Ariad, Biologics sales and marketing update

Ariad said it relaunched leukemia drug Iclusig ponatinib in the U.S. The biotech began shipping the drug to Biologics, which Ariad selected as the sole specialty pharmacy provider of the Iclusig and manager of the ARIAD PASS patient access and support services program. The wholesale acquisition cost is $10,350 for a 30-count bottle of 45 mg tablets. The recommended starting dose is 45 mg once daily. Biologics will also help transition patients to commercial or patient assistance offerings from the single-patient IND program and manage Ariad's patient assistance and co-pay support programs. The companies declined to disclose financial terms.

Ariad temporarily suspended U.S. marketing and distribution of Iclusig in late October at FDA's request due to the risk of arterial thrombotic events, which were observed in patients treated with the drug. In December, Ariad said it would resume U.S. marketing and distribution of Iclusig by mid-January after FDA approved a REMS and a revised label limiting use of the pan- BCR-ABL tyrosine kinase inhibitor (TKI). Iclusig is approved for chronic, accelerated or blast phase chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) in patients who have the T315I variant of BCR-ABL tyrosine kinase or in patients for whom no other TKI therapy is indicated (see BioCentury, Nov. 4, 2013 & Dec. 23, 2013). ...