Saturday, December, 14, 2019 05:06:58

Terumo Corporation, a leading global medical device manufacturer, has reportedly acquired exclusive rights for the global development and commercialization of Virtue® Sirolimus-Eluting Balloon for percutaneous coronary interventions by partnering with Orchestra BioMed, Inc.

The terms of the agreement between the two companies are detailed below:

• Terumo will be making a one-time up-front payment worth $30 million and an equity commitment of $5 million to Orchestra BioMed.

• Terumo will make considerable future payments to Orchestra BioMed on successful achievement of medical and regulatory milestones.

• Terumo will also make a strong commitment to finance and implement a global clinical program together with Orchestra BioMed in a bid to attain regulatory approval for commercial sale of Virtue® Sirolimus-Eluting Balloon across multiple markets and indications.

• Being the exclusive provider of the proprietary sustained-release formulation of sirolimus utilized in Virtue SEB, Orchestra BioMed will be a fair recipient of future commercial revenues from Virtue SEB upon commercialization by the way of royalties and per unit payments.

• Orchestra BioMed will retain the rights to develop and license technology utilized in Virtue SEB for clinical applications beyond coronary and peripheral vascular interventions.

According to sources familiar with the development, Orchestra BioMed and Terumo are looking to make Virtue SEB the first drug-eluting balloon permitted for coronary use in the United States. Orchestra BioMed is looking forward to initiating a U.S. registration trial for the product in in-stent restenosis (ISR) under an Investigational Device Exemption from the FDA within 2020, reported sources.

Presently, Virtue SEB is not approved in any market, however, Terumo and Orchestra BioMed plan on conducting clinical trials to attain global regulatory approvals for indications such as ISR, peripheral artery disease below-the-knee, small coronary vessels, and others. Moreover, the companies plan to commercialize Virtue SEB in the U. S., China, Japan, and other markets, reported sources.

Source Credit https://www.prnewswire.com/news-releases/terumo-enhances-coronary-interventional-product-portfolio-by-securing-exclusive-global-rights-to-orchestra-biomeds-virtue-sirolimus-eluting-balloon-seb-through-global-strategic-partnership-300866882.html