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New treatments for dependence disorders

After 10 years of work, the first drug in Biotie Therapies’ development pipeline – nalmefene – is nearing its commercial launch, with the latest set of studies about to begin; while an early-stage drug, now in Phase 1 clinical trials, promises relief for patients with autoimmune diseases. Both products address significant unmet medical needs.
Biotie Therapies Corp.

Nalmefene, a specific opioid receptor antagonist, is the first oral drug to have proved effective in reducing heavy drinking, and represents a major breakthrough in treating dependence disorders. The drug suppresses patients’ craving for alcohol by blocking the brain’s opiate receptors.

Unlike the few pharmaceuticals currently available for treating alcohol dependence, which are designed to sustain abstinence once a person has stopped drinking, nalmefene’s focus is on reducing drinking in patients who are unwilling or unable to stop drinking completely. Total sobriety is not a requirement.

Clinical trials with over 1,200 patients have proven the efficacy of nalmefene in countering alcohol dependence; and its potential as a treatment for nicotine addiction and pathological gambling is also being studied.

Working with strong partners

Alcohol dependence is estimated to affect 3-4% of the world’s population, and market research findings indicate that the alcohol pharmacotherapy market could expand by almost 600% by 2012, to some USD 840 million.

To succeed on this highly competitive market, a small company like Biotie needs world-class partners, which is why it has teamed up with two key licensing partners, H. Lundbeck A/S, a specialist in drugs for the treatment of psychiatric and neurological disorders, and Somaxon Pharmaceuticals on the North American market.

Biotie and Lundbeck have decided to carry out additional Phase III clinical studies with nalmefene starting in 2008 to further strengthen the product’s registration dossier before beginning EU-wide registration.

Targeting autoimmune diseases

Another promising Biotie drug – targeting autoimmune diseases – has just entered Phase I clinical trials. A fully human monoclonal antibody, the drug blocks the function of the Vascular Adhesion Protein-1 (VAP-1) inflammation receptor, and alleviates inflammation by regulating the migration of white blood cells to inflamed tissue.

An accumulation of white blood cells, and ensuing tissue destruction, are a common feature of many autoimmune diseases, such as rheumatoid arthritis, inflammatory bowel diseases, psoriasis, and multiple sclerosis.

All of these diseases are potentially crippling, and the therapies currently in use provide meaningful help to only around half of patients, which means that the market potential is huge. The rheumatoid arthritis market alone is predicted to be worth USD 27 billion by 2010.

To promote the drug, Biotie signed an agreement with Roche in November 2006, granting the latter the right to an exclusive option on an exclusive worldwide license.

Biotie’s drug development work focuses on dependence disorders, inflammatory diseases, and thrombosis.
> Timo Veromaa
(Published in HighTech Finland 2008)