Schizophrenia - Launch Of Serdolect(R) Commenced In Europe

Main Category: Schizophrenia
Article Date: 23 Jan 2006 - 22:00 PDT

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H. Lundbeck A/S today announced that Serdolect(R) (sertindole) is now available in the first country in Europe - Estonia. This is the first launch of Serdolect(R), which received marketing approval for the treatment of schizophrenia from the European Commission on 20 December 2005. Serdolect(R) is expected to be launched in a number of countries among others the Scandinavian countries and in Germany in the first half of 2006 and in more than 15 other countries during 2006 and 2007.

"We are very pleased that patients suffering from schizophrenia can now benefit from Serdolect(R). Schizophrenia is a serious disease, and there is still a great need for offering patients improved therapies. Schizophrenic patients frequently switch drugs, either due to side-effects or lack of response, and we look forward to the fact that patients now will have access to Serdolect(R), which is different from the other antipsychotic drugs available," says Anders Gersel Pedersen, head of Lundbeck's drug development, and he continues: "The fact that Serdolect(R) is now available to the patients is the result of diligent and skilful efforts by many Lundbeck employees. We are proud of this achievement."

About Serdolect(R)

Serdolect(R) is an effective antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extra pyramidal symptoms. Serdolect(R) has an inhibitory effect on central dopamine D2 and serotonin 5HT2 receptors as well as on alpha-adrenergic receptors.

Since the 1990s, the efficacy and safety of using Serdolect(R) has been evaluated in numerous studies including more than 17,000 patients. Serdolect's clinical and pharmacological profile indicates that the drug may increase the likelihood of patients remaining in therapy, improve their daily functioning and thereby increase their quality of life and reduce the remission rate.

Since CHMP's (Committee for Medicinal Products for Human Use, under EMEA) temporary suspension of the marketing authorisation for Serdolect(R) in 1998, Lundbeck has included an additional 5,000 patients in a study confirming that Serdolect(R) can be prescribed safely.

Serdolect(R) derives from Lundbeck's in-house research, and the company holds the global rights.

About schizophrenia

Schizophrenia is a mental disorder that occurs in varying degrees but is most often chronic. Up to 1% of the world's population will, at some point in their life, be affected by schizophrenia, while approximately 0.5% will be afflicted by the disease at any given time. Schizophrenia most often occurs in late adolescence or early adulthood and is characterised by distinct changes in the patient's way of thinking and perception of the outside world. Furthermore, the disease is characterised by short or long periods during which the patient is in an acute psychotic condition, suffering from definite hallucinations and delusions. But there are also stable periods during which the patient is symptom-free or experiences a significant reduction in symptoms. Even in stable periods, many patients have difficulty in establishing social contact, complete an education programme or hold a normal job. Schizophrenia patients may have difficulty in performing even everyday activities such as cooking, personal hygiene and cleaning.

The disease is often disabling and can be very painful, first and foremost to the patient, but also to the patient's family. Furthermore, schizophrenia is a major economic burden to society, not only on account of the costs of nursing and treating the patients, but also due to their reduced ability to work and the costs of social pensions and benefit schemes.

The content of this release will have no influence on the Lundbeck Group's financial result for 2005, which will be presented 15 March 2006.

About Lundbeck

H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2004, the company's revenue was DKK 9.7 billion (approximately EUR 1.3 billion). The number of employees is approx. 5,000.

For further information, visit www.lundbeck.com

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