ARIAD Announces Commercial Agreement for Iclusig (Ponatinib) in Israel
August 05 2014 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Medison Pharma
Ltd, Israel's leading international marketing group for innovative
pharmaceuticals, today announced that ARIAD has granted Medison
exclusive rights to commercialize Iclusig® (ponatinib) in Israel in
patients with Philadelphia-positive (Ph+) leukemias.
Under the terms of the agreement, ARIAD Pharmaceuticals (Israel)
Ltd will be the Marketing Authorization Holder (MAH) of Iclusig in
Israel, and Medison will be responsible for sales and marketing,
medical affairs, regulatory support, as well as obtaining, in
collaboration with ARIAD, the pricing and reimbursement approval of
Iclusig.
“The agreement with Medison illustrates our ongoing commitment
to provide patients access to Iclusig in geographies outside of our
core commercial footprint,” said Marty J. Duvall, executive vice
president and chief commercial officer of ARIAD. “Medison is
uniquely qualified to provide the complete spectrum of integrated
services for Iclusig in Israel, including a proven track record
with oncology and hematology products.”
ARIAD has submitted its Marketing Authorization Application for
Iclusig in Israel, which is currently under review with the Israel
Ministry of Health. Marketing approval and commercial launch of
Iclusig are expected to occur in the second half of 2015.
“We are very pleased with our new partnership with ARIAD. It is
another step in fulfilling Medison’s continuing vision to provide
innovative and unique treatments to patients in Israel,” said Meir
Jakobsohn, Chief Executive Officer and Founder of Medison Pharma.
“One of Medison's main focuses is providing treatments in the field
of hematology. ARIAD’s treatment offers new hope for refractory CML
patients.”
According to the EMA’s orphan drug designation and the HAEMACARE
project, there are approximately 700 patients in Israel with
CML.
“Iclusig is a very effective treatment option with utmost
importance to CML or Ph+ALL patients who are resistant to dasatinib
or nilotinib and for those patients with the T315I BCR-ABL
mutation,” said Prof. Arnon Nagler, director of hematology at Sheba
Medical Center. “It is of vital importance that Iclusig be
available to the Israeli market.”
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 Medison
Medison is Israel’s leading marketing group, representing
innovative niche healthcare products from companies such as Biogen
Idec, Amgen, Shire and Ipsen. Medison has built and maintained
long-standing relations with HMOs, local medical centers and
physicians. Backed by three generations of experience in the
healthcare industry since 1937, Medison is uniquely qualified to
provide the complete spectrum of integrated services for
international companies looking to enter or expand their presence
in the Israeli. Medison has an office and is very also active in
Romania. For more information, visit www.medisonpharma.com.
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).
Iclusig® is a registered trademark of ARIAD
Pharmaceuticals, Inc.
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 Iclusig to
Medison; the ability of Medison to perform the contracted services,
such as obtaining pricing and reimbursement approval for Iclusig in
Israel; Medison’s ability to distribute, promote, market and sell
Iclusig in Israel; the timing and scope of the marketing
authorization, as well as the level of pricing obtained in Israel;
third-party reimbursement; and the timing and success of sales of
Iclusig in Israel. 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
MedisonGoldfinger CommunicationsLidor Jacob,
972-3-5620024lidor@goldfingercom.com
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