Cometriq® approved in Europe for the treatment of progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
ET | Source:Swedish Orphan Biovitrum AB
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner 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 authorisation 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
"We're pleased that physicians in the European Union who treat patients with
progressive, unresectable locally advanced or metastatic MTC now have a new
treatment option in Cometriq," said Anders Edvell, MD, PhD, Vice President Sobi
The Committee for Orphan Medicinal Products (COMP) also reviewed the designation
for Cometriq (cabozantinib) as an orphan medicinal product for the treatment of
MTC, and recommended maintenance of orphan drug designation at the time of
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-centre, randomised 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.
Pursuant to the terms of a commercialization and distribution agreement between
Exelixis and Sobi signed in February 2013, Sobi will support the
commercialisation 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 tumor microenvironment.
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on Inflammation and Genetic diseases, with three late stage biological
development projects within Haemophilia and Neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi is
a pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2013, Sobi had total revenues of SEK 2.2 billion
(€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
About Sobi Partner Products
Sobi Partner Products (SPP) is a business unit within Sobi which offers a unique
commercial platform for partners with niche and specialty products. SPP provides
extensive knowledge and local experience through our direct presence across EU,
Eastern Europe, Russia, Middle East and North Africa. We apply an integrated
commercial, medical, and market access approach to products which address
important unmet needs, spanning from named patient use (NPU) programs, through
to reimbursement and full commercialization, primarily in the Centre of
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