Orchestra BioMed and Terumo have formed a global strategic partnership for the development and commercialisation of Virtue sirolimus-eluting balloon (SEB) in the percutaneous coronary and peripheral interventions field.
Virtue SEB is the first and only non-coated drug-eluting angioplasty balloon that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus, according to a press release, which also states that sirolimus is the gold standard drug for preventing restenosis following a percutaneous interventional procedure. In April, the US Food and Drug Administration (FDA) granted Virtue SEB breakthrough device designation for treatment of coronary in-stent restenosis, a cardiovascular condition that represents more than 10% of total interventional coronary procedures.
In a prospective study of very challenging in-stent restenosis patients, Virtue SEB demonstrated excellent angiographic results at six months as well as positive clinical outcomes out to three years. Orchestra BioMed plans to conduct a near-term US registrational trial for in-stent restenosis.
- Under the terms of the agreement, Terumo will make a one-time, up-front payment of US$30 million and an equity commitment of US$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 programme 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’s largest division, which includes a complete, solution-based product portfolio used in advanced coronary and peripheral endovascular treatments, with market-leading 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 USA. Orchestra BioMed expects to initiate a US registrational trial for Virtue SEB in in-stent restenosis 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 in-stent restenosis, small coronary vessels, peripheral artery disease below-the-knee and other indications. Terumo and Orchestra BioMed’s objective is to commercialise Virtue SEB in the USA, Japan, China, and other markets.