Ferring Pharmaceuticals has secured the rights to a Phase III treatment of radicular leg pain outside of Japan from Seikagaku. The drug, condoliase, is seen by Ferring as giving patients with lumbar disc herniation a nonsurgical way of managing the leg pain resulting from their condition.
Seikagaku has advanced the drug into two Phase III trials designed to give it the data it needs to win approval in the U.S. Having initiated this process, Seikagaku will stay in charge throughout the Phase III trials and subsequent regulatory filing, before handing off to Ferring in the event it wins approval. Ferring will then commercialize the drug in the U.S., while also potentially running the trials needed to win approval in other markets.
The deal sees Ferring pay an undisclosed upfront fee, plus development and regulatory milestones and sales royalties. An earlier release to disclose a letter of intent between the companies put the size of the upfront at $5 million (€4.5 million). In return, Ferring is gaining the rights to a drug it and some third parties think can provide another option to patients who suffer pain as the result of lumbar disc herniation, a degenerative process affecting intervertebral discs.
“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,” Dr. Ray Baker, a former president of the North American Spine Society, said in a statement.
Seikagaku has already tested condoliase, also known as SI-6603, in a Phase III trial in Japan. The 163-patient study found a single injection of condoliase was better than placebo at improving scores of worst leg pain. After 13 weeks, the leg pain scores of 72% of patients in the condoliase cohort improved by 50% or more compared with the baseline. Approximately half of patients in the placebo arm experienced similar improvements. Condoliase was also associated with improvements in physical function and quality of life scores.
Notably, while the treatment cohort featured a higher frequency of reports of back pain and other adverse events, Seikagaku saw the overall safety profile as supporting continued development of the drug. Condoliase works by chemonucleolysis, the process of using an enzyme to dissolve part of the disc. Another product with the same mechanism of action, Chymopapain, was subject to multiple lawsuits before being pulled from the U.S. market in 2003.
Ferring is now looking to enable physicians to once again offer chemonucleolysis and, in doing so, build out its portfolio of orthopedic treatments. The Swiss drugmaker has engaged in checkbook pipeline building over the past two years to expand its orthopedic range, adding Phase III assets through deals with BioSurface Engineering Technologies and now Seikagaku.