H. Lundbeck A/S, Denmark’s second-largest drugmaker, said its experimental antidepressant Brintellix improved symptoms better in a higher dose in a late-stage U.S. study, as the medicine awaits regulatory approval.
Brintellix, also known as vortioxetine, significantly improved symptoms in the 20-milligram dose, with patients’ scores on the Montgomery-Asberg Depression Rating Scale falling by 15.57 after 8 weeks of treatment, compared with 16.90 for patients taking 60 milligrams of Eli Lilly & Co.’s Cymbalta, Lundbeck and trial partner Takeda Pharmaceutical Co. said in a statement yesterday. The 15-milligram dose of Brintellix didn’t meet statistical significance, the companies said.
“As a clinician, I’m encouraged by these data,” Madhukar Trivedi, professor of psychiatry at the University of Texas Southwestern Medical Center and scientific adviser to Lundbeck, said in the statement. “They represent an important addition to the broader clinical profile for vortioxetine.”
Brintellix will probably be prescribed as a second-line treatment for patients who don’t respond to, or can’t tolerate, cheaper generic options, Chief Executive Officer Ulf Wiinberg has said. It will help offset lower revenue from Lexapro, which lost patent protection in the U.S. in March 2012. Sales of the antidepressant, called Cipralex outside the U.S., dropped to 6.4 billion kroner ($1.1 billion) last year from about 8.5 billion kroner in 2011.
Peak sales of Brintellix may reach as much as $3 billion, according to Deutsche Bank AG analyst Tim Race in London. The drug was filed in Europe in September and in the U.S. in December. The U.S. Food and Drug Administration will make a decision by Oct. 2, according to Copenhagen-based Lundbeck.
Lundbeck has been developing Brintellix with Osaka, Japan-based Takeda. If the drug is approved, the companies plan to co-promote it in the U.S. and in Japan.
Shares of Lundbeck rose 0.2 percent to close at 115.80 kroner in the Danish capital yesterday.