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Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients

Over Half of Patients Treated with Tanezumab Reported a 50 Percent or Greater Reduction in Osteoarthritis Pain of the Knee or Hip Pfizer and Lilly Present Late-Breaking Data at 2018 ACR/ARHP Annual Meeting

Tuesday, October 23, 2018 - 6:40pm
EDT

NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today
announced complete results from a Phase 3 study evaluating the efficacy
and safety of subcutaneous administration of tanezumab, an
investigational humanized monoclonal antibody, in patients with
osteoarthritis (OA) pain treated for 16 weeks. The 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 were associated with a statistically significant improvement
in pain, physical function and patient’s global assessment of their OA,
compared to placebo. These data were presented during a late-breaking
oral session at the 2018 American College of Rheumatology/Association of
Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in
Chicago.

“The results demonstrated by tanezumab in this study are particularly
meaningful, given that patients had moderate-to-severe pain and were
unable to achieve adequate pain relief with other treatment options,
including opioids and NSAIDs,” said Ken Verburg, tanezumab development
team leader, Pfizer Global Product Development. “Our goal is to be able
to offer tanezumab as a potential non-opioid treatment option for these
patients suffering from osteoarthritis pain.”

More than 27 million Americans are living with OA, a progressive disease
that can cause ongoing debilitating pain. Treatments for OA pain are
limited, and many individuals are unable to find relief from or tolerate
currently available options. Tanezumab is part of an investigational
class of pain medications known as nerve growth factor (NGF) inhibitors,
and in addition to OA pain, is also being studied as a potential
treatment for chronic low back pain (CLBP) and cancer pain (due to bone
metastases). If approved, tanezumab would be a first-in-class,
non-opioid treatment for OA pain and CLBP.

“Pfizer and Lilly each have a long-standing heritage of scientific
innovation in developing novel pain treatments and a shared commitment
to the development of tanezumab,” said Christi Shaw, senior vice
president, Eli Lilly and Company and president, Lilly Bio-Medicines.
“These initial results from our Phase 3 program for tanezumab are
promising, and we’re eager to gain further insights as additional data
report out next year.”

The Phase 3 OA study evaluated changes from baseline to 16 weeks for
three co-primary efficacy endpoints of pain intensity and physical
function, assessed using the Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) subscale and patient’s overall assessment
of their OA (PGA-OA). At 16 weeks of treatment, tanezumab was associated
with a significant reduction in pain compared to placebo; additional
efficacy findings are detailed in the table below.

                 
      Placebo  

Tanezumab

2.5 mg

 

Tanezumab

2.5/5 mg

        N = 232   N = 231   N = 233
WOMAC Pain: Change from Baseline (p-value) versus placebo       -2.6   -3.2*   -3.4**
Reduction from Baseline at Week 16                
≥30%       54.7%   68.0%**   70.4%***
≥50%       37.9%   54.5%***   57.1%***
≥70%       25.0%   34.6%*   36.5%**
≥90%       9.5%   14.7%   14.2%
WOMAC Physical Function: Change from Baseline (p-value)
versus placebo
      -2.6   -3.2**   -3.5***
PGA-OA: Change from Baseline (p-value) versus placebo       -0.65   -0.87*   -0.90**

*p ≤ 0.05; **p ≤ 0.01; ***p ≤ 0.001 vs. placebo

In the study, nasopharyngitis (common cold), pain in extremity and
paresthesia (tingling or numbing) were the most common adverse events
(AEs ≥3%) and had a higher frequency in both tanezumab treatment groups
compared to placebo-treated patients. Tanezumab was generally well
tolerated, with 0.4 percent and 1.3 percent of patients in the tanezumab
2.5 mg and 2.5/5 mg arms, respectively, discontinuing treatment due to
AEs; 1.3 percent of patients in the placebo arm discontinued treatment
due to AEs.

There were no cases of osteonecrosis observed in the study. Rapidly
progressive osteoarthritis (RPOA) was observed with tanezumab-treated
patients at a frequency of 1.3 percent and was not observed in the
placebo arm. The incidence of RPOA type 1 (accelerated joint space
narrowing) in the tanezumab 2.5 mg and 2.5/5 mg arms was 1.3 and 0.4
percent, respectively, and the incidence of RPOA type 2 (damage or
deterioration of the joint) was 0.9 and 0 percent, respectively. In the
study, 3.5 percent and 6.9 percent of patients receiving tanezumab 2.5
mg and 2.5/5 mg, respectively, had total joint replacement surgery,
compared to 1.7 percent receiving placebo. The majority of surgeries (68
percent) took place after treatment was completed, during or shortly
after the 24-week safety follow-up period of the study. All surgeries in
this study took place among patients with more severe OA at screening
(Kellgren-Lawrence grade 3-4).

The Phase 3 global clinical development program evaluating the efficacy
and safety of tanezumab includes six studies in approximately 7,000
patients with OA pain, CLBP and cancer pain (due to bone metastases).
Additional readouts from the Phase 3 program are anticipated beginning
in the first half of 2019.

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 treatment period, once every eight weeks; 696 patients received
treatment. 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.

Efficacy in the study was measured based on change from baseline to 16
weeks using the WOMAC Pain and Physical Function subscales (11-point
numerical rating scale, where higher scores indicate higher pain levels
or worse function) and PGA-OA scores (5-point numerical rating of the
patient’s condition, where 1 equals “very good” and 5 equals “very
poor”). The average baseline scores for this moderate-to-severe patient
population were as follows: the WOMAC Pain and Physical Function
subscales were approximately 7.1 to 7.4, and the PGA-OA scores were
approximately 3.4 to 3.5 across the treatment groups.

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 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. 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 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
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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 http://newsroom.lilly.com/socialchannels.

PFIZER DISCLOSURE NOTICE: The information contained in this release
is as of October 23, 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.



Contact: 

Pfizer Media:
Neha Wadhwa, 212-733-2835
[email protected]
or
Pfizer Investor:
Ryan Crowe, 212-733-8160
[email protected]
or
Eli Lilly Media:
Jen Dial, 317-220-1172
[email protected]
or
Eli Lilly Investor:
Kevin Hern, 317-277-1838
[email protected]