UCB and Jazz Pharmaceuticals, Inc. has announced the signing of an expanded product license agreement for Xyrem (sodium oxybate).
Under the agreement, UCB obtains the right to commercialise Xyrem for the treatment of fibromyalgia syndrome, if and when the product is approved for this indication. On September 7th 2006, Jazz Pharmaceuticals announced the initiation of its phase III clinical development program evaluating the use of Xyrem for the treatment of fibromyalgia syndrome.
In addition, the agreement doubles, from 27 to 54, the number of countries in which UCB has commercialisation rights to Xyrem Jazz Pharmaceuticals markets Xyrem in the US.
Commenting on the new agreement William Robinson, executive vice president, Global Operations, UCB said: "Fibromyalgia is an under-diagnosed, under-treated condition and we are encouraged by the initiation of the phase III trial to evaluate Xyrem as a treatment for this chronic pain illness. Acquiring the rights to in-licence Xyrem for fibromyalgia syndrome demonstrates the ongoing commitment of UCB to satisfying unmet medical needs.' He continued: 'we also look forward to making Xyrem available to narcolepsy patients in many more countries."
Under the expanded agreement, UCB has made an upfront payment and will make milestone payments to Jazz Pharmaceuticals, subject to future clinical development and sales results. UCB will also pay royalties to Jazz Pharmaceuticas on Xyrem sales across the 54 agreed territories.
"We are pleased to announce the significant expansion of our commercial partnership with UCB for Xyrem, which will bring this important therapy to patients in many more countries," said Robert M Myers, chief business officer of Jazz Pharmaceuticals. "We look forward to continuing the investigation of the clinical utility of Xyrem for the treatment of fibromyalgia syndrome."
Narcolepsy is a chronic, debilitating neurological disease, the primary symptoms of which are excessive daytime sleepiness (EDS), fragmented nighttimes sleep, and cataplexy. The hallmark symptom of narcolepsy is excessive and overwhelming daytime sleepiness, even after nighttimes sleep. EDS is present in all narcolepsy patients and causes patients to become drowsy or fall asleep, often at inappropriate times and places. Cataplexy, the sudden loss of muscle tone, is the most predictive symptom of narcolepsy. Cataplexy can range from slight weakness or a drooping of the face to the complete loss of muscle tone and is triggered by strong emotional reactions such as laughter, anger or surprise.
Fibromyalgia syndrome is a chronic pain illness, which is characterized by widespread musculoskeletal aches, pains and stiffness, soft tissue tenderness, general fatigue and sleep disturbances. The most common sites of pain include the neck, back, shoulders, pelvic girdle and hands, but any body part can be involved.