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Positive VIMPAT® (lacosamide) monotherapy Phase III trial results presented at European Academy of Neurology Congress

  • Trial further highlights UCB’s longstanding commitment to enhancing value for people living with epilepsy
  • Data submitted to EMA earlier this year to extend the marketing authorization for lacosamide to include monotherapy. In the Europe, lacosamide is currently only approved as adjunctive therapy.

Brussels (Belgium), 30 May 2016, 7:00am (CEST) – New clinical trial data, presented at the second Congress of the European Academy of Neurology (EAN), showed non-inferiority of lacosamide (VIMPAT®) monotherapy compared with controlled-release carbamazepine among patients with newly or recently diagnosed focal epilepsy.

The results are from a Phase III international, double-blind, randomized, active-controlled trial, the fourth in a series of non-inferiority trials conducted according to guidance issued by the European Medicines Agency and the International League Against Epilepsy.

Overall, 888 patients aged 16 years or older took part in the study, making it the largest trial of its kind so far. The proportion of patients completing six months of treatment without experiencing a seizure was 75.2% with lacosamide (200–600mg/day) and 71.8% with carbamazepine-CR (400–1200mg/day) per protocol population. This corresponded to 91.5% and 92.8% respectively, based on Kaplan Meier-predicted six month seizure freedom rates, the primary assessment for this trial. The adverse event (AE) profile was comparable to that observed in previous lacosamide trials, including dizziness, headache, fatigue, somnolence and nausea.1,2

Selection of the first antiepileptic drug is one of the most important decisions for patients with newly diagnosed disease – together, we need to choose one that is effective, has good tolerability, low potential for drug-drug interactions, and suits their profile and co-morbidities, so that they can take it for a long time”, explained Professor Michel Baulac, Hôpital de la Pitié-Salpêtrière, Paris, France. “Epilepsy is a complex, multifactorial disease and not all patients will respond to currently available options; consequently, addition of another antiepileptic drug to the selection we can choose from when seeing patients for the first time, is very welcome news”.

Earlier this year, UCB submitted the data to the European Medicines Agency to extend the marketing authorization of lacosamide to include monotherapy, further supporting the efficacy and safety of this treatment and reinforcing UCB’s belief in the potential for this indication.

VIMPAT® is already available as monotherapy in the United States and we hope it will soon reach patients in the EU. UCB is committed to making this product available to many more people living with epilepsy worldwide, regardless of the stage of their disease, whether newly diagnosed, or refractory”, said Jeff Wren, Patient Value Head Neurology and Executive Vice President UCB. “In recent years, VIMPAT® has helped many patients requiring adjunctive therapy for focal epilepsy. Results of this trial suggests that it may provide similar benefits as first-line monotherapy, building on our longstanding commitment to enhance value for people with seizure disorders at every point of their journey.”

Lacosamide (trade name VIMPAT®) is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages ≥ 17 years in the U.S., ages ≥ 16 years in the EU) and in the U.S. also as monotherapy. In the EU, lacosamide is not currently approved for use as monotherapy. Important safety information for lacosamide is available below.2,3

[ENDS]


About VIMPAT®
VIMPAT® 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. In countries of the EU, VIMPAT® 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 feasible. VIMPAT® tablets and injection were launched in the U.S. 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 the U.S. in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. In Asia, VIMPAT® is available Korea, Hong Kong, Malaysia, Philippines and Thailand. VIMPAT® is not approved in Japan and China. Important safety information about VIMPAT® is available below.

About Epilepsy4,5
Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of novel antiepileptic drugs. Every day, thousands of people use AEDs from our portfolio to help control their seizures. As a company with a long-term commitment to epilepsy research our goal is to address unmet medical needs and to deliver solutions that improve patients’ lives. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with epilepsy.

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® therapy can be initiated with either oral or IV administration. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. 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 counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. 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. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. 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, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration, contusion. 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 (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) 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. 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: 30 July 2015 http://www.ema.europa.eu/

For further information, UCB:

Corporate Communications
France Nivelle 
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Jim Baxter,
Neurology Communications, UCB
T+32.2.473.78.85.01 jim.baxter@ucb.com

Investor Relations
Antje Witte         
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@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 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document 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.

References

  1. Baulac, M. et al., Efficacy and tolerability of lacosamide monotherapy in patients with newly diagnosed epilepsy: A randomized double-blind trial versus controlled-release carbamazepine. Abstract presented at EAN 2016.
  2. VIMPAT Summary of Product Characteristics (SmPC) for European Union. Accessed 18 May 2016 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf.
  3. U.S. Food and Drug Administration. VIMPAT (lacosamide) Prescribing Information. Accessed 18 May 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf.
  4. The Epilepsy Foundation of America. Who gets epilepsy? Accessed 3 February 2016 from http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy.
  5. Fisher, R.S., et al., ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia, 2014. 55(4): 475-482.


Job Code: HQ/0516/VI/00011a   Date of preparation: 27/05/16


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