Healthcare Industry News: narcolepsy
News Release - October 3, 2006
UCB and Jazz Pharmaceuticals Announce Expansion of Xyrem(R) License Agreement to Include Fibromyalgia SyndromeUCB also adds new marketing territories under expanded agreement
BRUSSELS, Belgium and PALO ALTO, Calif., Oct. 3 (HSMN NewsFeed) -- UCB (Euronext Brussels: UCB) and Jazz Pharmaceuticals, Inc. today announced the signing of an expanded product license agreement for Xyrem® (sodium oxybate).
Under the agreement, UCB obtains the right to commercialize Xyrem for the treatment of fibromyalgia syndrome, if and when the product is approved for this indication. On September 7, 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 commercialization rights to Xyrem. Jazz Pharmaceuticals markets Xyrem in the United States.
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 on 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 Pharmaceuticals 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 nighttime sleep, and cataplexy. The hallmark symptom of narcolepsy is excessive and overwhelming daytime sleepiness, even after nighttime 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.
About Fibromyalgia Syndrome
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.
About Xyrem in Europe(1)
In 2005, Xyrem became the first and only medication approved by the European Medicines Agency (EMEA) for the treatment of cataplexy in adult patients with narcolepsy, and the product has since been launched for this indication in Denmark, Germany, Norway and the UK. In April 2006, UCB filed an application with the EMEA seeking marketing approval for the use of Xyrem in the treatment of narcolepsy in adult patients. The application spans all symptoms of narcolepsy, including excessive daytime sleepiness and fragmented night-time sleep.
The most commonly reported adverse drug reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients. Sodium oxybate is contraindicated in patients with succinic semialdehyde dehydrogenase deficiency. Sodium oxybate is contraindicated in patients being treated with opoids or barbiturates.
Xyrem is not approved for the treatment of patients with fibromyalgia syndrome.
About Xyrem in the United States(2)
Xyrem is approved for marketing in the United States for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. Xyrem is not approved for the treatment of patients with fibromyalgia syndrome. Xyrem is marketed in the United States by Jazz Pharmaceuticals.
Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma- hydroxybutyrate. Gamma-hydroxybutyrate is a substance with a history of abuse when acquired illicitly and used illegally. Abuse of illicit gamma- hydroxybutyrate has been associated with adverse CNS events including seizures, respiratory depression and profound decreases in level of consciousness, with instance of coma and death.
Xyrem is a Schedule III drug under the Controlled Substances Act and is only available through a restricted distribution system called the Xyrem Success Program. Please refer to the Xyrem package insert ( http://www.xyrem.com ) for full prescribing information.(2)
UCB ( http://www.ucb-group.com ) is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange. Worldwide headquarters are located in Brussels, Belgium.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, please visit http://www.JazzPharmaceuticals.com .
1. Xyrem SmPC Europe
2. Xyrem US Package Insert
Source: Jazz Pharmaceuticals
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