June 13, 2019 — Orchestra BioMed Inc. announced it has formed a global strategic partnership with Terumo Corp. for development and commercialization of the Virtue Sirolimus-Eluting Balloon (SEB), one of Orchestra’s lead assets, in the percutaneous coronary and peripheral interventions field.
Virtue SEB is the first and only non-coated drug-eluting angioplasty balloon, according to Orchestra BioMed, that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus, the gold-standard drug for preventing restenosis following a percutaneous interventional procedure. In April, the U.S. Food and Drug Administration (FDA) granted Virtue SEB Breakthrough Device Designation for treatment of coronary in-stent restenosis (ISR), which provides prioritized regulatory review for this challenging cardiovascular condition that represents more than 10 percent of total interventional coronary procedures and for which available treatment options are limited. In a prospective study of very challenging ISR patients, Virtue SEB demonstrated excellent angiographic results at six months as well as outstanding clinical outcomes out to three years. Orchestra BioMed plans to conduct a near-term U.S. registrational trial for ISR.
Under the terms of the agreement, Terumo will make a one-time, up-front payment of $30 million and an equity commitment of $5 million to Orchestra BioMed. Terumo will also make substantial future clinical and regulatory milestone payments to Orchestra BioMed. Terumo will also make a strong commitment to finance and execute a global clinical program in collaboration with Orchestra BioMed to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications.
Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SEB through royalties and per unit payments as the exclusive supplier of the proprietary sustained-release sirolimus formulation used in Virtue SEB. Orchestra BioMed retains the rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions.
Virtue SEB strengthens the current cardiovascular product offering of Terumo Interventional Systems, Terumo Corp.’s largest division, which includes a complete, solution-based product portfolio used in advanced coronary and peripheral endovascular treatments, with solutions for vascular access, lesion access and intervention.
Orchestra BioMed and Terumo are seeking to make Virtue SEB the first drug-eluting balloon approved for coronary use in the U.S. Orchestra BioMed expects to initiate a U.S. registrational trial for Virtue SEB in ISR under an Investigational Device Exemption (IDE) from the FDA within the next year.
Virtue SEB is currently not approved in any market, but Terumo and Orchestra BioMed plan to conduct trials to support global regulatory approvals in indications including ISR, small coronary vessels, peripheral artery disease below-the-knee and other indications. Terumo and Orchestra BioMed’s objective is to commercialize Virtue SEB in the U. S., Japan, China and other markets.
For more information: www.orchestrabiomed.com