Lundbeck will submit an NDA for clobazam for patients with Lennox-Gastaut syndrome with the FDA before year end 2010
In March 2009, H. Lundbeck A/S (Lundbeck) acquired Ovation Pharmaceuticals, Inc. (now Lundbeck Inc.). As part of the acquisition Lundbeck obtained the rights for clobazam in the US, a product in development for patients with Lennox-Gastaut syndrome (LGS). Lundbeck expects clobazam to be able to provide additional growth opportunities for the US operation as well as for the whole group. Lundbeck is very pleased to announce highly statistically significant positive findings from the pivotal clinical phase III study with clobazam. A New Drug Application (NDA) for clobazam is anticipated to be submitted with the U.S. Food and Drug Administration (FDA) before year end 2010. In the four armed placebo-controlled phase III study, including add-on treatment in 238 patients with LGS, clobazam met its primary endpoint and was further supported by results for several key secondary endpoints. Top-line data demonstrated that the two highest doses of clobazam, tested versus placebo, showed a highly statistically significant reduction in the number of drop seizures (average per week) from the 4-week baseline period to the 12-week maintenance period. In the study, clobazam was generally well tolerated and the overall safety profile in this study was consistent with that described in literature. The most frequent adverse events included somnolence and lethargy. The majority of patients completed the study and went on to receive clobazam in a long-term extension study. Following analysis of the clinical phase III results, Lundbeck is now initiating interactions with FDA as well as scientific advisors to discuss the study outcome and the plans for submitting an NDA for clobazam as a treatment for LGS. "Lennox-Gastaut syndrome is one of the most severe forms of epilepsy and there is a clear need for new treatment options. We are delighted to see these encouraging data for clobazam, bringing us an important step closer to providing a new treatment option to the patients in need" says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck, and continues: "Also, clobazam has the potential to contribute, in a significant manner, to Lundbeck's growth opportunities in the years to come." Financial guidance The content of this release will have no influence on the Lundbeck Group's financial guidance for 2010 which were provided on 4 March 2010 in connection with the release of the financial results for 2009. About the clinical phase III study The double-blind, placebo-controlled clinical phase III study was designed to evaluate the safety and efficacy of clobazam as adjunctive therapy in the reduction of drop seizures at three dose levels (0.25, 0.5 and 1.0 mg/kg) in children and adults (ages 2-60 years) with LGS. The primary outcome measure was the percent reduction in the number of drop seizures (average per week) from the 4-week baseline period compared to the 12-week maintenance period. 238 patients with LGS were recruited at more than 60 sites in the U.S. as well as in other countries around the world, including Australia and India. For more information and study locations, please visit www.clinicaltrials.gov. About clobazam As a 1,5-benzodiazepine, clobazam has a distinctive chemical structure as compared to other currently available benzodiazepines. In previous studies, clobazam was shown to be well tolerated in patients with LGS and a phase II study met the primary endpoint of a reduction in drop seizures compared to baseline. Drop seizures are the most debilitating of the LGS seizure types, which can result in severe trauma associated with falls. Currently, clobazam is widely available worldwide with approvals in more than 100 countries for various uses in both children and adults, including the treatment of epilepsy and anxiety. Though not currently approved for any use in the US, the current study is part of a clinical development program to obtain FDA approval for clobazam as adjunctive treatment for patients with LGS. About Lennox-Gastaut syndrome (LGS) LGS is a rare form of epilepsy which is characterized by multiple seizure types. Its onset typically occurs between three and 10 years of age and it frequently persists into adulthood. This severe and debilitating form of epilepsy represents up to 10 percent of all childhood epilepsies. Sudden drop attacks are a central feature of LGS and frequently result in injury. Up to 90 percent of children with LGS are affected by developmental delay or regression and commonly experience behavioural and sleep disturbances as well. LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug provides satisfactory relief for all or most patients with LGS, and a combination of treatments is often required. Many patients with LGS are refractory to standard anti-epileptic treatment. Lundbeck contacts Investors: Media: Jacob Tolstrup Mads Kronborg Vice President, IR & Communication Media Relations Manager +45 36 43 30 79 +45 36 43 28 51 Palle Holm Olesen Stine Hove Marsling Chief Specialist, Investor Relations External Communication Specialist +45 36 43 24 26 +45 36 43 28 33 Magnus Thorstholm Jensen Investor Relations Officer +45 36 43 38 16 About Lundbeck H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com. [HUG#1418334]