Orchestra BioMed, based in New Hope, recently partnered with medical device manufacturer Terumo Corporation, based in Tokyo, Japan, to develop and commercialize one of Orchestra BioMed’s lead assets, Virtue®Sirolimus-Eluting Balloon (SEB).
Under the terms of the agreement, Terumo will make a one-time $30 million up-front payment and an equity commitment of $5 million to Orchestra BioMed, in addition to substantial future clinical and regulatory milestone payments.
The agreement also calls for 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, and meaningful revenue sharing through royalty and exclusive drug formulation supply payments.
Virtue SEB is expected to become a flagship therapeutic product for Terumo, however Orchestra BioMed will retain the rights to develop and license technology used in Virtue SEB in clinical applications outside of peripheral and coronary 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 of a treated artery.
Its design and delivery mechanism allow the physician to navigate to the target lesion without time constraints, drug loss in transit or downstream particulates and micro-emboli associated with drug-coated balloon products.
The FDA recently granted Virtue SEB Breakthrough Designation for the treatment of coronary in-stent restenosis (ISR) – a condition that represents over 10 percent of total interventional procedures.
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.
Terumo and Orchestra BioMed also plan to conduct trials to support global regulatory approvals.
“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 David Hochman, chairman and chief executive officer of biomedical innovation company Orchestra BioMed.
“This strategic partnership is a major milestone for Orchestra BioMed. It validates our differentiated strategy to focus on the development of high-impact therapies while leveraging alliances with established market leaders, like Terumo, to drive global commercialization of our products.”