Ferring Pharmaceuticals has acquired exclusive licensing rights to the Phase III radicular leg pain candidate SI-6603 (condoliase) from Seikagaku, the companies said today.
Seikagaku said the deal could generate up to $95 million for it.
“This is a significant opportunity to expand our global orthopedics franchise with a new innovative drug therapy,” Michel Pettigrew, president of Ferring’s Executive Board and COO, said in a statement.
Condoliase is a chemonucleolytic product being developed for the treatment of radicular leg pain, such as sciatica, due to lumbar disc herniation. Condoliase is designed to work by breaking down selected components of the intravertebral disk, primarily within the nucleus pulposus. By reducing its water content and volume, condoliase is expected to relieve disc pressure and compression on the spinal nerve root, Ferring said.
Seikagaku has been developing condoliase for the U.S. and Japan and has been conducting two ongoing 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 FDA approval, Ferring said it will commercialize the product in the U.S. It has received further rights to develop, register, and commercialize condoliase worldwide, except in Japan.
In return, Ferring agreed to pay Seikagaku $5 million upfront and up to $90 million in payments tied to achieving development and commercialization milestones.
A Phase III study of 163 patients conducted in Japan met its primary endpoint of significantly reducing the worst leg pain at 13 weeks compared with placebo, with sustained relief at 52 weeks, Ferring said.
Orthopedics is one of Ferring’s pharmaceutical areas of focus; the others are reproductive health, urology, gastroenterology, and endocrinology.
Seikagaku said the deal will not affect guidance disclosed May 12 to investors for the fiscal year ending March 31, 2017. The company projected it will finish the fiscal year with ordinary income from day-to-day operations of ¥3.35 billion ($24.9 million) on net sales of ¥29.55 billion ($288.9 million).