Named patient distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient. In most countries, this program provides for full cost recovery of providing late-stage investigational drugs that are either pending regulatory approval or are in late-stage clinical trials that are intended to lead to formal regulatory approval.
Until now, the company had been supplying Genasense at no charge. The proceeds from this program, which are recorded as gross revenue for accounting purposes, will appear as of Q3 2007.
“With published results earlier this year of our randomized trials in melanoma and chronic lymphocytic leukemia, the company has received a number of requests for Genasense to treat specific patients. We are pleased to make this program available to patients outside the US We expect that proceeds from this new program will be used to offset costs associated with our confirmatory randomized trial in patients with advanced melanoma,” said Dr Raymond Warrell, Genta’s chairman and CEO.