ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. Food and Drug Administration Ahead of Plan
June 17 2016 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the
initiation of a New Drug Application (NDA) submission for its
investigational anaplastic lymphoma kinase (ALK) inhibitor,
brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD
is seeking U.S. marketing approval of brigatinib for patients with
ALK+ non-small cell lung cancer (NSCLC) who are resistant to
crizotinib. Brigatinib received Breakthrough Therapy designation
from the FDA for the treatment of patients with ALK+ NSCLC whose
tumors are resistant to crizotinib, and was granted orphan drug
designation by the FDA for the treatment of ALK+ NSCLC. The Company
is seeking accelerated approval for brigatinib from the FDA and
plans to request a priority review of the application.
“We are ahead of our previously announced schedule for
initiating the submission of our brigatinib NDA to the FDA and we
are grateful to have breakthrough status from the FDA, which
provides the opportunity to utilize the rolling submission
process,” stated Paris Panayiotopoulos, president and chief
executive officer of ARIAD. “If approved, we believe that
brigatinib will become an important new medicine for ALK+ NSCLC
patients who have become resistant or intolerant to prior
crizotinib therapy and will offer additional hope to these patients
and their families.”
ARIAD’s NDA is a rolling submission which will occur in three
parts. The initial submission contains all nonclinical portions of
the NDA and will be followed by submissions of the chemistry,
manufacturing and controls (CMC) and clinical data. The rolling NDA
submission is expected to be complete in the third quarter of
2016.
Phase 2 ALTA Results Presented at ASCO
Results from the ongoing Phase 2 ALTA trial of brigatinib
reported at this year’s annual meeting of the American Society of
Clinical Oncology earlier this month showed that, in patients on
the 180 mg regimen (Arm B, n=110) with a median follow-up of 8.3
months (range 0.1—20.2), 54 percent achieved a confirmed objective
response, the trial’s primary endpoint. In this arm, the median
progression free survival (PFS) exceeded one year (12.9 months) in
this post-crizotinib setting. Additionally, a confirmed
intracranial objective response rate (ORR) of 67 percent (12/18)
was achieved in patients with measurable brain metastases.
The most common treatment-emergent adverse events (TEAEs; ≥ 25%
of all patients, [Arm B/A]), regardless of relationship to
treatment, were nausea (40%/33%), diarrhea (38%/19%), cough
(34%/18%), and headache (27%/28%). TEAEs, ≥ grade 3, occurring in ≥
5 percent of all patients (Arm B/A), were increased blood creatine
phosphokinase (9%/3%) and hypertension (6%/6%).
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD. It is in development for the
treatment of patients with anaplastic lymphoma kinase positive
(ALK+) non-small cell cancer (NSCLC) whose disease is resistant to
crizotinib. Brigatinib is currently being evaluated in the global
Phase 2 ALTA trial that is the basis for its initial regulatory
review. ARIAD has also initiated the Phase 3 ALTA 1L trial to
assess the efficacy of brigatinib in comparison to crizotinib. More
information on brigatinib clinical trials, including the expanded
access program (EAP) can be found here.
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 the statements about the
anticipated timing for our NDA submission 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/20160617005128/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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