inhibitors.
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In this study, subcutaneous (SC) administration of tanezumab 2.5 mg or 5
mg was evaluated every eight weeks, for a total of 24 weeks, in patients
with moderate-to-severe OA pain. Patients enrolled in the study had
experienced inadequate pain relief from or intolerance to at least three
different classes of analgesics, and on average had OA for more than six
years. They also reported significant impact of their pain on their
ability to function in everyday life. Preliminary safety data showed
that tanezumab was generally well tolerated during the 24-week treatment
period, with similarly low rates of treatment discontinuations due to
adverse events observed among patients taking tanezumab and placebo. The
trial also included a 24-week safety follow-up period, for a total of 48
weeks of observation.
Overall, rapidly progressive osteoarthritis (RPOA) was observed in 2.1
percent of tanezumab-treated patients and was not observed in the
placebo arm. The ratio of RPOA type 1 (accelerated joint space
narrowing) to RPOA type 2 (damage or deterioration of the joint) was
2:1, consistent with the ratio from the previously reported SC Phase 3
study in OA pain (A4091056). There was one event of osteonecrosis and
one event of subchondral insufficiency fracture observed in
tanezumab-treated patients, and no events were observed in the placebo
arm. The rate of total joint replacement was similar across the
tanezumab treatment groups and placebo. Detailed efficacy and safety
results from this study will be submitted to a future medical congress.
“These findings build on the previously reported positive Phase 3
results in patients with osteoarthritis pain and add to the growing body
of evidence supporting tanezumab as a potential innovative treatment
option for this difficult-to-treat patient population,” said Ken
Verburg, PhD, tanezumab development team leader, Pfizer Global Product
Development. “We look forward to sharing data from additional ongoing
studies evaluating tanezumab for osteoarthritis pain and chronic low
back pain in the coming months.”
“For many people, living with osteoarthritis pain can limit their
ability to function, which can force them to make compromises in
everyday life,” said Christi Shaw, president, Lilly Bio-Medicines.
“Lilly and Pfizer have a shared commitment to advance the care of people
living with chronic pain, and we see the potential of tanezumab as an
innovative, non-opioid option to improve the treatment of osteoarthritis
pain, a debilitating, progressive condition.”
More than 27 million Americans are living with OA, a progressive joint
disease that can be life-altering and cause debilitating physical,
emotional and social effects. Approximately 11 million of these patients
suffer from moderate-to-severe OA pain. Currently available treatment
options for OA pain do not meet the needs of all patients, and many
cycle through multiple therapies to find relief from their pain.
Tanezumab has a novel mechanism that acts in a different manner than
other analgesics, including opioids and nonsteroidal anti-inflammatory
drugs (NSAIDs), and in studies to date, tanezumab has not demonstrated a
risk of addiction, misuse or dependence.
This is the second readout from the ongoing Phase 3 global clinical
development program for tanezumab, which includes six studies in
approximately 7,000 patients with OA pain, chronic low back pain (CLBP)
and cancer pain (due to bone metastases). Results from the first Phase 3
OA study (A4091056) evaluating SC administration of tanezumab for 16
weeks were previously reported. That study met all three co-primary
efficacy endpoints, demonstrating that among patients with
moderate-to-severe OA pain of the knee or hip, both dosing regimens of
tanezumab (2.5 mg and 2.5/5 mg) resulted in a statistically significant
improvement in pain, physical function and patients’ overall assessment
of their OA, compared to placebo.
About the Study
The Phase 3 OA study (A4091057) was a randomized, double-blind,
placebo-controlled, multicenter, parallel-group trial evaluating the
efficacy and safety of SC tanezumab compared to placebo for 24 weeks in
patients with moderate-to-severe OA pain of the knee or hip. The trial
was conducted in Europe and Japan.
Patients enrolled in the study had experienced inadequate pain relief
from or intolerance to at least three different classes of analgesics,
and on average had OA for more than six years. At the beginning of the
study, they reported significant impact of their pain on their ability
to function in everyday life. A total of 849 patients were randomized to
three treatment groups in a 1:1:1 ratio to receive three SC injections
over the 24-week treatment period, once every eight weeks. One group
received three doses of tanezumab 2.5 mg, the second group received
three doses of tanezumab 5 mg, and the third group received three doses
of placebo. The efficacy of tanezumab versus placebo was measured by
changes from baseline at 24 weeks in the Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) Pain subscale, the WOMAC
Physical Function subscale, and the patient’s Global Assessment of OA.
The trial also included a 24-week safety follow-up period.
About Tanezumab
Tanezumab is an investigational humanized 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 a different manner
than opioids and other analgesics, including NSAIDs, and in studies to
date, tanezumab has not demonstrated a risk of addiction, misuse or
dependence.
In 2013, Pfizer and Lilly entered into a worldwide co-development and
co-commercialization agreement for the advancement of tanezumab. In June
2017, Pfizer and Lilly announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track designation for tanezumab for
the treatment of OA pain and CLBP. Tanezumab is the first NGF inhibitor
to receive Fast Track designation, a process designed to facilitate the
development and expedite the review of new therapies that treat serious
conditions and fill unmet medical needs. If approved, tanezumab would be
a first-in-class treatment for OA pain and CLBP.
About 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
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In addition, to learn more, please visit us on www.pfizer.com and
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About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to
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 https://www.lilly.com/newsroom/social-channels.
PFIZER DISCLOSURE NOTICE: The information contained in this release
is as of January 29, 2019. 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, 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 trial commencement and completion dates and
regulatory submission dates, as well as the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
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 new drug applications may be
filed in any jurisdictions for tanezumab; 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 efficacy and
safety information submitted and, if approved, whether tanezumab will be
commercially successful; decisions by regulatory authorities regarding
labeling and 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, 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
.
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 osteoarthritis, chronic low back pain, and cancer pain,
and reflects Lilly’s current beliefs. However, as with any
pharmaceutical product, there are substantial risks and uncertainties in
the process of drug development and commercialization. Among other
things, there is no guarantee that future study results will be
consistent with study findings to date, or that tanezumab will be
approved by the U.S. FDA or other regulatory authorities on the
anticipated timeline or at all, or that tanezumab will 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:
Neha Wadhwa
212-733-2835
Neha.Wadhwa@pfizer.com
Pfizer
Investors:
Ryan Crowe
212-733-8160
Ryan.Crowe@pfizer.com
Eli
Lilly Media:
Jen Dial
317-220-1172
dial_jennifer_kay@lilly.com
Eli
Lilly Investors:
Kevin Hern
317-277-1838
hern_kevin_r@lilly.com
Source: Pfizer Inc.