UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain

U.S. Food and Drug Administration (FDA) has accepted for filing the New

Drug Application (NDA) for the use of lacosamide in the treatment of adults

with diabetic neuropathic pain.

Nov 29, 2007, 00:00 ET from UCB, Inc.

    ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Food
 and Drug Administration (FDA) has accepted for filing the New Drug
 Application (NDA) for the use of lacosamide in the treatment of diabetic
 neuropathic pain. The application relates to the tablet formulation of
 lacosamide, whose proposed trade name is Vimpat(TM).
     "The fact that a high proportion of patients with diabetic neuropathic
 pain do not achieve satisfactory pain relief with current management
 options is a powerful stimulus to research and develop new therapies," said
 Iris Loew- Friedrich, MD, PhD, Global Head of Development, UCB. "The FDA
 acceptance for review means that a full assessment will be carried out on
 lacosamide's potential to provide sustained pain relief in patients with
 moderate to severe diabetic neuropathic pain."
     In placebo-controlled clinical trials of over 800 people with diabetic
 neuropathic pain, significant and sustained reductions in pain scores were
 seen versus placebo. The pain relief achieved with lacosamide was
 associated with reduced interference with sleep and general activities. The
 most common adverse events of lacosamide (greater than or equal to 10%)
 reported in these trials included dizziness, nausea, tremor and headache.
     A similar filing made to the European Medicines Agency (EMEA) earlier
 this year for the use of lacosamide in the treatment of diabetic
 neuropathic pain, was also accepted and is currently under review.
     About Diabetic Neuropathic Pain: Diabetic Neuropathic Pain is a painful
 and potentially debilitating condition, resulting from damage or
 dysfunction to the peripheral nervous system as a result of diabetes or
 impaired glucose tolerance. The condition is often characterized by a
 stabbing or burning sensation in the legs, feet, and/or hands. With the
 overall prevalence of diabetes in the U.S. estimated at 20.8 million
 people, it is thought that as many as 7.7 million have some degree of
 diabetic neuropathic pain.
     About Lacosamide: Lacosamide 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).
     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 S.A. is listed on the
 Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of
 the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA (Monheim, Germany) is a
 member of the 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