According to the deal, Tillomed Labs is slated to provide Delcath with melphalan – the drug used in Delcath’s hepatic Chemosat delivery system. In Europe, the drug-device combo is approved to treat liver cancer.
“We are particularly pleased to be working with a supplier of Tillomed’s caliber and experience as it establishes firm control over our melphalan supply chain in Europe and, over time, will provide economies of scale,” president & CEO Jennifer Simpson said in prepared remarks.
“As part of our strategic plan to further secure our commercial efforts in Europe, our supply agreement with Tillomed gives Delcath access to the drug dossier for melphalan hydrochloride. This is an important asset that potentially provides us with a drug approval pathway with the European Medicines Agency for orphan diseases in Europe. As many of the cancers of the liver we are treating with Chemosat are orphan indications in the United States, EMA drug approval for Chemosat could potentially provide added market protection for these indications in Europe,” the chief executive added.
Delcath is developing a system for liver-directed high dose chemotherapy, which involves a procedure known as percutaneous hepatic perfusion. During the procedure, an infusion catheter is inserted into the femoral artery and the tip of the catheter is brought to the hepatic artery to deliver melphalan hydrochloride.
The company’s isolation-aspiration catheter is then inserted into the femoral vein and guided to the inferior vena cava, according to Delcath, at which point two occlusion balloons are inflated to block the normal flow of blood between the liver and heart.
After isolating the liver, the device delivers high doses of melphalan to the liver and tumor tissue over the course of 30 minutes.
As the blood leaves the liver, the isolation-aspiration catheter collects it and directs it out of the body, where the chemotherapy agent is removed using Delcath’s hemofiltration system. The filtered blood is then returned to the patient’s body using a third catheter in the internal jugalar vein.