H. Lundbeck A/S, Denmark’s second-largest drugmaker, plans to hire more than 200 salespeople in the U.S. to market its new anti-depressant Brintellix ahead of anticipated approval from regulators.
Peak sales of Brintellix, which will be co-promoted with Japanese partner Takeda Pharmaceutical Co., may reach $1 billion to $2 billion, Chief Financial Officer Anders Gotzsche said in a phone interview today. “It will be a significant sales force that Takeda and Lundbeck are providing for the launch of Brintellix,” he said. “It will definitely be more than 200.”
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 said last year. It will help offset declining revenue from Lexapro, another antidepressant, which lost patent protection in the U.S. in March 2012. Sales of that drug, known as Cipralex outside the U.S., dropped to 6.4 billion kroner ($1.1 billion) last year from about 8.5 billion kroner in 2011, according to the company.
An application for the distribution of Brintellix was filed in Europe in September and accepted by U.S. regulators for review three months later. The U.S. Food and Drug Administration will make a decision on whether to approve the drug by Oct. 2, Lundbeck said in December.
Lundbeck raised the bottom of its estimated range for 2013 sales to 14.6 billion kroner from 14.4 billion kroner today. It increased the lower end of the range for anticipated earnings before interest and taxes to 1.3 billion kroner from 1.2 billion kroner.
Lundbeck introduced its anti-alcoholism drug Selincro in 12 European countries including Poland, Norway, Finland and the U.K. earlier this year, Gotzsche said. The drug will be rolled out to more markets in Europe over the next two years, including France and Germany, he said. The drug has yet to be submitted for approval in Russia, and that process may take “a couple of years”.
The company booked a fine of $125.6 million from the European Commission, which found that Lundbeck held back sales of cheaper generic versions of the anti-depressant citalopram. The company plans to appeal the decision, and it may take as many as five years to achieve an outcome, Gotzsche said.
“We still think it was a totally wrong conclusion,” he said.