UCB Commences Phase 3 Lacosamide Study in Asia
11.19.2012
UCB announced the start of a new phase 3 clinical trial of lacosamide in Japan and China which is designed to investigate the efficacy and safety of lacosamide as adjunctive therapy in adult patients with partial-onset seizures. UCB obtained Japanese rights to lacosamide at the end of 2010 and since then holds the world-wide rights to development and marketing. Initial results from this phase 3 study are expected in the first half of 2015.
“At UCB, we are committed to improving the lives of people living with epilepsy. The start of this study is an important milestone for patients and lacosamide in Asia as well as for the global epilepsy community.” said Jan Sabbat, Vice President & Head of Medical Affairs, International Major Markets, UCB.
“We welcome new studies evaluating the efficacy and safety of antiepileptic drugs in the Japanese population. It is estimated that up to one third of people living with epilepsy worldwide including Japan have uncontrolled seizures which highlights the need for additional therapeutic options.” said Yushi Inoue, Director of National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders, Japan.
In this double-blind, randomized, placebo-controlled 27-week study, the efficacy and safety of lacosamide administered concomitantly with one to three anti-epileptic drugs (AEDs) will be evaluated in approximately 540 adult patients in Japan and China who have uncontrolled partial-onset seizures with or without secondary generalisation. The primary outcome measure is the change in partial-onset seizure frequency per 28 days from baseline to the end of the maintenance period. Secondary efficacy variables include responder rate, measured by percentage of patients achieving a ≥50% reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period.
Epilepsy is the most common serious brain disorder worldwide and affects an estimated 50 million individuals. Approximately 750,000 people in Japan currently live with the condition.
Lacosamide is currently not approved in Japan or in China for the treatment of epilepsy.
About Vimpat® (lacosamide)
Lacosamide has been used by more than 200,000 people with epilepsy worldwide. It 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 and 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.
In the U.S., lacosamide tablets and injections were launched in May 2009 as an adjunctive therapy for the treatment of partial onset seizures in people with epilepsy who are 17 years and older. Lasosamide injections are indicated as a short-term replacement when oral administration is not feasible in these patients. Lacosamide oral solution was launched in June 2010. The availability of oral tablets, oral solution and IV injection allows for consistent treatment in a hospital setting.
The most common adverse reactions occurring in 10 percent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.
For more information on Vimpat®, visit Vimpat.com or contact UCB at (800) 477-7877.
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.
About UCB
Headquartered in Brussels, Belgium, UCB (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 employees in about 40 countries, the company generated revenue of €3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
For further information, contact:
Laurent Schots, Media Relations, UCB
+32.2.559.9264, Laurent.Schots@UCB.com
France Nivelle, Global Communications, UCB
+32.2.559.9178, France.Nivelle@UCB.com
About RCT
RCT (Research Corporation Technologies) is a partner in Vimpat® (lacosamide) with UCB. Located in Tucson, Ariz., RCT is a technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies.
For further information, contact:
Chad Souvignier, Managing Director, RCT
520-748-4462, CSouvignier@RCTech.com