By Mary Welch
Maxim Pharmaceuticals Inc. registered to sell 2.5 million shares of stock currently valued at about $100 million in a public offering to help launch Maxamine as well as product research and development activities for the MaxDerm and MaxVax technology platforms.
In addition, the San Diego-based company will offer the underwriters an option to purchase another 375,000 shares of stock to cover overallotments. Currently the company has just more than 12.5 million shares outstanding, said Larry Stambaugh, the company's president, chairman and CEO.
J.P. Morgan & Co., of New York, is the lead manager, with Prudential Vector Healthcare Group, of New York, and Aragon Securities AB, of Stockholm, Sweden, acting as co-managers.
Citing the required "quiet period," Stambaugh refused to disclose other details about the filing.
However, he did state that the funds would be needed for the presumed launch of its lead drug candidate, Maxamine, now in three Phase III trials. Maxamine, which is based on the naturally occurring molecule histamine, is designed to improve immunotherapy by protecting critical immune cells. A histamine type-2 receptor agonist, Maxamine shuts off production of free radicals, thereby protecting T cells and natural killer cells. It is administered in combination with cytokines, a class of proteins that stimulate these same cells.
To date, more than 1,000 patients have been treated with Maxamine for several indications, including advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma.
"The first trial, for advanced malignant melanoma, should be unblinded this spring with an NDA [new drug application] filing in mid-2000," Stambaugh said.
Another Phase III trial is an international study in advanced malignant melanoma designed to broaden the exposure of clinicians outside the U.S., and the third is using Maxamine as a remission therapy for acute myelogenous leukemia, the most common acute adult leukemia. The latter trial is being conducted in 12 countries, including the U.S.
If Maxamine is approved, it will be marketed in Australia and New Zealand by F.H. Faulding & Co. Ltd., of Underdale, Australia, and in Israel by MegaPharm Ltd., of Hod Hasharon, Israel.
In the past year, the company has gone to the financial well three times. In July, it raised $20 million via a private placement, and in November it raised another $20 million by selling convertible preferred stock to a group of existing shareholders as well as new investors based in the U.S. and Europe. (See BioWorld Today, July 27, 1999, p. 1; and Nov. 3, 1999, p. 1.)
MaxDerm allows for the topical delivery of the active ingredient in Maxamine. It is designed to modulate the patient's immune, inflammatory and wound-healing responses to treat certain dermatological conditions, infections and other conditions in which a topical therapy is appropriate. So far, more than 75 patients have been treated in placebo-controlled studies in patients with herpes, oral mucositis, canker sores, decubitus ulcer and shingles.
MaxVax , a novel mucosal vaccine carrier platform, has the potential to facilitate a new class of vaccines, the company said. Mucosal immune protection is important, it said, because it represents a way to fortify the body's first-line defense on the linings of the mouth, eyes, ears, respiratory, gastrointestinal and urogenital tracts - the sites where most pathogens enter the body. The company will focus development of this product on sexually transmitted diseases, major respiratory diseases and gastrointestinal tract diseases. It currently is in preclinical development.
Maxim's stock (AMEX:MMP) closed Tuesday at $40, up 62.5 cents.