BUDAPEST (Reuters) - Forest Laboratories has recently submitted a new drug application to the U.S. Food and Drug Administration (FDA) for antipsychotic drug Cariprazine, its Hungarian partner Richter said in a statement on Wednesday.
Cariprazine was discovered by Richter and is licensed to Forest Laboratories Inc. in the U.S. and Canada.
Richter said Forest’s application to the FDA was submitted for the treatment of both schizophrenia and manic or mixed episodes associated with bipolar I disorder.
“In the schizophrenia and bipolar mania pivotal trials, Cariprazine was generally well tolerated,” Richter said in a statement.
At 0858 GMT, Richter shares traded 0.3 percent higher at 35,675 forints on the Budapest Stock Exchange, outperforming the blue chip index, which fell 0.6 percent.
Richter spokeswoman Zsuzsa Beke said if the FDA approves the new drug, Cariprazine could be launched in the U.S. sometime in the first half of 2014.
“In Europe, the required tests are ongoing, the launch here could happen in around 2015-16,” she said.
She declined to give a revenue or profit contribution estimate for the new drug but said the U.S. schizophrenia drug market was worth about $3 billion while the overall antipsychotic market was worth about $20 billion.
“Richter could be entitled to another milestone payment as a result of this announcement, which could add about 1 billion forints ($4.61 million) to its 4Q12 or 1Q13 results,” analysts at Erste Bank said in a research note.
“The positive news can lift the company’s share price after the strong selling pressure of the past days,” it said.
Richter earlier this month reported a 56.5 percent fall in third-quarter net profit as rising costs more than offset an increase in revenue and year-earlier results were lifted by one-off income.
($1 = 216.72 Hungarian forints)
Reporting by Gergely Szakacs; Editing by David Goodman