Jakafi® (ruxolitinib) receives expanded approval for treatment of polycythemia vera; available through Diplomat
FLINT, Mich. — Dec. 5, 2014 — Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent specialty pharmacy, announced that the U.S. Food and Drug Administration has approved an expanded indication of Jakafi® (ruxolitinib). Jakafi has received expanded approval for the treatment of uncontrolled polycythemia vera, a chronic bone marrow disease, in patients who have had an inadequate response to or cannot tolerate hydroxyurea, a medication often used to reduce the number of red blood cells and platelets in the blood.
Polycythemia vera occurs when there are too many red blood cells made in the bone marrow. This surplus of blood cells can cause bleeding problems, swelling of the spleen and blood clots in the veins near the skin surface. Patients may also be at increased risk of heart attack or stroke. It is estimated that 100,000 patients in the U.S. are living with polycythemia vera, with approximately 25,000 cases considered to be uncontrolled.
Jakafi received expanded approval for use in the treatment of polycythemia vera under the FDA’s priority review program and is the first drug approved for this condition. The FDA previously approved Jakafi in 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, another bone marrow disorder. Jakafi is marketed by Incyte Corp. For full prescribing information, visit http://www.incyte.com/sites/default/files/Jakafi_PI.pdf
Diplomat has access to distribute Jakafi. To learn more, visit diplomat.is.
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. Follow us on Twitter and LinkedIn and like us on Facebook.
Abigail Bearman, Diplomat
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Gary Rice, R.Ph., MS, MBA, CSP, Diplomat
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