UCB's Vimpat® (lacosamide) C-V Reaches 100,000 Patients Globally since Launch as an Add-On Treatment for Adults with Partial-Onset Seizures

ATLANTA — February 11, 2011 /PRNewswire/ — UCB today announced that sales of Vimpat® (lacosamide) have made this anti-epileptic drug available to 100,000 patients since its launch for use as an add-on treatment for adults with partial-onset seizures. Vimpat® has demonstrated effectiveness and tolerability when combined with a broad range of anti-epileptic drugs (AEDs).

UCB demonstrates its commitment to raising the standard of care in epilepsy through multiple channels – providing innovative medicines and patient programs that foster independence and empower people living with epilepsy to expect the best care possible. Additionally, UCB continues clinical investigation of Vimpat® for new indications, as well as research on its use in the treatment of partial-onset seizures.

In recent analyses, Vimpat® showed significant reduction in the frequency of seizures for up to five years, a consistent long-term tolerability profile and improvement of health-related quality of life assessments on a long-term basis.

Vimpat Milestones in the U.S.

  • October 2008 – Vimpat® tablets and injection were approved by the U.S. FDA as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older. Vimpat® injection is indicated as short-term replacement therapy when oral solution is temporarily not feasible.
  • May 2009 – Vimpat® tablets and injection were launched in the U.S. and available in pharmacies. Multiple formulations ensure that patients can maintain consistent Vimpat® treatment.
  • June 2010 – UCB launched Vimpat® oral solution, ensuring that patients can maintain consistent Vimpat® treatment in any clinical setting.
  • February 2011 – Vimpat® reached 100,000 patients.

The maximum recommended daily dose for Vimpat® in the U.S. is 400 mg/day. Vimpat® is also available in Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Finland, Germany, Greece, Ireland, Italy, Netherlands, Norway, Russia, Slovak Republic, Spain, Sweden, Switzerland, UK and the US. Indications and doses may vary by country.

Important safety information about Vimpat® in the U.S.

Warnings and Precautions

AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Patients should be advised that Vimpat® may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat® should be discontinued.

VIMPAT® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of VIMPAT® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Common Adverse Reactions

The most common adverse reactions occurring in ≥10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.

Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended.

For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx, and for more information on Vimpat®, visit Vimpat.com or contact UCB at (800) 477-7877.

Vimpat® is a Schedule V controlled substance.

Vimpat® is a registered trademark under license from Harris FRC Corporation.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting approximately 40 million people worldwide and three million people in the U.S.—making it as common as breast cancer. Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. More than 1 million patients in the U.S. continue to have seizures despite initial therapy, and more than 800K patients in the U.S. continue to have seizures despite treatment with two or more therapies. New medications and treatments give hope to those living with uncontrolled seizures.

About UCB

UCB, Brussels, Belgium (www.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 8,000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).

Forward-looking statements

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.

Further Information
Andrea Levin, Senior Manager, Communications & PR, CNS, UCB, Inc.
T 770.970.8352
M 404.483.7329
Andrea.Levin@ucb.com

Meghan Campbell
Cooney/Waters Group
T 212.886.2223
MCampbell@cooneywaters.com