News | June 10, 2014

Ariad, Medinol Undergoing Two Trials of NIRsupreme Ridaforolimus-Eluting Stent for Coronary Artery Disease

June 10, 2014 — Ariad Pharmaceuticals Inc. and Medinol Ltd. earlier this year initiated two registration trials of Medinol’s NIRsupreme ridaforolimus-eluting coronary stent system incorporating Ariad’s mTOR inhibitor, ridaforolimus. The two NIRsupreme 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.

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 (FDA), 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 first trial, BIONICS, 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 re-blockage 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 drug-eluting stent, 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.”

For more information: www.medinol.com, www.ariad.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init