SOURCE: Biotie Therapies Oyj

December 13, 2011 02:34 ET

US National Institute on Drug Abuse (NIDA) to Conduct Clinical Study on Biotie's Nepicastat in Cocaine Dependence

TURKU, FINLAND--(Marketwire - Dec 13, 2011) - Ongoing clinical study on nepicastat in post-traumatic stress disorder, funded and conducted by US Department of Defense, expected to complete in H2 2012

Biotie Therapies announced today that it has signed a Collaborative Research and Development Agreement with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health.

Under the agreement, NIDA and Biotie will investigate the safety and efficacy of Biotie's nepicastat (SYN117) in the treatment of cocaine dependence. NIDA will fund the conduct of a randomized, double-blind placebo-controlled trial, lasting 11 weeks, in 180 treatment-seeking cocaine-dependent subjects using nepicastat supplied by Biotie. The study will be conducted at approximately 12 US clinics specializing in the treatment of drug dependence.

"We are pleased to be working with NIDA and some of the world's most renowned investigators of treatments for cocaine dependence," said Timo Veromaa, Chief Executive Officer of Biotie. "There is currently no approved treatment for cocaine dependence, a condition which exacts a heavy toll on individuals, their families and society as a whole."

Biotie and NIDA have previously collaborated on preclinical studies evaluating potential pharmacokinetic and pharmacodynamic interactions between nepicastat and drugs of abuse. Biotie retains rights to nepicastat and will be able to use data from studies conducted with NIDA to support future potential regulatory submissions.

The trial is expected to start in H1 2012 and take approximately two years to complete.

In Turku, 13 December 2011

Biotie Therapies Corp.

Timo Veromaa
President and CEO

About nepicastat (SYN117)

Nepicastat is an orally administered, potent and selective inhibitor of the enzyme dopamine β-hydroxylase (DBH). The compound has demonstrated potential as a treatment for cocaine dependence and post-traumatic stress disorder (PTSD).

Like many other addictions, cocaine dependence is driven by dysregulation in the dopamine-reward system. Inhibition of DBH by nepicastat increases levels of dopamine, which may reduce craving for cocaine, and reduces the levels of norepinephrine, which may decrease the pleasurable responses to cocaine and the potential for stress-induced relapse following withdrawal.

Biotie has previously conducted a placebo-controlled Phase 2a study in non-treatment seeking cocaine addicts. This study showed that nepicastat had a favourable safety profile and was well tolerated when administered with cocaine.

Nepicastat is also in a Phase 2 US Department of Defense-funded study for the treatment of PTSD. This is a condition with significant unmet medical need and is becoming more prevalent in both the civilian and military communities. The ongoing placebo-controlled, double blind trial is scheduled to enroll up to 120 patients and is now expected to complete in H2 2012, instead of 2013 as previously announced.

SYN117 was licensed from Roche in 2007.

About Biotie

Biotie is an international biopharmaceutical company focused on the development of innovative, clinically differentiated medicines to address unmet medical needs primarily associated with neurological and psychiatric diseases and selected inflammatory diseases. Biotie aims to develop treatment solutions that will improve the lives of patients with conditions such as Parkinson's and Alzheimer's diseases, drug dependence and inflammatory liver disease.

Biotie's highly experienced development teams in Europe and the US are focused on efficiently delivering safety and efficacy data for the company's compounds. For niche indications, Biotie will consider bringing products to market by itself. For larger indications, it will seek strategic partnerships with pharmaceutical partners for late-stage development and commercialization. Current pharmaceutical partners include Lundbeck, Roche, UCB Pharma, and Seikagaku.

Biotie's most advanced product, nalmefene for alcohol dependence, has completed Phase 3 clinical development by licensing partner Lundbeck.

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