Pfizer Discontinues Global Development of Bococizumab, Its Investigational PCSK9 Inhibitor

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. announced today the discontinuation of the global clinical
development program for bococizumab, its investigational Proprotein
Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of
clinical information now available for bococizumab, taken together with
the evolving treatment and market landscape for lipid-lowering agents,
indicates that bococizumab is not likely to provide value to patients,
physicians, or shareholders. As a result, Pfizer has decided to
discontinue the development program, including the two ongoing
cardiovascular outcome studies.

With the completion of six bococizumab lipid-lowering studies, Pfizer
has observed an emerging clinical profile that includes an unanticipated
attenuation of low-density lipoprotein cholesterol (LDL-C) lowering over
time, as well as a higher level of immunogenicity and higher rate of
injection-site reactions with bococizumab than shown with the other
agents in this class. The goal of treating elevated cholesterol is to
reduce the occurrence of cardiovascular events such as heart attacks and
stroke, which requires long-term effective and durable
cholesterol-lowering.

“As a company, we understand that developing new and important medicines
for patients is a critical, but difficult undertaking. Accordingly, we
continually evaluate our development programs as data emerge to support
prudent decisions that provide value both to the patients we serve and
our shareholders,” said James Rusnak, MD, PhD, Chief Development
Officer, Cardiovascular and Metabolic Diseases, Pfizer Global Product
Development. “We are disappointed by this outcome, but remain committed
to investing in innovation, concentrating our pipeline on areas where we
can bring transformational therapies to address unmet needs, including
in patients with cardiovascular and metabolic diseases. We thank the
investigators, their patients, and support staff who have participated
in this important research program.”

Pfizer is working to ensure that all regulatory authorities are
informed, and that all trial investigators are informed and instructed
on next steps. If patients have questions, they should speak with their
study physician for more information.

“To honor the altruism of trial participants, and to maximize the
clinical and scientific knowledge derived from the halted trials, Pfizer
has committed to ensuring that the data will be made available to study
leaders for independent analysis and prompt public presentation. We
believe the available data will allow us to test the core scientific
questions posed by the overall program which is in the best interest of
patients who volunteered in these clinical trials, and for patients
worldwide who suffer from heart disease,” stated Paul M. Ridker, MD,
Co-chair Executive Committee, SPIRE clinical trials program and director
for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

It is estimated that the discontinuation of the bococizumab development
program will have a negative impact of approximately $0.04 per share on
both a GAAP and adjusted basis. Pfizer will record this as a Research
and Development charge in the fourth quarter of 2016 and is
incorporating this estimated impact into its updated 2016 financial
guidance, which will be provided in conjunction with its third quarter
earnings release to be issued this morning.

Bococizumab is a PCSK9i that was studied for its potential to lower
LDL-C and improve cardiovascular outcomes. It works by blocking the
function of the PCSK9 protein, which interferes with the clearance of
LDL-C, a leading known risk factor for heart disease. Bococizumab has
not received regulatory approval in any country.

The bococizumab SPIRE (Studies of PCSK9 Inhibition
and the Reduction of vascular Events) Phase 3 global
clinical development program included six lipid-lowering studies as well
as two cardiovascular outcome studies. Pfizer previously announced that
four of the lipid-lowering studies met their primary endpoints
(SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH). Recent top-line results also
showed the two remaining Phase 3 bococizumab lipid-lowering trials,
SPIRE-LDL (Low-Density Lipoproteins) and SPIRE-LL (Lipid
Lowering), met their primary endpoints, demonstrating a
significant reduction in the percent change from baseline in LDL-C at 12
weeks compared to placebo among adults with primary hyperlipidemia or
mixed dyslipidemia at high and very high risk for cardiovascular events
who were receiving statin therapy. Bococizumab was generally safe and
well tolerated in both trials.

An evaluation of cross-reactivity to other PCKS9i monoclonal antibodies
was not suggestive of clinically important concerns.

With this decision to discontinue the bococizumab development program,
Pfizer will now halt the two ongoing cardiovascular outcome studies,
SPIRE-1 and SPIRE-2.

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
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DISCLOSURE NOTICE: The information contained in this release is as of
November 1, 2016. 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 Pfizer’s
discontinuation of the global clinical development program for
bococizumab, including the anticipated charge and impact on the
Company’s GAAP and adjusted earnings for the fourth quarter and full
year of 2016, which 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, continuing evaluation of the estimated costs associated with
discontinuation of the program as well as the potential impact of
unanticipated costs, expenses or liabilities.

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, 2015 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.

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