Press Release
Press Release
Exelixis and Swedish Orphan Biovitrum AB (Sobi) Extend and Restructure Distribution Agreement for COMETRIQ® for Medullary Thyroid Cancer
“Our amended agreement with Sobi will continue to allow
“We are very pleased to extend the agreement with
Sobi exclusively markets, sells, and distributes COMETRIQ for its MTC
indication in the covered territory of the
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. 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
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
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,
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 two late
stage biological development projects within Haemophilia. 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
About
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 for the stated
duration; commercial rights to cabozantinib for other oncology
indications and their potential value; Exelixis’ belief that the
referenced agreement will enable Exelixis to continue to make COMETRIQ
available to MTC patients outside the US; the performance by the parties
under the referenced agreement; the expected benefits to each party
arising under the referenced agreement; and Exelexis’ expectation to
reach key milestones in 2015, including METEOR top-line data in RCC in
the second quarter and regulatory progress with cobimetinib for
metastatic melanoma in the US and EU. Words such as “extend,” “support,”
“will,” “transition,” “continue,” “maintain,” “allow,” “potential,”
“provide,” “anticipate,” “reaching,” “look forward,” “progress,”
“become,” “retain,” “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 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
regulatory review and approval processes and Exelixis’ and Sobi’s
compliance with applicable legal and regulatory requirements, including
healthcare fraud and abuse laws; Exelixis’ dependence on Sobi under the
referenced agreement; market competition; risks related to the potential
failure of cobimetinib or cabozantinib to demonstrate safety and
efficacy in clinical testing; the availability of data at the expected
times; the clinical, therapeutic and commercial value of cobimetinib and
cabozantinib; the general sufficiency of Exelixis’ capital and other
resources and the specific risk of unforeseen expenses that could
diminish Exelixis’ financial ability to support its operations through
the release of top-line results from METEOR; the uncertain timing and
level of expenses associated with the development of cabozantinib;
changes in economic and business conditions. These and other risk
factors are discussed under “Risk Factors” and elsewhere in Exelixis’
quarterly Form 10-Q filed with the Securities and Exchange
Commission (
Source:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor
Relations & Corporate Communications
shubbard@exelixis.com