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| |  SEPA Testosterone Transdermal Gel Receives IND Application by FDA LEXINGTON, Mass., Jan. 15, 1997 -- MACROCHEM CORPORATION (Nasdaq: MCHM) announced today that the FDA has cleared an Investigational New Drug Application (IND) allowing MacroChem to commence Phase I/II clinical studies of its SEPA(R)/testosterone gel for the transdermal delivery of testosterone, without use of a patch. MacroChem's formulation combines the male hormone, testosterone, and SEPA(R), the Company's proprietary absorption enhancer for transdermal drug delivery. The SEPA(R)/testosterone gel will be targeted for the treatment of men suffering from hypogonadism, a condition which affects an estimated 4-5 million American men of all ages. Hypogonadism in men is evidenced by a reduction in blood levels of the hormone testosterone, which is essential for the development and maintenance of male physical and sexual characteristics. Men with testosterone deficiency can suffer from a variety of problems, including decreased libido, fatigue and muscle wasting. Testosterone is usually administered by injection or with transdermal patches. "We believe that our gel formulation could provide hypogonadal patients currently on a patch or injection regimen with advantages such as: lower cost, less irritation at application site, easier adjustment of dosage needs and greater overall convenience," said Dr. Carlos M. Samour, Chairman and Scientific Director of MacroChem. The Phase I/II clinical trial, expected to start in January 1997, has a two-fold objective. First, it will be a pharmacokinetic study to evaluate safety factors and various dosage levels of the topical treatment. Secondly, this study is intended to reproduce the normal daily variation in blood levels of testosterone needed to maintain the normal rate of metabolism of this male hormone. Alvin J. Karloff, MacroChem's President and CEO stated: "We believe that our SEPA/testosterone gel could provide the male population afflicted with hypogonadism with a user-friendly therapeutic alternative. MacroChem is currently engaged in two clinical development programs, topical testosterone for hypogonadism and alprostadil for the treatment of erectile dysfunction, which reflect our focus on the development of unique topical formulations which offer significant medical and patient advantages for treatment of male disorders." To the extent this press release discusses matters relating to a product and a clinical trial, these are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in any forward-looking statements. The relevant risk factors are set forth in MacroChem's report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical studies and risks involving regulatory approval of products. MacroChem develops, licenses and markets products and technology for the transdermal and topical delivery of agents used for prescription and OTC pharmaceutical and cosmetic applications. The Company's patented technology, SEPA(R), an absorption enhancer for transdermal delivery, can effectively increase the passage of therapeutic agents through the skin, offering significant advantages over current methods of drug delivery.
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