Business briefs: Lundbeck/Otsuka, Abbott, Merck
Lundbeck and Otsuka's experimental Alzheimer's disease treatment will be moving into Phase III trials this year. The companies said Tuesday that the Phase II clinical studies of its selective 5-HT6 receptor antagonist showed improved cognitive performance among moderate Alzheimer's patients when used as an add-on to donepezil therapy. Researchers tested Lu AE58054 among 278 patients in Europe, Canada and Australia over 24 weeks. The treatment focuses on serotonin's role in cognition and behavior.
Abbott's second-quarter results show sales at the pharma-free company rose 2.5% to $5.4 billion, compared to $5.3 billion for the same period the year before. Emerging market expansion marked the quarter, and sales were $2.3 billion. Nutrition sales rose 7.9% in the quarter, to $1.8 billion, rising internationally, but sinking 3.1% in the US. Diagnostics sales rose 5.3% during the quarter to $1.1 billion, while medical device sales fell 1.6%, to $1.3 billion compared to the same period last year. Device sales fell across all categories, with vascular dipping 6.8%, diabetes 6.8% and optics 0.8%.
The FDA's Anesthetic and Analgesic advisory committee gave Merck an “it's me, not you” notice Tuesday, when it said it was cancelling its Thursday discussion of Merck's injection drug sugammadex. The drug helps reverse rocuronium and vecuronium muscle relaxants which are used during surgery. The Whitehouse Station, NJ, company said in a statement that the agency needed “additional time to assess the results of the FDA's recently completed inspection of a clinical trial site.” Merck said it is talking with the regulator about what it needs to complete its review. The FDA rejected the drug, whose proposed brand name is Bridion, in 2009 when it was submitted by then-independent Schering-Plough. European regulators approved the drug in 2008 and it is sold in 40 countries. The setback comes on top of other recent R&D disappointments for Merck, including the FDA's rejection of its sleep drug, suvorexant.