The Oros technology was originally developed by US pharmaceutical firm Alza, now part of Johnson & Johnson (J&J), as a way of gradually releasing active pharmaceutical ingredients (API) over an extended period.
Terry Novak, Patheon’s president of North American operations, told Outsourcing-pharma that: “Patheon has developed the expertise for the Oros technology in collaboration with clients and the equipment manufacturer and developed the Cincinnati facility as the Center of Excellence for controlled release technologies.”
Novak added that: “The development and manufacture of Oros technology products is highly involved and challenging compared to other conventional dosage forms,” explaining that considerable technical expertise is needed to produce any osmotic drug delivery technology.
He went on to say that the Cincinnati plants’ solvent capable coating pans, humidity-controlled tray dryers, bi-layer tablet presses, laser drills, fluid bed granulators and dissolution testing capabilities had made the project possible.
The first drug is expected to launch in the US later this year with the second expected to reach the market in 2010.
Oros’ impact on life-cycle
In 2007, J&J’s Janssen-Cilag unit gained European Union approval for its Oros-based schizophrenia drug Invega (paliperidone), having gained similar clearance in the US a year earlier.
J&J’s use of the technology was designed to stave off the loss of revenue as its leading schizophrenia product Risperdal (risperidone), from which paliperidone is derived, started to lose patent protection.
With the threat of patent expiry looming large over a pharmaceutical industry desperate to reduce manufacturing costs Patheon’s ability to manufacture potentially life-cycle extending delivery technologies is sure to attract interest.
Novak further emphasised these potential benefits, explaining that: “the development and commercial expertise available at our Cincinnati facility allows our customers to quickly and successfully launch OROS-based products and extend the life cycle of their products."