MCHM Macrochem (MM)

MacroChem Announces Initiation of Next Clinical Trial of Opterone(R), First Testosterone Cream For Male Hypogonadism Company plans to initiate Phase 3 program in 2005 LEXINGTON, Mass., Dec. 8 /PRNewswire-FirstCall/ -- MacroChem Corporation (NASDAQ:MCHM) has announced the initiation of the next clinical study in its development program for Opterone(R), its investigational topical cream for male hypogonadism. Opterone combines testosterone with SEPA(R), MacroChem's patented skin-absorption enhancer. The SEPA in Opterone makes the stratum corneum of the skin more permeable to testosterone, enhancing the delivery of this hormone into the body. The purpose of this bioavailability study is to compare the rate and extent of absorption of testosterone into the bloodstream following administration of different dose volumes of Opterone to different application areas. The study was initiated at a U.S. clinical site following successful completion of a pharmacokinetic study of Opterone cream in hypogonadal males, results of which were announced in August 2004. "Results from these two studies will allow us to move into a Phase 3 program that we expect to initiate next year," explained Robert J. DeLuccia, president and chief executive officer of MacroChem. "Male hypogonadism is a medical condition of increasing importance, and represents a growing market open to new and improved therapies," Mr. DeLuccia said. "I believe Opterone can make an important contribution to managing this condition." About Testosterone Therapy Low circulating testosterone is an underdiagnosed medical condition with potential long term health consequences if left untreated. Some men do not produce enough testosterone, resulting in a condition known as hypogonadism. Signs and symptoms of hypogonadism include low sex drive, erectile dysfunction, fatigue, depression, reduced muscle mass and strength, increased body fat and decreased bone mineral density. According to the Endocrine Society, approximately four to five million men in the U.S. may be hypogonadal. Currently, only about 5 percent are treated. In 2003, U.S. sales of testosterone products for male hypogonadism grew 20% and exceeded half a billion dollars. About MacroChem MacroChem is a specialty pharmaceutical company that innovates, develops and commercializes pharmaceuticals administered in novel ways, to treat important medical conditions. MacroChem is developing two products containing its patented enhancer, SEPA(R): Opterone(R), a SEPA-enhanced topical testosterone treatment for male hypogonadism; and EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis. Visit our website at: http://www.macrochem.com/. Forward-Looking Statements With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. MacroChem's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed or referred to in the section entitled "Risk Factors" in MacroChem's Annual Report on Form 10-K, as well as those discussed elsewhere therein, and include, without limitation, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MacroChem undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Visit our web site at: http://www.macrochem.com/ Contact: Bernard Patriacca - VP/CFO (781) 862-4003 Media Contact: Donna LaVoie (LaVoie Group) (781) 596-0200 x103 DATASOURCE: MacroChem Corporation CONTACT: Bernard Patriacca, VP/CFO of MacroChem Corporation, +1-781-862-4003; or Media - Donna LaVoie of LaVoie Group, +1-781-596-0200 x103, for MacroChem Corporation Web site: http://www.macrochem.com/

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