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
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
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
). All stocks carry a Zacks Rank #1 (Strong Buy).
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