H. Lundbeck A/S (LUN), the Nordic region’s second-largest drugmaker, is in talks with several potential partners to help develop a treatment for Alzheimer’s disease, Chief Executive Officer Ulf Wiinberg said.
The company, which released results from a mid-stage study on the AE58054 drug in May, will start late-stage trials as early as the end of 2012, Wiinberg said today. Pfizer Inc. (PFE) and Johnson & Johnson’s announcement this week that they were ending development of their failed bapineuzumab Alzheimer’s drug may benefit Copenhagen-based Lundbeck.
“The goal of bapineuzumab was disease modification, and that’s obviously very attractive, but now with the results that we have announced, this may be one of the lead compounds in Alzheimer’s development,” Wiinberg said in a phone interview. Lundbeck has encountered “a lot of companies being very interested, and now we are having discussions.”
Unlike bapineuzumab, which was aimed at slowing progression of the disease, AE58054 targets 5-HT6 receptors in the areas of the brain associated with cognition, resulting in increased concentrations of chemicals that aid learning and memory processes. About 18 million people worldwide have Alzheimer’s disease, and the population may almost double to 34 million by 2025, according to the World Health Organization.
Statistically significant improvement in cognition was observed in the mid-stage study, in which 278 patients with Alzheimer’s disease took AE58054 in combination with donepezil, a generic version of Eisai Co. (4523)’s Aricept, for 24 weeks.
Lundbeck dropped 6.3 percent, the most in a year, to close at 111 kroner in Copenhagen, after the company published second- quarter profit and revenue that missed analyst estimates. The drugmaker expects full-year revenue to be in the lower end of its forecast range of 14.5 billion kroner ($2.4 billion) to 15.2 billion kroner because of increasing pressure from health-care reforms in Europe, Lundbeck said today.
While U.S. sales of Lundbeck’s best-selling Lexapro antidepressant plunged 75 percent in the second quarter after the drug’s patent expired, the company has introduced three products in the last year and plans five more over the next 18 months, Wiinberg said.
“We remain bullish given one of the broadest late-stage pipelines,” Jefferies International Ltd. analyst Peter Welford said in a note to investors today.
As a follow-up to Lexapro, Lundbeck is developing a new antidepressant, Vortioxetine, which it will submit to U.S. and European regulators by the end of this year. Sales of the drug may exceed $1 billion, Welford said.
The company is also awaiting approval of Selincro, which may become the first new anti-alcoholism treatment in more than 15 years.
European Union antitrust regulators said last month they sent Lundbeck a complaint over agreements with drugmakers that may have held back sales of cheaper generic versions of its antidepressant citalopram.
“Anything the commission says we take very seriously,” Wiinberg said. Still, “we don’t think we’ve done anything wrong.”
Lundbeck is preparing a response that will be submitted over the next few months, he said.
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