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.”
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.
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.
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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