Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab
March 23 2015 - 8:00AM
Business Wire
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)
announced today that they are preparing to resume the Phase 3
clinical program for tanezumab. As a result, Pfizer expects to
receive a $200 million upfront payment from Lilly in accordance
with their collaboration agreement. This announcement follows a
decision by the U.S. Food and Drug Administration (FDA) to lift the
partial clinical hold on the tanezumab development program after a
review of a robust body of nonclinical data characterizing the
sympathetic nervous system response to tanezumab. The data were
submitted to the FDA in February 2015.
In the prior clinical studies of more than 11,000 patients,
tanezumab demonstrated clinically meaningful efficacy vs. placebo
and other select commonly used pain medicines. A partial clinical
hold has been in place for tanezumab and all other anti-nerve
growth factor antibodies since December 2012 due to adverse changes
in the sympathetic nervous system of mature animals. Studies in
terminal cancer pain were allowed to proceed.
“We are pleased with the FDA’s decision as chronic pain remains
an area of significant unmet medical need and we believe tanezumab
has potential to offer a new, non-narcotic option,” said Steve
Romano, MD, senior vice president and head of Global Medicines
Development at Pfizer’s Global Innovative Pharmaceuticals
Business.
“We’re pleased to work with Pfizer to resume the Phase 3
program, and we’re confident that tanezumab, if approved, can be an
innovative treatment with the potential to help millions suffering
from painful conditions,” said David Ricks, Lilly senior vice
president and president, Lilly Bio-Medicines.
It is estimated that nearly one in five adults suffer from
chronic pain.
About Tanezumab
Tanezumab is a humanized monoclonal antibody that selectively
targets nerve growth factor (NGF), a regulator of pain processing
and sensitivity. NGF levels increase as a result of injury or
inflammation and in chronic pain states. Tanezumab selectively
binds to NGF, thereby inhibiting this protein from activating
pain-signaling neurons.
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At Pfizer, we apply science and our global resources to bring
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For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
About Eli Lilly and Company (NYSE: LLY)
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/social-channels.
PFIZER DISCLOSURE NOTICE: The information contained in
this release is as of March 23, 2015. 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
involve 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, without limitation, the ability to meet anticipated
clinical trial commencement and completion dates as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when new drug applications may be filed
in any jurisdictions for tanezumab; whether and when 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; 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, 2014 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned "Risk Factors" and
"Forward-Looking Information That May Affect Future Results", as
well as in its subsequent reports on Form 8-K, all of which are
filed with the SEC and available at www.sec.gov and
www.pfizer.com.
LILLY DISCLOSURE NOTICE: This press release contains
forward-looking statements about tanezumab as a potential treatment
for patients with osteoarthritis, chronic low back pain, and cancer
pain. It reflects Lilly's current beliefs; however, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of drug development, regulatory
review, and commercialization. There is no guarantee that future
study results will be consistent with study findings to date, or
that tanezumab will receive regulatory approvals or, if approved,
will be commercially successful. For further discussion of these
and other risks and uncertainties, please see Lilly's latest Forms
10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Lilly undertakes no duty to update forward-looking
statements.
Pfizer Media:Steven DanehyOffice:
212-733-1538Steven.Danehy@pfizer.comorPfizer Investor:Ryan
CroweOffice: 212-733-8160Ryan.Crowe@pfizer.comorLilly Media:Scott
MacGregorOffice: 317-440-4699jsmacgregor@lilly.comorLilly
Investor:Phil JohnsonOffice:
317-655-6874johnson_philip_l@lilly.com
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