Johnson & Johnson (JNJ) halted an early phase III study (n=509) on a three-month formulation of Invega Sustenna (paliperidone palmitate) on recommendation of an Independent Data Monitoring Committee (:IDMC). The IDMC also recommended Johnson & Johnson to unblind data from the study based on certain positive efficacy results.
The international, randomized, multicenter, double-blind study was evaluating the efficacy of the three-month formulation of Invega Sustenna in delaying time to first occurrence of relapse of symptoms of schizophrenia in adults compared to placebo. The patients in the study were initially randomized with the one-month formulation of Invega Sustenna after which they received the three-month formulation.
We note that the one-month formulation of Invega Sustenna is already approved for the treatment of schizophrenia. The one-month formulation utilizes Alkermes' (ALKS) proprietary NanoCrystal technology enabling solubility of poorly water-soluble compounds.
The IDMC’s recommendation was based on certain pre-specified criteria from the phase III study. Invega Sustenna achieved a statistically significant difference in delaying time to relapse based on the interim analysis after 60% (42 events) of the projected relapses occurred compared to placebo.
Johnson & Johnson intends to file a New Drug Application (:NDA) in the U.S. for the three-month formulation of Invega Sustenna by year end following final analysis of the study results and discussions with the U.S. regulatory body.
We note that Johnson & Johnson is already well established in the schizophrenia market with products like the one-month formulation of Invega Sustenna and Risperdal Consta. The products together contributed around $2.6 billion in 2013. In the event of the three-month formulation of Invega Sustenna getting approved, Johnson & Johnson will strengthen its position in the market further.
Johnson & Johnson currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Alexion Pharmaceuticals (ALXN) and Gilead Sciences Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).