SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 19, 2013--
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Committee
for Medicinal Products for Human Use (CHMP) has issued a positive
opinion of the Marketing Authorization Application (MAA) for COMETRIQ®
(cabozantinib) for the treatment of adult patients with progressive,
unresectable locally advanced or metastatic medullary thyroid carcinoma
(MTC). The proposed indication also states that for patients in whom
Rearranged during Transfection (RET) mutation status is not known or is
negative, a possible lower benefit should be taken into account before
individual treatment decisions. 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 MAA upon which the CHMP issued its opinion contains data from EXAM,
the international, multi-center, randomized double-blinded controlled
phase 3 clinical trial conducted in 330 patients with progressive,
unresectable locally advanced or metastatic MTC, in which cabozantinib
met its primary efficacy endpoint of improving progression-free survival
(PFS) as compared to placebo. This trial also served as the basis for
Exelixis’ New Drug Application with the U.S. Food and Drug
Administration, which approved COMETRIQ for the treatment of
progressive, metastatic MTC in the United States on November 29, 2012.
Please see Important Safety Information for COMETRIQ, including Boxed
“The positive opinion issued by the CHMP marks an important milestone
for Exelixis and the next step in making COMETRIQ commercially available
in the European Union,” said Michael Morrissey, Ph.D., president and
chief executive officer of Exelixis. “We are looking forward to working
with the European Commission to complete the review process for
COMETRIQ’s proposed indication as a treatment for progressive,
unresectable locally advanced or metastatic MTC.”
If the European Commission approves COMETRIQ based on the CHMP’s
positive opinion, Swedish Orphan Biovitrum (Sobi) would support the
product’s commercialization in the European Union for the approved
indication through the end of 2015, pursuant to the terms of a
commercialization and distribution agreement between Exelixis and Sobi
signed in January 2013.
Cabozantinib inhibits the activity of tyrosine kinases including RET,
MET and VEGFR2. These receptor tyrosine kinases are involved in both
normal cellular function and in pathologic processes such as
oncogenesis, metastasis, tumor angiogenesis, and maintenance of the
tumor microenvironment. COMETRIQ® (cabozantinib) is currently approved
by the U.S. Food and Drug Administration for the treatment of
progressive, metastatic medullary thyroid cancer.
Important Safety Information, including Boxed WARNINGS
WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE
Serious and sometimes fatal gastrointestinal perforations and
fistulas occur in COMETRIQ-treated patients.
Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated
COMETRIQ treatment results in an increase in thrombotic events, such
as heart attacks.
Wound complications have been reported with COMETRIQ.
COMETRIQ treatment results in an increase in hypertension.
Osteonecrosis of the jaw has been observed in COMETRIQ-treated
Palmar-Plantar Erythrodysesthesia (PPE) Syndrome occurs in patients
treated with COMETRIQ.
The kidneys can be adversely affected by COMETRIQ. Proteinuria and
nephrotic syndrome have been reported in patients receiving COMETRIQ.
Reversible Posterior Leukoencephalopathy Syndrome has been observed
Avoid administration of COMETRIQ with agents that are strong CYP3A4
inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or
severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.
Adverse Reactions – The most commonly reported adverse drug reactions
(≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia
syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue,
oral pain, hair color changes, dysgeusia, hypertension, abdominal pain,
and constipation. The most common laboratory abnormalities (≥25%) are
increased AST, increased ALT, lymphopenia, increased alkaline
phosphatase, hypocalcemia, neutropenia, thrombocytopenia,
hypophosphatemia, and hyperbilirubinemia.
Please see full prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf
Exelixis is a biotechnology company committed to developing small
molecule therapies for the treatment of cancer. Exelixis is focusing its
proprietary resources and development efforts exclusively on COMETRIQ®
(cabozantinib). Exelixis has also established a portfolio of other novel
compounds that it believes have the potential to address serious unmet
medical needs, many of which are being advanced by partners as part of
collaborations. For more information, please visit the company's web
site at www.exelixis.com.
This press release contains forward-looking statements, including,
without limitation, statements related to: the review by the European
Commission of the CHMP’s referenced positive opinion and of the
referenced MAA for COMETRIQ® (cabozantinib); Exelixis’ plan to work with
the European Commission to complete the review process for COMETRIQ’s
proposed indication as a treatment for progressive, unresectable locally
advanced or metastatic MTC; the potential approval by the European
Commission of the proposed indication of COMETRIQ for the treatment of
progressive, unresectable locally advanced or metastatic MTC; the
potential commercial availability of COMETRIQ in the European Union and
the plan for Sobi to support the product’s commercialization in the
European Union; and the continued development and clinical, therapeutic
and commercial potential of, and opportunities for, cabozantinib. Words
such as “should,” “will,” “milestone,” “next step,” “available,”
“looking forward,” “working,” “complete,” “review,” “proposed,” “would,”
“support,” “believe,” “potential,” and similar expressions are intended
to identify forward-looking statements. These forward-looking statements
are based upon Exelixis' current plans, assumptions, beliefs and
expectations. Forward-looking statements involve risks and
uncertainties. Exelixis' actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation: the uncertainty of the regulatory approval
processes; the sufficiency of Exelixis' capital and other resources;
risks related to the potential failure of cabozantinib to demonstrate
safety and efficacy in clinical testing; the uncertain timing and level
of expenses associated with the development of cabozantinib; Exelixis'
ability to conduct clinical trials of cabozantinib sufficient to achieve
a positive completion; market competition; and changes in economic and
business conditions. These and other risk factors are discussed under
“Risk Factors” and elsewhere in Exelixis' quarterly report on Form 10-Q
for the three months ended September 27, 2013, filed with the Securities
and Exchange Commission (SEC) on October 30, 2013, and Exelixis' other
filings with the SEC. 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.
Source: Exelixis, Inc.
Charles Butler, 650-837-7277
Investor Relations and Corporate Communications