MacroChem Corporation is a specialty pharmaceutical company that develops and seeks to commercialize pharmaceutical products. The Company's portfolio of product candidates is based on its three drug delivery technologies: Soft Enhancement of Percutaneous Absorption (SEPA), MacroDerm and DermaPass. The SEPA topical drug delivery technology enhances the efficiency and rate of diffusion of drugs into and through the skin. MacroChem owns a composition of matter patent on the SEPA family of compounds, which will expire in November 2006. It also owns five composition of matter and use patents, with expiration dates ranging from 2015 to 2019, for the combination of SEPA with numerous existing classes of drugs, including antifungals and human sex hormones. The MacroDerm drug delivery technology encompasses a family of low- to moderate-molecular weight polymers that impede dermal drug or chemical penetration, which may be usable, to prevent chemicals in insect repellant from penetrating the skin. MacroChem owns three patents covering the composition of matter and methods of use of the MacroDerm polymers that expire in 2015. The Company has also filed a patent application for the DermaPass family of transdermal absorption enhancers that have a different drug delivery profile than SEPA, which could be used with a wider range of active pharmaceutical ingredients. The Company's lead product candidate is EcoNail, a topically applied SEPA-based econazole lacquer for the treatment of onychomycosis, a condition commonly known as nail fungus. Econazole, a commercially available topical antifungal agent most commonly used to treat fungal skin infections, inhibits in vitro growth of the fungi most commonly implicated in onychomycosis. When used in EcoNail, SEPA works by allowing more rapid and complete release of econazole from the lacquer into and through the nail plate. In a pre-clinical study using human cadaver nails, EcoNail delivered through the nail more than 14,000 times the minimum concentration of econazole needed to inhibit the fungi most commonly associated with onychomycosis. Following its laboratory studies, MacroChem conducted a randomized, double blind controlled Phase 1 tolerance/human exposure trial of EcoNail in eighteen patients with onychomycosis of the toenails. In this study, EcoNail was well tolerated, and investigators reported no serious drug-related adverse events. Serum assays used to determine the level of drug in the bloodstream showed no detectable levels of econazole, further supporting EcoNail's systemic safety profile. Full data from the 18-week trial were presented in May 2005 at the annual meeting of the Society for Investigative Dermatology. MacroChem expects to commence a Phase 2 efficacy study of EcoNail in the second quarter of 2006. The Company contemplates that this study will be conducted through a contract research organization with significant experience in onychomycosis trials. MacroChem's other clinical stage product candidate, Opterone, is a topically applied SEPA-based testosterone cream designed to treat male hypogonadism. Male hypogonadism is a condition in which men have levels of circulating testosterone below the normal range and may exhibit one or more associated symptoms, including low energy levels, decreased sexual performance, loss of sex drive, increased body fat or loss of muscle mass. In August 2004, MacroChem announced the completion of a pharmacokinetics study of Opterone in hypogonadal males. In May 2005, the Company announced results from a bioavailability study of Opterone. In that study, patients using a 2.5 gram dose of Opterone applied to the upper arms and shoulders reached the natural physiologic range of testosterone levels over a 24-hour period. In December 2005, MacroChem received a letter from the Division of Reproductive and Urologic Products of the United States Food and Drug Administration (FDA) in response to questions posed by MacroChem regarding a proposed Phase 3 clinical program for Opterone. In the letter, the FDA requested that the Company conduct a

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