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.
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, 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.
Copyright Business Wire 2015