UCB announces positive top-line results from phase II open-label pilot study of Vimpat® (lacosamide) in primary generalized tonic-clonic seizures | UCB
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UCB announces positive top-line results from phase II open-label pilot study of Vimpat® (lacosamide) in primary generalized tonic-clonic seizures

• Lacosamide to move into Phase III development for primary generalized tonic-clonic (PGTC) seizures

Brussels (Belgium), January 9th, 2012, 0700 CET – regulated information – UCB announced today positive topline results from an open-label pilot Phase II study which was conducted with the primary objective of assessing the safety of oral lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in patients with idiopathic generalized epilepsy (IGE).

Preliminary analysis of the open-label study with 49 enrolled patients suggested that lacosamide was generally well tolerated1. Further analyses are ongoing.

“The results from the study are encouraging and we look forward to advancing the planned Phase III clinical programme.” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.

About the Phase II safety study2
Patients, aged 16-65, with uncontrolled PGTC seizures and idiopathic generalized epilepsy, began a dose titration phase of lacosamide starting at 100 mg/day (50 mg bid) and up to a maximum dose of 400 mg/day at weekly increments, as deemed clinically appropriate. The final titration was followed by a six-week maintenance phase. The primary-outcome measures of the study were the change in the number of seizure days with absence seizures from the Baseline to the Maintenance Phase and the change in the number of seizure days with myoclonic seizures from the Baseline to the Maintenance Phase. The secondary-outcome measures included changes in count of generalized spike-wave discharges EEG from the Baseline to the Maintenance Phase, changes in count of 3 Hertz (Hz) spike-wave discharges, the number of patients with treatment emergent adverse events (TEAEs) during the 10-week treatment period, and the number of patients withdrawing from the study due to TEAEs.

About Vimpat®
In the European Union, Vimpat® (film-coated tablets and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Vimpat® solution for infusion may be used when oral administration is temporarily not feasible.

Vimpat® tablets and injection were launched in the US in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. Vimpat® injection is a short-term replacement when oral administration is not feasible in these patients. Vimpat® oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for Vimpat® is available at the end of the press release.

Important safety information about Vimpat® in the EU and EEA
Vimpat® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Lacosamide 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 lacosamide 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 lacosamide have been observed in clinical studies. Lacosamide 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 lacosamide is used in combination with products known to be associated with PR prolongation. Second-degree or higher AV block has been reported in post-marketing experience. In the placebo-controlled trials of lacosamide 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 lightheadedness and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with antiepileptic agents. 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. The solution for infusion contains sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Lacosamide may have minor to moderate influence on the ability to drive and use machines. Lacosamide 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 lacosamide on their ability to perform such activities. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with lacosamide 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 lacosamide 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 lacosamide and if multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. 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. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 24 November, 2011.

http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed 5th January 2012)

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

Warnings and Precautions
AEDs 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 should be advised that Vimpat® may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with 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
The most common adverse reactions occurring in ≥10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.

Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. The use of Vimpat® in patients with severe hepatic impairment is not recommended.

For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx (Accessed 18th October, 2011).

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.
Vimpat® is a registered trademark used under license from Harris FRC Corporation.

1. UCB data on file
2. http://clinicaltrials.gov/ct2/show/NCT01118949?term=Vimpat&rank=28 (Accessed 5th January 2012)

For further information
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
Eimear O Brien, Director, Brand Communications, UCB
T +32.2.559.9271, Eimear.obrien@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 2010. 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.


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