SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 4, 2017--
Exelixis,
Inc. (NASDAQ:EXEL) today announced that it has earned a $10 million
milestone payment from Bristol-Myers Squibb under the terms of the two
companies’ worldwide collaboration for compounds targeting retinoic
acid-related orphan receptor (ROR), a family of nuclear hormone
receptors implicated in inflammatory conditions. The milestone payment
was triggered by Bristol-Myers Squibb’s filing of a Clinical Trial
Authorization in Europe for a first-in-human study of a RORγt inverse
agonist.
“Exelixis is closely focused on oncology today, but our legacy of drug
discovery across diverse therapeutic areas lives on through our
collaborations with our partners, including the RORγt inverse agonist
program now advanced by Bristol-Myers Squibb,” said Michael M.
Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We
congratulate Bristol-Myers Squibb on its plans for a first-in-human
study and look forward to future updates.”
From October 2010 to July 2013, Exelixis and Bristol-Myers Squibb
undertook collaborative research around RORγt, with Exelixis and
Bristol-Myers Squibb responsible for the discovery, optimization, and
characterization of RORγt inverse agonists that could subsequently be
developed and commercialized by Bristol-Myers Squibb. Since the end of
the collaborative research period, Bristol-Myers Squibb has been solely
responsible for all further research, development, manufacture, and
potential commercialization of compounds developed under the
collaboration, as well as all related costs and expenses. Exelixis
received an upfront payment at the start of the collaboration in 2010,
as well as a $2.5 million development milestone related to preclinical
progress in February 2017. Exelixis could potentially receive additional
development and regulatory milestones of up to $240 million,
commercialization milestones of up to $150 million, and royalties on net
sales depending on the advancement of the product candidate and eventual
product.
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 them to patients
globally. With growing revenues from the three resulting commercialized
products – CABOMETYX®, COMETRIQ®, and COTELLIC®
– we are reinvesting in our business to maximize the potential of our
pipeline, which we intend to supplement 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. 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: Bristol-Myers Squibb’s plans
for a first-in-human study of a RORγt inverse agonist and its RORγt
inverse agonist program generally; the potential for Exelixis to receive
additional development, regulatory, and commercialization milestones,
and royalties on sales under collaboration with Bristol-Myers Squibb;
Exelixis’ focus on the discovery, development and commercialization of
cancer therapies; growing revenues from CABOMETYX, COMETRIQ, and
COTELLIC 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; and Exelixis’
mission to deliver the next generation of Exelixis medicines and help
patients recover stronger and live longer. Words such as “plans,”
“strives,” “could,” “future,” “further,” “intend,” “potential,”
“mission,” 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 related to
the potential failure of any RORγt inverse agonist to demonstrate safety
and efficacy in clinical testing; Exelixis’ dependence on its
relationship with Bristol-Myers Squibb with respect to RORγt inverse
agonists, including the level of Bristol-Myers Squibb’s investment in
the resources necessary to successfully develop, manufacture and
commercialize any RORγt inverse agonists in territories where they are
ultimately approved; risks and uncertainties related to regulatory
review and approval processes; market acceptance of CABOMETYX, COMETRIQ,
and COTELLIC and the availability of coverage and reimbursement for
these products; 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’ quarterly report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on August 2, 2017, 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, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are
registered U.S. trademarks.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171004005691/en/
Source: Exelixis, Inc.
Investors Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194
EVP, Public Affairs and Investor
Relations
shubbard@exelixis.com
or
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcommunications.com
