Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab

NEW YORK & INDIANAPOLIS–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today
announced that the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation for tanezumab for the treatment of chronic pain
in patients with osteoarthritis (OA) and chronic low back pain (CLBP).
Tanezumab is an investigational humanized monoclonal antibody that
selectively targets, binds to and inhibits nerve growth factor (NGF). It
is the first NGF inhibitor to receive Fast Track designation, a process
designed to facilitate the development and expedite the review of new
therapies to treat serious conditions and fill unmet medical needs.

This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20170613005499/en/

“If approved, tanezumab would be the first in a new class of non-opioid
chronic pain medications,” said Ken Verburg, Chief Development Officer,
Neuroscience & Pain, Pfizer Global Product Development. “We believe it
would represent an important medical advance in the treatment of
debilitating osteoarthritis and chronic low back pain for patients who
do not experience adequate pain relief or cannot tolerate currently
available pain medications.”

The Phase 3 global clinical development program for tanezumab is
currently ongoing and includes six studies in approximately 7,000
patients with OA, CLBP or cancer pain who did not experience adequate
pain relief with approved therapies. Results are projected to begin
reporting out in 2018. All studies are investigating subcutaneous
administration of tanezumab by a health care provider once every eight
weeks for treatment periods ranging from 16 to 56 weeks, followed by a
24-week safety follow-up period.

« It is estimated that there are more than 27 million Americans currently
living with osteoarthritis and 23 million living with chronic low back
pain, many of whom fail to achieve adequate pain relief despite
treatment with various types of pain medications,” said Christi Shaw,
Senior Vice President and President, Lilly Bio-Medicines. “We are
committed to offering innovative solutions to people suffering from
chronic pain conditions, and look forward to working closely with the
FDA to facilitate the development of tanezumab.”

For more information on ongoing clinical trials of tanezumab, visit www.clinicaltrials.gov.

About Tanezumab

Tanezumab is an investigational humanized monoclonal antibody, which
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).

In 2013, Pfizer and Lilly entered into a worldwide co-development and
co-commercialization agreement for the advancement of tanezumab.

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/social-channels.

PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of June 13, 2017. 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 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; 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, 2016 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: http://www.businesswire.com/news/home/20170613005499/en/