ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib
October 31 2016 - 7:35AM
Business Wire
Brigatinib Granted Priority Review, with a
PDUFA Date of April 29, 2017
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
the U.S. Food and Drug Administration (FDA) has accepted for review
the New Drug Application (NDA) for ARIAD’s investigational oral
anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients
with metastatic ALK-positive (ALK+) non-small cell lung cancer
(NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s
request for Priority Review and has set an action date of April 29,
2017 under the Prescription Drug User Fee Act (PDUFA).
“The FDA acceptance of our application is an important milestone
in our ongoing efforts to discover, develop and deliver highly
innovative treatments for patients with rare cancers,” said Paris
Panayiotopoulos, president and chief executive officer of ARIAD.
“We are pleased that our significant R&D investments in
brigatinib and our work with the FDA are bringing us closer to
potentially offering a treatment option for patients with ALK+
NSCLC who are refractory to crizotinib. We look forward to
continuing to work closely with the FDA during the brigatinib NDA
review and remain committed to developing critical therapies for
unserved and underserved small patient populations suffering from
rare cancers.”
ARIAD’s NDA submission includes clinical data from its Phase 1/2
and pivotal Phase 2 ALTA trials of brigatinib. The FDA’s Priority
Review status accelerates the review time from 10 months to a goal
of six months from the filing of the application. 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-positive, ROS1-positive, and EGFR-positive
NSCLC. ARIAD plans to submit a Marketing Authorization Application
(MAA) for brigatinib to the European Medicines Agency (EMA) in
early 2017.
ARIAD is a small, research-driven biotechnology company. ARIAD
has invested more than $1.3 billion in R&D since the Company
was founded. In 2015, ARIAD generated $119 million in total revenue
and invested $171 million, or 143 percent of revenue, in
R&D.
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 lung cancer (NSCLC). The global Phase 2 ALTA
trial, in patients with locally advanced or metastatic ALK+ NSCLC
who were previously treated with crizotinib, is the primary basis
for brigatinib’s initial regulatory review. ARIAD has also
initiated the Phase 3 ALTA 1L trial to assess the efficacy and
safety of brigatinib in comparison to crizotinib in patients with
locally advanced or metastatic ALK+ NSCLC who have not received
prior treatment with an ALK inhibitor. More information on
brigatinib clinical trials, including the expanded access program
(EAP) for ALK+ NSCLC can be found here.
About ALK+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of
lung cancer, accounting for approximately 85 percent of the
estimated 228,190 new cases of lung cancer diagnosed each year in
the United States, according to the American Cancer Society.
Anaplastic lymphoma kinase (ALK) was first identified as a
chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL).
Genetic studies indicate that chromosomal rearrangements in ALK are
key drivers in a subset of NSCLC patients as well. Approximately
three to eight percent of patients with NSCLC have a rearrangement
in the ALK gene.
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 about the
anticipated timing for potential regulatory approval of brigatinib
in the United States, the potential for brigatinib to provide
a new treatment option to ALK+ NSCLC patients, the Company’s plans
to file for regulatory approval of brigatinib with the EMA, and the
Company’s ongoing clinical development of brigatinib, 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 our products; 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; competition from
alternative therapies; our reliance on the performance of
third-party manufacturers, specialty pharmacies, distributors and
other collaborators for the supply, distribution, development
and/or commercialization 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
and investigations; our operations in foreign countries with or
through third parties; 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/20161031005233/en/
ARIAD Pharmaceuticals, Inc.For InvestorsJennifer Robinson,
617-621-2286Jennifer.Robinson@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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