MCHM Macrochem (MM)

MacroChem Reports on Clinical Trial Progress at Annual Shareholder Meeting BOSTON, June 23 /PRNewswire-FirstCall/ -- Today at its annual shareholders meeting, MacroChem Corporation (NASDAQ:MCHM) reported on progress of its two clinical-stage product candidates -- Opterone(TM), a topical treatment for male testosterone deficiency, and EcoNail(TM), a topical lacquer for treating fungal infections of the nails. Robert J. DeLuccia, president and CEO, told shareholders attending the company's annual meeting that all patients have completed the current Opterone clinical study. Data are being collected, and the company expects to announce results next month. Mr. DeLuccia also told shareholders that the company's current EcoNail study is approximately 60 percent enrolled, and that the company expects to announce results later this year. "These two products are being developed to treat important medical conditions in large, underserved markets," Mr. DeLuccia said. Current testosterone replacement products account for approximately $400 million in sales annually in the U.S., and yet only 5% of the 4 to 5 million men with testosterone deficiency have been diagnosed and treated. Opterone contains the male hormone testosterone plus SEPA(R), MacroChem's proprietary enhancer. Of the more than 30 million people in the U.S. with nail fungal infections, less than a quarter currently receive prescription drug therapy. Current annual sales of drugs for treating nail-fungus infections are estimated at more than $700 million in the U.S. MacroChem's EcoNail contains the antifungal drug econazole, plus SEPA. Mr. DeLuccia also commented on the outcome of its pharmacodynamic study of Topiglan, a topical treatment for erectile dysfunction. That study did not meet clinical endpoints, as previously announced, and the company has decided not to conduct further clinical trials of Topiglan at this time. "During the past year, we made substantial progress in advancing our product portfolio -- and raising capital is critical to implementing our strategy," Mr. DeLuccia said. "We raised approximately $10.5 million in private financings with life science investors, increasing our institutional ownership to approximately 25%." As of March 31, 2004, MacroChem reported $11.9 million in cash and short-term investments. In the formal business part of the meeting, shareholders re-elected five members of the Board of Directors, ratified the appointment of Deloitte & Touche LLP as independent auditors, approved a proposal to amend the 2001 Incentive Plan to increase the number of shares of Common Stock authorized for issuance under the Incentive Plan by 4,000,000 and approved a proposal to amend the Company's Certificate of Incorporation, as amended, to increase the number of authorized shares of capital stock from 60,000,000 shares of common stock and 6,000,000 of Preferred Stock to 100,000,000 shares of Common Stock and 6,000,0000 shares of Preferred Stock. "As we continue our transition to a specialty pharmaceutical company, we intend to focus our resources on our products in clinical development," Mr. DeLuccia concluded. "We are also working to expand our product portfolio by developing second-generation enhancers, developing new product candidates using our core technologies, and evaluating new technologies for potential development. MacroChem seeks to eventually build a sales force to promote its products to specialists, and to partner with other pharmaceutical companies to cover primary care practitioners." About MacroChem Corporation 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: Opterone(TM), a SEPA-enhanced topical treatment for men with testosterone deficiency; and EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis. 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/ Investors: Bernard Patriacca - VP/CFO (781) 862-4003 Media: Donna LaVoie - LaVoie Strategic Communications Group, Inc. (781) 596-0200 x103 DATASOURCE: MacroChem Corporation CONTACT: Investors, Bernard Patriacca -- VP/CFO, MacroChem Corporation, +1-781-862-4003; or Media, Donna LaVoie -- LaVoie Strategic, Communications Group, Inc., +1-781-596-0200 ext. 103 Web site: http://www.macrochem.com/

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