Washington Editor

Genta Inc. received its first drug approval Thursday when the FDA cleared Ganite for the treatment of cancer-related hypercalcemia that is resistant to hydration.

Ganite (gallium nitrate injection), originally developed by the National Cancer Institute in Bethesda, Md., and once sold in the U.S. by Fujisawa Pharmaceutical Co. Ltd., was removed from the market in 1991 and further studied by Memorial Sloan-Kettering Cancer Center in New York.

Company officials were not available for comment, but a company spokeswoman said the drug should be launched in the next few weeks. A prepared release from the company stated that the approval "marks our transition from development to commercialization."

That transition to commercialization is what makes FDA clearance of Ganite so important for the Berkeley Heights, N.J.-based company, Cory Kasimov, an analyst with Ryan Beck & Co. in New York, told BioWorld Today.

"Right now this is nothing more than a significant milestone in that it's the company's first commercially approved product and it will help them build some commercial infrastructure," Kasimov said. "But in terms of what it's going to add to Genta's bottom line, it is really not that material at this point in time, in our estimation."

He described expected U.S. sales in the approved indication to be "tiny."

Indeed, Kasimov said, "We're talking very low single-digit millions of dollars - it's not going to really impact what's out there now."

In the prepared statement, Bruce Williams, senior vice president of sales and marketing at Genta, said the company's oncology-focused sales team covers 18 territories in the U.S., and added that "we plan to leverage this marketing, sales and reimbursement expertise to future products from Genta."

As for Ganite, there is light at the end of the tunnel, Kasimov said. "If Ganite is ultimately used for non-Hodgkin's lymphoma, which is what it was originally developed for the NCI, then it could lead to something more material in terms of its impact on Genta's financials."

Genta has initiated a Phase II 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 (Rituxan, developed by Genentech Inc., of South San Francisco).

Regarding approval in the cancer-related hypercalcemia indication, Genta said Ganite has proven safe and effective in normalizing high levels of blood calcium by inhibiting calcium resorption from bone. In a double-blind clinical trial that compared Ganite with calcitonin (a commonly used anti-hypercalcemia drug), 50 patients were randomized to receive either Ganite at a dosage of 200 mg/m2/day for five days, or calcitonin at a dosage of 8 IU/kg four times per day for five days. Normalization of calcium was achieved in 75 percent of patients who received Ganite, compared with 27 percent of patients treated with calcitonin (p value = 0.0016). Ganite appeared to be useful in treating hypercalcemia associated with many different types of cancer, irrespective of the initial severity of the disorder, the company said.

Cancer-related hypercalcemia is a life-threatening elevation of blood calcium that can occur in up to 50 percent of patients with advanced cancer, the company said.

Genta acquired Ganite in April 2000 via its purchase of Relgen LLC, a privately held New Jersey corporation that had licensed rights to Ganite from Sloan-Kettering. Since the acquisition, Genta has been conducting preclinical and manufacturing work, as well as studying shelf-life extension and cleaning up some of the old data. The FDA reactivated the Ganite new drug application in January. (See BioWorld Today, Jan. 6, 2003.)

Also on Thursday, the company said it established a patient assistance program, called GentaCARES (Creating Access to Reimbursement Expertise Solutions). Reimbursement services include benefit verification, prior authorization, claims tracking, appeals and a patient assistance program for qualifying uninsured patients.

In unrelated news last week, Genta and partner Aventis SA, of Strasbourg, France, initiated filing of a rolling new drug application for Genasense, an antisense oncology compound for use in malignant melanoma patients. (See BioWorld Today, Sept. 11, 2003.)

Genta's stock (NASDAQ:GNTA) closed Thursday at $14.89, down 9 cents.