IBRANCE® (palbociclib) approved for advanced breast cancer, Diplomat to dispense
FLINT, Mich. — Feb. 4, 2015 — Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent specialty pharmacy, announced today it will dispense Pfizer’s new breakthrough medication, IBRANCE® (palbociclib), starting tomorrow, Feb. 5. IBRANCE® received approval from the Food and Drug Administration yesterday for use, when paired with letrozole, to treat metastasized tumors in postmenopausal women with a specific form of breast cancer.
The approval for IBRANCE® came more than two months ahead of schedule, through the FDA’s Breakthrough Therapy designation and Priority Review programs. According to Pfizer, the registration trial showed that, compared to letrozole alone, IBRANCE® in combination with letrozole nearly doubled the time before tumors progressed. The drug is the first in a new class of anti-cancer agents, CDK 4/6 inhibitors, to be FDA-approved.
“IBRANCE® offers hope for the breast cancer community, and we’re excited to be able to offer it at Diplomat,” said Gary Kadlec, president of the company. “Patients facing metastatic breast cancer need the support of advancements like these, and we are honored to complement this treatment with focused care.”
IBRANCE® is indicated for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
IBRANCE® is available through a limited-distribution network. For full prescribing information, click here.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including relating to Diplomat’s distribution of the drug(s) set forth above (and any implied financial impact). The forward-looking statements contained in this press release are based on management’s good-faith belief and reasonable judgment based on current information, and these statements are qualified by important risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those forecasted or indicated by such forward-looking statements. These risks include the number of patients prescribed such drug(s) currently and in the future, patient’s adherence to such drug(s), the number of distributors on panel and our relative distribution share, the timing of drug sales, the cost of such drug(s) and reimbursement rates by payors, drug competition, and the factors set forth in “Risk Factors” in Diplomat’s prospectus dated October 10, 2014 and in subsequent reports filed with or furnished to the Securities and Exchange Commission. Except as may be required by any applicable law, Diplomat assumes no obligation to publicly update such forward-looking statements, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments or otherwise.
Diplomat (NYSE: DPLO) serves patients and physicians in all 50 states. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues – always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is.
Jenny Cretu, Diplomat
810.768.9370 | email@example.com
Gary Rice, RPh, MS, MBA, CSP, Diplomat
810.768.9863 | firstname.lastname@example.org
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