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UCB commences phase 3 lacosamide study in Asia

First patients enrolled in new study in Asia to assess the efficacy and safety of lacosamide as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization
• Initial results expected in the first half of 2015

Brussels (Belgium), Monday 19th November 2012 – 0700 CEST – UCB announces the start of a new phase 3 clinical trial of lacosamide in Japan and China which is designed to investigate the efficacy and safety of lacosamide as adjunctive therapy in adult patients with partial-onset seizures. UCB obtained Japanese rights to lacosamide at the end of 2010 and since then holds the world-wide rights to development and marketing. Initial results from this phase 3 study are expected in the first half of 2015.

“At UCB, we are committed to improving the lives of people living with epilepsy. The start of this study is an important milestone for patients and lacosamide in Asia as well as for the global epilepsy community.” said Jan Sabbat, Vice President & Head of Medical Affairs, International Major Markets, UCB.

“We welcome new studies evaluating the efficacy and safety of antiepileptic drugs in the Japanese population. It is estimated that up to one third of people living with epilepsy worldwide including Japan have uncontrolled seizures which highlights the need for additional therapeutic options.” said Yushi Inoue, Director of National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders, Japan.

In this double-blind, randomized, placebo-controlled 27 week study, the efficacy and safety of lacosamide administered concomitantly with one to three anti-epileptic drugs (AEDs) will be evaluated in approximately 540 adult patients in Japan and China who have uncontrolled partial-onset seizures with or without secondary generalisation. The primary outcome measure is the change in partial-onset seizure frequency per 28 days from baseline to the end of the maintenance period. Secondary efficacy variables include responder rate, measured by percentage of patients achieving a ≥50% reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period1.

Epilepsy is the most common serious brain disorder worldwide and affects an estimated 50 million individuals2. Approximately 750,000 people in Japan currently live with the condition3.

Lacosamide is currently not approved in Japan or in China for the treatment of epilepsy.

Lacosamide has been used by over 200,000 people with epilepsy worldwide. It was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy and is available as film-coated tablets, syrup and solution for infusion. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible4.

In the US, lacosamide tablets and injection were launched in May 2009 as an adjunctive therapy for the treatment of partial onset seizures in people with epilepsy who are 17 years and older. Lasosamide injection is indicated as a short-term replacement when oral administration is not feasible in these patients. Lacosamide oral solution was launched in June 2010. The availability of oral tablets, oral solution and IV injection allows for consistent treatment in a hospital setting5.

The most common adverse reactions occurring in 10 percent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information is available below4,5.

About Vimpat® (lacosamide)

Important safety information about Vimpat® in the EU and EEA

Vimpat® (lacosamide) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. Vimpat® solution for infusion is an alternative for patients when oral administration is temporarily not feasible. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with Vimpat® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with Vimpat® have been observed in clinical studies. Cases with second- and third-degree AV block associated with Vimpat® treatment have been reported in post-marketing experience. Vimpat® should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when Vimpat® is used in combination with products known to be associated with PR prolongation. In the placebo-controlled trials of Vimpat® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counselled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Vimpat® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Vimpat® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Vimpat® may have minor to moderate influence on the ability to drive and use machines. Vimpat® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of Vimpat® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. The use of Vimpat® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with Vimpat® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of Vimpat® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with Vimpat® and if multiorgan hypersensitivity reaction is suspected, Vimpat® should be discontinued.
Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 19th March 2012.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf

Important safety information about Vimpat® C-V in the U.S.

Warnings and Precautions
Antiepileptic drugs (AEDs), including Vimpat®, increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider.

Patients should be advised that Vimpat® may cause dizziness and ataxia. Therefore patients should not drive a car or operate complex machinery until they are familiar with the effects of Vimpat® on their ability to perform such activities.

Dose-dependent PR interval prolongation has been observed in Vimpat® clinical studies in patients and in healthy volunteers. When Vimpat® is given with other drugs that prolong the PR interval, further PR prolongation is possible. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting) and told to contact their physician should any of these occur. Vimpat® should be used with caution in patients with known cardiac conduction problems or with severe cardiac disease. In such patients, obtaining an ECG before beginning Vimpat®, and after Vimpat® is titrated to steady state, is recommended.

Vimpat® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid pulse, shortness of breath) and told to contact their physician should these symptoms occur.

Patients should be advised that Vimpat® may cause syncope.

Vimpat® should be gradually withdrawn (over a minimum of 1 week) to minimize the potential of increased seizure frequency.

Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, Vimpat® should be discontinued.

Vimpat® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Common Adverse Reactions
In clinical trials, the most frequently seen adverse reaction with Vimpat® was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of Vimpat®-treated patients, and greater than placebo, were headache, nausea, and diplopia.

Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended. Dose titration should be performed with caution in all renally impaired patients.

In clinical trials, adverse reactions with intravenous administration generally appeared similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).

For full prescribing information on Vimpat®, visit https://www.ucb.com/_up/ucb_com_products/documents/Vimpat_COL%20_03_2012.pdf (Accessed 31st October, 2012)

For more information on Vimpat®, visit www.Vimpat.com or contact UCB at (800) 477-7877.

Vimpat® (C-V) is a Schedule V controlled substance in the US.
Vimpat® is a registered trademark used under license from Harris FRC Corporation.

References
1. A Study to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial Onset Seizures. Accessed 25th October 2012 from http://www.clinicaltrials.gov/ct2/show/NCT01710657?term=NCT01710657&rank=[Accessed
2. Epilepsy Fact Sheet Number 999. Accessed 10th October 2012 from http://www.who.int/mediacentre/factsheets/fs999/en/
3. Epilepsy in the Western Pacific Region. Accessed 10th October 2012 from http://www.wpro.who.int/publications/pub_9290610999/en/index.html
4. Vimpat® EU Summary of Product Characteristics. Accessed 10th October 2012 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf
5. Vimpat® US Prescribing Information. Accessed 10th October from https://www.ucb.com/_up/ucb_com_products/documents/Vimpat_COL%20_03_2012.pdf

For further information
Eimear O Brien, Director, Brand Communications, UCB
T +32.2.559.9271, eimear.obrien@ucb.com
Laurent Schots, Media Relations, UCB
T +32.2.559.9264, laurent.schots@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.

LCM-PRR-016903_102012


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