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MacroChem's Novel NailFungus Technology Shows Potential to Deliver 10x More
Antifungal Through Nail Than Needed to Treat Common Disorder UCSF research shows MacroChem's SEPA (R) could enable development of novel
new topical competitors for the current $1.4 billion worldwide
oral nailfungus drug market
LEXINGTON, Mass., Nov. 19 /PRNewswire/ MacroChem Corporation (Nasdaq: MCHM) announced today that its analysis of a University of California at San Francisco study of its novel nail fungus treatment shows nailpenetrating quantities of drug approximately ten times greater than needed to inhibit the organisms most commonly responsible for onychomycosis, a toenail and fingernail disorder that affects about 37 million Americans.
Drugs based on MacroChem's throughthenail technology would bypass the stomach, liver and systemic circulatory pathways that today's oral medications take to reach infected nails, and instead, would deliver curative medication right through the infected nail and surrounding skin. Instead of a tablet or capsule, MacroChem's new technology, when available in finished products, could look like cosmetic lacquers marketed today as "clear nail polish."
Onychomycosis ("ahnikomyKOsis"), a fungal disease of the nails, causes yellowing and thickening of finger and toenails, and occasionally, pain.
Today, two oral drugs Lamisil(R), by Novartis, and Sporanox(R), by Janssen dominate a market estimated by Datamonitor at $1.4 billion in 2000. These drugs demonstrate cure rates as high as 70%, but both carry label precautions about potential organ toxicity and interactions with common prescription and nonprescription drugs.
Drug additive developed to increase skin absorption has nailtreatment potential
At the heart of MacroChem's technology is SEPA(R)1, a drug additive originally developed to enhance skin absorption of topically applied pharmaceuticals. Last Friday, a research team headed by one of the world's most prominent dermatology researchers, Howard I. Maibach, MD, UCSF professor of dermatology, told dermatologists attending the 25th annual meeting of the Skin Disease Education Foundation (SDEF) that SEPA, when added to a mixture of antifungal drug and nail lacquer, delivered six times more antifungal drug through human nail than identical lacquerdrug formulations without SEPA. The formulation tested by UCSF was a formulation MacroChem calls EcoNail(TM)because it contains the offpatent antifungal drug econazole.
"The levels of antifungal drug found by UCSF researchers in nail surfaces ordinarily in contact with the nail bed, were ten times higher than customarily believed necessary to inhibit the growth of infecting fungi," explained Robert J. Palmisano, president and chief executive officer of MacroChem.
"In addition to Dr. Maibach's study, previous MacroChem studies have shown that lacquers containing SEPA and antifungal drugs deliver more drug through skin than identical lacquers without SEPA," Mr. Palmisano continued. "We believe that drug delivery through the skin and through the nail could yield lacquers that provide properties we think both clinicians and patients will find appropriate for treating a condition that is largely cosmetic."
Last June, Mr. Palmisano told shareholders attending MacroChem's annual meeting in Boston that the company had decided not to invest in EcoNail clinical trials, because those trials would be too costly for a small drugdelivery company like MacroChem to pursue on its own. Instead, the company decided to meet with dermatology researchers throughout North America, to see if any of them knew of a less costly method of determining whether its technology could enhance nail penetration.
"Our discussions with Dr. Maibach led to the study at UCSF, where researchers used a carbon14 labeled econazole to study precisely how much antifungal drug reached the underside of nails treated with lacquers containing econazole with and without SEPA," Mr. Palmisano said. "Dr. Maibach had developed and published on this sensitive assay that can show not only how much drug passes through the nail, but more important, how much drug stays in the lower nail surface where the infection normally resides."
"While we cannot predict if or when we might be able to secure a partner based on this research, we believe the UCSF data represents a major advance in commercializing a technology that would be too costly for us to pursue on our own."
EcoNail(TM) or proprietary antifungals: MacroChem exploring all options MacroChem has developed a "testbed" product it calls EcoNail(TM)to demonstrate the potential of its nailfungus treatment technology, for which it received a sweeping 40claim U.S. patent this past April. EcoNail contains the offpatent antifungal drug econazole, a drug with a long history of safety and efficacy in treating athlete's foot, which is caused by the same organisms that cause nail infections. However, the MacroChem patent covers the SEPA enhanced formulation of a broad range of patented and offpatent antifungal drugs that might be used to treat nail fungus.
"We are currently pursuing parallel licensing possibilities," Mr. Palmisano said. "We have EcoNail as a product that a company might license, develop and market. And we are talking to companies that have proprietary antifungal drugs they 'd like to combine with SEPA in a lacquer."
In addition to its nailfungus technology, MacroChem is developing topical drugs to treat erectile dysfunction (Topiglan(R)) and hypogonadism.
(1) SEPA(R) 'Soft Enhancement of Percutaneous (through the skin)
Absorption'
With the exception of historical information contained in this document, the matters described herein are forwardlooking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forwardlooking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses.
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