Zicronapine shows significant positive data in clinical phase II in the treatment of patients with schizophrenia - planning for continued clinical work

H. Lundbeck announced strongly positive headline results from the clinical trials in the phase II development programme with zicronapine in schizophrenia

EL CAIRO, EGYPT | December 18, 2009 | H. Lundbeck A/S (Lundbeck) today announced strongly positive headline results from the clinical trials in the phase II development programme with zicronapine in schizophrenia. The programme consisted of two studies which in total involved approximately 375 patients.

In the two recently completed randomised clinical phase II trials, zicronapine was tested in several dosages between 3-10 mg/day. The two studies were exploratory and therefore not powered to show clear statistical differences. However, in the studies zicronapine did show clear statistical significant separation from placebo at 7 and 10 mg and very convincing efficacy and safety data when compared to olanzapine justifying further development.

In the placebo-controlled trial, zicronapine showed clear dose-response and a statistically significant improvement in PANSS score on both 7 and 10 mg. In the olanzapine-referenced study, zicronapine showed comparable reduction in PANSS score.

From both trials it can be concluded that zicronapine was safe and well-tolerated. In the olanzapine-referenced study the number of withdrawals was similar to the level of withdrawals in the olanzapine-group.

"We are pleased to see the efficacy and supportive data enabling us to continue the development program," says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. "We are also pleased that the good safety profile seen in earlier studies now is confirmed in a much larger patient population."

In the coming months, Lundbeck will finalise the planning for additional clinical work including plans for the pivotal programme.

About the study

In the placebo-controlled clinical phase II study approximately 280 patients from 11 countries suffering from schizophrenia were enrolled. Eligible patients have been randomised in a 2:1 ratio to blinded treatment with either zicronapine (3, 5, 7 and 10 mg/day) or placebo for 8 weeks. The primary focus of this trial was safety and tolerability measured by adverse events, clinical safety laboratory tests and metabolic parameters. Secondary outcome measures included Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Severity/Improvement (CGI-S/I) scores.

In the second clinical phase II study approximately 93 patients were enrolled from nine countries. Eligible patients were randomised to treatment with either flexible doses (5-7 mg/day) of zicronapine or flexible doses of olanzapine (10-15 mg/day) for 12 weeks. The efficacy and the safety of zicronapine were explored in comparison to olanzapine. The primary outcome measures included the PANSS score. Secondary outcome measures included CGI-S/I and Calgary Depression Scale for Schizophrenia (CDSS) scores.

About zicronapine (previously known as Lu 31-130)

Zicronapine has a multi-receptorial profile. In vitro and in vivo, zicronapine has shown potent antagonistic effects at dopamine D1, D2 and 5-HT2a receptors. Based on the profile from antipsychotic animal models, zicronapine was expected to show clear and convincing effects in patients with schizophrenia and likely associated with low potential for neurological side effects and a benign safety/tolerability profile.

About schizophrenia

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptoms of the disease. Thus, only one dimension of the morbidity, that is, the positive symptoms, can be expected to respond to treatment whereas negative symptoms and cognitive deficits are, at best, only marginally targeted.

Given this, there is no doubt that the current antipsychotic drugs leave much room for improvement and call for new, more effective pharmacotherapies in the treatment of schizophrenia.

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 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.

SOURCE: H. Lundbeck A/S

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