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FDA Accepts Lundbeck Inc.'s Submission Of NDA For Clobazam


3/4/2011 1:48:38 PM

March 4, 2011 -- H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older. The filing was assigned a standard review and an action letter is anticipated in the fourth quarter 2011. Additionally, Lundbeck announced Onfi(TM) (pronounced "on-fee") as the proposed trade name for clobazam in the US.

The NDA submission is based on a clinical development program that evaluated the safety and efficacy of OnfiTM as add-on therapy in patients with LGS. Positive results from the largest clinical phase III trial ever conducted in patients with LGS were presented at the December 2010 annual meeting of the American Epilepsy Society (AES).1,2

"We are very pleased that we have submitted an NDA for Onfi(TM) as this will potentially provide patients suffering from Lennox-Gastaut syndrome in the US with a new treatment option," says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck, and continues: "Lennox-Gastaut syndrome is a serious disease and most patients experience multiple types of seizures with periods of frequent seizures, and daily seizures are common. There is still a great need for improved therapies to offer patients."

LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood.3,4,9 Most patients with LGS experience multiple types of seizures with periods of frequent seizures, and daily seizures are common.10 Some of these seizures may cause falls, or "drop seizures," which may result in injury.6

About OnfiTM (clobazam)

Clobazam is a 1,5-benzodiazepine that potentiates the inhibitory action of gamma-aminobutyric acid (GABA) by binding to GABA-A receptors.7,8 GABA-A receptors contain a benzodiazepine binding site, also referred to as the omega receptor , of which three subtypes have been identified.7 In non-clinical studies, clobazam was shown to have higher affinity for the omega-2 compared to the omega-1 receptor.7 The precise mechanism of action by which clobazam exerts its antiepileptic effects is unknown.

Clobazam is marketed outside of the US under various brand names, including Frisium® and Urbanyl®. Brand names listed are property of their owners.

About Lennox-Gastaut Syndrome

Lennox-Gastaut syndrome (LGS) is a rare and severe form of epilepsy characterized by multiple types of seizures, mental retardation or regression, and abnormal electroencephalogram (EEG) with generalized slow spike and wave discharges (1.5-2 Hz).3,5,9 Responsible for 1-4 percent of all childhood epilepsies,5 LGS typically occurs between two and eight years of age (peak onset occurs from 3-5 years).3 Eighty percent of those with LGS will have continued seizures throughout childhood and into their adult years.3 LGS is associated with multiple seizure types, including atonic, tonic and myoclonic seizures, which can all cause falls, or "drop seizures", that are associated with a high rate of recurrent injuries.6 Prognosis for individuals with LGS varies, and complete recovery, including freedom from seizures and normal development, is uncommon.9

Financial guidance

The content of this release will have no influence on the Lundbeck Group's financial guidance for 2011 which was provided on 24 February 2011 in connection with the release of the financial results for 2010.

Lundbeck contacts

Investors: Media:

Palle Holm Olesen Mads Kronborg Chief Specialist, Investor Relations Media Relations Manager +45 36 43 24 26 +45 36 43 28 51

Magnus Thorstholm Jensen Stine Hove Marsling Investor Relations Officer External Communication Specialist +45 36 43 38 16 +45 36 43 28 33

Jacob Tolstrup Vice President +1 847 282 5713

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2010, the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.

Sources

1 Conry, Joan A. et. Al "Efficacy and Safety of Clobazam in the Treatment of Seizures Associated with Lennox-Gastaut Syndrome: Results of a Phase III Trial." Lundbeck Poster 1.283 December 2010.

2 Hancock, Eleanor and Helen Cross. "Treatment of Lennox-Gastaut syndrome." Cochrane Collaboration 2009

3 Van Rijckevorsel, Kenou et al. Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatric Disease and Treatment. 2008: 4(6) 1001-1019

4 Arzimanoglou, Alexis et al. Lennox-Gastaut syndrome: a consensus approach on diagnosis, assessment, management, and trial methodology. The Lancet. 2009: 8(1) 82-93

5 Medscape. Lennox-Gastaut Syndrome. http://emedicine.medscape.com/article/1176735-overview. Last accessed 10/11/10

6 Dulac, Olivier and Jerome Engel. Lennox-Gastaut Sydnrome. International League Against Epilepsy. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/lennox_gastaut.cfm. Last accessed 10/11/10

7 Nakajima H. A pharmacological profile of clobazam (Mystan), a new antiepileptic drug. Nippon Yakurigaku Zasshi 2001;118(2):117-122.

8 Sanger DJ, Benavides J, Perrault G, et al. Recent developments in the behavioral pharmacology of benzodiazepine (omega) receptors: evidence for the functional significance of receptor subtypes. Neuroscience and Biobehavioral Review 1994;18:355-372.

9 NINDS. Lennox-Gastaut Syndrome Information Page. http://www.ninds.nih.gov/disorders/lennoxgastautsyndrome/lennoxgastautsyndrome. htm. Last accessed 9/28/10

10 Borggraefe I, Noachtar S. Pharmacotherapy of Seizures Associated with Lennox-Gastaut Syndrome. Clinical Medicine Insights: Therapeutics. 2010:2 15-24.


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