Delcath Systems, Inc. (Nasdaq: DCTH) announced today that it has executed a multi-year supply agreement with Synerx Pharma, LLC and Bioniche Teoranta, an affiliate of Mylan, Inc., for the supply of Delcath’s branded melphalan hydrochloride for injection (“melphalan”). Melphalan is the chemotherapeutic drug used with Delcath’s Chemosaturation system in its Phase III clinical study for the treatment of patients with hepatic metastases from ocular or cutaneous melanoma.
This agreement provides Delcath an exclusive right of reference to the Synerx Abbreviated New Drug Application (ANDA) for use with the Delcath ChemoSaturation system as well as a reliable, long-term and already United States Food and Drug Administration (FDA) approved source of melphalan for the U.S. market. The approved ANDA and its associated files are registered to Synerx and licensed to Bioniche Teoranta. Under the terms of the agreement, Synerx will grant Delcath a limited license to reference the ANDA and associated data files in Delcath’s New Drug Application (“NDA”) submission, and Bioniche Teoranta shall manufacture and supply Delcath with Delcath-branded melphalan hydrochloride through its FDA-approved cGMP (current Good Manufacturing Practices) contract manufacturer. The term of the agreement is seven years following FDA approval of Delcath’s NDA.
“We are extremely pleased to have signed an agreement with such established and market-leading companies as Synerx and Mylan’s Bioniche. We believe that the right to reference an approved ANDA for melphalan and utilize a proven supply chain will greatly simplify and enhance the quality of our own NDA submission,” said Eamonn P. Hobbs, President and CEO of Delcath Systems. “We are presently preparing the remaining modules for our NDA submission to the FDA, and continue to expect to complete our NDA filing during the fourth quarter of 2010.”
SOURCE Delcath Systems, Inc.