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UCB, Inc. (UCBJF.PK) Release: New Neupro(R) Data in Parkinson's Disease and Restless Legs Syndrome to be Presented at the 64th American Academy of Neurology


4/23/2012 9:31:47 AM

ATLANTA, April 20, 2012 /PRNewswire/ -- Data examining the effect of Neupro® (rotigotine transdermal system) in both Parkinson's disease and Restless Legs Syndrome (RLS) will be presented at the 64th American Academy of Neurology (AAN) Annual Meeting in New Orleans, LA, between April 21-28, 2012. Key data presentations will focus on post hoc analyses of pivotal and other studies of rotigotine transdermal system and are designed to investigate the impact of rotigotine transdermal system on the core symptoms of RLS and on the motor and underlying symptoms of Parkinson's disease such as depression, anxiety, anehdonia, fatigue and pain.

"These results add to the body of clinical evidence supporting rotigotine transdermal system. The data underscore UCB's continuing commitment to discovering and developing therapies that address unmet medical needs for potentially debilitating central nervous system disorders," said Dr. James Zackheim, PhD, Senior Medical Director, Central Nervous System Business Unit, UCB, Inc.

Earlier this month, the U.S. Food and Drug Administration (FDA) approved Neupro® (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary RLS. Neupro® was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. The FDA has also approved UCB's new formulation of Neupro®.

Following is a guide to UCB-supported research featuring rotigotine transdermal system being presented during the AAN Annual Meeting. For more information please contact Andrea Levin at 404.483.7329 or Andrea.Levin@ucb.com.

Parkinson's disease abstracts

1. [P.06.088] Abstract Title: Rotigotine Transdermal System Improves Neuropsychiatric Features (Apathy, Anhedonia, Anxiety, and Depression) and Fatigue in Patients With Parkinson's Disease: A Post-hoc Analysis of Five Double-blind Placebo-controlled Studies
Date/Time:Thursday, April 26, 2012 7:30 am 12:00 pm
Session Info: Session P06: Assessment and Treatment of Parkinson's Disease

2. [P.06.085] Abstract Title: Rotigotine Transdermal System Improves Pain in Patients With Parkinson's Disease: A Post-hoc Analysis of Patients Reporting Pain in the RECOVER Study
Date/Time:Thursday, April 26, 2012 7:30 am 12:00 pm
Session Info: Session P06: Assessment and Treatment of Parkinson's Disease

3. Abstract Title: An International Study to Investigate Rotigotine Dose Response (2-8 mg/24 h) on 'Off' Time in Patients With Advanced Stage Parkinson's Disease
Date/Time:Wednesday, April 25, 2012 5:45 pm 7:00 pm

RLS abstracts

4. [P04.032] Abstract Title: Effects of 24-h Transdermal Delivery of Rotigotine on the Core Symptoms and Symptom Impact of Restless Legs Syndrome/Willis-Ekbom Disease: A Post-hoc Analysis of IRLS Single Item Data from a 6-month Placebo-controlled European Study
Date/Time: Wednesday, April 25, 2012 7:30 am 12:00 pm
Session Info: Session P04: Movement Disorders: Restless Legs Syndrome, and Tardive Dyskinesia

5. [P04.037] Abstract Title: Rotigotine Improves Core Symptoms and Symptom Impact in Patients with Restless Legs Syndrome/Willis-Ekbom Disease: A Post-hoc Analysis of IRLS Single Item Data from a 6-month Placebo-controlled US Study
Date/Time: Wednesday, April 25, 2012 7:30 am 12:00 pm
Session Info: Session P04: Movement Disorders: Restless Legs Syndrome, and Tardive Dyskinesia

Notes to Editors

About Neupro® in the U.S.

Neupro® (Rotigotine Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS). For more information about Neupro visit www.neupro.com.

Neupro® in the U.S. Important Safety Information

Neupro® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.

Patients treated with Neupro® have reported falling asleep while engaged in activities of daily living and somnolence. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for somnolence was 16% for early-stage Parkinson's disease, 4% for advanced-stage Parkinson's disease, and 6% for Restless Legs Syndrome. Some patients perceived no warnings signs, such as excessive drowsiness. Patients should be advised to exercise caution while driving, operating heavy machinery or working at heights during treatment with Neupro®.

There is an increased risk for hallucinations in patients with advanced-stage Parkinson's disease treated with Neupro®. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for hallucinations was 4%, and this difference increased with increasing dose. Patients also may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Neupro® treatment or after starting or increasing the dose of Neupro®.

Neupro® may cause symptomatic postural/orthostatic hypotension and syncope, especially during dose escalation, elevated blood pressure, elevated heart rate, weight gain and fluid retention. Neupro® should be used with caution in patients with severe cardiovascular disease.

Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, and the inability to control these urges while taking medications, including Neupro®, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. Patients should be monitored for the development of new or increased urges while being treated with Neupro®. Dose reduction or discontinuation of Neupro® should be considered if such urges develop.

Neupro® may increase the dopaminergic side effects of levodopa and may cause and/or exacerbate pre-existing dyskinesia. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for dyskinesia was 7% for advanced-stage Parkinson's disease, and this difference increased with increasing dose.

Neupro® can cause application site reactions, and some may be severe. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for application site reactions was 15% for early-stage Parkinson's disease, 23% for advanced-stage Parkinson's disease, and 39% for Restless Legs Syndrome. Most reactions were mild or moderate in intensity and were limited to the patch area.

Patients with Parkinson's disease have a higher risk of developing melanoma than the general population. Patients should be monitored for melanomas frequently when using Neupro®.

Dopaminergic medicinal products, including Neupro®, may cause augmentation and rebound in RLS patients.

The most common adverse reactions (>/=5% greater than placebo) for the highest recommended doses of Neupro® for treatment of Parkinson's disease are nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, and insomnia. The most common adverse reactions (>/=5% greater than placebo) for the highest recommended dose of Neupro® for treatment of Restless Legs Syndrome are application site reactions, nausea, somnolence, and headache.

Additional important safety information for Neupro® can be accessed at www.neupro.com/pi.

About Neupro® in the European Union
Neupro® (rotigotine) is approved in the European Union 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 also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Neupro® in the European Union Important Safety Information
Neupro® is contraindicated in case of hypersensitivity to the active substance or to any of its excipients, and in case of magnetic resonance imaging (MRI) or cardioversion. Neupro® should be removed if the patient has to undergo MRI or cardioversion to avoid skin burns.

It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the risk of postural/orthostatic hypotension associated with dopaminergic therapy and reported during Neupro® treatment.Neupro® has been associated with somnolence and episodes of sudden sleep onset. Patients treated with dopamine agonists including Neupro®, have been reported pathological gambling, increased libido and hypersexuality. Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper treatment.

Hallucinations have been reported, and patients should be informed that hallucinations can occur.

Cases of cardiopulmonary fibrotic complications have been reported in some patients treated with ergot-derived dopaminergic agents. Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists. Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.

External heat, from any source should not be applied to the area of the patch. Exposure of a skin rash or irritation to direct sunlight could lead to changes in the skin color. If a generalized skin reaction (e.g. allergic rash) associated with the use of Neupro® is observed, Neupro® should be discontinued.

Caution is advised when treating patients with severe hepatic impairment or acute worsening of renal function, a dose reduction might be needed.

The incidence of some dopaminergic adverse events, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa. This should be considered when prescribing Neupro®.

Neupro® contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.

Neupro® should not be used during pregnancy. Breast-feeding should be discontinued.

In restless legs syndrome augmentation may occur. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.

At the beginning of therapy, dopaminergic adverse reactions, such as nausea and vomiting, may occur. These are usually mild or moderate in intensity and transient, even if treatment is continued.

Adverse drug reactions reported in more than 10% of Parkinson's patients treated with Neupro® are nausea, vomiting, application site reactions, somnolence, dizziness and headache. The majority of these application site reactions are mild or moderate in intensity.

Adverse drug reactions reported in more than 10% of RLS patients treated with Neupro® are nausea, application site reactions, asthenic conditions (including fatigue, asthenia, malaise) and headache. The majority of these application site reactions are mild or moderate in intensity.

All Neupro® supply should be stored in a refrigerator (2o C-8o C). There is no need for patients to transport Neupro® patches in special containers and they must not be stored in a freezer compartment.

Please refer to the European Summary of Product Characteristics for full prescribing information (Revised August 2011):

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000626/human_med_000926.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124

For further information
Andrea Levin, Associate Director, US Communications and Public Relations, UCB
T +1.770.970.8352,
andrea.levin@ucb.com
Eimear O'Brien, Director, Brand Communications, UCB
T +32.2.559.9271, eimear.obrien@ucb.com
Antje Witte, Investor Relations, UCB
T +32.2.559.9414,
antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T +32.2.559.9178,
france.nivelle@ucb.com

About UCB
UCB, Brussels, Belgium (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 of the immune system or of the central nervous system. With more than 8,500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

SOURCE UCB, Inc.



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