Medincell (PA:MEDCL) is developing long-acting injectable (LAI) products using its proprietary BEPO copolymer technology with active pharmaceutical ingredients (APIs) for optimal drug delivery. Partnered with Teva, MedinCell is developing three CNS products, the most advanced of which is a two-month subcutaneous (SC) risperidone LAI in Phase III for schizophrenia, with interim data expected in H219. MedinCell is also working with the Arthritis Innovation Corporation (AIC) on a celecoxib LAI for post-surgical pain and inflammation in Phase II, with data expected in summer 2019.
Targeting schizophrenia with Teva
Schizophrenia is a severe mental illness that requires a strict drug regimen. Other intramuscular LAIs have been developed to combat non-adherence including Otsuka’s Abilify Maintena (FY17 sales: $632m) as well as Janssen’s Risperdal Consta ($805m) and Invega franchise ($2,569m). Interestingly, a UCLA study found that psychotic relapse was significantly lower for Risperdal Consta (intramuscular risperidone) versus oral risperidone (p<0.004) and that treatment with the LAI led to significantly improved medication adherence over oral (p<0.001). MedinCell is developing mdc-IRM as a ready-to-use (ie does not require reconstitution or dosing initiation regimen) two-month SC LAI formulation of risperidone, which may increase compliance and can potentially reduce morbidity and costs of care. Interim data from its 596-patient Phase III trial are expected to read out in H219, with full data in H120. Teva is responsible for all development costs and MedinCell is entitled to up to $366m in milestones (for all three CNS programs partnered with Teva) and high single-digit royalties on tiered net sales.
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