Sycrest® roll-out starts with the launch of the product in the important European region
* Denmark is the first country to launch Sycrest(®)
* Sycrest(®) is a unique opportunity and an excellent fit to Lundbeck's
psychiatry franchise with strong commercial synergies
* Significant unmet need still exists for therapies effectively achieving
remission in bipolar disorder
* Sycrest(®) is expected to add significant revenue to Lundbeck in the coming
years
H. Lundbeck A/S (Lundbeck) today announced the launch of Sycrest(®) (asenapine)
sublingual tablets (5 mg, 10 mg) for the treatment of moderate to severe manic
episodes associated with bipolar I disorder in adults in Europe with Denmark
being the first country to launch. Sycrest(®) was licensed from Merck & Co.
(known as MSD outside the United States and Canada) in October 2010, and
Lundbeck was granted exclusive commercial rights in all markets outside the
United States, Japan and China. On September 1 2010, Sycrest(®) received
European Union (EU) approval from the European Medicines Agency (EMA) based on
clinical data showing significant remission (vs. placebo) in bipolar patients
with manic and mixed episodes.
Adult bipolar I disorder in the EU is still highly under-diagnosed and
undertreated. In addition change in treatment schedule is common due to lack of
efficacy or safety and tolerability concerns. Sycrest(®) represents another
treatment option for patients within this undertreated population.
Lundbeck expects to launch the product in additional approximately 15 European
and international markets during 2011
"We are extremely pleased that we are now ready to start the roll-out of Sycrest
in Europe as it will be an important product in Lundbeck's portfolio of
innovative CNS products," says Executive Vice President Stig Løkke Pedersen,
Head of Commercial Operations. He continues: "Sycrest will be an important, new
choice for healthcare providers to help patients manage the symptoms of bipolar
I disorder."
About Sycrest(®
)Sycrest(®), a new untypical antipsychotic medication, received marketing
approval in the EU on 1 September 2010 for the treatment of moderate to severe
manic episodes associated with bipolar I disorder in adults. The marketing
approval applied to all 27 EU member states.
Additional regulatory applications for Sycrest(®) are pending in other markets.
For full prescribing information, please refer to the Summary of Product
Characteristics.
Sycrest(®) is a registered trademark of N.V. Organon, a subsidiary of Merck &
Co., Inc., Whitehouse Station, N.J., U.S.A.
Financial guidance
The content of this release will have no influence on the Lundbeck Group's
financial guidance for 2011 which was provided on 24 February 2011 in connection
with the release of the financial results for 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, 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 2010,
the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.
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