SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 25, 2015--
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Medicines
Agency’s Committee for Medical Products for Human Use (CHMP) has adopted
a positive opinion of the Marketing Authorization Application for
cobimetinib, a selective MEK inhibitor discovered by Exelixis, in
combination with vemurafenib for the treatment of BRAF V600
mutation-positive unresectable or metastatic melanoma. The CHMP's
positive opinion will now be reviewed by the European Commission, which
has the authority to approve medicines for the European Union. The
European Commission is expected to release its final decision regarding
the approval of the combination of cobimetinib and vemurafenib by the
end of 2015.
“The CHMP’s positive opinion on cobimetinib for use in combination with
vemurafenib is an important milestone in bringing this new therapeutic
option to patients in Europe,” said Michael M. Morrissey, Ph.D.,
president and chief executive officer of Exelixis. “We congratulate
Genentech and Roche on this latest milestone in the European regulatory
process. We also look forward to the regulatory decision anticipated
this year in the United States, where we are fully prepared to
co-promote cobimetinib with our partners.”
The CHMP’s recommendation is based on data from coBRIM, the
international, randomized double-blind controlled phase 3 pivotal trial
evaluating cobimetinib in combination with vemurafenib in previously
untreated patients with unresectable locally advanced or metastatic
melanoma harboring a BRAF V600 mutation.
The combination of cobimetinib and vemurafenib recently received its
first approval in Switzerland, where cobimetinib is marketed as
Cotellic™.
The coBRIM trial was conducted by Roche and Genentech, a member of the
Roche Group. Genentech filed a New Drug Application (NDA) for
cobimetinib in the United States, for which the Prescription Drug User
Fee Act action date is November 11, 2015.
About the Cobimetinib Development Collaboration
After discovering cobimetinib internally, Exelixis advanced the product
to investigational new drug (IND) status. In late 2006, the company
entered into its worldwide collaboration with Genentech, under which
Exelixis received initial upfront and milestone payments for signing the
agreement and submitting the IND. Following the determination of the
maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its
option to further develop cobimetinib. Under the terms of the
collaboration, Exelixis is eligible to receive royalties on sales of
cobimetinib outside the United States.
If cobimetinib is 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 in U.S. marketing and
commercialization costs. In November 2013, Exelixis exercised its option
to co-promote cobimetinib in the United States and, under the terms of
the agreement, the company is prepared to field up to 25 percent of the
U.S. sales force.
About the cobimetinib and vemurafenib Combination
Cobimetinib is a selective inhibitor that blocks the activity of MEK, a
protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK
pathway) that promotes cell division and survival. This pathway is
frequently activated in human cancers including melanoma, where mutation
of one of its components (BRAF) causes abnormal activation in about 50
percent of tumors. About 50 percent of patients with BRAF mutation
positive melanoma experience a tumor response when treated with a BRAF
inhibitor, however development of resistance and subsequent tumor
progression limits treatment benefit. Clinical and preclinical analyses
indicated that reactivation of the MEK-ERK pathway may underlie
development of resistance to BRAF inhibitors in many progressing tumors,
and that co-treatment with a BRAF and MEK inhibitor delays the emergence
of resistance in the preclinical setting, providing the rationale for
testing the combination of vemurafenib and cobimetinib in clinical
trials. In addition to the combination with vemurafenib in melanoma,
cobimetinib is also being investigated in combination with several
investigational medicines, including an immunotherapy, in several tumor
types, including non-small cell lung cancer, colorectal cancer,
triple-negative breast cancer and melanoma.
About Melanoma and its BRAF V600 Mutation-Positive Form
Melanoma is the less common, but more serious category of skin cancer
that starts in the skin’s pigment producing cells known as melanocytes.
According to the American Cancer Society, approximately five percent of
skin cancer diagnoses are melanoma, but melanoma accounts for a large
majority of skin cancer deaths. In recent years, there have been
significant advances in treatment for metastatic melanoma and people
with the disease have more options. However, it continues to be a
serious health issue with a high unmet need and a steadily increasing
incidence over the past 30 years. It is projected that approximately
half of all melanomas, and eight percent of solid tumors, contain a
mutation of the BRAF protein. BRAF is a key component of the
RAS-RAF-MEK-ERK pathway involved in normal cell growth and survival.
However, mutations that keep the BRAF protein in an active state may
cause excessive signaling in the pathway, leading to uncontrolled cell
growth and survival. The BRAF V600 mutation-positive form of melanoma is
associated with high-risk characteristics of the disease, including
early onset, the absence of chronic skin damage, and decreased survival.
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
cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine
kinases. Another Exelixis-discovered compound, cobimetinib, a selective
inhibitor of MEK, received its first regulatory approval and 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: the potential for regulatory
approvals for cobimetinib in EU and U.S. by the end of 2015, including
by the FDA in the U.S. and European Commission in the EU; the potential
for cobimetinib to advance melanoma treatment; Exelixis’ preparedness to
support U.S. co-promotion efforts for cobimetinib in the U.S.; the plan
of Genentech and Exelixis to share U.S. profits and losses and U.S.
marketing and commercialization costs for cobimetinib; and, Exelixis’
potential receipt of royalties on sales of cobimetinib products outside
the U.S. Words such as “expect,” “look forward,” “anticipated,”
“entitled,” “eligible,” “will,” “prepared,” 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,
and projections. Exelixis’ actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of 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 August 11, 2015 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150925005265/en/
Source: Exelixis, Inc.
Investor Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194
Investor Relations and
Corporate
Communications
shubbard@exelixis.com
or
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcommunications.com