ARIAD Announces Continuation of Iclusig Review under the Article 20 Procedure in Europe
July 14 2014 - 7:35AM
Business Wire
Completion Expected in October 2014
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that
the Pharmacovigilance Risk Assessment Committee (PRAC) of the
European Medicines Agency (EMA) has provided the Company with a
request for limited additional information regarding Iclusig®
(ponatinib) as part of its ongoing review under the Article 20
referral procedure. The PRAC has requested further information
regarding proposed dose modifications after achievement of a
response and patient monitoring and details concerning a risk
management plan. Following ARIAD’s response and input from the
agency’s Scientific Advisory Group, the Company expects that the
PRAC will complete its review and make final recommendations to the
Committee for Medicinal Products for Human Use (CHMP) at its
meeting in October 2014.
“As we finalize our recommendations on dose modifications of
Iclusig and response monitoring of patients, we will work closely
with the European regulatory agency and its expert advisors so that
CML patients and their treating physicians have the best guidance
available supporting the appropriate use of Iclusig,” said Timothy
P. Clackson, Ph.D., president of research and development and chief
scientific officer at ARIAD.
In March 2014 ARIAD submitted responses to initial questions
outlined by the PRAC as part of the Article 20 process, which was
initiated in December of last year, and responses to a second set
of questions were submitted to the PRAC in June.
The authorized indications of Iclusig in Europe, as approved in
July 2013, remain as follows:
- The treatment of adult patients with
chronic phase, accelerated phase or blast phase chronic myeloid
leukaemia (CML) who are resistant to dasatinib or nilotinib; who
are intolerant to dasatinib or nilotinib and for whom subsequent
treatment with imatinib is not clinically appropriate; or who have
the T315I mutation, or
- The treatment of adult patients with
Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+
ALL) who are resistant to dasatinib; who are intolerant to
dasatinib and for whom subsequent treatment with imatinib is not
clinically appropriate; or who have the T315I mutation.
To view the Iclusig Summary of Medicinal Product
Characteristics, click here.
The PRAC is the committee at the EMA that is responsible for
assessing and monitoring safety issues for human medicines. The
PRAC's recommendations are considered by the CHMP when it adopts
opinions for centrally authorized medicines and referral
procedures.
About CML and Ph+ ALL
CML is a cancer of the white blood cells that is diagnosed in
approximately 7,000 patients each year in Europe[1]. CML is
characterized by an excessive and unregulated production of white
blood cells by the bone marrow due to a genetic abnormality that
produces the BCR-ABL protein. After a chronic phase of production
of too many white blood cells, CML typically evolves to the more
aggressive phases referred to as accelerated phase and blast
crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that
carries the Ph+ chromosome that produces BCR-ABL. It has a more
aggressive course than CML and is often treated with a combination
of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein
is expressed in both of these diseases.
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 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”
including, but not limited to, updates on regulatory developments
in Europe. Forward-looking statements are based on the Company’s
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 risks and uncertainties include,
but are not limited to, a potential decision by the CHMP not to
adopt the recommendations of the PRAC or the European Commission
not to adopt the recommendation of the CHMP, or, in either case, to
adopt the recommendation but with revisions affecting the Company’s
ability to successfully commercialize and generate profits from
sales of Iclusig; difficulties in commercializing Iclusig arising
from the post-marketing approval review process or from its
results; the emergence of new safety concerns based on additional
adverse events in patients being treated with Iclusig and other
risk 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. The Company does not intend to update any of the
forward-looking statements after the date of this document to
conform these statements to actual results or to changes in the
Company's expectations, except as required by law.
Iclusig® is a registered trademark of ARIAD Pharmaceuticals,
Inc.
Reference:
1. Rohrbacher M, Hasford J. Epidemiology of chronic myeloid
leukaemia (CML). Best Pract Res Clin Haematol. 2009
Sept;22(3):295-302. Based on current estimate of population of
Europe (738,199,000 in 2010).
For Investors:ARIADKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor U.S. Media:ARIADLiza
Heapes, 617-621-2315liza.heapes@ariad.comorFor EU
Media:Heather Grant, +44 (0) 207 632
1873hgrant@biosector2.co.uk
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