DIPLOMAT SPECIALTY PHARMACY SELECTED BY EXELIXIS, INC. AS EXCLUSIVE SPECIALTY PHARMACY FOR COMETRIQ™ (CABOZANTINIB)
FLINT, MI and SOUTH SAN FRANCISCO, Calif. – December 3, 2012 –Diplomat Specialty Pharmacy and Exelixis, Inc. (NASDAQ: EXEL) announced today that Diplomat Specialty Pharmacy has been selected as the exclusive specialty pharmacy for COMETRIQ™ (cabozantinib).
COMETRIQ was approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive, metastatic medullary thyroid cancer (MTC) on November 29, 2012. The recommended dose of COMETRIQ is 140 mg orally, once daily (one 80 mg capsule and three 20 mg capsules). COMETRIQ should not be taken with food, and patients are advised to not eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. The COMETRIQ label has boxed warnings concerning risk of perforations and fistulas, and hemorrhage. Full prescribing information, including Boxed Warning, is available at www.exelixis.com or www.COMETRIQ.com.
As the nation's largest, privately owned specialty pharmacy, Diplomat Specialty Pharmacy and its leadership team are very excited about this new partnership with Exelixis. Diplomat was chosen as the exclusive distributor for this product due to its commitment to high-touch patient care. Diplomat's focus on timely prescription delivery, side effect management support, 24/7 access to pharmacists and continuum of care through strong relationships with Hematologists/Oncologists throughout the United States have all added to Exelixis' decision to choose Diplomat. Diplomat will also provide prior authorization management, copay support, and assistance to patients that meet certain financial criteria. The significance of these high touch services at Diplomat have been validated through independent patient surveys which reported 98% satisfaction overall with Diplomat's services and care. Additionally, 98% of prescribers surveyed in 2012 responded with satisfaction overall with Diplomat's focus on services to the patient.
"This strategic partnership is a direct result of our incredible staff and their commitment to comprehensive patient care," said Diplomat Specialty Pharmacy CEO Phil Hagerman. "It is a clear indicator of Diplomat's recognized influence in the specialty pharmacy market place. We look forward to managing the full suite of activities that are required to support the needs of COMETRIQ patients."
COMETRIQ's safety and efficacy was assessed in an international, multi-center, randomized double-blinded controlled trial called EXAM of 330 patients with progressive, metastatic medullary thyroid carcinoma (MTC). Patients were required to have evidence of actively progressive disease within 14 months prior to study entry confirmed by an Independent Radiology Review Committee (IRRC) masked to treatment assignment (89%) or the treating physician (11%). Patients were randomized (2:1) to receive COMETRIQ 140 mg (n = 219) or placebo (n = 111) orally, once daily until disease progression determined by the treating physician or until intolerable toxicity. Randomization was stratified by age (≤65 years vs. > 65 years) and prior use of a tyrosine kinase inhibitor (TKI). No cross-over was allowed at the time of progression. The main efficacy outcome measures of PFS, objective response and response duration were based on IRRC-confirmed events using the modified RECIST criteria.
A statistically significant prolongation in PFS was demonstrated among COMETRIQ-treated patients compared to those receiving placebo [HR 0.28 (95% CI: 0.19, 0.40); p<0.0001], with median PFS times of 11.2 months and 4.0 months in the COMETRIQ and placebo arms, respectively. Partial responses were observed only among patients in the COMETRIQ arm (27% vs 0; p<0.0001). The median duration of objective responses was 14.7 months (95% CI: 11.1, 19.3) for patients treated with COMETRIQ. There was no statistically significant difference in overall survival between the treatment arms at the planned interim analysis.
COMETRIQ Mechanism of Action
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.
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 Diplomat Specialty Pharmacy
Michigan-based Diplomat Specialty Pharmacy, founded in 1975, serves patients nationwide as the country's largest privately held Specialty Pharmacy and focuses on complete medication management programs for patients with serious and chronic conditions. Diplomat's business model creates unique partnerships around both distribution and services with all industry stakeholders including physicians, patients, group purchasing organizations, hospital systems, retail chains and managed markets, always focused on improving adherence and the patient experience.
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 its lead product, COMETRIQ. 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.
This press release contains forward-looking statements, including, without limitation, statements related to the launch, commercialization, distribution and availability of COMETRIQ. Words such as "will," "look forward," 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' compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-marketing requirements; the company's dependence on third-party vendors; market competition; and changes in economic and business conditions. These and other risk factors are discussed under "Risk Factors" and elsewhere in Exelixis' quarterly report on Form 10-Q for the quarter ended September 28, 2012, filed with the Securities and Exchange Commission (SEC) on November 7, 2012, 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.
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