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UCB, Inc. (UCBJF.PK) Release: New Data on Switching Parkinson's Disease Patients With Pre-Existing Gastrointestinal Symptoms From Oral PD Medications to Neupro® (Rotigotine Transdermal System)


3/20/2013 9:02:29 AM

ATLANTA, March 19, 2013 /PRNewswire/ -- UCB today announced data from a non-interventional, observational study conducted in Germany that found that when Parkinson's disease (PD) patients were switched from an oral PD medication to Neupro® (Rotigotine Transdermal System), they reported improvements in pre-existing gastrointestinal (GI) symptoms. The data were presented at the American Academy of Neurology's (AAN) 2013 Annual Scientific Meeting in San Diego, March 16-23, 2013.

"GI symptoms are common non-motor symptoms in PD patients, and can significantly affect their daily life," said Dirk Woitalla, MD, lead study author, St. Josef-Hospital Universitatsklinik. "The findings presented at AAN show the potential improvement rotigotine may have on these symptoms for people living with PD. Controlled clinical studies are needed to confirm this finding."

In the study conducted in a clinical practice setting in Germany, PD patients experiencing GI symptoms (e.g., heartburn, bloating, nausea, vomiting, abdominal pain or diarrhea) while receiving oral drug treatment were switched by their physician to rotigotine transdermal system.1

Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale [intensity; 0-100 mm]) and the sum score of GI complaints (six items each rated 0-12 for sum of 0-72), in addition to patient satisfaction in relation to GI symptoms approximately six weeks after treatment switch.1

Of the 76 patients enrolled in the study, 58 had follow up data available for final analysis. The intensity of GI complaints improved numerically on the visual analogue scale (47.5+/-24.4 mm at baseline; 19.7+/-23.3 mm after approximately six weeks), as well as the sum score of GI complaints (11.2+/-9.0 at baseline; 2.1+/-4.4 after approximately six weeks). Fifty of the 58 patients reported being satisfied or very satisfied with the improvement in GI symptoms after approximately 6 weeks of treatment with rotigotine transdermal system. The study suggests that a switch from oral PD medication to rotigotine transdermal system may improve pre-existing GI symptoms among patients with PD.1 Neupro® can cause nausea, vomiting, and gastrointestinal distress, which may occur more frequently during initial therapy.

Neupro® is approved in the U.S. to treat the signs and symptoms of idiopathic PD.2 In the European Union, Neupro® is approved for the treatment of the signs and symptoms of early-stage idiopathic PD, 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.3

About Parkinson's disease
Parkinson's disease is a chronic neurological condition that develops with the loss of nerve cells in the brain that produce a chemical called dopamine.4 The symptoms of PD include both motor and non-motor symptoms and can have a broad impact on patients.5 As dopamine levels fall, movement (motor) symptomstremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement)can progress, along with other non-motor symptoms of PD. 4

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 and is seen more frequently in people with asthma.

Patients treated with Neupro® have reported somnolence and falling asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some patients believed they were alert immediately prior to the event. Patients may not recognize or acknowledge increased drowsiness or sleepiness. Therefore, prescribers should directly question patients about these possible occurrences and continually reassess patients, as some events have been reported well after the start of treatment. Patients should be advised to exercise caution while driving, operating heavy machinery, or working at heights during treatment with Neupro®. If patients develop daytime sleepiness or episodes of falling asleep during activities of daily living, Neupro® should be discontinued.

There is an increased risk for hallucinations in patients with advanced-stage Parkinson's disease treated with Neupro®. 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 Parkinson's disease patients appear to have an impaired capacity to respond to postural challenge. Both Parkinson's and RLS patients treated with dopamine agonists require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk. Neupro® may also cause syncope, 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. Because patients may not recognize these behaviors as abnormal, prescribers should specifically ask patients and their caregivers about 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 preexisting dyskinesia.

Neupro® can cause application site reactions, and some may be severe. In clinical trials, 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.

Neupro® should be removed before magnetic resonance imaging or cardioversion, because the aluminum backing layer in the patch could cause skin burns. Heat application has been shown to increase absorption several fold with other transdermal products. Therefore, patients should be advised to avoid exposing the application site to sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

The most common adverse reactions (less than or equal to 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, insomnia, peripheral edema, and dyskinesia. The most common adverse reactions (less than or equal to 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.

The full prescribing 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 to exhibit impulse control disorders such as pathological gambling, binge eating and compulsive eating, punding, compulsive spending and buying, aggression, 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. Application site reactions lasting more than a few days, spreading outside the area of the patch, or that increase in severity, should lead to risk/benefit balance re-assessment. 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.

Please refer to the European Summary of Product Characteristics for full prescribing information (Revised January 2013): http://ec.europa.eu/health/documents/communityregister/2013/20130114125141/dec_125141_en.pdf [Accessed February 2013]

Neupro® is a registered trademark of the UCB Group of companies.

For further information
Andrea Levin, Associate Director, Public Relations and Communications, 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
Laurent Schots, Media Relations, UCB
T +32.2.559.9264, laurent.schots@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 9000 people in approximately 40 countries, the company generated revenue of EUR 3.4 billion in 2012. 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.

###

1. Abstract 1321: Woitalla, D., Lauterbach, T., Berkels, R., et al. Non-Interventional Study of the Switch from Oral Treatment to Rotigotine Transdermal System in Patients with Parkinson's Disease and Gastrointestinal Symptoms. Presented at the Annual Scientific Meeting of the American Academy of Neurology (AAN) 2013.

2. Neupro PI - http://www.neupro.com/pdf/Neupro-PI.pdf

3. European Summary of Product Characteristics:http://ec.europa.eu/health/documents/communityregister/2013/20130114125141/dec_125141_en.pdf [Accessed February 2013]

4. Parkinson's Disease Foundation. Causes. http://www.pdf.org/en/causes

5. National Parkinson Foundation. How do you know if you have PD? http://www.parkinson.org/Parkinson-s-Disease/PD-101/How-do-you-know-if-you-have-PD-

SOURCE UCB


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