ARIAD Pharmaceuticals, Inc. announced that it has granted exclusive rights to Specialised Therapeutics Australia Pty Ltd. to commercialize Iclusig in Australia. In the third quarter of 2013, ARIAD submitted a marketing application for Iclusig for the treatment of Philadelphia-positive (Ph+) leukemia to the Therapeutic Goods Administration (TGA) in Australia.
Per the terms of the deal, Specialised Therapeutics will be responsible for obtaining marketing authorization and pricing and reimbursement approval of Iclusig in Australia. Furthermore the Australian company will also assist ARIAD in regulatory filings for Iclusig in Australia.
The agreement is for seven years from the first commercial sale of Iclusig in Australia. ARIAD will have the option to take over the commercialization rights or extend the deal with Specialised Therapeutics following the expiry of the seven-year period.
ARIAD expects Iclusig to be approved and launched in Australia in the fourth quarter of 2014. However, prior to the market launch, it will be available under a Special Access Program for patients suffering from chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL).
As per data from the Australian Institute of Health and Welfare, currently there are over 1500 patients in Australia being treated for CML. The incidence of the disease is on the rise.
ARIAD has witnessed many ups and downs regarding Iclusig over the last few quarters. Earlier in the month, the company announced that Iclusig was once again available in the U.S. after the marketing and commercial distribution of the drug was temporarily suspended in Oct 2013. The drug was temporarily banned following instructions from the U.S. regulatory authority in the wake of a higher-than-expected incidence of blood clots and narrowing of blood vessels.
ARIAD's shares were battered by the Oct 2013 development. The stock has regained some ground since then. We expect investor focus to remain on Iclusig going forward.
ARIAD carries a Zacks Rank #2 (Buy). Some other stocks worth considering include Actelion Ltd. , Affymetrix Inc. and Gentium S.p.A . All stocks carry a Zacks Rank #1 (Strong Buy).