Clinigen signs global access deal with Galen for chemotherapy drug DaunoXome

Under the deal, Clinigen’s Idis Global Access (GA) division will make the drug available on request in 20 European countries as well as Australia, New Zealand and Hong Kong.

Galen will retain the rights to supply DaunoXome in the UK and selected countries outside Europe.

DaunoXome, a single use vial for intravenous infusion, has Medicines and Healthcare products Regulatory Agency (MHRA) approval to treat AIDS-related Kaposi’s sarcoma.

Clinigen managing director Steve Glass said: "This is our first exclusive supply agreement since Clinigen’s acquisition of Idis in 2015 and an important part of Idis GA’s ongoing strategy to increase the number of product agreements to better meet patients unmet needs.

"This agreement enables us to leverage our expertise and international network to ensure that physicians in key European markets receive the right medicine at the right time to better treat their patients."

DaunoXome is a liposomal preparation of daunorubicin formulated to maximize the selectivity of daunorubicin for solid tumors in situ.

The DaunoXome formulation helps in protecting the entrapped daunorubicin from chemical and enzymatic degradation in the circulation. It lowers protein binding, and decreases uptake by normal tissues.

Clinigen said the specific mechanism by which DaunoXome is able to offer daunorubicin to solid tumors in situ is not known.

It is thought to be a function of increased permeability of the tumor neovasculature to various particles in the size range of DaunoXome.