Lundbeck has submitted a marketing authorisation application to the EMA for its novel opioid receptor ligand for alcohol dependence Selincro (nalmefene).

The application is based on the results from Phase III studies which demonstrated how patients decreased their heavy drinking days by more than half after six months of treatment.

Executive Vice President, Anders Gersel Pedersen, Head of Research & Development at Lundbeck says the treatment is “well tolerated” and has demonstrated “clinical benefit in reducing heavy drinking days and overall alcohol consumption”.

Around 2,000 Europeans were enrolled in three separate clinical studies. The trials showed that that overall safety profile of the medication was consistent and that after a year of treatment there was a 60% overall reduction in total alcohol consumption.

Approximately two-thirds of the individuals in the studies had not previously been treated for alcohol dependence, suggesting that the reduction of alcohol intake is an attractive alternative compared to existing treatments that require abstinence.

“Alcohol dependence is a significant burden for both individuals and society with only limited medical treatment options,” said Mr Pedersen. “We are very pleased that we now are at a stage where we can start the regulatory review and approval process for Selincro in Europe.”

Lundbeck has appointed Jens Peter Balling and Iman Barilero as vice presidents in its R&D organisation.

The new appointments follow Lundbeck’s recent consolidation of its R&D activities into one organisation, creating a new unit.

Peter Balling (pictured, right) has been appointed as Vice President of the new unit, which will focus on regulatory product support, patient safety and quality assurance of clinical research.

Barilero (pictured, below) will be responsible for increasing Lundbeck's strategic efforts to build and maintain constructive cooperation and dialogue with national and international regulatory authorities.

Anders Gersel Pedersen, Executive Vice President of R&D at Lundbeck, said: “The regulatory and safety areas are an increasingly important prerequisite for this. The creation of one new unit and the increased focus on the other gives us a strong position in these areas.”

Peter Balling joined Lundbeck in 2006 as divisional director of global pharmacovigilance, previously working at Novo Nordisk and Nycomed.

Barilero began work for Lundbeck in 2007, when she served divisional director of regulatory development, strategy and policy, with previous experience at Hoffmann-La Roche and Johnson & Johnson.

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Lundbeck has appointed Marie-Laure Pochon as its new Executive Vice President of Commercial Operations and slim lined its Executive Management Group in the process.

The new EVP has joined the Group after “realising high growth” as the Chief Executive of Lundbeck France and the Regional Vice President for France, Belgium, UK, Spain, Italy, Turkey & Germany.

Ulf Wiinberg, President and CEO, says he is “very pleased that Marie-Laure Pochon is joining Lundbeck’s Executive Management Group, where she can contribute with her strong commercial experience from a long career in the pharmaceutical industry”.

The company says it will “execute on many new opportunities” to implement its strategy and secure long-term growth and will reduce its Executive Management from six to four members in order to do so.

Peter Høngaard Andersen will now exit the Executive Management, but continue as part of Lundbeck’s corporate management team as Senior Vice President, External Scientific Relations & Patents.

Lars Bang will also leave the Group, but continue his role as Senior Vice President, Supply Operations & Engineering, leading Lundbeck’s global supply chain.

As a result, Anders Götzsche, Executive Vice President, CFO, Anders Gersel Pedersen, Executive Vice President, R&D, plus Ulf Wiinberg and Marie-Laure Pochon, now complete the Group.

Lundbeck plans to submit a European Marketing Authorisation Application for its alcohol dependence drug Nalmefene within the next 12 months.

The decision follows the completion of the third and final ESENSE2 Phase III study which saw alcohol consumption fall by 50% in patients using the treatment.

Anders Gersel Pedersen, Executive Vice President and Head of Drug Development at Lundbeck says the trials showed that “consistency and robustness were observed” during the studies.

The three trial programmes were conducted in Europe and enrolled around 2,000 people with alcohol dependence.

A wide range of primary and secondary endpoints were assessed during the trials. The number of heavy drinking days per month, total alcohol consumption, proportion of responders based on drinking measures, plus liver functions and other laboratory tests were all analysed. Assessments were all consistently in favour of Nalmefene compared to placebo.

The presentation of the efficacy and safety data is now planned for scientific meetings and conferences during the next 12 months.