– Filing triggers $20 million milestone payment
to Exelixis –
Exelixis, Inc. (NASDAQ: EXEL) today announced that its partner
Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has submitted
its regulatory application for esaxerenone (INN; code name CS-3150)
as a treatment for patients with hypertension to the Japanese
Pharmaceutical and Medical Devices Agency. Esaxerenone is a
compound identified during the prior research collaboration between
Exelixis and Daiichi Sankyo, and has been subsequently developed by
Daiichi Sankyo. As a result of the submission, Exelixis will
receive a $20 million milestone payment per the two companies’
collaboration agreement.
Daiichi Sankyo’s application is based on the results of phase 3
studies including ESAX-HTN, a randomized, double-blind, three-arm
parallel group comparison study evaluating the efficacy and safety
of esaxerenone versus eplerenone in patients with essential
hypertension in Japan. Top-line results for ESAX-HTN were announced
in September 2017, and Daiichi Sankyo plans to disclose detailed
study results at a future scientific meeting.
“Daiichi Sankyo has been an excellent partner throughout the
years, and continues to be effective in its clinical and regulatory
progress. Daiichi Sankyo’s regulatory filing for esaxerenone is an
important step toward a potential new therapeutic option for
patients with hypertension in Japan, where more than 43 million
people are estimated to have high blood pressure,” said Michael M.
Morrissey, Ph.D., President and Chief Executive Officer of
Exelixis. “This milestone is another example of the critical role
our partnered compounds can play by generating additional revenues
for us to reinvest in our business as we work to bring new
medicines to market for difficult-to-treat cancers.”
In March 2006, Daiichi Sankyo and Exelixis entered into a
research collaboration agreement to discover, develop and
commercialize novel therapies targeting the mineralocorticoid
receptor (MR). Under the terms of the agreement, Daiichi Sankyo has
exclusive global development, manufacturing and commercialization
rights for the compounds. Esaxerenone, a non-steroidal, selective
novel MR blocker, is one of the compounds identified during the
research collaboration, and has subsequently been developed by
Daiichi Sankyo. As esaxerenone advances, Exelixis is eligible for
substantial commercialization milestones, as well as double-digit
royalties on sales.
About Hypertension in Japan
According to the 2012 Japan National Health and Nutrition
Survey, there are an estimated 43 million patients with
hypertension in the country, which accounts for 60% of men and 45%
of women over the age of 30 in the general Japanese population.1
Only approximately 30% of men and 40% of women with hypertension
who are treated with antihypertensive medication typically achieve
the goal of systolic and diastolic blood pressure lower than
140/90mm Hg.
Hypertension is one of the major risk factors for cardiovascular
disease, such as stroke and coronary heart disease, and the
condition also raises the risk of chronic kidney disease and
end-stage renal disease.1 Essential hypertension is the most common
form of hypertension, affecting 90% of hypertensive patients, and
is associated with heterogeneous contributory factors such as
genetics and lifestyle habits, while secondary hypertension is
associated with identified underlying disease factors.1
About Esaxerenone (CS-3150)
Esaxerenone is an oral, non-steroidal, selective blocker of the
mineralocorticoid receptor (MR), a nuclear hormone receptor
implicated in a variety of cardiovascular and metabolic diseases.
MR blockers can be used to treat hypertension and congestive heart
failure due to their vascular protective effects. Recent studies
have also suggested beneficial effects of adding MR blockers to the
treatment regimen for Type 2 diabetic patients with nephropathy. As
a non-steroidal, selective MR blocker, esaxerenone may have
potential for the treatment of hypertension, diabetic nephropathy
and congestive heart failure, and may provide protection from end
organ damage due to vascular complications.
Esaxerenone is one of the compounds identified during Exelixis’
research collaboration with Daiichi Sankyo, which the companies
entered into in March 2006. Under the terms of the agreement,
Exelixis granted Daiichi Sankyo an exclusive, worldwide license to
certain intellectual property primarily relating to compounds that
modulate MR. In exchange, Exelixis received a $20 million upfront
payment, research funding for a joint research period, and the
potential for substantial clinical development, regulatory and
commercialization milestone payments, as well as double-digit
royalties on sales. Since the conclusion of the joint research
period in November 2007, Daiichi Sankyo has been responsible for
all subsequent preclinical and clinical development, and will also
oversee regulatory, manufacturing and commercialization activities
for the compound.
About Exelixis
Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model genetic systems, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. We discovered our lead compounds, cabozantinib and
cobimetinib, and advanced them into clinical development before
entering into partnerships with leading biopharmaceutical companies
in our efforts to bring these medicines to patients globally. We
are steadfast in our commitment to prudently reinvest in our
business to maximize the potential of our pipeline. We intend to
supplement our existing therapeutic assets with targeted business
development activities and internal drug discovery – all to deliver
the next generation of Exelixis medicines and help patients recover
stronger and live longer. Exelixis recently earned a spot on
Deloitte’s Technology Fast 500 list, a yearly award program
honoring the 500 fastest-growing companies over the past four
years. For more information about Exelixis, please visit
www.exelixis.com or follow @ExelixisInc on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Daiichi
Sankyo’s payment of a $20 million milestone to Exelixis in
connection with its submission of a regulatory application in Japan
for esaxerenone; Daiichi Sankyo’s intention to present ESAX-HTN
results at a future scientific meeting; esaxerenone’s potential as
a new therapeutic option for patients with hypertension, diabetic
nephropathy and congestive heart failure, and its ability to
provide protection from end organ damage due to vascular
complications; the potential for esaxerenone to meaningfully
contribute to Exelixis’ business and directly support the
development of future Exelixis medicines; Exelixis’
eligibility for future commercialization milestones, plus royalties
on sales under its collaboration with Daiichi Sankyo;
Exelixis’ mission of helping cancer patients recover stronger and
live longer; growing revenues from Exelixis’ products and plans to
reinvest in its business to maximize the potential of the company’s
pipeline, including through targeted business development
activities and internal drug discovery; and Exelixis’ mission to
deliver the next generation of Exelixis medicines and
help patients recover stronger and live longer. Words such as
“will”, plans,” “can”, eligible,” “future,” “intention,”
“potential,” “mission,” “may,” or other similar expressions
identify forward-looking statements, but the absence of these words
does not necessarily mean that a statement is not forward-looking.
In addition, any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements. These forward-looking statements are
based upon Exelixis’ current plans, assumptions, beliefs,
expectations, estimates and projections. Forward-looking statements
involve risks and uncertainties. Actual results and the timing of
events could differ materially from those anticipated in the
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation: risks and
uncertainties related to regulatory review and approval processes;
Exelixis’ dependence on its relationship
with Daiichi Sankyo with respect to esaxerenone,
including the level of Daiichi Sankyo’s investment in the
resources necessary to successfully commercialize esaxerenone in
territories where it is ultimately approved; market acceptance of
CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), and COTELLIC®
(cobimetinib) and the availability of coverage and reimbursement
for these products; the availability of data at the referenced
times; the risk that unanticipated developments could adversely
affect the commercialization of CABOMETYX, COMETRIQ, and COTELLIC;
the level of costs associated with Exelixis’ commercialization,
research and development and other activities; Exelixis’ ability to
protect the company’s intellectual property rights; market
competition; changes in economic and business conditions, and other
factors discussed under the caption “Risk Factors” in Exelixis’
annual report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on February 26, 2018, and in
Exelixis’ future filings with the SEC. The forward-looking
statements made in this press release speak only as of the date of
this press release. Exelixis expressly disclaims any duty,
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Exelixis’ expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Exelixis and the Exelixis logo are registered
U.S. trademarks.
References:
1 The Japanese Society of Hypertension Guidelines for the
Management of Hypertension (JSH 2014). Hypertens Research 2014; 37:
253-392.
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version on businesswire.com: http://www.businesswire.com/news/home/20180226006626/en/
Investors Contact:Exelixis, Inc.Susan Hubbard,
650-837-8194EVP, Public Affairs and Investor
Relationsshubbard@exelixis.comorMedia Contact:For Exelixis,
Inc.Hal Mackins, 415-994-0040hal@torchcommunications.com
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