LONDON (Reuters) - Danish group Lundbeck is looking forward to a “feast” of new drugs to refresh its product line-up, kicking off next week with a possible European Union green light for a novel medicine to treat alcohol abuse.
In all, there is scope for regulatory approval of three medicines in 2013 - an impressive tally for a small company focused on brain disorders - as well as a potential partnership deal for a drug to fight the symptoms of Alzheimer’s disease.
“Sometimes people say it is feast or famine for this industry and we are in a feast phase, especially considering our size,” chief executive Ulf Wiinberg told Reuters.
Lundbeck needs these new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States, which is now coming off patent.
Doubts about the company’s ability to make the transition from reliance on Cipralex has taken its toll on the stock in recent months, with the shares underperforming the European drugs sector by 23 percent this year.
There have even been suggestions the Lundbeck Foundation, which owns a 70 percent stake, might delist the drugmaker.
Wiinberg said this option had not be discussed. “If we were working on it I would say something, but I have nothing to say.”
While Wiinberg has already said earnings will stall until 2015 as a result of patent losses, he is increasingly confident the pieces are in place to lift sales in the medium term.
The next catalyst could come as early as December 13 or 14, when Lundbeck expects the European Medicines Agency to decide whether or not to recommend Selincro for alcohol dependence. A positive decision would lead to approval early next year.
The drug is breaking new ground in an uncertain market, and Wiinberg said it was “a bit of a joker in our portfolio”. Analysts currently pencil in only modest sales.
More important will be the verdict from regulators in North America and Europe later next year on a new antidepressant being developed with Japanese partner Takeda Pharmaceutical that analysts see as a potential $1-$2 billion-a-year seller.
Developing new treatments for depression has proved an uphill battle for drugmakers in recent times but vortioxetine has produced encouraging clinical trial results and its unique mode of action and flexible dosing could make it a winner.
The third approval prospect for next year is Abilify Maintena, a once-monthly version of schizophrenia drug Abilify that Lundbeck is working on with Otsuka.
Further out, Lundbeck is developing a drug for the symptoms of Alzheimer’s - a more modest ambition than that of disease-modifying treatments which have so far failed to gain much traction in tackling the underlying causes of the disorder.
That drug will be ready to go into final-stage clinical testing next year and Wiinberg said he would look to strike a partnership deal for the product, known as LuAE58054, at the same time as preparing for Phase III trials.
Editing by Dan Lalor