Alkermes expands facility to produce long-acting Risperdal

Alkermes has signed an agreement with Johnson & Johnson unit JanssenPharmaceutica that provides for the expansion of the former's manufacturing capacity to produce the new, long-acting injectable formulation of the antipsychotic Risperdal (risperidone). The product makes use of the Medisorb drug delivery technology developed by Alkermes. A New Drug Application was recently submitted to the US Food and Drug Administration (Marketletter September 10) for the new product, and it is expected to be the first atypical antipsychotic to be available in a formulation that only requires administration every two weeks.

David Broecker, Alkermes' chief operating officer, said that the firm's current manufacturing facility "is fully equipped to support launch quantities and to meet the early demand projected for long-acting Risperdal." The expansion will include the construction of a separate, large-scale Good Manufacturing Practice-standard facility on the same site, and Mr Broecker added that the agreement with Janssen "eliminates the financial risk associated with the acceleration of this expansion."