UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epilepsy Patients

Dec 03, 2007, 00:00 ET from UCB, Inc.

    ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced new data
 demonstrating that the investigational drug lacosamide, with the proposed
 brand name Vimpat(TM), administered as oral, adjunctive therapy,
 significantly reduced the frequency of seizures and was generally
 well-tolerated in patients with uncontrolled partial-onset seizures, for up
 to 5.5 years. The results of the two Phase II trials (Abstracts 3.197 and
 3.191) were presented today at the 61st annual meeting of the American
 Epilepsy Society.
     "These findings are encouraging because they show lacosamide
 significantly reduced seizure frequency in this refractory patient
 population over a long-term period," said Steve S. Chung, Director of
 Clinical Epilepsy Research at the Barrow Neurological Institute in Phoenix.
 "Approximately one third of people with epilepsy are resistant to current
 antiepileptic drugs. These data show lacosamide's potential to fill an
 unmet need in this patient population."
     The first presentation (SP754) was a double-blind, randomized,
 parallel-group, placebo-controlled Phase II trial involving 405 patients
 with refractory partial onset seizures, which were uncontrolled despite
 treatment with one to three AEDs. The patients were randomized to receive
 lacosamide 400 mg/day or 600 mg/day (given in 2 doses), or placebo over the
 12-week treatment period.
     The median reduction in seizure frequency from baseline was
 significantly greater for lacosamide than placebo: 37.3%, 37.8% and 20.8%
 for lacosamide 400 mg/day, 600 mg/day, and placebo, respectively.
 Significantly more patients achieved a 50% or greater reduction in seizure
 frequency with lacosamide than placebo: 38.3%, 41.2% and 18.3% for
 lacosamide 400 mg/day, 600 mg/day, and placebo, respectively. Nine subjects
 who completed the Maintenance Phase were seizure free throughout the entire
 12-weeks: 4 of 160 completers in the 400 mg/day group (2.5%) and 5 of 62
 completers in the 600 mg/day group (8.1%).
     The most common adverse events associated with lacosamide, occurring in
 10% or more of patients, included dizziness, nausea, diplopia, blurred
 vision, vomiting, headache, tremor, abnormal coordination, sleepiness, and
 nystagmus. A small increase in mean PR interval (4-6 msec) was associated
 with 400-600mg/day lacosamide treatment.
     Patients in the SP754 trial had the option to transition to an
 open-label extension trial (SP615). The presentation of the SP615 data
 included an interim analysis of long-term efficacy and safety findings with
 lacosamide in 370 patients. The patients received lacosamide 100-800 mg/day
 based on the investigator's clinical judgment (median dose 400 mg/day). Of
 the 370 patients enrolled, 284 (76.8%) were exposed to lacosamide for more
 than 12 months, 224 (60.5%) for more than 24 months, and 140 (37.8%) for
 more than 36 months.
     The study supported the long-term use (up to 5.5 years) of lacosamide
 as an adjunctive treatment in epilepsy patients with partial onset
 seizures, finding that the median percent reduction in seizure frequency
 across all prior treatment groups was 45.9%. Additionally, 46.6% of
 patients had at least a 50% reduction in seizure frequency with lacosamide.
     The most common adverse events associated with lacosamide, occurring in
 10% or more of patients, were dizziness, headache, fatigue,
 nasopharyngitis, diplopia, upper respiratory tract infection, nausea,
 abnormal coordination, contusion, vision blurred, vomiting, skin
 laceration, and sinusitis. Long-term lacosamide treatment was not
 associated with any pattern of change in hematology, clinical chemistry,
 vital sign, and body weight measurements with increasing duration of
 exposure. A small increase in median PR interval (5 to 9 msec) across all
 subjects (all modal doses) was observed on the ECG.
     About Lacosamide: Lacosamide is a new chemical entity being developed
 as an oral and intravenous formulation for the treatment of partial-onset
     Lacosamide-a functionalized amino acid-has a novel and dual mode of
 action. It selectively enhances slow inactivation of sodium channels and
 interacts with the neuroplasticity-relevant target -- collapsin-response
 mediator protein-2 (CRMP-2).
     An application for lacosamide was filed by UCB and has been accepted by
 the U.S. Food and Drug Administration.
     About Epilepsy: Almost 2 million people in the U.S. have epilepsy.
 Between 70-80% of them are successfully treated with one of the more than
 20 antiepileptic drugs now available. However, 20-30% of patients have
 either intractable or uncontrolled seizures, or have significant adverse
 side effects secondary to medication, highlighting the ongoing need for the
 development of new antiepileptic drugs.
     About UCB
     UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the
 biopharmaceutical industry dedicated to the research, development and
 commercialisation of innovative pharmaceutical and biotechnology products
 in the fields of central nervous system disorders, allergy/respiratory
 diseases, immune and inflammatory disorders and oncology -- UCB focuses on
 securing a leading position in severe disease categories. Employing more
 than 10,000 people in over 40 countries, UCB achieved revenue of 3.5
 billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext
 Brussels Exchange and owns approx. 88% of the shares of SCHWARZ PHARMA AG.
 SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.
     Forward looking statement
     This press release contains forward-looking statements based on current
 plans, estimates and beliefs of management. Such statements are subject to
 risks and uncertainties that may cause actual results to be materially
 different 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, effects of future judicial decisions, changes in
 regulation, exchange rate fluctuations and hiring and retention of its