ARIAD Announces Commercial Agreement for Iclusig (Ponatinib) in Australia
January 28 2014 - 7:35AM
Business Wire
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.”
About Iclusig® (ponatinib)
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.
About Specialised Therapeutics Australia Pty Ltd
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
http://www.specialisedtherapeutics.com.au.
About ARIAD
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.
For ARIAD InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor ARIAD MediaLiza
Heapes, 617-621-2315Liza.heapes@ariad.comorFor Specialised
Therapeutics AustraliaMonsoon CommunicationsEmma Power, 03 9620
3333emmap@monsoon.com.au
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