H. Lundbeck A/S’s antidepressant Brintellix was recommended for approval by the European Union’s drug regulator.
Brintellix won the backing of the Committee for Medicinal Products for Human Use for the treatment of adults with major depression, Copenhagen-based Lundbeck said in a statement today.
Brintellix will probably be prescribed as a second-choice 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 declining revenue from Lexapro, another antidepressant, which lost patent protection in the U.S. in March 2012.
Lundbeck climbed as much as 2.5 percent and was up 2 percent to 118.80 kroner at 2:49 p.m. in Copenhagen. The shares have gained 46 percent this year, including reinvested dividends.
Peak sales of the drug, which will be co-promoted with Japanese partner Takeda Pharmaceutical Co., may reach $1 billion to $2 billion, and Lundbeck plans to hire more than 200 salespeople in the U.S. to market it, Chief Financial Officer Anders Gotzsche said in an interview in August. The U.S. Food and Drug Administration approved the product Sept. 30.
The EMA’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region. The EC usually follows the committee’s advice.
Lundbeck will present results from a late-stage clinical trial studying the effect of Brintellix on cognitive dysfunction at a U.S. medical meeting starting Dec. 8, according to Andreas Eggert, Lundbeck’s head of global product strategy.
As many as 90 percent of patients with depression complain of cognitive dysfunction where they have trouble with concentration, attention and decision-making, Eggert said in an interview today. The study will compare Brintellix with a placebo, and a second trial, to be completed next year, will examine the drug against Eli Lilly & Co.’s Cymbalta, he said.
Brintellix may have “blockbuster upside” if a cognition benefit is shown in the two trials, Jefferies International Ltd. analyst Peter Welford said in a note to investors on Oct. 1.