ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the
completion of its strategic review and its plans for future growth
and vision to become a leader in the discovery, development and
commercialization of precision therapies for patients with rare
cancers. ARIAD detailed its new strategy for growth and increased
patient and shareholder value, and provided an update on its
continued progress in its R&D and commercial programs during
the Company’s Analyst & Investor Day, held today in New York
City.
Initiated at the beginning of this year, ARIAD’s strategic
review included rigorous, quantitative analyses to evaluate the
Company’s business in its entirety, with a focus on five key areas:
geographic reach, commercial maximization, research and development
(R&D) portfolio, cost efficiencies and business development
opportunities.
Key outcomes of the strategic review that are focused on
achieving rapid progress in transforming the Company’s strategy,
culture and financial position include:
- A commitment to commercializing
brigatinib in the U.S., subject to approval by the U.S. Food and
Drug Administration (FDA). The Company announced initiation of its
rolling new drug application (NDA) to the FDA today, ahead of
previously announced plans.
- A focus on the valuable U.S. market,
with the divestiture of the Company’s European operations and
out-license of Iclusig® (ponatinib) rights in Europe and other
selected countries to Incyte Corporation, while also maintaining
future strategic flexibility through a buy-back provision for the
licensed Iclusig rights following a change of control of ARIAD. In
addition, ARIAD today announced the entry into new distribution
agreements for Iclusig in Latin America and the Middle East/North
Africa.
- A significant reduction in the
Company’s expense base, together with more rigorous cost controls,
while also planning to commit resources to expand its product
pipeline and conducting clinical trials to expand potential market
opportunities.
- Changes to its executive leadership
team and board of directors.
- A decision to build upon the Company’s
core strengths in precision small molecule therapies and rare
cancers, including investing in potential new opportunities in
immuno-oncology, with pharmacologic proof-of-concept achieved
against a validated lead target.
“We are confident that the completion of our strategic review
and our announced decisions throughout the process strongly
position ARIAD for growth and an opportunity to deliver increased
patient and shareholder value,” said Paris Panayiotopoulos,
president and chief executive officer of ARIAD. “We are dedicated
to building on our core strengths in precision therapies to treat
rare cancers, to potentially becoming a two product commercial
company in the near-term, to expanding our market opportunities
through our development programs in the mid-term, and to delivering
on our drug discovery programs in the long-term.”
Reaffirmed 2016 Financial Guidance
Key progress on ARIAD’s strategy include product revenue and
royalty revenue guidance of $170-$180 million for 2016; an expected
25 percent reduction in SG&A expense in 2016, compared to 2015,
with guidance of $120-$125 million; and R&D expense guidance of
$175-180 million to support potential near- to long-term growth
through the Company’s ongoing OPTIC and OPTIC 2L clinical trials,
the ALTA 1L trial and the Phase 1/2 trial of AP32788. In addition,
ARIAD expects to end 2016 with a strengthened financial position,
with cash, cash equivalents and marketable securities expected to
be $280-$290 million.
A replay of today’s Analyst & Investor Day webcast and a
copy of the presentation slides will be archived for one month and
can be accessed by visiting the investor relations section of
ARIAD’s website at http://www.ariad.com/investor.
About Iclusig® (ponatinib) tablets
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.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
• Treatment of adult patients with T315I-positive chronic
myeloid leukemia (chronic phase, accelerated phase, or blast phase)
or T315I-positive Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL).
• Treatment of adult patients with chronic phase, accelerated
phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom
no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no
trials verifying an improvement in disease-related symptoms or
increased survival with Iclusig.
Limitations of use:
Iclusig is not indicated and is not recommended for the
treatment of patients with newly diagnosed chronic phase CML.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing information for complete boxed
warning
• Vascular Occlusion: Arterial and venous thrombosis
and occlusions have occurred in at least 27% of Iclusig treated
patients, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularization procedures.
Patients with and without cardiovascular risk factors, including
patients less than 50 years old, experienced these events. Monitor
for evidence of thromboembolism and vascular occlusion. Interrupt
or stop Iclusig immediately for vascular occlusion. A benefit risk
consideration should guide a decision to restart Iclusig
therapy.
• Heart Failure, including fatalities, occurred in 8%
of Iclusig-treated patients. Monitor cardiac function. Interrupt or
stop Iclusig for new or worsening heart failure.
• Hepatotoxicity, liver failure and death have
occurred in Iclusig-treated patients. Monitor hepatic function.
Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
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).
Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to statements regarding the
outcome of the Company’s strategic review and plans for future
growth and increased patient and shareholder value; the Company’s
commitment to commercializing brigatinib in the U.S.; the Company’s
focus on the valuable U.S. market; the Company’s plans to
significantly reduce its expense base, while committing resources
to expanding its product pipeline and conducting clinical trials to
expand potential market opportunities; the Company’s decision to
build upon its core strengths in precision small molecule therapies
and rare cancers, including investing in potential new
opportunities in immuno-oncology; the Company’s reaffirmed 2016
financial guidance; and the statements made by Mr. Panayiotopoulos,
are forward-looking statements that 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 factors, risks and uncertainties
include, but are not limited to, our ability to successfully
commercialize and generate profits from sales of Iclusig and our
product candidates, if approved; competition from alternative
therapies; our ability to meet anticipated clinical trial
commencement, enrollment and completion dates and regulatory filing
dates for our products and product candidates and to move new
development candidates into the clinic; our ability to execute on
our key corporate initiatives; regulatory developments and safety
issues, including difficulties or delays in obtaining regulatory
and pricing and reimbursement approvals to market our products; our
reliance on the performance of third-party manufacturers and
specialty pharmacies for the supply and distribution of our
products and product candidates; the occurrence of adverse safety
events with our products and product candidates; the costs
associated with our research, development, manufacturing,
commercialization and other activities; the conduct, timing and
results of preclinical and clinical studies of our products and
product candidates, including that preclinical data and early-stage
clinical data may not be replicated in later-stage clinical
studies; the adequacy of our capital resources and the availability
of additional funding; the ability to satisfy our contractual
obligations, including under our leases, convertible debt and
royalty financing agreements; patent protection and third-party
intellectual property claims; litigation; our operations in foreign
countries; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and
other risk factors detailed in our public filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q. Except as otherwise noted, these forward-looking statements
speak only as of the date of this press release and we undertake no
obligation to update or revise any of these statements to reflect
events or circumstances occurring after this press release. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20160617005676/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet S. Soni,
(617) 503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes,
(617) 621-2315Liza.heapes@ariad.com
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