ARIAD & Medinol Announce Initiation of Two Registration Trials of the NIRsupreme™ Ridaforolimus-Eluting Stent for Use in Co...
January 14 2014 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Medinol, Ltd.
today announced the initiation of two registration trials of
Medinol’s NIRsupremeTM Ridaforolimus-Eluting Coronary Stent System
incorporating ARIAD’s mTOR inhibitor, ridaforolimus. The two
NIRsupreme clinical trials are randomized, single-blind, global
studies taking place in the United States, Europe, Israel and
Canada and will enroll approximately 2,200 patients with coronary
artery disease. ARIAD licensed ridaforolimus to Medinol for use in
drug-eluting stents in 2005. Drug-eluting stents (DES) are now
implanted in over 500,000 patients yearly in the United States.
The commencement of patient enrollment in Medinol’s clinical
trials, along with the submission of an investigational device
exemption with the U.S. Food and Drug Administration, triggers
milestone payments to ARIAD of $3.75 million, with the potential
for additional regulatory, clinical and sales milestones, as well
as royalties on product sales.
The BIONICS trial aims to show that the NIRsupreme stent is
comparable (non-inferior) to a comparator drug-eluting stent with
the primary endpoint of coronary target lesion failure (a composite
of cardiac death, target vessel myocardial infarction or
ischemia-driven target lesion revascularization) at 12 months. This
trial is expected to enroll approximately 1,900 patients.
The NIREUS trial aims to demonstrate angiographic
non-inferiority of the NIRsupreme stent to a comparator stent and
has a primary endpoint of late loss in lumen diameter within the
stent determined by coronary angiography at six months. This trial
is expected to enroll approximately 300 patients.
“We are pleased to have one of the most innovative and
successful medical device companies advance the development and
potential commercialization of drug-delivery stents incorporating
ridaforolimus,” said Timothy P. Clackson, Ph.D., president of
research and development and chief scientific officer at ARIAD. “We
believe that Medinol has developed a unique elastomeric formulation
and stent platform, and we are delighted by the value created
through this successful long-term collaboration with a true
innovator.”
ARIAD entered into a non-exclusive agreement with Medinol to
develop and commercialize stents and other medical devices to
deliver ridaforolimus to prevent reblockage of injured vessels
following stent-assisted angioplasty. ARIAD is eligible to receive
additional regulatory, clinical and commercial milestones of up to
$34.75 million, if two products are developed, plus royalties on
worldwide product sales. ARIAD is responsible for supplying
ridaforolimus to Medinol, and Medinol is responsible for the
development and commercialization of the medical devices delivering
ridaforolimus. These rights are separate from those licensed to
Merck for use of ridaforolimus in oncology.
“We are proud and excited to initiate the BIONICS and NIREUS
clinical trials,” said Yoram Richter, Ph.D., chief scientific
officer at Medinol. “NIRsupreme, the first ever elastomer-based
DES, is the outcome of meticulous research towards uniform,
controlled drug release. We believe that this is the evolution that
interventional cardiologists have been waiting for. Medinol is
privileged to cooperate with ARIAD, a leading drug developer, and
has high expectations for this partnership,” Dr. Richter
concluded.
About Ridaforolimus
Ridaforolimus is an investigational targeted and potent
small-molecule inhibitor of the protein mTOR, a protein that acts
as a central regulator of protein synthesis, cell proliferation,
cell cycle progression and cell survival, integrating signals from
proteins, such as PI3K, AKT and PTEN, known to be important to
malignancy. Ridaforolimus also blocks the proliferation and
migration of vascular smooth muscle cells, the primary cause of
narrowing and reblockage of injured arteries, and is an analog of
sirolimus, another mTOR inhibitor that has been approved for use on
drug-eluting stents. Ridaforolimus is currently licensed to Medinol
for medical devices and to Merck for oncology.
About Medinol
Medinol, Ltd. is a global leader in the field of stents and
stenting systems. Medinol has developed the QualitySurfaceTM
technology, a unique approach to stent manufacturing and coating.
Its new-generation stents, the NIRsupremeTM drug-eluting stent and
NIRxcellTM bare-metal stent, reflect the company's commitment to
continuous innovation, unique product design and uncompromising
quality products. NIRsupremeTM, the first ever elastomer-based
drug-eluting stent (eDESTM), provides an elastomeric coating to
ensure perfect surface integrity combined with uniform
drug-release. Medinol, founded in 1992, is privately held and
headquartered in Tel Aviv, Israel. Additional information about
Medinol can be found on the web at http://www.medinol.com.
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” which
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: the availability
and adequacy of supply of NIRsupreme Ridaforolimus-Eluting coronary
stents for conducting the clinical trials; the pace of enrollment
of subjects in the clinical trials and time to completion of the
studies; the results obtained from the studies, the review and
acceptance of such results by appropriate regulatory agencies, and
the decisions made by regulatory agencies based on such results;
the achievement and timing of future milestone-triggering events
and the clinical and commercial success of the NIRsupreme
Ridaforolimus-Eluting coronary stents. These factors, risks and
uncertainties also include, but are not limited to: preclinical
data and early-stage clinical data for ARIAD’s product candidates
that may not be replicated in later-stage clinical studies; the
costs associated with ARIAD’s research, development, manufacturing,
commercial and other activities; the conduct, timing and results of
pre-clinical and clinical studies of ARIAD’s product candidates;
the adequacy of ARIAD’s capital resources and the availability of
additional funding; and other factors detailed in the ARIAD'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. After the date of this
document, ARIAD does not intend to update any of the
forward-looking statements to conform to actual results or to
changes in ARIAD’s expectations, except as required by law.
CONTACTS for ARIADFor InvestorsKendra Adams,
617-503-7028kendra.adams@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.comorCONTACT for MedinolMatt
Donnelly, 973-908-7486mattd@medinol.com
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