The clinical phase III programme commenced on zicronapine
* Based on the solid outcome from the clinical phase II studies, the clinical
phase III programme has now been initiated
* The first study is a risperidone-controlled fixed-dose study which will
enrol ~160 patients with schizophrenia. Treatment duration is six months
* Classical short term efficacy studies will be initiated in due time.
H. Lundbeck A/S (Lundbeck) announced today the advancement of zicronapine into
clinical phase III based on the positive clinical phase II data.
The first study in the clinical phase III programme is expected to enrol some
160 patients with the aim to measure the efficacy of zicronapine and risperidone
and their relative impact on key metabolic parameters. Long term relative safety
and efficacy is a key factor in determining appropriate use of newer
antipsychotics. The patients will be randomly assigned to zicronapine (7.5
mg/day) or risperidone (5 mg/day) treatment in a 1:1 ratio. The study is
expected to enrol patients in several countries in Europe. Classical short term
efficacy studies will be initiated in due time.
The pivotal program is planned to include further phase III studies to
investigate the compound's benefit and risk profile.
"We are very pleased to be able to announce the initiation of the continued
programme for zicronapine", said Executive Vice President Anders Gersel
Pedersen, head of Development at Lundbeck. "With zicronapine, we look forward to
be able to offer patients and their physicians a new treatment option within an
area still characterised by substantial unmet medical needs"
Zicronapine (formerly known as Lu 31-130) is a new type of compound with a
strong pro-cognitive effect in animal models and the potential to treat a number
of neurological and psychiatric diseases. In the phase II development programme,
zicronapine has shown strong, positive anti-psychotic effects. The programme
consisted of a placebo-controlled study and an olanzapine-referenced study,
which in total involved approximately 375 patients. In the placebo-controlled
trial, zicronapine showed clear dose-response and a statistically significant
improvement in Positive and Negative Syndrome Scale (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.
About the clinical phase II 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
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.
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.
Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2010 which was provided on 4 March 2010 in connection
with the release of the financial results for 2009 and further specified with
the release of the third quarter report on 3 November 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 and 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 2009,
the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.
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