MADISON, Wis. and NEW YORK, Aug. 22,
2018 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) and
Pfizer Inc. (NYSE: PFE) today announced an agreement through 2021
to co-promote Cologuard, the first and only FDA-approved
non-invasive stool DNA screening test for colorectal cancer. Pfizer
will join Exact Sciences' sales representatives in reaching both
physicians and health systems and will also actively participate in
extending and deepening the Cologuard marketing campaign.
Colorectal cancer is recognized as the most preventable yet
least prevented form of cancer and remains the second leading cause
of cancer death in the U.S., with more than 50,000 deaths each
year. Nine out of 10 people survive more than five years when
colorectal cancer is diagnosed in Stages I or II, but only one out
of 10 people survive more than five years when the disease is
diagnosed in Stage IV. While patient outcomes can be improved
through early detection, fewer than two-thirds of people are
up-to-date with recommended colorectal cancer screening
guidelines.
"This partnership marks a turning point in the fight to end
colorectal cancer," said Kevin
Conroy, chairman and CEO of Exact Sciences. "Pfizer is
joining Exact Sciences' mission of eradicating colorectal cancer by
helping detect the disease at its earliest, most treatable stages.
Together we can help reduce the prevalence of colorectal cancer by
combining the power of Cologuard and the talented Exact Sciences
team with Pfizer's experience, relationships and resources."
Exact Sciences and Pfizer seek to increase colorectal cancer
screening rates by accelerating adoption of Cologuard, an accurate,
easy-to-use test that's fully covered by Medicare and most major
health insurance plans. Exact Sciences brings a sales force with
expertise in colorectal cancer, the innovative science of Cologuard
and a recognizable direct-to-consumer marketing campaign. Pfizer
brings a large and experienced sales force and relationships
integrating with the leading health systems, two areas where
Cologuard is most often prescribed, along with deep marketing
expertise.
"There is a significant patient need to increase colorectal
cancer screening, and our field force has long established
relationships with providers who prescribe first-line preventative
treatments to patients," said Nick
Lagunowich, regional president, North America, Pfizer Internal Medicine. "By
joining forces with Exact Sciences to bring this non-invasive
colorectal cancer screening option to more providers and their
patients, we hope to substantially increase the early detection of
colorectal cancer."
Under the terms of the agreement, Pfizer will co-promote
Cologuard with Exact Sciences beginning in the fourth quarter of
2018. Exact Sciences will maintain responsibility for all
aspects of manufacturing and laboratory operations of Cologuard.
Pfizer will share gross profits and marketing expenses equally
above an agreed upon baseline.
More information about the agreement is available here, in a
form 8-K that Exact Sciences will file in compliance with
Securities and Exchange Commission rules.
Exact Sciences Conference Call & Webcast
Exact Sciences will host a conference call and webcast on
Wednesday, Aug. 22, 2018, at
8:00 a.m. ET to discuss the
agreement. The webcast will be available at www.exactsciences.com.
Domestic callers should dial (877) 201-0168 and international
callers should dial +1 (647) 788-4901.
An archive of the webcast will be available at
www.exactsciences.com. A replay of the conference call will be
available by calling 800-585-8367 domestically or 416-621-4642
internationally. The access code for the replay of the call is
5278277. The webcast, conference call and replay are open to all
interested parties.
About Cologuard
Cologuard was approved by the FDA in August
2014 and results from Exact Sciences' prospective 90-site,
point-in-time, 10,000-patient pivotal trial were published in the
New England Journal of Medicine in April
2014. Cologuard is included in the American Cancer Society's
(2018) colorectal cancer screening guidelines and the
recommendations of the U.S. Preventive Services Task Force (2016)
and National Comprehensive Cancer Network (2016). Cologuard is
indicated to screen adults of either sex, 50 years or older, who
are at typical average-risk for CRC. Cologuard is not for
everyone; not for high risk individuals, including those with a
family history of colorectal cancer, a personal history of cancer
or advanced adenoma, IBD, and certain hereditary
syndromes. Positive Cologuard results should be referred to
diagnostic colonoscopy. A negative Cologuard test result does not
guarantee absence of cancer or advanced adenoma. Following a
negative result, patients should continue participating in a
screening program at an interval and with a method appropriate for
the individual patient. Cologuard performance when used for repeat
testing has not been evaluated or established. Medicare and most
major insurers cover Cologuard. For more information about
Cologuard, visit www.cologuardtest.com. Rx only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company
focused on the early detection and prevention of the deadliest
forms of cancer. The company has exclusive intellectual property
protecting its non-invasive, molecular screening technology for the
detection of colorectal cancer. For more information, please visit
the company's website at www.exactsciences.com,
follow Exact Sciences on Twitter @ExactSciences or
find Exact Sciences on Facebook.
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 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.
Exact Sciences Safe Harbor Statement
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
that are intended to be covered by the "safe harbor" created by
those sections. Forward-looking statements, which are based on
certain assumptions and describe our future plans, strategies and
expectations, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "would," "could," "seek," "intend," "plan," "goal,"
"project," "estimate," "anticipate" or other comparable terms. All
statements other than statements of historical facts included in
this news release regarding our strategies, prospects, financial
condition, operations, costs, plans and objectives are
forward-looking statements. Examples of forward-looking statements
include, among others, statements we make regarding expected future
operating results, anticipated results of our sales and marketing
efforts, expectations concerning payer reimbursement and the
anticipated results of our product development efforts.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: our ability to successfully
and profitably market our products and services; the acceptance of
our products and services by patients and healthcare providers; our
ability to meet demand for our products and services; the
willingness of health insurance companies and other payers to cover
Cologuard and adequately reimburse us for our performance of the
Cologuard test; the amount and nature of competition from other
cancer screening and diagnostic products and services; the effects
of the adoption, modification or repeal of any healthcare reform
law, rule, order, interpretation or policy; the effects of changes
in pricing, coverage and reimbursement for our products and
services, including without limitation as a result of the
Protecting Access to Medicare Act of 2014; recommendations,
guidelines and quality metrics issued by various organizations such
as the U.S. Preventive Services Task Force, the American
Cancer Society, and the National Committee for Quality
Assurance regarding cancer screening or our products and
services; our ability to successfully develop new products and
services; our success establishing and maintaining collaborative,
licensing and supplier arrangements; our ability to maintain
regulatory approvals and comply with applicable regulations; and
the other risks and uncertainties described in the Risk Factors and
in Management's Discussion and Analysis of Financial Condition and
Results of Operations sections of our most recently filed Annual
Report on Form 10-K and our subsequently filed Quarterly Reports on
Form 10-Q. We undertake no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Pfizer Disclosure Notice
The information contained in this release is as of August 22, 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 U.S.
co-promote agreement between Pfizer and Exact Sciences Corp. to
co-promote Cologuard 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, uncertainties regarding
the commercial success of Cologuard; the willingness of health
insurance companies and other payers to cover Cologuard and
adequately reimburse us for performance of the Cologuard test; the
amount and nature of competition from other cancer screening and
diagnostic products and services; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of Cologuard; 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.
Exact Sciences contact:
J.P. Fielder – jpfielder@exactsciences.com
+1 608 210 5220
Pfizer contact:
Neha Wadhwa –
neha.wadhwa@pfizer.com
+1 212 733 2835
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