The drug candidate in question is a gel-based topical medication that employs a photodynamic activation mechanism to ensure the powerful active pharmaceutical ingredient (API) only affects targeted areas.
Under the deal SCM will supply the delivery gel, mix it with the API and conduct filling and randomisation of vials at its plant in Northumberland in the UK. The firm will also manage distribution of the drug for an upcoming Phase II trial.
An SCM spokesman told Outsourcing-pharma.com that: "It is a very significant deal in that it highlights our capability to deal with complex products and processes. It also helps underline our core competence of clinical trial manufacturing and supporting pharmaceutical companies of all sizes with continuity of product supply during any phase of a trial.
However, he explained that although SCM's core focus is trial-scale, specialist production, if the the drug goes on to win regulatory approval, the firm would be interested in discussing commercial supply contracts.
"We have supported other clients with scale-up and commercial supply, helping minimise high tech transfer costs, so it would potentially be an option. Depending on the volume of the commercial requirements, we could also act as a secondary supply source, giving the client the benefits of continued supply, but also providing them greater flexibility for small scale changes, new markets and additional product developments.
The new manufacturing agreement is further testament to the CMOs unique capabilities according to SCM's technical director Neal Wesley.
“The aseptic manufacture of a gel product into a vial is certainly not an ordinary project but is one that fits perfectly with our position as the world’s leading CMO when it comes to delivering novel and difficult sterile drug products.”
This was echoed in a press release by Giacomo Chiti, head of analysis and bioanalysis at Molteni, who said: “Their introduction of in-house sterility testing along with the team’s flexible approach to help meet our needs made them the ideal choice to support our scaled-up Phase II clinical trial supply needs.”
The Molteni contract is also one of a number of manufacturing deals SCM has signed of late, the most recent of which was the agreement it formed with Prostrakan for the production of Ketenisin.
It also follows just a few months after the UK CMO expanded its capacity to handle cyctotoxic compounds with the installation of new clean-room space at its facility.