IMBRUVICA® (ibrutinib) receives expanded approval for treatment of Waldenström’s macroglobulinemia
FLINT, Mich. — Jan. 29, 2015 — Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent specialty pharmacy, announced today that the U.S. Food and Drug Administration has approved an expanded indication of IMBRUVICA® (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM). The drug was granted expanded approval under the breakthrough therapy designation.
WM is a type of non-Hodgkin lymphoma that begins in the body’s immune system. For patients living with WM, abnormal blood cells grow within bone marrow, lymph nodes, liver and spleen which then overproduce a protein known as immunoglobulin M. IMBRUVICA® treats the disease by blocking the enzyme that supports the growth and division of the abnormal blood cells. According to the American Cancer Society, 1,000–5,000 cases of WM are diagnosed each year, with the average age of diagnosis in the mid-60s.
“We are pleased to continue to be a part of the narrow distribution network for IMBRUVICA®,” said Gary Kadlec, president of Diplomat. “The expanded indication will allow Diplomat to provide care and support for a previously underserved patient population. Our high-touch model and patient-centric approach to care supports our commitment to administering this therapy in accordance with our high standards.”
Diplomat is currently distributing IMBRUVICA® for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia. IMBRUVICA® was approved by the FDA in November 2013 under the breakthrough therapy designation for the treatment of MCL in patients who have received prior therapy for the disease. IMBRUVICA® was granted expanded approval for the treatment of CLL in patients who have received at least one prior therapy for the disease in February 2014 and for treatment of CLL in patients with 17p deletion in July 2014.
Full prescribing information is available at the manufacturer’s website, www.imbruvica.com
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