Lundbeck to file alcoholism pill this year

pharmafile | June 16, 2011 | News story | Sales and Marketing Biotie, Lundbeck, alcohol 

Lundbeck plans to submit its alcohol dependency treatment for European approval later this year after trials showed it to cut alcohol consumption in half.

Nalmefene a small molecule opioid receptor antagonist being jointly developed with Finish drug development company Biotie.

It removes the desire for a person to drink by inhibiting the reward pathway in the brain that reinforces the craving for alcohol and other addictive substances.

Unlike existing therapies, nalmefene can be used on an as-needed basis and does not require complete abstinence, but analysts Jefferies were cautious about nalmefene’s commercial potential.

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They cite low awareness in the alcohol dependence market and that drugs have previously failed to achieve significant sales. They also don’t expect anticipate Lundbeck to seek US approval of nalmefene due to a lack of patent protection and a 10-year EU data exclusivity – and predict sales to peak at $250-300 million.

Head of drug development at Lundbeck, executive vice president Anders Gersel Pedersen is more positive of its future. He said: “We are pleased that we now have reached a stage with nalmefene where we can plan the regulatory process with an expected submission of the Marketing Authorisation Application towards the end of the year.”

Pedersen added that in phase III trials nalmefene showed “consistency and robustness” and that the studies supported its overall positive clinical profile.

Brett Wells

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