August 29, 2016 03:13 AM Eastern Daylight Time
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.
About radicular leg pain and Condoliase (SI-6603)
Lumbar disc herniation (LDH) is the result of a progressive and degenerative process within the intravertebral disc (IVD) that affects between 1.6% of the general population to 43% of individuals in selected working groups worldwide, with the majority of incidents occurring in the fourth and fifth decades of life1,2. In the US, 3 to 5% of the population is symptomatic (i.e. sciatica)3. The IVD is made up of the nucleus pulposus and annulus fibrosis that together cushion and allow flexibility within the spine. The disc herniation may increase pressure on a surrounding root nerve resulting in lower back pain and radicular leg pain (e.g. sciatica).
Condoliase is being developed for use as a chemonucleolysis treatment to break down selected components of the IVD, primarily within the nucleus pulposus. This reduces its water content and volume, thereby relieving disc pressure and compression on the spinal nerve root. A Japanese Phase III study (163 patients) met its primary endpoint of significantly reducing worst leg pain at 13 weeks (vs. a saline placebo injection) with sustained relief at 52 weeks4.
About Ferring Pharmaceuticals
Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
FERRING is a trademark of Ferring B.V.
1 Konstantinou, K., Dunn, K.M. Spine (Phila Pa 1976) 2008, 33, 2464-2472
2 Ropper, A.H., Zafonte, R.D. New Engl J Med 2015, 372, 1240-1248
3 Tarulli, A, W et al. Neurol Clin 2007, 25, 387-405
4 Seikagaku (Study 6603/1031) Data on File)