Terumo Corporation has secured exclusive global development and commercialization rights to Virtue sirolimus-eluting balloon (SEB) for percutaneous coronary interventions by entering into a strategic partnership with Orchestra BioMed, Inc., a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine.
Under the terms of the agreement, Terumo will make a one-time, up-front payment of USD 30 million and an equity commitment of USD 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. Upon commercialization, Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SEB through royalties and per-unit payments as the exclusive supplier of its proprietary sustained-release formulation of sirolimus, 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 is the first and only non-coated drug-eluting angioplasty balloon 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 US Food and Drug Administration (USFDA) granted Virtue SEB breakthrough device designation for treatment of coronary in-stent restenosis (ISR), which may expedite its development and 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 to 3 years. Orchestra BioMed plans to conduct a near-term US registrational trial for ISR.