PLC, and our London based Partner Sirius Regulatory Consulting, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Jennerex’s product JX-594 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. JX-594 is a novel Oncolytic Virus based on genetic modifications to a Vaccinia virus strain. JX-594 is expected to enter a Phase 3 pivotal trial in the second half of 2010. European Orphan Drug Designation encourages the development of products that demonstrate promise for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. The designation criteria also specify that there is no other satisfactory therapy for that indication and that if JX-594 is shown to be effective in pivotal trials, it would represent a significant clinical benefit to HCC patients. Orphan Drug status for JX-594 entitles Jennerex to 10 year market exclusivity in Europe if the Market Authorization Application (MAA) is approved as well as potentially increasing reimbursement pricing. PLC and partner Sirius Regulatory Consulting prepared and managed the procedure with the EMA to award Orphan designation under the corporate umbrella of Sirius Regulatory Consulting. Thus, Sirius facilitated the approval of JX-594 as an Orphan not only through their regulatory expertise, but also flexibility by using their corporate entity to facilitate our clients needs and timelines. PLC has supported the development efforts of Jennerex Inc. for approximately 3-years. “The approval of JX-594 as an Orphan product by the EMA will add considerable value to our client companies, Jennerex Inc, product value and reduce the cost of development in the EU”, said PLC President Richard E. Lowenthal MS MBA. He added, “Our partnership with Sirius Regulatory Consulting and long relationship with Neil Edwards, Principle at Sirius, was instrumental in obtaining this important milestone for our client. Mr. Edwards has significant European regulatory expertise the allows PLC to manage critical filings from offices in London”.
Written by Tracy Paul
- Pacific-Link Consulting today announced the establishment of Pacific-Link Consulting KK (PLC-KK), an affiliated kabushiki kaisha
- Pacific-Link Consulting (PLC) is proud to announce that the Japan External Trade Organization (JETRO) has