Lundbeck And Biotie Sign Agreement For Nalmefene
27 November 2006, H. Lundbeck A/S and Biotie Therapies Corp. have today signed an agreement on worldwide rights for nalmefene, excluding North America, Mexico, UK, Ireland, Turkey, and South-Korea. Under the terms of the agreement, BioTie has granted Lundbeck an exclusive license to market and distribute nalmefene as a prescription medicine for the treatment of substance abuse disorders and impulse control disorders.
Under the terms of the agreement, BioTie will receive an execution fee of EUR 15 million, of which EUR 10 million is payable on signing. The license enters into force in 2007. In total, BioTie is eligible for up to EUR 88 million in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product in its territory.
BioTie has recently announced that it has submitted the first Marketing Authorisation Application on nalmefene for the treatment of alcohol dependence to the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK. UK acts as reference in the Mutual Recognition Process for EU approval.
Timo Veromaa, President and CEO of BioTie, said: “We are extremely pleased to have Lundbeck as our partner for nalmefene. Lundbeck is a global leader in therapeutics for psychiatric disorders, which makes it an ideal partner for BioTie. With this agreement we now have partnered the product worldwide and expect it to generate significant revenues to the company in the long term.”
Claus Bræstrup, President and CEO of H. Lundbeck A/S, said: “Nalmefene has a significant potential for helping patients with alcohol abuse. Alcohol abuse is comorbid among patients suffering from depression and schizophrenia as well as other psychiatric disorders and alcohol abuse constitute a major health and social problem.”
Nalmefene is a specific opioid receptor antagonist. BioTie has studied the safety and efficacy of nalmefene in a total of 1,200 patients, including two phase III studies in the UK and Finland in patients suffering from alcoholism and alcohol dependence.
Nalmefene is the first oral drug showing efficacy in reducing heavy drinking in multicenter, controlled studies.
The treatment of alcoholism represents a significant unmet medical need. More than 30 million people in the US, Europe and Japan suffer from alcohol abuse (Datamonitor 04/2002). Every year, in the UK alone, there are 150,000 hospital admissions and 20,000 premature deaths directly due to alcohol, 1.2 million alcohol related violent incidents, and National Health Service estimates the annual costs of alcohol abuse to range between GBP 1.4 billion and GBP 1.7 billion.
The upfront payment of EUR 10 million made by Lundbeck to BioTie will be depreciated over a period of several years and will not affect previously guided expectations for the Lundbeck group’s financial result for 2006 of approximately DKK 1.6 billion on the EBIT line excluding the financial gain from the initial public offering of LifeCycle Pharma.
Turku, November 27, 2006
Biotie Therapies Corp.
Timo Veromaa President and CEO
Biotie Therapies Corp.
BioTie is a Finnish biotech company with focus on dependence disorders, inflammatory diseases and thrombosis. The Company started operations in 1996 and as a pioneer in dependence disorders has been developing nalmefene for the treatment of alcoholism and pathological gambling since 1999. (www.biotie.com)
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2005, the company’s revenue was DKK 9.1 billion (approximately EUR 1.2 billion or USD 1.5 billion). The number of employees is approximately 5,000 globally. For further information, please visit www.lundbeck.com
- Contact Information
- Timo Veromaa
- President and CEO
- Biotie Therapies Corp.
- Contact via E-mail
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