SOUTH SAN FRANCISCO, Calif. & STOCKHOLM--(BUSINESS WIRE)--Feb. 21, 2013--
Exelixis, Inc. (NASDAQ:EXEL) and Swedish
Orphan Biovitrum (Sobi) (STO: SOBI) today announced that they have
entered into a three-year agreement to support the distribution and
commercialization of COMETRIQ™ (cabozantinib) for metastatic medullary
thyroid cancer (MTC) in the European Union (EU) and potentially other
countries. No other indication is covered by this agreement, and
Exelixis maintains full commercial rights for COMETRIQ in MTC outside
the covered territory and for all other indications on a global basis.
On November 29, 2012, Exelixis announced that the European Medicines
Agency (EMA) accepted for review the Marketing Authorization Application
(MAA) for COMETRIQ for the proposed indication of treatment of
progressive, unresectable, locally advanced, or metastatic MTC.
“We are pleased to be working with Sobi to distribute and commercialize
COMETRIQ for MTC in the EU, while at the same time maintaining
commercial rights for all other oncology indications on a global basis,”
said Michael M. Morrissey, Ph.D., president and chief executive officer
of Exelixis. “By contracting with Sobi for distribution and
commercialization services, we believe we will be able to realize the
full value of the MTC opportunity in Europe and potentially other
regions without the need for a large-scale investment in sales and
marketing infrastructure. This strategy is consistent with our
commitment to match our commercialization investments with the potential
value of each opportunity. We look forward to working with Sobi, which
has proven sales and marketing expertise in Europe, to make COMETRIQ
available under a Named Patient Use (NPU) program and then more broadly
assuming EMA approval.”
“COMETRIQ is an important potential new treatment option for patients
with metastatic MTC,” said Anders Edvell, Vice President and Head of
Partner Products at Sobi. “We look forward to leveraging our years of
specialized expertise in these markets to support the COMETRIQ NPU
program and, upon EMA approval, its commercial development in MTC.”
Under the terms of the agreement, Exelixis will continue to be
responsible for regulatory approvals in the covered territory. Sobi will
serve as the exclusive distributor of COMETRIQ in the covered territory
where applicable for NPU requests, and will, if approved by the EMA,
promote, market, and sell COMETRIQ for MTC in the covered territory.
Exelixis’ payments to Sobi include certain pre-determined fixed fees as
well as potential performance based milestones related to the
commercialization of the product in the covered territory. Exelixis will
book revenues based on product sold to Sobi. Exelixis has the ability to
terminate the agreement at will at any time upon payment of certain
pre-determined fees.
About Named Patient Use (NPU) Programs
A named patient use (NPU) program provides access to unapproved drugs
for a single patient or group of patients in a particular country.
Products offered through NPU programs can be investigational (e.g. still
in clinical studies) or approved in one country but not yet approved in
the patient’s home country. Regulations governing NPU programs vary by
country but companies offering products through NPU can sometimes charge
for the product being administered.
About COMETRIQ™
COMETRIQ (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. Exelixis received approval by the FDA to
market COMETRIQ in the United States for the treatment of progressive,
metastatic MTC in November 2012. Please see important safety information
below, and the full prescribing information, including Boxed Warning,
for COMETRIQ at www.exelixis.com
or www.COMETRIQ.com.
COMETRIQ™ Important Safety Information, including Boxed Warning
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 (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
with COMETRIQ.
-
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.
Drug Interactions – COMETRIQ is a CYP3A4 substrate. Co-administration of
strong CYP3A4 inhibitors can increase cabozantinib exposure. Chronic
co-administration of strong CYP3A4 inducers can reduce cabozantinib
exposure.
For full prescribing information, including Boxed Warning, please visit www.exelixis.com
or www.COMETRIQ.com.
About Exelixis
Exelixis, Inc. 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.
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, working
from named patient use (NPU) programs through to reimbursement and
commercialization, primarily in the Centre of Expertise setting. The key
SPP therapeutic areas are Oncology, Hematology, Infectious Diseases, and
Emergency Medicines & Antidotes.
About Sobi
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 hemophilia 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
2012, Sobi had total revenues of SEK 1.9 billion (€ 215 M) and about 480
employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More
information is available atwww.sobi.com.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements by Exelixis,
including, without limitation, statements related to: the clinical,
therapeutic and commercial potential of COMETRIQ; the clinical and
commercial opportunity for COMETRIQ in MTC in the EU and potentially
other countries; the companies’ plan for Sobi to provide the referenced
distribution and commercialization services for COMETRIQ; Exelixis’
belief that the referenced agreement will enable Exelixis to realize the
full value of the MTC opportunity in Europe and potentially other
regions without the need for a large-scale investment in sales and
marketing infrastructure; Exelixis’ commitment to match
commercialization investments with the potential value of each
opportunity; the referenced review by the EMA of the MAA, and the
potential approval of the MAA; the plan for Exelixis to continue to be
responsible for regulatory approvals in the covered territory; the
performance by the parties under the referenced agreement; the expected
benefits to each party arising under the referenced agreement; and
Exelixis’ expectation for booking revenues under the referenced
agreement. Words such as “support,” “maintains,” “review,” “proposed,”
“believe,” “will,” “realize,” “opportunity,” “potential,” “strategy,”
“look forward,” “assuming,” “continue,” “ability,” “can,” 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 in the covered
territory; 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’
compliance with applicable regulatory requirements, including healthcare
fraud and abuse laws; Exelixis’ dependence on Sobi under the referenced
agreement; market competition; the uncertainty of the regulatory
approval process; 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 28, 2012, filed with the Securities and Exchange Commission
(SEC) on February 21, 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.
Source: Exelixis, Inc.
Exelixis, Inc.
Charles Butler, 650-837-7277
Vice President,
Investor Relations and Corporate Communications
cbutler@exelixis.com
or
Sobi
Anders
Edvell, +46 8 697 2000
Vice President, Sobi Partner Products
anders.edvell@sobi.com
Jorgen
Winroth, +46 8 697 3427
Vice President, Investor Relations
jorgen.winroth@sobi.com