Forest Laboratories and its Hungarian development partner Gedeon Richter proffered a set of promising pivotal data from their late-stage study of an experimental drug for bipolar disorder. Investigators reported that cariprazine demonstrated a statistically significant result compared to placebo when it was used to treat mania associated with bipolar disorder. And at least one analyst says the data is good enough to position the companies for a 2012 application on a drug that could earn anywhere from $500 million to $1 billion a year in revenue.
The oral drug is designed to adjust levels of dopamine in the brain, setting it up as an add-on treatment for schizophrenia and major depression as well as bipolar disorder. There was a high 32% discontinuation rate among patients taking the drug, but that closely matched the 31% discontinuation rate among patients taking a sugar pill.
"The positive Phase III data underscore that Forest's pipeline is underappreciated," noted Collins Stewart analyst Louise Chen, according to a report from Reuters. Chen also projected sales of up to a billion dollars a year for the drug's various indications. The upbeat news today helps Forest CEO Howard Solomon, who not only beat back a coup attempt by activist investor Carl Icahn but also saw regulators back away from a controversial attempt to bar him from federal health programs.
"These exciting positive Phase III results in patients with bipolar mania demonstrate the potential of cariprazine as a novel antipsychotic agent," said Dr. Marco Taglietti, R&D chief of the Forest Research Institute. "We will continue to investigate the therapeutic benefits of this novel dual acting D3/D2 compound across other CNS disorders as well."
- read the Forest release
- check out the Reuters story