FLINT -- Diplomat Specialty Pharmacy and South San Francisco, Calif.-based Exelixis Inc. (Nasdaq: EXEL) announced Monday that it had been selected as the exclusive specialty pharmacy for Cometriq (cabozantinib).
Cometriq was approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer on Nov. 29.
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.
Diplomat, the nation's largest privately owned specialty pharmacy, 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, around-the-clock access to pharmacists and continuum of care through strong relationships with hematologists and 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 percent satisfaction overall with Diplomat's services and care. Additionally, 98 percent 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 of 330 patients with progressive, metastatic medullary thyroid carcinoma. Patients were required to have evidence of actively progressive disease within 14 months prior to study entry confirmed by an Independent Radiology Review Committee masked to treatment assignment or the treating physician. Patients were randomized to receive Cometriq or placebo orally once daily until disease progression determined by the treating physician or until intolerable toxicity.
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