ARIAD Pharmaceuticals' Iclusig now commercially available to patients in the U.S.

Jan 18 2014

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the commercial availability of Iclusig^® (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

"We are pleased to again have Iclusig commercially available to patients in the United States," stated Marty J. Duvall, executive vice president and chief commercial officer for ARIAD. "Iclusig is now in our distribution channel with Biologics, and our dedicated sales force will begin promoting Iclusig immediately. We are highly confident in our commercial launch of Iclusig and look forward to reporting on our progress on a quarterly basis."

Last month, the U.S. Food and Drug Administration (FDA) approved revised U.S. Prescribing Information (USPI) and a communications Risk Evaluation and Mitigation Strategy (REMS) for Iclusig that allowed for the immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers. Iclusig is now indicated for the treatment of adult patients with:

• T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or
• Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.

The starting dose of Iclusig remains 45 mg daily.

On November 1, 2013, there were approximately 640 patients receiving Iclusig obtained through commercial channels in the U.S. Since then, Iclusig was made available through emergency and single-patient investigational new drug (IND) applications, which were reviewed and approved by the FDA on a case-by-case basis. The FDA has approved more than 370 INDs since early November, and more than 300 patients have received Iclusig at no cost through this process. ARIAD expects most of these patients, many of whom received a three-month supply of Iclusig, to transition from the IND program to commercial therapy by the end of the first quarter of 2014. The Iclusig IND program is now closed to new patients with Philadelphia-positive leukemias.

In addition to providing specialty pharmacy services, Biologics will help transition patients from the Iclusig IND program to commercial product. Biologics will further support the ARIAD Patient Access and Support Services (ARIAD PASS™) program by managing ARIAD's reimbursement and patient access services and co-pay support programs by conducting benefits investigations and prior authorizations to assess and assist with patient eligibility. Iclusig is currently priced in the U.S. at approximately $125,000 per year. The new annual cost of Iclusig is approximately a 17 percent premium to second-generation TKIs.