Against tough odds, Lundbeck touts high-stakes R&D end game

With revenue numbers sliding now that Lexapro is getting battered by generic competition, Lundbeck has been refining its late-stage R&D game, and top execs want the world to know that it has a comeback strategy.

CEO Ulf Wiinberg has been showcasing three new products that could make it to the market next year. And while Lundbeck is targeting some of the toughest R&D challenges in the business, the CEO also has high hopes for striking a partnership for an experimental Alzheimer's drug headed into Phase III testing.

First up is Selincro, a new drug for alcohol dependence, which is now up for review at the European Medicines Agency (EMA). As Wiinberg tells Reuters, an endorsement at the EMA could open the door to a launch in 2013--though analysts have been distinctly unenthusiastic about its commercial prospects. The analysts have been far more impressed with the blockbuster potential of Lundbeck's antidepression drug, vortioxetine, which has been partnered with Takeda. And then there's a once-monthly version of the schizophrenia drug Abilify, which is partnered with Otsuka.

Wiinberg showcased the Alzheimer's drug Lu AE58054 for Bloomberg as well. The drug is designed to inhibit the 5-HT6 receptor, spurring development of chemicals that promote cognition. While the industry has been transfixed by attempts to tackle the root cause of the disease--with a string of failures to show for billions of dollars in investments--Lundbeck is out to demonstrate that its drug can help rectify one of the key symptoms of the disease. And the CEO says that the company will begin a Phase III study in the middle of next year, whether it has a partner or not. The company released positive top-line results from the midstage study back in May. 

Lundbeck has been having a hard time making its case with analysts of all stripes. It's focused on a field that a number of Big Pharma companies have either dropped or pulled back on. GlaxoSmithKline ($GSK), for example, won't mount new programs for depression because researchers have no way of reducing the extraordinary risks associated with a big placebo response. And AstraZeneca ($AZN), which has been blasted by a series of setbacks, has gone virtual with its approach as part of the ongoing cutbacks in R&D. Alzheimer's drug research, meanwhile, has continued to draw huge investments with little to show for it. 

- here's the Reuters story
- get the Bloomberg report

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