Unlike other angioplasty balloons involving a drug, Virtue SEB is unique in that it is not a drug-coated balloon, but rather a drug-eluting balloon designed to deliver a bioabsorbable sustained-release formulation of sirolimus, a drug commonly used for preventing restenosis after a percutaneous interventional procedure.Orchestra BioMed
Orchestra BioMed gained a powerful strategic partner to help push one of its lead products to the market.
Tokyo-based Terumo has agreed to give New Hope, PA-based Orchestra a $30 million up-front payment and an equity commitment of $5 million. Terumo said it will also make “substantial” future clinical and regulatory milestone payments to Orchestra BioMed, plus a “strong commitment” to finance and execute a global clinical program in collaboration with Orchestra to gain regulatory approval for the Virtue sirolimus-eluting balloon (SEB).
Orchestra said it will “share meaningfully” in future commercial revenues of Virtue SEB through royalities and per unit payments as the exclusive supplier of the sustained-release sirolimus formulation used in Virtue SEB. The company also retains rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions.
Unlike other angioplasty balloons involving a drug, Virtue SEB is unique in that it is not a drug-coated balloon, but rather a drug-eluting balloon designed to deliver a bioabsorbable sustained-release formulation of sirolimus, a drug commonly used for preventing restenosis after a percutaneous interventional procedure.
In April, FDA granted the device a breakthrough device designation for treatment of coronary in-stent restenosis (ISR). FDA’s breakthrough device designation allows companies to have more frequent and less formal interactions with senior FDA reviewers. The program is intended to expedite the development and review process.
In a prospective study of “very challenging” ISR patients, Virtue SEB demonstrated “excellent angiographic results” at six months and “outstanding clinical outcomes” out to three years, according to Orchestra BioMed. The company plans to conduct a near-term U.S. trial for Virtue SEB in ISR within the next year.
“This strategic partnership is a major milestone for Orchestra BioMed,” said David Hochman, chairman and CEO of Orchestra. “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.”
James Rushworth, CEO of Terumo Medical Corporation (North America) and chief commercial officer of the interventional systems division of Terumo said the company intends to make Virtue SEB a flagship therapeutic product. He said Virtue is a strong compliment to Terumo’s portfolio of interventional solutions.
“We believe Virtue SEB is an important innovation that has the potential to address key unmet needs in the interventional vascular space, while fitting seamlessly within current clinical practice and workflow,” Rushworth said. “The unique design of Virtue SEB demonstrates Orchestra BioMed’s deep knowledge of the needs of interventional cardiologists and its capability to deliver innovative solutions that have the potential to improve patient outcomes.”