Lundbeck disclosed Wednesday that two Phase III studies of the experimental drug idalopirdine in patients with Alzheimer's disease failed to demonstrate efficacy of the 5-HT6 antagonist. In September last year, the company and partner Otsuka reported that the drug, also known as Lu AE58054, failed to meet the primary and secondary endpoints in another late-stage trial in patients with mild-to-moderate Alzheimer's disease.
According to Lundbeck, the results of the three studies taken together do "not demonstrate efficacy as observed in the positive clinical Phase II study and hence do not suffice to support a regulatory submission." The company indicated that it took a charge of 140 million Danish kroner ($20.1 million) related to the drug. Shares in the Danish company fell more than 4 percent on the news.
Idalopirdine was granted fast track designation by the FDA last year for the treatment of mild-to-moderate Alzheimer's disease. Companies developing similar drugs include Axovant Sciences with its experimental agent intepirdine, while Pfizer terminated a mid-stage study of the investigational 5-HT6 receptor antagonist PF-05212377 last year after pre-specified futility criteria were met.
Separately on Wednesday, Lundbeck announced that full-year revenue for 2016 totalled 15.6 billion kroner ($2.2 billion), up 7 percent versus the prior year. Meanwhile, annual net income equalled 2.3 billion kroner ($331 million), versus a loss of 6.8 billion kroner ($978 million) in 2015.
Regarding specific markets, sales in the US rose by 32 percent year-over-year to 8.4 billion kroner ($1.2 billion), while European revenue fell 25 percent to 2.9 billion kroner ($417 million). Sales in other markets reached 4 billion kroner ($575 million), an improvement of 4 percent compared to 2015.
Lundbeck CEO Kåre Schultz commented "I am pleased with our strong operational performance in 2016 where we have delivered results that exceeded our own expectations," continuing "I am confident that we can deliver on our targets for the coming years."
For 2017, Lundbeck anticipates net income in the range of 3.4 billion kroner ($489 million) to 3.8 billion kroner ($546 million), on between 16.3 billion kroner ($2.3 billion) and 17.1 billion kroner ($2.5 billion) in revenue.
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