Ferring Pharmaceuticals acquired exclusive development and commercialization rights to Seikagaku’s SI-6603 injectable condoliase, a potential treatment for lumbar disc herniation, for an upfront cash payment of US $5MM and milestone payments up to $90MM over multiple years.
Seikagaku will complete development and pursue FDA regulatory clearance. Ferring will market the product in the U.S., and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan.
Seikagaku submitted a new drug application for SI-6603 in Japan in 2014, and expects to gain marketing approval there within its FY16.
The company completed enrollment in a pivotal double-blind U.S. Phase III clinical trial in mid-2015. An additional open-label trial, commenced in 2Q15, continues to enroll in Europe and the U.S.
The SI-6603 enzyme is thought to be effective in reducing pressure on the nerve that causes lumbar disc herniation pain. A single injection into the lumbar disc may be as effective as surgical removal.
Sources: Seikagaku; Ferring Pharmaceuticals; ORTHOWORLD Inc.
Ferring Pharmaceuticals acquired exclusive development and commercialization rights to Seikagaku's SI-6603 injectable condoliase, a potential treatment for lumbar disc herniation, for an upfront cash payment of US $5MM and milestone payments up to $90MM over multiple years.
Seikagaku will complete development and pursue FDA regulatory...
Ferring Pharmaceuticals acquired exclusive development and commercialization rights to Seikagaku’s SI-6603 injectable condoliase, a potential treatment for lumbar disc herniation, for an upfront cash payment of US $5MM and milestone payments up to $90MM over multiple years.
Seikagaku will complete development and pursue FDA regulatory clearance. Ferring will market the product in the U.S., and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan.
Seikagaku submitted a new drug application for SI-6603 in Japan in 2014, and expects to gain marketing approval there within its FY16.
The company completed enrollment in a pivotal double-blind U.S. Phase III clinical trial in mid-2015. An additional open-label trial, commenced in 2Q15, continues to enroll in Europe and the U.S.
The SI-6603 enzyme is thought to be effective in reducing pressure on the nerve that causes lumbar disc herniation pain. A single injection into the lumbar disc may be as effective as surgical removal.
Sources: Seikagaku; Ferring Pharmaceuticals; ORTHOWORLD Inc.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.