The FDA reactivated the new drug application for Genta Inc.'s Ganite, an intravenous cancer treatment originally developed by the National Cancer Institute and once marketed in the U.S. by Fujisawa Pharmaceutical Co. Ltd.
Ganite (gallium nitrate injection) in the early 1990s was on the U.S. market as a treatment for cancer-related hypercalcemia, or elevated blood calcium sometimes occurring in advanced cancer patients. Ganite was removed from the market in 1991 and further studied by Memorial Sloan-Kettering Cancer Center in New York.
Genta acquired Ganite in April 2000 through its acquisition of Relgen LLC, a privately held New Jersey corporation that had licensed rights to Ganite from Sloan-Kettering. At that point, Ganite was approved for hypercalcemia patients who had failed to respond to conventional measures including hydration.
Genta released a press statement at the time of the acquisition saying its strategy was to re-manufacture, market and sell Ganite. Furthermore, the company said it would seek to develop and commercialize an oral gallium-containing compound for disorders of accelerated bone resorption, including cancer-related hypercalcemia and bone metastases.
Therefore, on Friday, Genta not only announced reactivation of the new drug application, but also said it had submitted the first of two planned regulatory supplements related to the chemistry, manufacturing and controls (CMC) portion of the application.
Joy Schmitt, a spokeswoman for Berkeley Heights, N.J.-based Genta, told BioWorld Today the company believes it will complete the submissions by the end of the first quarter, with a launch sometime later in 2003.
Raymond Warrell, the company's chairman and CEO, released a prepared statement saying, "This first CMC submission updates information related to the drug substance, and the second filing will address the final drug product. We have been advised by the FDA that both submissions will be treated as manufacturing updates, which imply a four-month review process, thereby enabling the company to achieve its goal of launching Ganite during the current year."
Since acquiring the product nearly three years ago, Schmitt said the company has been conducting preclinical and manufacturing work, as well as studying shelf-life extension and cleaning up some of the old data.
Meanwhile, Genta has initiated a Phase IIb study of Ganite in patients with low- or intermediate-grade non-Hodgkin's lymphoma who have low blood counts and who have failed prior chemotherapy and rituximab (Genentech Inc.'s Rituxan).
Schmitt said based on earlier work from the National Cancer Institute, there may be some promise in the exploration of Ganite's utility in bladder cancer, gastric cancer and bone metastases.
And even though Ganite may be Genta's first marketed product, the company continues to have high hopes for its lead compound, Genasense.
Genta is completing accrual in several Phase III studies, including ones for malignant melanoma, multiple myeloma and chronic lymphocytic leukemia. The company intends to submit an NDA, along with its partner, Aventis Pharma AG, of Frankfurt, Germany, in the summer of 2003.
Genta does not have a partner for Ganite.
Genta's stock (NASDAQ:GNTA) closed Friday at $8.23, up 6 cents.