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.
About Cabozantinib
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 tumor microenvironment.
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 patients.
- 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 patients.
- 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 with COMETRIQ.
- 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, at
www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf
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 once posted.
About Exelixis
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.
Forward-Looking Statements
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) 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 based.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
trademarks.
Exelixis, Inc.Hal Mackins, 650-837-7277Investor Relations and
Corporate Communicationshmackins@exelixis.com
Exelixis (NASDAQ:EXEL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Exelixis (NASDAQ:EXEL)
Historical Stock Chart
From Apr 2023 to Apr 2024