Allergan and Richter win FDA approval for a once-rejected schizophrenia pill

Gedeon Richter's Erik Bogsch

Partners Allergan ($AGN) and Gedeon Richter convinced a once-skeptical FDA to clear the antipsychotic drug cariprazine on a second pass, winning approval to treat schizophrenia and bipolar disorder.

The agency rejected cariprazine in 2013 and demanded more clinical trial data to determine the ideal dose of the drug, its inventors said at the time. Two years later, Allergan and Gedeon completed a follow-up Phase III trial in which cariprazine met its goals of reducing schizophrenic relapses compared with placebo, adding those results to combined data from more than 2,700 schizophrenia and bipolar patients in their successful resubmission.

Cariprazine, to be sold as Vraylar, was once considered a potential blockbuster, with Richter setting its sales potential at as much as $2 billion a year. But the drug's long path to market has dampened enthusiasm among analysts, and Evercore-ISI's Umer Raffat pegs its peak value closer to $200 million a year.

Despite the delay, cariprazine's approval "is a notable achievement for Gedeon Richter's discovery platform," Managing Director Erik Bogsch said in a statement. "Despite the variety of treatments available for the millions living with bipolar I disorder and schizophrenia, unmet needs remain and we are proud to offer an additional option to help patients manage their symptoms."

Cariprazine came into Allergan's possession through a long string of biopharma deals. In 2004, Richter licensed the drug to Forest Laboratories only to see that company acquired by Actavis for $25 billion in 2014. Earlier this year, Actavis closed its $66 billion deal to buy Allergan and adopted its name, cementing cariprazine's final commercial home.

- read the FDA announcement
- here's Allergan's statement

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