Orchestra BioMed is partnering up with Terumo to help develop and commercialize its sirolimus-eluting balloon in both coronary and peripheral cardiovascular interventions.
The Virtue angioplasty system is designed to deliver a bioabsorbable, sustained-release formulation of sirolimus directly into the artery wall. The drug helps prevent the vessel from narrowing and reclogging following the placement of a stent or other intervention, a process known as restenosis.
The device was granted a breakthrough designation by the FDA this past April for the treatment of coronary in-stent restenosis, which Orchestra says occurs after more than 10% of the total number of interventional procedures for the arteries of the heart muscle.
“We are excited to partner with Orchestra BioMed and secure global rights to Virtue SEB, which we intend to make a flagship therapeutic product,” said James Rushworth, CEO of Terumo’s North American division. He described the balloon system as complementary to the company’s other endovascular interventions as well as its access products.
Under the deal, Orchestra will receive $30 million upfront from the Tokyo-based medical device manufacturer, plus an equity commitment of $5 million. Terumo has also agreed to “substantial future clinical and regulatory milestone payments,” the companies said in a statement—and Terumo has committed to help finance and launch a global clinical program aimed at approvals in markets such as the U.S., Japan and China.
“We believe Virtue SEB is an important innovation that has the potential to address key unmet needs in the interventional vascular space, while fitting seamlessly within current clinical practice and workflow,” added Rushworth, who also serves as chief commercial officer of Terumo’s interventional systems division.
If approved, Orchestra will also receive royalties and per unit payments as the exclusive supplier of the device’s sirolimus formulation. The New Hope, Pennsylvania-based company also retains the rights to develop the Virtue system for applications outside coronary and peripheral vascular work.
“Terumo has a proven global distribution and operations infrastructure with the sales and marketing expertise necessary to make Virtue SEB broadly accessible to physicians and patients worldwide, pending regulatory approvals,” said Orchestra’s chairman and CEO David Hochman.
Within the next year, Orchestra and Terumo plan to conduct a registrational trial in the U.S. for in-stent restenosis. The two companies also plan to conduct studies in small coronary vessels, peripheral artery disease below-the-knee and in other indications.