By Lisa Seachrist

Washington Editor

Maxim Pharmaceuticals Inc. submitted a new drug application for its lead product, Maxamine, as an adjuvant to interleukin-2 for treating Stage IV melanoma.

The submission is the first by the San Diego-based company, and FDA has informed the company the drug is eligible for a priority review once the agency has accepted the submission.

"We are very pleased," said Larry Stambaugh, Maxim's chairman and CEO. "This is the culmination of a lot of hard work."

The company initiated the filing with the manufacturing section in May and completed the entire submission this week. The pivotal Phase III study supporting the application was completed in March. The FDA has to officially accept the submission before a likely six-month review clock is started.

"I suspect we will be at the December meeting of ODAC [Oncologic Drugs Advisory Committee]," Stambaugh said, referencing the FDA's advisory panel schedule.

The NDA is supported by a pivotal Phase III clinical trial testing Maxamine (histamine dihydrochloride) plus IL-2 against IL-2 therapy alone in patients with end-stage melanoma. The study included 305 patients with Stage IV melanoma. Melanoma is the most deadly and serious form of skin cancer and is one of the most rapidly increasing cancers in the world. For patients receiving the combination therapy, the median survival was 326 days compared to 251 days for patients receiving IL-2 alone.

Patients suffering from liver metastases had an even greater survival advantage with Maxamine, with a median survival of 363 days compared to 157 days with IL-2.

"We are hopeful that this application can be approved and permit a product that can provide a survival benefit for late-stage melanoma to be marketed," Stambaugh said. "This drug can increase patient survival, improving the quality of life."

Robert Toth, vice president and analyst for Prudential Vector Healthcare Group, said in a note that the filing was expected but represented a strong positive for the company.

"The filing essentially starts the clock ticking for the final phase of Maxamine's regulatory approval, which we continue to expect by mid-2001," Toth wrote.

In addition, Toth noted the drug is considered controversial by some because only one of the two co-primary endpoints had been achieved with statistical significance. Nevertheless, Toth said, "We believe that it will be sufficient to warrant the approval."

Upon approval, Maxim intends to market the drug itself in the U.S. The company already has licensing agreements with F.H. Faulding & Co. Ltd., of Underdale, Australia, to market Maxamine in Australia and New Zealand and with MegaPharm Ltd., of Hod-Hasharon, Israel, to market the product in that country. Stambaugh said the company would seek additional partners around the world.

"We hope to have our partners in place by the end of this year or the beginning of next," Stambaugh said.

Maxamine is a histamine type-2 receptor agonist, a potent molecule that shuts off production of free radicals, thereby protecting T cells and natural killer cells. Maxamine therapy combines the drug with different immunostimulatory cytokines such as IL-2 and interferon-alpha. The therapy is based on a mechanism that suppresses the body's ability to detect and destroy tumor cells. Maxamine allows the body the get past that immune suppression.

In addition to melanoma, Maxim has Maxamine therapy in Phase III trials for acute myelogenous leukemia. The company also is studying the therapy as a means of treating hepatitis C and advanced renal cell carcinoma in Phase II studies.

Maxim also is developing Max Vax, a mucosal vaccine carrier platform, and MaxDerm, for the treatment of oral mucositis, herpes, shingles, burns and related conditions. And it is developing small-molecule inhibitors and activators of caspases, key enzymes modulating cell signaling pathways involved in program cell death, or apoptosis. The small molecules are being developed as cancer therapeutics, drugs for cardiovascular disease and other degenerative diseases.

Maxim's stock (NASDAQ:MAXM) closed Wednesday at $56.625, down $2.437.

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