UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): October
24, 2014
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer
Identification
No.)
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26 Landsdowne Street, Cambridge, Massachusetts
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02139
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
On October 24, 2014, ARIAD Pharmaceuticals, Inc. (the “Company”) issued
a press release announcing that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) 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.
A copy of the press release is being filed herewith as Exhibit 99.1 and
is incorporated by reference herein.
Exhibit Number
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Description
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99.1
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Press Release dated October 24, 2014.
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The press release contains hypertext links to information on our website
and/or other websites. The information on our website and any other
website is not incorporated by reference into this Current Report on
Form 8-K and does not constitute a part of this Form 8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ARIAD Pharmaceuticals, Inc.
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By:
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/s/ Edward M. Fitzgerald
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Edward M. Fitzgerald
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Executive Vice President, Chief Financial Officer
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Date:
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October 24, 2014
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3
Exhibit 99.1
ARIAD
Announces Adoption of Final Opinion for Iclusig by Committee for
Medicinal Products for Human Use in Europe
CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--October 24,
2014--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).
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra
Adams, 617-503-7028
Kendra.adams@ariad.com
or
For
U.S. Media
Liza Heapes, 617-621-2315
liza.heapes@ariad.com
or
For
EU Media
Gemma White, +44 (0)20 337 25 221
gwhite@biosector2.co.uk
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