H. Lundbeck A/S (Lundbeck) and Merck & Co. (Merck), also known outside the United States and Canada as MSD, today announced a commercialisation agreement for SYCREST® (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST® in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST® in the European Union (EU), where it is already approved at the beginning of 2011. Merck will retain exclusive commercial rights to asenapine in the United States, China and Japan. Merck has launched asenapine in the United States under the brand name SAPHRIS® (asenapine) sublingual tablets (5 mg, 10 mg).
"We are very pleased to be collaborating with Lundbeck on this important commercial milestone. Lundbeck has extensive experience in psychiatry and is the ideal partner to provide physicians and their patients with access to this important medicine in the markets where they will commercialise SYCREST®," said Beverly Lybrand, senior vice president and general manager, neuroscience and ophthalmology, Merck. "Merck will continue to focus our efforts on marketing SAPHRIS® in the United States, as part of our ongoing commitment to researching, developing and delivering medicines in the neurosciences disease areas."
"This agreement highlights our strategic focus on late-stage specialty central nervous system (CNS) products and our ambition to provide long-term growth opportunities for Lundbeck," said Ulf Wiinberg, president & chief executive officer at Lundbeck. "We are very pleased to include SYCREST® in our existing portfolio of specialty CNS products and see great opportunities to leverage our highly dedicated sales infrastructure."
About SYCREST®/SAPHRIS®
SYCREST®, an atypical 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.
In the United States, SYCREST® is marketed as SAPHRIS®. It was approved by the U.S. Food and Drug Administration (FDA) on 13 August 2009 for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. On 7 September 2010, two supplemental new drug applications (sNDA's) for SAPHRIS® were approved in the United States to expand the product's indications to the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
About MSD (Merck & Co.)
Today's MSD is a global healthcare leader working to help the world be well. MSD is a trade name of Merck & Co., Inc. with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information visit www.msd.com.
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.
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.