SerdolectTreatment for Schizophrenia
Serdolect NDA Update
Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia
COPENHAGEN, May 18, 2009--H. Lundbeck A/S announced today that it has not yet received an action letter from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for Serdolect (sertindole) for the treatment of schizophrenia. The company anticipated receipt of the action letter on May 15, 2009, the originally assigned Prescription Drug User Fee Act (PDUFA) date. The FDA informed the company that they would receive the action letter as soon as possible.
Serdolect derives from Lundbeck's in-house research and the company holds the global rights. Serdolect has a unique neuropharmacological profile, characterized by inhibitory effects on dopamine D2, serotonin 5-HT2 and 5-HT6 receptors, as well as on alpha1-adrenergic receptors. Serdolect has a high limbic selectivity, indicating antipsychotic activity without potential for extrapyramidal motor side effects. It has no effect on muscarinic cholinergic and histamine H1 receptors, which could be associated with cognitive and sedative side effects. The preclinical profile has been confirmed in clinical trials.
Schizophrenia is a serious and often chronic mental disorder affecting up to one percent of the world's population. In many patients the disorders start during late adolescence or early adulthood leading to severe changes in the patient's way of thinking and perceiving the outside world.
During the course of the illness, periods during which the patient is in an acute psychotic condition and suffering from definite hallucinations and delusions alternate with more stable periods during which the patient experiences a significant reduction in symptoms. However, even in stable periods, many patients have difficulty in establishing social contact, completing an education programme or holding a normal job. Schizophrenia patients may have significant difficulties in performing daily activities necessary for independent living. The occurrence of suicide and suicidal behaviour is a major burden for patients, families and society. Suicide is a leading cause of premature deaths among patients with schizophrenia. Schizophrenia is also associated with increased medical morbidity like respiratory or cardiovascular diseases which all contribute to a significantly lower life expectancy.
The disorder is often disabling and produces important emotional and financial hardship for the patient and the patient's family. Furthermore, schizophrenia causes a major economic burden to society, not only due to the direct treatment costs but also because of a reduced ability to work forcing many patients to claim disability or pensions.
Financial guidance The content of this release will have no influence on the Lundbeck Group's financial result for 2009.
Jacob Tolstrup Mads Kronborg
Director, IR & Communication Media Relations
+45 36 43 30 79 +45 36 43 28 51
Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26
H. Lundbeck A/S 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, Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today over 5.500 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2008, the company's revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD 2.2 billion). For more information, please visit www.lundbeck.com.
Posted: May 2009
- FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia - April 8, 2009
- Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia - September 15, 2008