Richter To Start Late Stage Tests On Key Schizophrenia Drug
29 October 2009 - 8:54PM
Dow Jones News
Hungarian drugmaker Richter Gedeon Nyrt. (RICHTER.BU) said
Thursday it plans to move schizophrenia drug cariprazine into
late-stage testing early next year after the experimental drug
showed encouraging results in an intermediate trial.
Richter is developing the drug jointly with Forest Laboratories
Inc. (FRX), of the U.S.
Data from an intermediate trial involving 732 patients showed
that patients with schizophrenia treated with cariprazine
experienced significant symptom improvement compared to those who
were given a dummy pill, or placebo, the companies said in a joint
press release.
In an earlier study, the drug had already shown promise in the
treatment of bipolar disorder. Forest and Richter now plan to start
phase III trials of the drug for both indications early next
year.
Drugs are typically tested in three phases. Data from the third
phase is typically the base for a possible approval from
regulators, and study a drug's effect in sick people. Earlier
phases aim at finding the right dose, and establishing the safety
and efficacy of a drug.
"Both the latest clinical trial results for cariprazine in
patients suffering from schizophrenia and the previous proof of
concept results in bipolar mania, confirm our long held belief in
this compound," said Howard Solomon, Chairman and Chief Executive
of Forest Laboratories, in a statement.
The study results are positive and came earlier than expected,
said Gergely Palffy, analyst at KBC Securities. If the drug
succeeds in late-stage testing, it may be introduced on the market
after 2012, he said.
Richter, which has a large portfolio of generic drugs - drugs
that lost patent protection - and a strong presence in Eastern
Europe, said the test results are confirming its strategy of
investing into the development of original drugs.
"These results are considered as a further step towards our
commitment conducting original research in the field of CNS
disorders, where our team has excellent expertise," said Erik
Bogsch, Richter's Chief Executive, in a statement.
Richter shares rose on the news in a lower Hungarian market.
At 0915 GMT, they were up HUF200, or 0.5%, to HUF39,700 on the
news. The shares gained 40% so far this year, outperforming the
broader European healthcare sector which is up 4.4%
year-to-date.
-By Veronika Gulyas and Anita Greil, Dow Jones Newswires;
Veronika.Gulyas@dowjones.com and anita.greil@dowjones.com