The global agreement covers all territories except the US. Named patient distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient.
Ganite is approved and marketed in the US for treatment of cancer-related hypercalcemia that is resistant to hydration. It is also being tested for use in with bone metastases, in Paget's disease of bone as well as in non-Hodgkin's lymphoma.
A marketing authorization application for Genasense plus dacarbazine in patients with advanced melanoma is currently pending review in Europe. Genta is also testing Genasense in ongoing clinical trials with other chemotherapy drugs in patients with melanoma and other diseases.
Genta expects to allocate a percentage of net proceeds from the IDIS program to support compassionate use in indigent patients; the remainder will support further clinical research.
“We are pleased to be able to provide these drugs that address critical unmet medical needs to seriously ill patients in response to prescriber requests,” said Dr Raymond Warrell Jr, Genta's CEO.