Alkermes plc (ALKS) Tuesday said that a three-month formulation of Invega Sustenna, an injectable medicine for the treatment of schizophrenia, representing a first for the field of atypical antipsychotics, has entered phase 3 clinical research program.
Atypical antipsychotics, a type of medication used to treat schizophrenia and other psychotic disorders, are a new generation of antipsychotic drugs, and are said to have significant advantages over typical antipsychotics - the first generation of antipsychotic drugs.
The three-month formulation of Invega Sustenna is being developed by Johnson & Johnson's (JNJ) subsidiary Janssen Pharmaceutica NV, a licensee to Alkermes' proprietary technology for nanoparticles.
According to Alkermes, under the phase III program, two studies of the three-month formulation of Invega Sustenna have been initiated and are expected to enroll about 1,800 patients with schizophrenia.
The clinical studies are expected to be completed in the second half of calendar year 2014.
A once-monthly formulation of Invega Sustenna for schizophrenia - a long-acting atypical antipsychotic that incorporates Alkermes' proprietary technology, has been available in the U.S. since 2009. The same was also approved in the EU in 2011, where it is available under the trade name Xeplion.
Yet another long-acting atypical antipsychotic that incorporates Alkermes' extended-release injectable technology and developed through collaboration with Johnson & Johnson is Risperdal Consta, a twice-monthly injection. In 2011, Risperdal Consta generated $1.6 billion in sales for J&J, representing an increase of 5.5% compared to 2010.
The long-acting atypical antipsychotic franchise, including both Risperdal Consta and Invega Sustenna, is worth over $2 billion annually.
Alkermes receives royalties from Johnson & Johnson for Risperdal Consta and Invega Sustenna.
Commenting on the development, Elliot Ehrich, Chief Medical Officer at Alkermes said, " A three-month formulation of a long-acting atypical antipsychotic could significantly advance the treatment paradigm for schizophrenia, and we are looking forward to seeing the results from these phase 3 studies of Invega Sustenna."
ALKS has thus far hit a 52-week low of $13.48 and a 52-week high of $20.00. The stock is currently down 0.83% trading at $15.62.
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