South San Francisco, CA and Stockholm, Sweden
Exelixis, Inc. (NASDAQ:EXEL) and Swedish Orphan Biovitrum AB (Sobi) (STO: SOBI) today announced that they have entered into a three-year agreement to support the distribution and commercialization of COMETRIQ(TM) (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 patients home country. Regulations governing NPU programs vary by country but companies offering products through NPU can sometimes charge for the product being administered.
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 orwww.COMETRIQ.com.
COMETRIQ(TM) 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 (equal to or more than 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 (equal to or more than 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.
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(TM) (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 atwww.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.
The above information has been made public in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was released for public distribution on 22 February 2013 at 08.30 CET.
Vice President, Investor Relations and Corporate Communications
Vice President, Sobi Partner Products, Sobi
+46 8 697 2000
Vice President, Investor Relations, Sobi
+46 8 697 3427
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 Inflamma-tion 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 infor-mation is available at www.sobi.com.