Biotie Signs Further Nalmefene Marketing Agreements, Is Submitting MAA
- Deals concluded to cover Turkey and South-Korea
- Final MAA package to be submitted to the UK MHRA imminently
Biotie Therapies Corp. has today signed marketing and distribution agreements for nalmefene with Eczacibasi Ilaç Pazarlama AS (Eczacibasi), based in Istanbul, for nalmefene in Turkey; and with Whanin Pharmaceutical Co., Ltd. (Whanin), based in Seoul, for nalmefene in South-Korea.
Under the terms of the Eczacibasi agreement, BioTie has granted Eczacibasi an exclusive license to market and distribute nalmefene as a prescription medicine for the treatment of substance abuse disorders and impulse control disorders in Turkey. Eczacibasi will purchase nalmefene finished product from BioTie and Eczacibasi will be responsible for its registration, sales and marketing. BioTie will receive an undisclosed amount upfront and is eligible for milestone payments plus royalty on sales.
Under the terms of the Whanin agreement, BioTie has granted Whanin an exclusive license to market and distribute nalmefene as a prescription medicine for the treatment of substance abuse disorders and impulse control disorders in South-Korea. Whanin shall be responsible for the regulatory filings in South-Korea on behalf of BioTie and commits to a clinical program for the registration and development of nalmefene in the territory. BioTie is eligible for an undisclosed amount in milestone payments plus royalty on sales.
BioTie is currently in advanced negotiations with potential licensing and distribution partners in key markets, and expects to conclude similar marketing and distribution agreements by mid 2007. From now on, as a policy BioTie intends to issue separate stock exchange releases on nalmefene marketing and distribution agreements only for major territories. Due to their expected limited immediate financial impact to BioTie, executed agreements covering smaller territories will be announced in connection with the interim reports issued quarterly, or in connection with other announcements.
BioTie has provided its UK marketing partner Britannia Pharmaceuticals all regulatory documentation to be included in the Marketing Authorisation Application (MAA) for the product’s alcoholism indication. The final electronic submission package is to be submitted to the UK Medicines and Healthcare products Regulatory Authority (“MHRA”) imminently.
A decision from the MHRA is expected in the second half of 2007. Pending approval of the MAA Britannia Pharmaceuticals anticipates launching oral nalmefene in the UK in 2007. Following the anticipated approval in the UK in 2007, marketing authorisations in other EU member states will be pursued via the mutual recognition procedure. Launches in other EU member states for the alcoholism indication are expected in 2008. Oral nalmefene is expected to gain 10 year market exclusivity in the EU.
Nalmefene is a specific opioid receptor antagonist. BioTie has studied safety and efficacy of nalmefene in a total of 1,200 patients, including two pivotal phase III studies in the UK and Finland in patients suffering from alcoholism and alcohol dependence, and a phase II clinical study in the USA in patients diagnosed with pathological gambling disorder. BioTie holds several patents and other intellectual property rights on nalmefene and its use in the USA, Europe, and Japan for the treatment of alcoholism and alcohol dependence.
The treatment of alcoholism represents a significant unmet medical need. Between 30-60 million people in the US, Europe and Japan suffer from alcohol abuse. 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 of the annual costs of alcohol abuse range between GBP 1.4 billion and GBP 1.7 billion.
Nalmefene is the first oral drug showing efficacy in reducing heavy drinking in multicenter, controlled studies. Whereas all presently marketed pharmaceuticals for the treatment of alcoholism aim at complete abstinence or aversion therapy, nalmefene has been developed for the reduction of heavy drinking.
Turku, 27 October, 2006
Biotie Therapies Corp.
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)
Eczacibasi is a prominent Turkish industrial group with a combined net turnover of close to USD 2.6 billion, 37 companies and more than 8,000 employees in 2005. Eczacibasi’s core sectors are pharmaceuticals, building materials and consumer products. The Eczacibasi Pharamaceuticals Division (Eczacibasi Ilaç Pazarlama AS) is the largest Turkish manufacturer of pharmaceuticals, veterinary drugs and personal care products.
For further information please contact: General Manager Mrs.Ayse Deniz Ozger. E-mail: firstname.lastname@example.org , Phone : + 90 212 350 8639
Whanin Pharmaceutical Co., Ltd.
Whanin Pharmaceutical Co., Ltd. is a publicly held South Korean pharmaceutical company that develops, markets, manufactures and sells therapeutic products focusing for the treatment of psychiatric, neurological and metabolic diseases. Sales in 2005 were 66.5 billion Korean Won (about 55 million Euros).
For further information please contact:
Sean Kim, Executive Director, New Product Planning, Whanin Pharmaceutical Co., Ltd. Tel. +82 2 405 3000, e-mail: email@example.com (www.whanin.com or www.whanin.com/jsp/eng/index.jsp)
- Contact Information
- Timo Veromaa
- President and CEO
- Biotie Therapies Corp.
- Contact via E-mail
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