|[March 25, 2014]
Exelixis Receives Approval for COMETRIQ® (Cabozantinib) in the European Union for Treatment of Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European
Commission has approved COMETRIQ® (cabozantinib) for the treatment of
adult patients with progressive, unresectable locally advanced or
metastatic medullary thyroid carcinoma (MTC). The European Commission
granted conditional marketing authorization following a positive opinion
from the European Committee for Medicinal Products for Human Use (CHMP)
issued in December 2013. Similar to another drug approved in this
setting, the approved indication 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.
"We are pleased that physicians who treat patients with progressive,
unresectable locally advanced or metastatic MTC in the European Union
will now have COMETRIQ as a treatment option," said Michael Morrissey,
Ph.D., president and chief executive officer of Exelixis. "This patient
population is in need of new therapies, and we believe that COMETRIQ
provides an important new option for these patients."
Additionally, the Committee for Orphan Medicinal Products (COMP) during
its January 2014 meeting reviewed the designation for COMETRIQ
(cabozantinib) as an orphan medicinal product for the
treatment of medullary thyroid carcinoma and recommended maintenance of
orphan drug designation at the time of marketing authorization.
The U.S. Food and Drug Administration approved COMETRIQ for the
treatment of progressive, metastatic MTC in the United States on
November 29, 2012. The approvals of COMETRIQ in both the United States
and the European Union were based on 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. Please see Important Safety Information for
COMETRIQ, including Boxed Warnings, below.
Pursuant to the terms of a commercialization and distribution agreement
between Exelixis and Swedish Orphan Biovitrum (Sobi) signed in February
2013, Sobi will support the commercialization of COMETRIQ in the
European Union for the approved indication through the end of 2015.
Cabozantinib inhibits the activity of tyrosine kinases including RET,
MET and VEGFRs. 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
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 hemorrhag 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 Syndrome (PPES) 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 U.S. prescribing information, including Boxed WARNINGS,
Please refer to the full European Summary of Product Characteristics for
full European Union prescribing information, including contraindication,
special warnings and precautions for use at www.sobi.com
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 referenced conditional
marketing authorization for COMETRIQ® (cabozantinib) in the European
Union; the belief that COMETRIQ provides an important new option for
patients in the European Union with progressive, unresectable locally
advanced or metastatic MTC; the 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 "conditional," "should," "will,"
"believe," "new," "option," "support," "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 risk that unanticipated
developments could delay or prevent the launch, commercialization,
manufacturing, distribution and availability of COMETRIQ; the degree of
market acceptance of COMETRIQ; the extent to which coverage and
reimbursement for COMETRIQ will be available from third-party payors;
risks and uncertainties related to Exelixis' ability to maintain
compliance with the requirements for conditional marketing authorization
in the European Union; risks and uncertainties related to Exelixis'
compliance with other applicable regulatory requirements, including
healthcare fraud and abuse laws and post-marketing requirements;
Exelixis' dependence on third-party vendors; market competition; the
uncertainty of regulatory approval processes; and changes in economic
and business conditions. These and other risk factors are discussed
under "Risk Factors" and elsewhere in Exelixis' annual report on Form
10-K for the fiscal year ended December 27, 2013, filed with the
Securities and Exchange Commission (SEC (News - Alert)) on February 20, 2014, 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
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
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