UCB Announces Approval of NEUPRO® in China to Treat Parkinson's Disease

Brussels (ots/PRNewswire) -

- NEUPRO now approved in China for the treatment of the signs and
symptoms of early-stage idiopathic Parkinson's Disease as
monotherapy (i.e. without levodopa) or in combination with levodopa
- NEUPRO approval in China reinforces UCB's ongoing commitment to
supporting patient value across China and to offering Chinese
patients additional treatment choice to help manage their disease

Belgium-based global bio-pharmaceutical company UCB today
announced it has received an Import Drug License (IDL) from the China
Food and Drug Administration (CFDA), creating a pathway to make the
company's 24-hour continuous delivery transdermal rotigotine patch
NEUPRO® available to patients in China.

Parkinson's disease (PD) is a chronic, degenerative neurological
disease with an estimated prevalence of 1.7% in China in people aged
65 years and older.[1] Estimates suggest that around 3 million people
in China are affected by the condition.[2]

With this IDL, NEUPRO is now indicated in China for the treatment
of the signs and symptoms of early-stage idiopathic Parkinson's
Disease as monotherapy (i.e. without levodopa) or in combination with
levodopa, i.e. over the course of the disease, through to late stages
when the effect of levodopa wears off or becomes inconsistent and
fluctuations of the therapeutic effect occur (end of dose or 'on-off'
fluctuations).

NEUPRO is designed to support and improve individual patient
treatment experiences for people living with Parkinson's Disease. The
product's unique transdermal patch formulation is administered once
daily, providing a continuous release of rotigotine over a 24-hour
period.

"The availability of NEUPRO® in China is testament to UCB
fulfilling our commitment to provide additional value to patients
around the world," said Jeff Wren, Executive Vice-President, Head of
UCB's Neurology Patient Value Unit. "We know the significant impact
Parkinson's can have on the lives of patients and their family
members, and how important it is to effectively manage symptoms to
allow patients to keep their independence and maintain their quality
of life. With the approval of NEUPRO® in China, we are very excited
that we will be able to make this medicine available to the millions
of people affected by Parkinson's Disease in the country, providing
them with a convenient treatment option to help them to manage their
condition."

As a result of the IDL, UCB will now progress with NEUPRO launch
planning, to ensure patients in China with Parkinson's are able to
benefit from this approval as quickly as possible.

UCB has been present in China since 1996 and has a prominent
presence in the country, having launched Keppra for the treatment of
some forms of epilepsy in 2007. This important landmark helped
established the company's reputation as a leader in neurology.
Additionally, in 2014, UCB inaugurated a new state of the art 13,000
m² manufacturing site in Zhuhai, which strengthened our footprint in
the country.

Alongside approval for NEUPRO, these activities reinforce UCB's
ongoing commitment to supporting patients with severe diseases in
China.

About Parkinson's Disease

Parkinson's Disease (PD) is a chronic, degenerative neurological
disease which affects approximately 10 million people worldwide.[3]
PD usually affects people over the age of 50.[4] PD develops with the
loss of nerve cells in the brain that produce a chemical called
dopamine. The symptoms of PD can have an impact on many dimensions of
patients' lives. As dopamine levels fall, movement (motor)
symptoms-tremors (uncontrollable shaking), rigidity (stiffness or
muscle tensing) and bradykinesia (slowness and loss of spontaneous
movement)-can progress, along with the underlying symptoms of PD,
which are less well recognized and may be under-treated. Underlying
symptoms can occur in over 90% of PD patients and include sleep
disturbance, such as insomnia, vivid dreams and daytime drowsiness,
mood and cognitive changes, pain, depression, anxiety, apathy,
gastrointestinal disorders, sexual dysfunction, bladder problems and
fatigue.[5]

About UCB

UCB, Brussels, Belgium (http://www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases in immunology or neurology. With around 7
500 people in approximately 40 countries, the company generated
revenue of EUR 4.5 billion in 2017. UCB is listed on Euronext
Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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References

1. Zhang ZX, et al. Parkinson's disease in China: prevalence in
Beijing, Xian, and Shanghai. Lancet. 2005;365(9459):595-7.
2. Dorsey ER, et al. Projected number of people with Parkinson
disease in the most populous nations, 2005 through 2030.
Neurology. 2007 Jan 30;68(5):384-6.
3. EPDA: What is Parkinsons (
http://www.epda.eu.com/about-parkinsons/what-is-parkinsons/) date
accessed 21 June 2018
4. World Parkinson's Coalition: About Parkinson's Disease (
http://www.worldpdcoalition.org/?page=AboutParkinson) date
accessed 21 June 2018
5. Chaudhuri KR, Odin P, Antonini A, Martinez-Martin P. Parkinson's
disease: the non-motor issues. Parkinsonism and Related Disorders
2011; 17: 717-723.

ots Originaltext: UCB Pharma
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Contact:
France Nivelle
Global Communications UCB
+32-2-559-9178
france.nivelle@ucb.com

Jim Baxter
Neurology Communications UCB
+32-2-473-78-85-01
jim.baxter@ucb.com

Laurent Schots
Media Relations UCB
+32-2-559-92-64
laurent.schots@ucb.com. Investor Relations: Antje Witte
Investor Relations UCB
+32-2-559-94-14
antje.witte@ucb.com

Isabelle Ghellynck
Investor Relations UCB
+32-2-559-9588
isabelle.ghellynck@ucb.com.

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