Delcath Systems, a medical technology company testing its treatment system for primary and metastatic cancers to the liver, has signed research, distribution, sales and marketing agreement for its Percutaneous Hepatic Perfusion (PHP) System (the Delcath PHP System) with Chi-Fu Trading.
The agreement grants Chi-Fu Trading the right to market and sell the Delcath PHP System in Taiwan for hepatic malignancies and infectious disease upon Taiwan FDA (TFDA) approval and any other approved use, with a conditional option for Singapore.
Under terms of the agreement, Chi-Fu is expected to fund and manage clinical studies at up to four sites to gather data for submission to Taiwan government regulatory agencies for approval. For the clinical studies, Chi-Fu will purchase, at a discount, Delcath PHP Systems to treat up to 200 patients with hepatic cancer.
Additionally, Delcath is expected to receive $1m in milestone payments, comprised of $300,000 upon execution of the agreement and the balance upon receipt of the CE Mark and upon receipt of FDA approval. In addition Chi-Fu will purchase a minimum number of systems annually during the term of the agreement, commencing when commercial sales begin in Taiwan.
The term of the agreement extends for five years from the month when TFDA approval is received. If during the agreement, other indications for the Delcath PHP System are approved by the TFDA, Chi-Fu is expected to have the right to distribute the Delcath PHP System in Taiwan for those indications as well.
Eamonn Hobbs, CEO of Delcath Systems, said: “This agreement is a step in bringing our technology to Asia, where the incidence of liver cancer and related hepatic disease is a major health issue and a leading cause of death. In Taiwan, malignant neoplasms represent 29% of all deaths and as such, we view Taiwan as an excellent opportunity to seek approval to demonstrate the ability of the Delcath PHP System to help patients and improve outcomes.
“In addition, we look forward to working with Chi-Fu to identify additional indications for our targeted drug delivery platform technology. We believe the Chi-Fu agreement is a validation for the Delcath PHP System and we are continuing to pursue additional strategic partnerships to address other key Asian markets.”