ARIAD Pharmaceuticals, Inc. has signed an agreement with Specialised Therapeutics Australia Pty Ltd (STA), a specialty pharmaceutical company, under which ARIAD has granted STA exclusive rights to commercialize Iclusig (ponatinib) in Australia in patients with Philadelphia-positive (Ph+) leukaemias.
Under the terms of the agreement, STA will be responsible for obtaining marketing authorization and pricing and reimbursement approval of Iclusig and assisting ARIAD in regulatory filings for Iclusig in Australia. STA will book sales of Iclusig to pharmacies and other distributors, while ARIAD will supply packaged drug to STA. The term of the agreement is seven years from the first commercial sale of Iclusig following reimbursement approval. At the conclusion of the term, ARIAD will have the option to take over commercialization of Iclusig in Australia or to extend the agreement with STA.
"This agreement illustrates how we plan to make Iclusig available to patients in geographies where we do not anticipate setting up our own commercial activities near term," said Marty J Duvall, executive vice president and chief commercial officer of ARIAD. "STA has a proven track-record in oncology marketing and market access in Australia and is successfully distributing several important oncology brands in this region."
ARIAD submitted a marketing application for Iclusig in the third quarter of 2013 to the Therapeutic Goods Administration (TGA) in Australia. Marketing approval and commercial launch of Iclusig are expected in the fourth quarter of 2014. Prior to launch, ARIAD and STA will collaborate to make Iclusig available to patients with refractory chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL) under a Special Access Programme.
"Iclusig is as an important cancer medicine for patients with difficult-to-treat CML or Ph+ ALL who have few options available to them," said Carlo Montagner, chief executive officer at STA. "We look forward to a successful collaboration with ARIAD providing refractory CML patients in Australia with a new highly effective treatment option."
According to the Australian Institute of Health and Welfare, there are more than 1,500 patients in Australia being treated for CML and approximately 290 patients are newly diagnosed with the disease each year.
"Some patients with this disease build resistance to current therapies and eventually run low on treatment options," said Professor Timothy Hughes, Consulting Haematologist at the Royal Adelaide Hospital and one of the PACE trial investigators. "I anticipate that Iclusig will be a valuable new therapy for adult patients with refractory CML."
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD's computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
STA is dedicated to working with leading pharmaceutical companies worldwide to provide acute care therapies for high unmet medical needs to people living in Australia and New Zealand. The STA therapeutic portfolio and pipeline at present encompasses oncology, hematology, ophthalmology and infectious diseases.
ARIAD Pharmaceuticals, Inc., is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines.