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UCB, Inc. (UCBJF.PK) Release: Interim results of VITOBA(TM) (VImpaT(R) added to One Baseline AED) Study Presented at the 64th Annual Meeting of the American Academy of Neurology


4/27/2012 9:32:02 AM

ATLANTA, April 26, 2012 /PRNewswire/ -- UCB today announced interim results from the VITOBA (VImpaT® added to One Baseline AED) study, which showed that patients with less refractory partial-onset seizures treated with Vimpat® (lacosamide) C-V as add-on to monotherapy experienced seizure reduction. These data were presented today at the 64th annual meeting of the American Academy of Neurology (AAN) in New Orleans.

VITOBA is a six-month prospective, non-interventional study of the efficacy, safety and tolerability of lacosamide when added to a single AED in patients with partial-onset seizures. The study has a planned enrollment of 500 adult patients. This interim analysis included efficacy data for 99 patients and safety data for 109 patients.

The patient population in VITOBA reflects epilepsy patients treated in routine clinical practice. The majority of patients (73.4 percent) had received only 1-3 AEDs since diagnosis. The mean lacosamide maintenance dose was 250mg/day and the median was 200mg/day.

Compared to the overall VITOBA study population, patients treated with only one lifetime AED experienced the greatest benefit from add-on therapy with lacosamide:

  • 86.7 percent showed a 50 percent or greater reduction in seizure frequency (vs. 77.8 percent of the overall study population)
  • 80 percent showed a more than 75 percent or greater reduction in seizure frequency (vs. 64.6 percent of the overall study population)
  • 66.7 percent of those with a history of one lifetime AED experienced seizure freedom (vs. 43.4 percent of the overall study population)

Treatment emergent adverse events (TEAEs) included fatigue (11.9 percent), dizziness (10.1 percent) and convulsion (5.5 percent).

"While preliminary, this interim analysis is noteworthy because it reflects a real-world treatment setting and suggests the effect of adding Vimpat® as an adjunctive therapy after initial monotherapy. These results need to be confirmed by the final analysis when the study concludes," said Matthias Noack-Rink, lead study author and Medical Affairs Director, Epilepsy, UCB Germany.

Vimpat® is indicated as an adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy. The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of lacosamide-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.

About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and 3 million people in the U.S. Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. More than 1 million patients in the U.S. continue to have seizures despite initial therapy, and more than 800,000 patients in the U.S. continue to have seizures despite treatment with two or more therapies. [1],[2]

About Vimpat
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 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.

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.

The maximum recommended daily dose for Vimpat® in the European Union and the U.S. is 400 mg/day.

Important safety information about Vimpat®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. Multi-organ 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 greater than or equal to 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 under license from Harris FRC Corporation.

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 patients with epilepsy aged 16 years and older. 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. Second degree or higher AV block has been reported in post-marketing experience. 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 and 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. 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. Undesirable effects: The most common adverse reactions (greater than or equal to 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 de-creased over time. Other common adverse reactions (greater than or equal to 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. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 21st February 2012.

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

Further Information
Andrea Levin, Associate Director, Communications & PR, CNS, UCB, Inc.
T 770.970.8352 / M 404.483.7329 / Andrea.levin@ucb.com

Dana Gulick, Cooney/Waters Group
T 212.886.2227 / M 917.216.6268 / dgulick@cooneywaters.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.

[1] http://epilepsyfoundation.org/aboutepilepsy/

[2] http://epilepsyfoundation.org/aboutepilepsy/treatment/index.cfm

SOURCE UCB



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