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Vimpat® (Lacosamide) Generates Positive Results in U.S. Phase 3 Monotherapy Study

3.5.2013

  • Top-line results demonstrate that the study met its primary endpoint
  • Submission to FDA planned for second half of 2013

UCB today announced positive results of a Phase 3 study designed to evaluate the efficacy and safety of conversion to lacosamide monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control. The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide (400 mg/day) was significantly lower than the historical control. UCB plans to submit these data as part of its supplemental New Drug Application for lacosamide to the U.S. Food & Drug Administration (FDA), which is planned in the second half of 2013.

“We are very pleased with these top-line results and look forward to discussing the detailed study results with the regulatory agencies and the scientific community,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President of UCB. “These encouraging data support our development program for lacosamide as monotherapy for partial onset seizures, starting in the United States. Lacosamide is currently approved in 36 countries as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy; UCB’s comprehensive development program aims to make the product available to many more people living with epilepsy worldwide.”

The Phase 3 study was an international, historical-controlled, multicenter, double-blind, randomized trial evaluating lacosamide (400mg/day) for conversion to monotherapy in 427 patients, aged 16-70 years with partial-onset seizures taking one to two other anti-epileptic drugs (AEDs). A lacosamide 300 mg/day arm was added to blind the treatment group and to ensure a study design consistent with the historical control studies on which the conversion to lacosamide monotherapy study was based.

The primary efficacy endpoint of the study was the percentage of patients who met at least one of the defined exit criteria by Day 112 relative to the start of withdrawal of background antiepileptic drugs and compared with the historical control. Patients were evaluated from the first day of tapering of the background AEDs and required to discontinue the study if they experienced any of the protocol exit events defined by seizure frequency, duration or severity.

These topline results will be followed by full efficacy and safety analyses, which will be submitted for presentation at an upcoming epilepsy meeting.

Lacosamide (tradename 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). Lacosamide is not currently approved for use as monotherapy.

Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and 2.2 million people in the U.S. — making it more common than autism, cerebral palsy, multiple sclerosis and Parkinson’s disease combined. Anyone can develop epilepsy; it occurs across all ages, races and genders and is defined as two or more unprovoked seizures.

About Vimpat®

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 June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment.

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