PharmAust’s cancer drug candidate monepantel (MPL) is set to enter Phase II clinical trials but an unpleasant taste in its current formulation, associated with poor patient compliance in Phase I, has led the firm to contract Juniper to reformulate the drug.
As part of the deal, the contract development and manufacturing organisation (CDMO) will also manufacture 20,000 capsules of the reformulated MPL solution from its facility in Nottingham, UK.
While Nikin Patel, president at Juniper Pharma Services, said the method of reformulating the product remains confidential, he told us Juniper’s approach “is to work with clients to scientifically understand their end point needs and then formulate an appropriate approach.”
The firm has a broad range of oral dosage and liquid capabilities that meet PharmAust’s needs, and no new equipment or extra staff will be employed to service the deal.
According to PharmAust, Phase II trials are expected to begin in April 2016 and will take 6-9 months.
Reformulation work is a strong area of growth for the CDMO, whether due to a clinical driver for reformulation as seen with the PharmAust contract - Nikin continued – or from the drive to reformat and repurpose existing drug products for new indications or improved formulations.
“Typically from an FDA perspective this falls under the 505(b)(2) route to commercialisation and is an area we are receiving a significant increase in demand,” he said.“We also are seeing up to 90% of new chemical entities having certain properties that make them a challenge to successfully formulate.”
“Today early in preclinical activities more time has to be spent considering the best formulation route for compounds. We are seeing our clients accessing our screening services to get this insight early, for example to get through toxicology studies to get satisfactory exposure.”