Melbourne, Australia January 28, 2014: ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Specialised Therapeutics Australia Pty Ltd (STA), a specialty pharmaceutical company, today announced that ARIAD has granted STA exclusive rights to commercialize Iclusig® (ponatinib) in Australia in patients with Philadelphia-positive (Ph+) leukemias.
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 Program.
“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.
Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical company 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. STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at www.specialisedtherapeutics.com.au
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
This press release contains “forward-looking statements” which are based on management's good-faith expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to the Company’s ability to manufacture, and supply STA with Iclusig; the ability of STA to perform the contracted services, such as obtaining marketing authorization and pricing and reimbursement approval for Iclusig in Australia; STA’s ability to distribute, promote, market and sell Iclusig in Australia; the timing and scope of the marketing authorizations, as well as the level of pricing obtained in Australia; the availability of Iclusig to patients under a Special Access Program in Australia; third-party reimbursement; and the timing and success of sales of Iclusig in Australia. These factors, risks and uncertainties also include, but are not limited to: the costs associated with ARIAD’s development and manufacturing, commercial and other activities; the adequacy of capital resources and the availability of additional funding; and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. After the date of this document, the Company does not intend to update any of the forward-looking statements to conform to actual results or to changes in the Company's expectations, except as required by law.
Chief Executive Officer
Specialised Therapeutics Australia
(03) 9859 1493