Market Overview

Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain


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:

"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

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
In addition, to learn more, please visit us on
and follow us on Twitter at @Pfizer
and @Pfizer_News,
and like us on Facebook at

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

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

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 Comments and Join the Discussion!