Pfizer Inc.(NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today
announced that a 16-week Phase 3 study in patients with
osteoarthritis (OA) pain evaluating subcutaneous administration of
tanezumab, an investigational humanized monoclonal antibody, met
all three co-primary endpoints. The study demonstrated that
patients who received two doses of tanezumab separated by eight
weeks experienced a statistically significant improvement in pain,
physical function and the patients’ overall assessment of their OA,
compared to those receiving placebo. Tanezumab is part of an
investigational class of pain medications known as nerve growth
factor (NGF) inhibitors and in addition to OA pain, is being
evaluated for chronic low back pain (CLBP) and cancer pain (due to
bone metastases).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20180718005341/en/
“There is a substantial need for innovative new treatment
options for osteoarthritis, as many patients are unable to find
relief with currently available medicines and continue to suffer,”
said Ken Verburg, tanezumab development team leader, Pfizer Global
Product Development. “We are encouraged by these results, which
speak to the potential of tanezumab as a non-opioid treatment
option for pain reduction and improvement in physical function in
people living with osteoarthritis pain.”
Preliminary safety data showed that tanezumab was generally well
tolerated, with approximately 1% of patients discontinuing
treatment due to adverse events. Rapidly progressive osteoarthritis
was observed in tanezumab-treated patients at a frequency of less
than 1.5%, and was not observed in the placebo arm. There were no
events of osteonecrosis observed in the trial. No new safety
signals were identified.
“Worldwide, millions are living with osteoarthritis, a
progressive disease that can significantly impact people’s everyday
lives,” said Christi Shaw, senior vice president, Eli Lilly and
Company and president, Lilly Bio-Medicines. “We look forward to
continuing to advance tanezumab in our ongoing global Phase 3
development program, which includes six studies in approximately
7,000 patients with osteoarthritis, chronic low back pain and
cancer pain.”
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.
About the Study
The Phase 3 OA study (A4091056) was a 16-week randomized,
double-blind, placebo-controlled, multicenter, parallel-group trial
evaluating the efficacy and safety of subcutaneous administration
of tanezumab compared to placebo in patients with OA of the knee or
hip. The trial included a 24-week safety follow-up period. In the
study, patients were enrolled with moderate to severe OA pain who
had experienced inadequate pain relief with other treatment options
for OA pain or were unable to take other pain medications. A total
of 698 patients were randomized to three treatment groups in a
1:1:1 ratio to receive two injections over the 16-week study, once
every eight weeks. One group received two doses of placebo, the
second group received two doses of tanezumab 2.5 mg, and the third
group received one dose of tanezumab 2.5 mg followed by one dose of
tanezumab 5 mg eight weeks later. The efficacy of tanezumab vs.
placebo was measured by changes from baseline at 16 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. In the study, both tanezumab
treatment arms met all three co-primary endpoints.
About Tanezumab
Tanezumab, an investigational humanized monoclonal antibody, is
a potential first-in-class, non-opioid treatment being evaluated
for OA pain, CLBP and cancer pain (due to bone metastases).
Tanezumab 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 nonsteroidal anti-inflammatory drugs
(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. The Phase 3 global clinical development
program for tanezumab is currently ongoing and includes six studies
in approximately 7,000 patients.
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 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 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 http://newsroom.lilly.com/socialchannels.
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of July 18, 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180718005341/en/
Pfizer Media Contact:Neha Wadhwa,
212-733-2835Neha.Wadhwa@pfizer.comorEli Lilly Media Contact:Jen
Dial, 317-220-1172dial_jennifer_kay@lilly.comorPfizer Investor
Contact:Ryan Crowe, 212-733-8160Ryan.Crowe@pfizer.comorEli Lilly
Investor Contact:Kevin Hern, 317-277-1838hern_kevin_r@lilly.com
Grafico Azioni Pfizer (NYSE:PFE)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Pfizer (NYSE:PFE)
Storico
Da Apr 2023 a Apr 2024