SAINT PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today that it has signed an agreement with Seikagaku Corporation granting Ferring the exclusive worldwide rights (excluding Japan) to SI-6603 (condoliase), a chemonucleolytic product in Phase III development for the treatment of radicular leg pain (e.g. sciatica) due to lumbar disc herniation.
Seikagaku has been developing condoliase for the U.S. and Japan and has two on-going Phase III clinical trials (a pivotal double-blind study and an open-label safety study). Seikagaku is responsible for completing development and obtaining U.S. regulatory approval. Following approval from the Food and Drug Administration, Ferring will commercialize the product in the United States and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan. In consideration, Ferring will pay Seikagaku an upfront licensing fee, development and regulatory milestones and royalties.
“We believe condoliase may answer a substantial unmet need among those patients suffering from radicular leg pain due to lumbar disc herniation,” said Michel Pettigrew, President of the Ferring Executive Board and COO. “This is a significant opportunity to expand our global Orthopaedics franchise with a new innovative drug therapy.”
“Condoliase is an exciting product being developed with the potential to return a proven mechanism, chemonucleolysis, as a treatment alternative for radicular leg pain associated with lumbar disc herniation,” said Gunnar Andersson, MD, Professor and Chairman Emeritus of the Department of Orthopaedic Surgery at Rush University Medical Center in Chicago, U.S.A.
“Condoliase could offer a non-surgical alternative to patients for whom conservative therapy and/or corticosteroid injections have failed to provide durable relief, while maintaining the option for surgery should it later become medically necessary,” said Ray Baker, MD, past president, North American Spine Society.
Last updated on: 30/08/2016
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