UK-based biopharmaceutical company Protherics has filed for approval in the USA for Voraxaze, a drug designed as a rescue treatment for cancer patients suffering from the side effects of chemotherapy.
The filing comes more than a year after Protherics filed for Voraxaze (carboxypeptidase G2) in the European Union, where it is hoping for approval in the first half of next year. A US green-light should come in the latter half of the year, assuming all goes well with the regulatory review.
Specifically, Voraxaze is intended for use alongside methotrexate, a chemotherapy drug with broad applications across a range of cancers. It prevents blood concentrations of the drug rising too high in patients who struggle to eliminate the drug, usually as a result of impaired renal function. This reduces the risk of serious toxicities and death which can result from prolonged exposure to methotrexate following high dose treatment.
At present there is no such treatment available on the market, and Protherics estimates that Voraxaze could be pitching at a market of up to $200 million a year, providing the company is successful in extending the indications of the drug to include more routine use to prevent the side effects of methotrexate treatment.
If approved, Voraxaze would be Protherics’ first product detailed and marketed by in-house sales staff, said chief executive Andrew Heath.
The UK firm was boosted earlier this month by the publication of Phase IIb data for its anti-sepsis drug CytoFab, which will soon be taken by partner AstraZeneca into a full Phase III programme.