FDA accepts Lundbeck's submission of the New Drug Application for clobazam
* Onfi(TM) (clobazam) proposed as United States trade name
* Lennox-Gastaut syndrome is one of the most severe forms of epilepsy and
there is a clear need for new treatment options
* If approved, clobazam has the potential to contribute to Lundbeck's growth
opportunities in the years to come
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 Onfi(TM) 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 Onfi(TM) (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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