Shares in Irish drug company Alkermes jumped over 10 per cent yesterday after it announced plans to seek US marketing approval for its experimental schizophrenia drug.
The move came as the company announced positive results from a late-stage trial for the injectable drug, aripiprazole lauroxil.
The drug is a long-acting atypical antipsychotic, a class of drugs with fewer side effects than older antipsychotics. The growing market for atypical antipsychotics for schizophrenia was worth $4.5 billion in the United States, Mr Pops said.
Chief executive Richard Pops said the company expected to file with the FDA in the third quarter and would launch aripiprazole lauroxil using its own sales force.
"We now have multiple doses with established efficacy that may help physicians to address the specific needs of individual patients," Alkermes' chief medical offer Elliot Ehrich said.
The company said two doses of the drug injected monthly reduced the severity of schizophrenia symptoms in the study, compared with a placebo. Once inside the body, the drug converts into aripiprazole, a blockbuster marketed as Abilify by Otsuka Pharmaceutical.
Alkermes’ technology allows the drug to be released at a controlled rate in the body, allowing patients to take the drug less frequently.
Eli Lilly’s antipsychotic injection Zyprexa Relprevv is approved to treat schizophrenia and is administered once in two-four weeks, depending on the dose. Otsuka’s injection Abilify Maintena is dosed once a month.
Alkermes receives royalty payments from a Johnson & Johnson unit for two atypical antipsychotic injections, Risperdal Consta and Invega Sustenna, which use its technology.
The company is also developing the Invega Sustenna as a schizophrenia treatment to be dosed once in three months.
The company said today the drug was generally well tolerated by the 623 patients enrolled in the study. The most common adverse events were insomnia, headache and akathisia, a condition characterised by uncontrollable restlessness.
Alkermes said all participants in the study were eligible to continue in treatment for 12 months to monitor the safety and long-term durability of the treatment.
Schizophrenia affects about 24 million people worldwide, according to the World Health Organization.
Alkermes’ shares were up 3.7 per cent at $42.64 on the Nasdaq on Tuesday, having risen to $45.48 earlier in the session. – Reuters
