COPENHAGEN Danish drugmaker Lundbeck A/S and Japanese partner Takeda Pharmaceutical Co have submitted a new antidepressant for regulatory approval in the United States.
Lundbeck hopes the new antidepressant - vortioxetine - will provide a new source of revenue as its key anti-depressant, Cipralex, sold as Lexapro in the United States and Japan, comes off patent protection.
The company has already warned earnings will stall until 2015 due to cheap generic competition, meaning new products will be vital for future earnings.
"We are encouraged by the results that indicate the potential for vortioxetine, if approved, to help address the needs of people suffering from major depressive disorder who are seeking additional therapeutic options," Anders Gersel Pedersen, head of research and development at Lundbeck, said in a statement.
A spokesman at Lundbeck said the company would receive a 250 million crown ($43 million) milestone payment from Takeda if the U.S. FDA agreed to accept the filing.
"You probably should count on a year in the United States (for an approval), but we are hopeful," spokesman Mads Kronborg said. "We have conducted many studies and have had many thousands of patients undergo the trials with good results, so we certainly are optimistic about approval."
Last week, Lundbeck filed for regulatory approval in Europe for vortioxetine, the first filing of a non-copy antidepressant in Europe in five years.
In September 2007, Lundbeck and Takeda formed a strategic alliance for the exclusive co-development and co-commercialisation in the United States and Japan of several compounds in Lundbeck's pipeline for the treatment of mood and anxiety disorders.
($1 = 5.7773 Danish crowns)
(Reporting by Mette Fraende and Shida Chayesteh; Editing by Matt Driskill and Louise Heavens)