SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 15, 2014--
Exelixis, Inc. (NASDAQ:EXEL) today announced its collaborator Genentech,
a member of the Roche Group, has completed the filing of its New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA) for
cobimetinib, a specific MEK inhibitor discovered by Exelixis, in
combination with vemurafenib for previously untreated patients with
unresectable locally advanced or metastatic melanoma harboring a BRAF
V600 mutation. Cobimetinib has received Fast Track designation by the
FDA. Roche submitted a Marketing Authorization Application for the
combination to the European Medicines Agency in September of this year.
The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial
conducted by Genentech in 495 patients with BRAF V600 mutation-positive
unresectable locally advanced or metastatic melanoma. As presented
during the Presidential Symposium at the European Society for Medical
Oncology 2014 Congress, coBRIM met its primary endpoint, demonstrating a
statistically significant increase in investigator-determined
progression-free survival (PFS). The median PFS was 9.9 months for the
combination of cobimetinib and vemurafenib versus 6.2 months for
vemurafenib alone (hazard ratio [HR] = 0.51, 95 percent CI 0.39-0.68; p
< 0.0001). The safety profile of the combination was consistent with
that observed in a previous study of the combination. The most common
Grade 3 or higher adverse events in the combination arm included liver
lab abnormalities, elevated creatine phosphokinase and diarrhea. The
most common adverse events seen in the combination arm included
diarrhea, nausea, rash, photosensitivity and lab abnormalities.
About the Cobimetinib Development Collaboration
Exelixis discovered cobimetinib internally and advanced the compound to
investigational new drug (IND) status. In late 2006, Exelixis entered
into a worldwide co-development agreement with Genentech, under which
Exelixis received initial upfront and milestone payments in connection
with signing the agreement and submitting the IND. Exelixis was
responsible for development of cobimetinib through the determination of
the maximum tolerated dose in phase 1, at which point Genentech
exercised its option to further develop the compound.
In November 2013, Exelixis exercised its option to co-promote
cobimetinib, if approved, in the United States. Exelixis is entitled to
an initial equal share of U.S. profits and losses, which will decrease
as sales increase, and will share equally in the U.S. marketing and
commercialization costs. Exelixis is eligible to receive royalties on
any sales of the product outside the United States.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
COMETRIQ® (cabozantinib), its wholly-owned inhibitor of
multiple receptor tyrosine kinases. Another Exelixis-discovered
compound, cobimetinib, a highly selective inhibitor of MEK, is being
evaluated by Roche and Genentech (a member of the Roche Group) in a
broad development program under a collaboration with Exelixis. For more
information, please visit the company's web site at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: potential regulatory approval
for cobimetinib; Exelixis’ future U.S. co-promotion efforts for
cobimetinib in the United States; the plan of Genentech and Exelixis to
share U.S. profits and losses for cobimetinib and U.S. marketing and
commercialization costs for cobimetinib; and Exelixis’ potential receipt
of royalties on sales of cobimetinib products outside the United States.
Words such as “if,” “entitled,” “will,” “eligible,” 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. Exelixis’ 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 clinical, therapeutic and
commercial value of cobimetinib; Exelixis’ dependence on its
relationship with Genentech/Roche with respect to cobimetinib and
Exelixis’ ability to maintain its rights under the collaboration; risks
and uncertainties related to regulatory review and approval processes
and Exelixis’ compliance with applicable legal and regulatory
requirements; 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 November 4, 2014 and in Exelixis' other
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, and COMETRIQ are registered U.S.
trademarks.
Source: Exelixis Inc.
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor
Relations and
Corporate Communications
shubbard@exelixis.com