Published Press Releases
Marketing Authorization Application for Vimpat® - the proposed new trade name for lacosamide -
to treat Diabetic Neuropathic Pain has been submitted to the European regulatory authority.
Brussels (Belgium), 17 August 2007 at 9:00 AM (CET) – UCB announced today that an application for marketing authorization (MAA) for Vimpat® (lacosamide) as therapy for diabetic neuropathic pain has been submitted to the European Medicines Agency (EMEA) by UCB's subsidiary SCHWARZ PHARMA and has been accepted for review.
"Treatment with Vimpat® significantly reduced pain in patients with diabetic neuropathic pain during the clinical trial program, which included more than 1,500 patients. Additionally, Vimpat® was well tolerated", comments Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB "The application for marketing approval in Europe was submitted as planned in the third quarter and it is intended that the US application will be submitted in the fourth quarter of 2007."
Vimpat® (lacosamide), taken as an oral tablet, has been dosed twice daily in clinical trials. Possible tablet strengths range from 50 to 300mg tablets.
Lacosamide is an anticonvulsant drug of a new generation with a novel dual mode of action acting on CRMP-2 (collapsing response mediator protein 2) and sodium channel slow inactivation. Lacosamide has not shown clinically relevant interactions with other antiepileptic drugs, oral contraceptives or food, neither have oedema or weight gain been reported during the clinical trial program. Dizziness and nausea were the most commonly reported side effects whereas somnolence was notably low.
Diabetic neuropathic pain is a very common chronic pain syndrome with approximately eleven million people suffering from the consequences of this complication of diabetes. Neuropathic pain is caused by a damage to a peripheral or central nerve and can lead to spontaneous sensations of pain.
An application for marketing approval for Vimpat® (lacosamide) as adjunctive therapy for adult patients with epilepsy with partial onset seizures was accepted for review by the European Authorities in May 2007. Filing to the US authorities is planned for the fourth quarter of 2007.
Proof of concept clinical studies with lacosamide in additional indications such as fibromyalgia, osteoarthritis and migraine prophylaxis have already been initiated and shall report first results in 2008.
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the l 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.
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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 employees.