Roche (RHHBY) suffered a setback when two phase III studies on schizophrenia candidate bitopertin (RG1678) failed to meet their primary endpoints.
These endpoints were based on the negative symptoms (social withdrawal and lack of motivation) factor score of the positive and negative symptom scale (:PANSS).
As per the data from the studies, the addition of bitopertin to antipsychotic therapy did not significantly reduce negative symptoms after twenty weeks compared to placebo.
We note that Roche is evaluating bitopertin as a potential add-on (adjunct) therapy to antipsychotics for symptoms of schizophrenia in six phase III studies.
Meanwhile, a third phase III study evaluating bitopertin for persistent, predominant negative symptoms of schizophrenia is currently ongoing. Bioterpin is also being evaluated in three phase III studies for sub-optimally controlled symptoms (hallucinations and delusions) of schizophrenia.
Roche will observe results from these phase III studies before deciding on the development program on bitopertin.
We note that bitopertin is also being evaluated for obsessive compulsive disorder in a phase II study.
We remind investors that Roche specializes in oncology drugs. Roche has a solid position in the breast cancer market with drugs like Herceptin, Perjeta, and Kadcyla in its kitty and continues to innovate further to strengthen its already dominant position. Roche’s efforts to develop drugs for other indications are noteworthy.
However, the failure of the two phase III studies on bitopertin was disappointing. We expect investor focus to remain on updates from the remaining phase III studies.
Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the pharma industry include Allergan, Inc. (AGN), Salix Pharmaceuticals (SLXP) and Endocyte, Inc. (ECYT). All three carry a Zacks Rank #1 (Strong Buy).