Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner
Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) received
approval from the Japanese Ministry of Health, Labour and Welfare
(MHLW) for esaxerenone tablets, MINNEBRO™ 1.25 mg, 2.5 mg, and 5
mg, as a treatment for patients with hypertension. This approval
allows for the marketing of MINNEBRO for this indication within
Japan. MINNEBRO is a compound identified during the prior research
collaboration between Exelixis and Daiichi Sankyo, which the
companies entered into in March 2006, and has been subsequently
developed by Daiichi Sankyo.
“The approval of MINNEBRO brings an important new therapeutic
option to clinicians in Japan. It also marks a significant
scientific milestone for Exelixis, joining cabozantinib and
cobimetinib as the third molecule from our discovery efforts to
receive regulatory approval,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer of Exelixis. “We congratulate
our partner Daiichi Sankyo on their superb clinical development
program and recent approval. As partnered compounds like MINNEBRO
are commercialized, we are committed to using resulting
collaboration revenues to reinvest in our business, build our
pipeline, and pursue long-term, sustainable growth.”
Per the collaboration agreement between Exelixis and Daiichi
Sankyo, Exelixis will receive a $20 million milestone payment upon
the first commercial sale of MINNEBRO in Japan. Exelixis previously
received a $20 million milestone payment in the first quarter of
2018 triggered by the filing of Daiichi Sankyo’s associated
regulatory application. Exelixis is eligible for substantial
commercialization milestones, as well as low double-digit royalties
on sales of MINNEBRO. Since the conclusion of Exelixis and Daiichi
Sankyo’s joint research period in November 2007, Daiichi Sankyo has
been responsible for all subsequent preclinical and clinical
development, and also oversees regulatory, manufacturing and
commercialization activities for MINNEBRO.
The MINNEBRO approval was 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, with a primary endpoint of sitting systolic
blood pressure (SBP) / diastolic blood pressure (DBP) change from
baseline after 12 weeks of treatment. Daiichi Sankyo is also
evaluating the compound’s effectiveness in Japanese patients with
diabetic nephropathy in the ongoing phase 3 pivotal ESAX-DN
study.
The MINNEBRO approval comes as Exelixis builds out its pipeline
behind CABOMETYX, its lead medicine, through targeted in-licensing
and a return to internal drug discovery. Prior to its decision to
focus on clinical development in 2010, Exelixis researchers
discovered the compounds that would become the company’s marketed
medicines, COMETRIQ, CABOMETYX and COTELLIC, and filed multiple
INDs per year. During this same time period, the company entered
into the research collaboration with Daiichi Sankyo that led to
MINNEBRO.
About MINNEBRO™ (Esaxerenone) Tablets
MINNEBRO™ (Esaxerenone) Tablets 1.25 mg, 2.5 mg and 5 mg are
approved by the Japanese Ministry of Health, Labour, and Welfare as
a treatment for patients with hypertension in Japan. The
application for approval was submitted in Japan in February 2018 on
the basis of results including a phase 3 clinical trial conducted
in Japan (ESAX-HTN study) in patients with essential hypertension.
Excessive mineralocorticoid receptor activation has been found to
be involved in hypertension, and MINNEBRO is considered to exert an
antihypertensive effect by blocking this receptor activation.
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 percent of men
and 45 percent of women over the age of 30 in the general Japanese
population.1 Only approximately 30 percent of men and 40 percent 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 percent 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 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 three commercially
available products, CABOMETYX® (cabozantinib),
COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib), and
have entered into partnerships with leading pharmaceutical
companies to bring these important medicines to patients worldwide.
Supported by revenues from our marketed products and
collaborations, we are committed to prudently reinvesting in our
business to maximize the potential of our pipeline. We are
supplementing 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 is a member of Standard & Poor’s
(S&P) MidCap 400 index, which measures the performance of
profitable mid-sized companies. For the second consecutive year,
Exelixis 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, follow
@ExelixisInc on Twitter or
like ExelixisInc on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
timing for receipt of a $20 million milestone payment from Daiichi
Sankyo upon the first commercial sale of MINNEBRO in Japan; the
potential of MINNEBRO as a new therapeutic option for clinicians in
Japan; Exelixis’ eligibility for substantial commercialization
milestones as well as royalties on the sale of MINNEBRO; and
Exelixis’ 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. Any
statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements and 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: the degree of market acceptance of MINNEBRO in
the territories where it is approved; Exelixis’ dependence on its
relationships with Daiichi Sankyo, including Daiichi Sankyo’s
investment in the resources necessary to successfully commercialize
MINNEBRO in the territories where it is approved and to execute its
commercial strategy; market competition, including the potential
for competitors to obtain approval for generic versions of
MINNEBRO; Exelixis’ and Daiichi Sankyo’s continuing compliance with
applicable legal and regulatory requirements; Exelixis’ and Daiichi
Sankyo’s ability to protect their respective intellectual property
rights; changes in economic and business conditions; and other
factors discussed under the caption “Risk Factors” in Exelixis’
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 1, 2018, and in
Exelixis’ future filings with the SEC. All forward-looking
statements in this press release are based on information available
to Exelixis as of the date of this press release,
and Exelixis undertakes no obligation to update or revise
any forward-looking statements contained herein.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and
COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese
trademark.
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: https://www.businesswire.com/news/home/20190108005473/en/
Investors Contact:Susan HubbardEVP, Public Affairs &
Investor RelationsExelixis,
Inc.650-837-8194shubbard@exelixis.com
Media Contact:Hal MackinsFor Exelixis,
Inc.415-994-0040hal@torchcommunications.com
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