SuperGen Inc has received approval from the U.S. Food and Drug Administration (FDA) to market Mitozytrex (MitoExtra), the company's proprietary version of the generic drug mitomycin, for use in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitozytrex becomes the first approved drug based on SuperGen's patented 'supergenerics' Extra technology platform.
"We are very pleased to have received FDA clearance to market Mitozytrex. This approval marks a milestone as it is the first New Drug Application - from beginning to end - that the company has seen through to approval," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "Although much of the external focus is on Nipent and our late stage investigative compounds Orathecin and decitabine, Mitozytrex becomes our fifth marketable product, joining Nipent, mitomycin, daunorubicin and the SurfaceSafe disposable cleaning system.
"Receiving FDA approval for MitoExtra is extremely gratifying, from both a personal and professional standpoint, as SuperGen was founded on the concept of the Extra technology," added Dr. Rubinfeld. "It is our belief that this could lead to a whole new generation of improved generics, or supergenerics, and we intend to develop the leading anticancer generics into Extra compounds."
Most anticancer drugs are cytotoxic; in addition, most must be administered intravenously. If a vein is missed on injection, the drug can extravasate, or leak, to surrounding tissue, causing ulceration that sometimes requires even plastic surgery to correct. SuperGen's Extra technology is designed to 'shield' the drug from the injection site, thus providing the patient protection from tissue ulceration.
"In addition to its so-called shielding benefit, the Extras could offer other important advantages over existing generics, such as increased solubility, stability and shelf life," said Dr. Rubinfeld. "With generics becoming more prominent in the marketplace, this approval offers SuperGen a strong toehold in this burgeoning business segment."