Recipharm has penned a deal to supply the material for trials of a new drug designed to prevent side-effects in chemotherapy patients.
The drug, PledOx PLIANT, is being developed by Swedish pharmaceutical company PledPharma and has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA).
Maria Lundberg, General Manager of Pharmaceutical Development at Recipharm – a contract development and manufacturing organization (CDMO) based in Sweden – expressed in a press release her delight in the company’s contribution to the drug. “Manufacturing material for an FDA-approved clinical study reflects the highest standards of service quality and capabilities,” she added.
The current supportive cancer care market has been estimated to be worth $11.3bn (€8.4bn) and in receiving the nod from the FDA, PledPharma can tap into the US market, described as “perhaps the single most important market” by CEO Jacques Näsström.
The drug, which is to enter Phase IIb clinical trials, is designed to protect cancer sufferers from further complications after chemotherapy including oxidative stress.
The over-production of free radicals in the normal oxidation process causes the burden on the body known as oxidative stress which can be exacerbated by chemotherapy treatment. Oxidative stress can interfere with cancer drugs and cause a number of other complications.
The deal is not the first time the two companies have worked together. Last year Recipharm assisted PledPharma in gaining regulatory approval and restarting clinical trials of its candidate therapy, mangafodipir, after supplies of the heart attack drug ran out.