June 12, 2019
Orchestra BioMed Partners With Terumo to Develop and Commercialize the Virtue Sirolimus-Eluting Balloon
June 13, 2019—Orchestra BioMed, Inc. announced it has formed a global strategic partnership with Terumo Corporation for development and commercialization of Virtue sirolimus-eluting balloon (SEB) for percutaneous coronary and peripheral interventions. The Virtue SEB is a noncoated drug-eluting angioplasty balloon that delivers a bioabsorbable, sustained-release formulation of sirolimus. In April, the Virtue SEB was granted FDA Breakthrough Device designation for the treatment of coronary in-stent restenosis (ISR).
Currently, the device is not approved in any market. 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.
The company stated that in a prospective study of very challenging ISR patients, the Virtue SEB demonstrated excellent angiographic results at 6 months as well as outstanding clinical outcomes out to 3 years. Orchestra BioMed plans to conduct a near-term United States registrational trial for ISR.
Under the terms of the agreement, Terumo will make a one-time, upfront 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 commit 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.
Additionally, Orchestra BioMed will share 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.