MCHM Macrochem (MM)

MacroChem Announces Clinical Trial Results of First Topical Testosterone Cream Improved Delivery Profile over Its First - Generation Gel LEXINGTON, Mass., Aug. 3 /PRNewswire-FirstCall/ -- MacroChem Corporation (NASDAQ:MCHM), a specialty pharmaceutical company, announced top-line results from a pharmacokinetics study of Opterone(TM), its absorption-enhanced topical cream for male testosterone deficiency. "The results of this pharmacokinetics study demonstrate that MacroChem's SEPA technology delivered testosterone into the bloodstream within the first few hours of application," said Thomas C.K. Chan, PhD, vice president, R&D and chief technology officer at MacroChem. "Opterone cream also provided more sustained delivery of testosterone over 24 hours when compared with our first generation gel formulation," said Dr. Chan. "This was an important goal in the reformulation of Opterone from a gel to a cream." The recently completed trial was designed to study the pharmacokinetics of testosterone following administration of Opterone to hypogonadal adult males. Thirty-two patients were randomized to receive one of three dose volumes of Opterone with all patients completing the assigned dosing regimen. In this study, the amount of testosterone delivered was not linearly correlated to dose volume. Dr. Chan said that these results will guide the design of a bioavailability study, the next step in the clinical development plan. "I'm pleased that the results of this study advance development of an important treatment for men's health," said Robert J. DeLuccia, president and CEO of MacroChem. "The next Opterone study is a top clinical development priority for our company." The Company will host a conference call on the results of this study at 9:00 a.m. EDT today. The conference call will also be webcast. The webcast will be available to all interested parties through MacroChem's website at http://www.macrochem.com/. The dial-in number for the conference call is 800-299-7098 [domestic] and 617-801-9715. All callers should use reservation number 94617063 to gain access to the call. A replay of the conference will be available at 888-286-8010 [domestic] and 617-801-6888. Passcode is 71940778. About Testosterone Therapy Low 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. alone may be hypogonadal. Currently, only about 5 percent are treated. Hypogonadism is a medical condition of increasing importance, and represents a growing market open to new and improved therapies. About MacroChem MacroChem innovates, develops and commercializes pharmaceuticals administered in novel ways to treat important medical conditions. In addition to Opterone, MacroChem is actively developing EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis. For further information please consult 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 of MacroChem Corporation, VP/CFO, +1-781-862-4003; or Media: Donna LaVoie of LaVoie Group, +1-781-596-0200, ext. 103, for MacroChem Corporation Web site: http://www.macrochem.com/

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