ARIAD Announces Adoption of Final Opinion for Iclusig by Committee for Medicinal Products for Human Use in Europe
October 24 2014 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted its final opinion on
Iclusig® (ponatinib) following the recommendations made by the
Pharmacovigilance Risk Assessment Committee (PRAC) earlier this
month. The PRAC conducted an 11-month review of the available data
on Iclusig and consulted with a scientific advisory group in
oncology. This week, the EMA recommended that Iclusig continue to
be used in accordance with its already approved indications as a
treatment of certain leukaemias and confirmed that the benefit-risk
profile of Iclusig continues to be positive in each of these
indications. The EMA also recommended additional warnings in the
European product information to minimize the risk of vascular
events.
“We are now well positioned to complete pricing and
reimbursement negotiations in Europe and to ensure that Iclusig is
available to appropriate Philadelphia-chromosome positive leukaemia
patients,” said Jonathan E. Dickinson, general manager, ARIAD
Pharmaceuticals (Europe). “The authorized indications and the
favorable benefit-risk balance of Iclusig give healthcare providers
the ability to optimize the use of Iclusig in patients with
resistant or intolerant CML.”
The authorized indications of Iclusig in Europe, as approved in
July 2013, are 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.
“Over the past year, we have closely monitored patients on
Iclusig and are confident that the updated safety information will
help us provide this important therapy to patients who have become
resistant or intolerant to certain other tyrosine-kinase
inhibitors,” said Giuseppe Saglio, M.D., professor of internal
medicine and haematology at the University of Turin and director of
the Department of Internal Medicine and head of the Division of
Haematology at the San Luigi University Hospital of the University
of Turin in Italy. “The flexibility to reduce the dose after
achievement of response is an important factor for physicians in
treating CML patients with Iclusig.”
The CHMP is a scientific committee composed of representatives
from the 28-member states of the EU, and Iceland and Norway. The
CHMP reviews medical product applications on their scientific and
clinical merit and provides advice to the European Commission,
which has the authority to approve medicines for the EU. The
European Commission is expected to issue a final legally binding
decision on Iclusig in December 2014, which will be valid
throughout the EU.
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 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 management'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 decision by the European Commission not
to endorse the final opinion of the CHMP or to endorse the final
opinion but with revisions affecting the Company’s ability to
successfully launch, commercialize and generate profits from sales
of Iclusig; the impact of the strengthened warnings recommended by
the CHMP on sales of Iclusig; difficulties in commercializing
Iclusig arising from the post-marketing approval review process or
from its results; the emergence of other 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
Sep;22(3):295-302. Based on current estimate of population of
Europe (738,199,000 in 2010).
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor U.S. MediaLiza
Heapes, 617-621-2315liza.heapes@ariad.comorFor EU MediaGemma
White, +44 (0)20 337 25 221gwhite@biosector2.co.uk
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