Xyrem® license agreement to include fibromyalgia

[Guest guest]

UCB and Jazz Pharmaceuticals announce expansion of Xyrem® license

agreement to include fibromyalgia syndrome, Market Wire > October,

2006

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 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 commercialization rights to Xyrem®. Jazz

Pharmaceuticals markets Xyrem® in the United States.

Commenting on the new agreement , 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

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. "

About Narcolepsy

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 ( www.xyrem.com ) for full prescribing information

[2].

About UCB

UCB ( www.ucb-group.com ) is a leading global biopharmaceutical

company dedicated to the research, development and commercialisation

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.

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 www.JazzPharmaceuticals.com .