Positive Pivotal Results on escitalopram in Japan - Lundbeck's Partner Mochida Plans to File escitalopram for Regulatory Approval in First Quarter 2011 at the Latest
COPENHAGEN, Denmark, May 17, 2010--H. Lundbeck A/S (Lundbeck) today announced that the results from the pivotal study with escitalopram in Japan have been received. The results are positive and according to expectations.
In April 2008 Mochida
Pharmaceutical Co., Ltd. (Mochida) initiated the clinical phase III
placebo-controlled study in major depression (MDD).
Approximately 480patients with
MDD were randomised to receive escitalopram (10 or 20mg),
paroxetine or placebo.
In May 2002,
Lundbeck entered a license agreement for the development and
commercialisation of escitalopram in Japan with Mochida. In January
2010, Mochida announced that the company had signed an agreement to
co-market escitalopram in Japan with Mitsubishi Tanabe Pharma
Corporation.
The financial
terms of the agreement have not been
disclosed, but Lundbeck is to receive regulatory
milestone payments and royalties on sales.
Following the
results of the pivotal trial in Japan, Mochida will proceed towards
a regulatory filing of escitalopram in Japan in the first quarter
of 2011 at the latest. If
approved, Lundbeck expects that escitalopram in Japan could be an
important contributor to Lundbeck's financial performance in the
coming years.
Japan
anti-depressant
market
The number of patients with depression in Japan is increasing every year, and is currently estimated to exceed one million. Escitalopram has been very well-received by patients and doctors worldwide for the treatment of depression, and is expected to offer a new treatment option for patients with depression in Japan.
The number of patients with depression in Japan is increasing every year, and is currently estimated to exceed one million. Escitalopram has been very well-received by patients and doctors worldwide for the treatment of depression, and is expected to offer a new treatment option for patients with depression in Japan.
In 2009, the
Japanese antidepressant market (N6A) had a value of USD 1.1 billion
according to IMS, and increasing with double digit growth rates in
the past years. The three most dominant antidepressants in Japan
were by the end of 2009 paroxetine with a value market share of
approximately 42%, sertraline with a share of approximately 20% and
fluvoxamine with a share of approximately 16%.
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.
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.
Lundbeck contacts
|
Investors:
|
Media:
|
|
|
|
|
Jacob Tolstrup
|
Mads Kronborg
|
|
Vice President, IR &
Communication
|
Media Relations Manager
|
|
+45 36 43 30 79
|
+45 36 43 28 51
|
|
|
|
|
Palle Holm Olesen
|
Stine Hove Marsling
|
|
Chief Specialist, Investor
Relations
|
External Communication
Specialist
|
|
+45 36 43 24 26
|
+45 36 43 28 33
|
|
|
|
|
Magnus Thorstholm Jensen
|
|
|
Investor Relations
Officer
|
|
|
+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, epilepsies, Alzheimer's and Parkinson's diseases.
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, epilepsies, Alzheimer's and Parkinson's diseases.
Lundbeck was
founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and
employs today 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.
H. Lundbeck A/S (Lundbeck) today announced that the results from the pivotal study with escitalopram in Japan have been received. The results are positive and according to expectations.
In April
2008 Mochida Pharmaceutical Co., Ltd.
(Mochida) initiated the clinical phase III placebo-controlled study
in major depression (MDD). Approximately
480patients with MDD were randomised to receive
escitalopram (10 or 20mg), paroxetine or
placebo.
In May 2002,
Lundbeck entered a license agreement for the development and
commercialisation of escitalopram in Japan with Mochida. In January
2010, Mochida announced that the company had signed an agreement to
co-market escitalopram in Japan with Mitsubishi Tanabe Pharma
Corporation.
The financial
terms of the agreement have not been
disclosed, but Lundbeck is to receive regulatory
milestone payments and royalties on sales.
Following the
results of the pivotal trial in Japan, Mochida will proceed towards
a regulatory filing of escitalopram in Japan in the first quarter
of 2011 at the latest. If
approved, Lundbeck expects that escitalopram in Japan could be an
important contributor to Lundbeck's financial performance in the
coming years.
Japan
anti-depressant
market
The number of patients with depression in Japan is increasing every year, and is currently estimated to exceed one million. Escitalopram has been very well-received by patients and doctors worldwide for the treatment of depression, and is expected to offer a new treatment option for patients with depression in Japan.
The number of patients with depression in Japan is increasing every year, and is currently estimated to exceed one million. Escitalopram has been very well-received by patients and doctors worldwide for the treatment of depression, and is expected to offer a new treatment option for patients with depression in Japan.
In 2009, the
Japanese antidepressant market (N6A) had a value of USD 1.1 billion
according to IMS, and increasing with double digit growth rates in
the past years. The three most dominant antidepressants in Japan
were by the end of 2009 paroxetine with a value market share of
approximately 42%, sertraline with a share of approximately 20% and
fluvoxamine with a share of approximately 16%.
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.
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.
Lundbeck contacts
|
Investors:
|
Media:
|
|
|
|
|
Jacob Tolstrup
|
Mads Kronborg
|
|
Vice President, IR &
Communication
|
Media Relations Manager
|
|
+45 36 43 30 79
|
+45 36 43 28 51
|
|
|
|
|
Palle Holm Olesen
|
Stine Hove Marsling
|
|
Chief Specialist, Investor
Relations
|
External Communication
Specialist
|
|
+45 36 43 24 26
|
+45 36 43 28 33
|
|
|
|
|
Magnus Thorstholm Jensen
|
|
|
Investor Relations
Officer
|
|
|
+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, epilepsies, Alzheimer's and Parkinson's diseases.
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, epilepsies, Alzheimer's and Parkinson's diseases.
Lundbeck was
founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and
employs today 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.
Posted: May 2010
