Lundbeck receives FDA Complete Response Letter on Serdolect® for the treatment of schizophrenia
H. Lundbeck A/S (LUN.CO; LUN DC) announced today that the company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Serdolect® (sertindole) for the treatment of schizophrenia.
The Agency's complete response included request for additional data to best understand the appropriate patient population for which Serdolect® could be made available. Lundbeck is currently evaluating the feedback from FDA and will work with the Agency to resolve these outstanding questions and discuss appropriate next steps required to bring Serdolect® safely to market. In the coming months Lundbeck is committed to addressing the FDA's CRL and will work with the Agency to expedite completion of its review. About Serdolect® Serdolect® is an anti-psychotic drug under regulatory review in the US for the treatment of schizophrenia. It is believed that Serdolect® has an inhibitory effect on central dopamine D2 and serotonin 5-HT2 receptors as well as on alpha-adrenergic receptors. Clinical trial data from short-term studies suggest that Serdolect® do not have a sedative effect and has placebo level extrapyramidal symptoms (EPS). Serdolect® received marketing approval for the treatment of schizophrenia from the European Commission on 20 December 2005. Serdolect® is launched in 40 countries worldwide. It is not yet approved for use in the United States. Serdolect® derives from Lundbeck's in-house research and the company holds the global rights. About schizophrenia 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 major 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. Lundbeck contacts Investors: Media: Jacob Tolstrup Mads Kronborg Director, IR & Communication Media Relations +45 36 43 30 79 +45 36 43 28 51 Palle Holm Olesen Kasper Riis Head of Investor Relations Media Relations +45 36 43 24 26 +45 36 43 28 33 Magnus Thorstholm Jensen Investor Relations Manager +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, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck was founded in1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today over 5.500 people worldwide. Lundbeck is one of the worlds 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.