Datamonitor Report 2010: Datamonitor And Merck & Co., Inc. Take Center Stage To Present New Schizophrenia Therapies

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Schizophrenia played a prominent role at this year's American Psychiatric Association Annual Meeting due to the prevailing high level of unmet need. Merck & Co and Dainippon Sumitomo presented data for new drugs which Datamonitor believes represent important additions to the current treatment portfolio. Elsewhere, an interesting lecture predicted a future of personalized schizophrenia treatments.

Dainippon Sumitomo: lurasidone Phase III data validates potential

This year's American Psychiatric Association meeting (APA 2010) provided an opportunity for attendees to assess the potential of Dainippon Sumitomo's lurasidone ahead of its expected approval in late 2010. At the meeting, the Japanese company presented four posters describing lurasidone's use in schizophrenia, in addition to a poster assessing lurasidone's receptor binding profile. These data demonstrate lurasidone's efficacy and safety, which provided the basis of the company's New Drug Application (NDA) submission in late December 2009.

Key data were presented from the pivotal Phase III trials PEARL 1 and PEARL 2 involving more than 2,500 lurasidone patients. In the first trial, Dainippon Sumitomo demonstrated that lurasidone was significantly more effective than placebo in the primary Positive and Negative Syndrome Scale (PANSS) total and change in Brief Psychiatric Rating Scale rating. Lurasidone also proved to be significantly effective on a variety of supplementary scales which formed the secondary outcomes.

In the PEARL 2 Phase III trial, Dainippon successfully replicated the statistical efficacy of lurasidone compared to placebo and also showed lurasidone to be significantly effective for patients suffering from an acute exacerbation of schizophrenia. With changes in lipids, glucose and weight comparable to placebo, lurasidone's statistical efficacy, high tolerability and low discontinuation rates indicate that the drug has mood enhancing and pro-cognitive effects and is set to become an important treatment for non-adherent patients.

Merck & Co: validation data to differentiate Saphris from the competition

Having gained FDA approval for Saphris (asenapine) in August 2009, Merck & Co used APA 2010 as a platform to share data from long-term trials. Merck's strong presence was notable: historically, it has not been a big psychiatry player and entered the market by default via the acquisition of Schering Plough. That said, the company's sheer size, scale and marketing power will serve Saphris well in penetrating the market.

Saphris is a twice-daily fast-dissolving sublingual formulation of the atypical antipsychotic asenapine-a 5-HT2A and dopamine D1/D2 receptor antagonist. At this year's meeting, Merck presented an analysis of Saphris compared to olanzapine in a three-year safety and efficacy study in patients with schizophrenia or schizoaffective disorder. In 440 adult patients with schizophrenia or schizoaffective disorder, efficacy was maintained in both Saphris and olanzapine based on the change in PANSS total score. In addition, Saphris was generally well tolerated and average weight gain was 1.6kg compared to 5.0kg exhibited by olanzapine.

Meanwhile, Merck presented positive efficacy and safety data of Saphris for persistent negative symptoms of schizophrenia, thus supporting previous trial data. According to the results, over 52 weeks, treatment with Saphris significantly improved patients' negative symptoms compared to olanzapine on the 16-item Negative Symptom Assessment scale total score. However, dropout rates were higher for Saphris compared to patients on olanzapine and extrapyramidal symptoms were recorded for 24% of Saphris patients compared to only 10% in the olanzapine group.

Nevertheless, despite increased extrapyramidal symptoms and concerns raised over the twice-daily sublingual dosing of Saphris, data presented at this year's meeting may prove significant as currently available antipsychotics only provide modest benefits at best when treating the negative symptoms of schizophrenia. With treatment of negative symptoms one of the key unmet needs, Saphris may prove to be an important tool in treating this schizophrenia population.

Burgeoning paradigm shift to personalized medicine for schizophrenia

Elsewhere at APA 2010, Dr Stephen Marder, an attending psychiatrist at UCLA's Psychosis Clinic, gave a lecture titled 'Update on Clinical Research in Schizophrenia'. In this talk, Dr Marder described the safety of the current therapies, noting that patients prescribed antipsychotics have a premature mortality, on average 25 years earlier. With this concern and the side effects associated with current schizophrenia therapies, Dr Marder highlighted the need to identify new potential targets and the introduction of biomarkers, adding "recent developments from pharma are relatively pedestrian."

Looking to the future, Dr Marder predicts that the advent of pharmacogenetics will help in the search of these elusive targets, ultimately resulting in more personalized medicines. Given that no truly novel antipsychotics have launched since the emergence of the atypical antipsychotics and the lack of candidates in the pipeline with a novel mechanism of action, Datamonitor agrees that more targeted approaches to effectively treat schizophrenia will improve treatment outcomes and provide interesting new opportunities for drug developers.

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