MCHM Macrochem (MM)

MacroChem CEO Reports on Year of Progress and Innovation at Annual Shareholders' Meeting BOSTON, June 14 /PRNewswire-FirstCall/ -- MacroChem Corp. (NASDAQ:MCHM) president and CEO Robert J. DeLuccia told shareholders here today that, armed with the strongest clinical data in the company's history, its executive team is now focused on partnering discussions and securing the financial resources necessary to fully exploit its opportunities and create additional shareholder value. "This past year, our development focus resulted in two of the most successful clinical trials in our Company's history," Mr. DeLuccia said. "As a result, our absorption-enhanced testosterone cream Opterone(R) is now ready to be advanced to a Phase 3 clinical trial, and our antifungal nail lacquer EcoNail(TM) is now ready to move into a definitive efficacy program. The most formidable challenge ahead of us now is to secure the resources necessary to move these promising products forward." Mr. DeLuccia noted that, during the past year, the pharmaceutical industry had faced increased regulatory scrutiny, volatile financial markets and rising development costs, which made it imperative for companies like MacroChem to demonstrate greater innovation and tangible progress. "Despite this challenging environment," Mr. DeLuccia said, "I believe we've done just that by advancing our innovative product pipeline and continuing our transformation into a company capable of innovating, developing and, at the appropriate time, participating in the marketing of our proprietary products." Clinical trial results reviewed MacroChem recently announced results of a successful bioavailability study of Opterone, a topical testosterone cream for treatment of male hypogonadism. Opterone contains 1% testosterone and 5% SEPA(R), MacroChem's drug absorption enhancer. In the trial initiated in late 2004 and reported last month, a single 2.5 gram dose of Opterone applied to the upper arms and shoulders normalized circulating testosterone levels over 24 hours in all ten patients in the trial. "Our primary goal was for Opterone to replace testosterone in hypogonadal men using half the dose and volume of the marketed gels -- and we achieved that goal in this trial," Mr. DeLuccia recalled. "These results not only represent a major advancement for our nearest-to-market product and our SEPA technology, but also validate our new cream formulation as a drug delivery vehicle." Mr. DeLuccia reported that Dr. Thomas Chan, MacroChem vice president of R&D and chief technology officer, is in Seoul, Korea this week participating in a panel discussion on testosterone therapy at the International Congress for Andrology, where he will present the data from the recent trial and the preceding development programs. "We believe Opterone is now ready to be advanced to a Phase 3 clinical trial," Mr. DeLuccia told shareholders. Current treatments for hypogonadism have been estimated at about one-half billion dollars in the U.S. alone, he said. In addition to reviewing its Opterone advances, Mr. DeLuccia also summarized results from the first human safety and tolerability study of the company's antifungal nail lacquer, EcoNail(TM). That study showed that EcoNail was well-tolerated and warrants advancement to efficacy trials, he said. "In addition to safety and tolerability data, clinical observations included photographs of target toenails," Mr. DeLuccia said. "Although not formally part of the clinical protocol procedures, photographs from 5 of the first 14 completed patients, who received either 12 or 18 weeks of EcoNail, were judged by independent dermatologists to have shown initial signs of nail improvement. We are very pleased with the results of this trial and the early clinical observations and look forward to advancing into efficacy trials as soon as practicable." EcoNail is being developed to treat onychomycosis, a fungal infection of the nails that affects more than 30 million Americans, the overwhelming majority of which do not receive treatment. Despite this low treatment rate, the current U.S. market for drugs treating this condition approximates three quarters of a billion dollars. Current focus: Additional capital, partners, managing expenses Mr. DeLuccia noted that management is now focused on using the results of these trials to secure additional investment capital and partners on Opterone and EcoNail. "Since March 2004, we completed two private placements that total approximately $8.1 million," he noted. "The new clinical data for both Opterone and EcoNail provide a more substantive platform for discussions with potential partners with whom we plan to share development costs and to collaborate in the marketing of these two clinical stage products. We are now actively engaged in discussions with a number of interested U.S. and European companies. Partnering our clinical stage products could allow us to bring forth new product candidates into development, further enhancing shareholder value." 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), and EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis. For more information on MacroChem, and its technology and products, please 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. For more information visit our website, http://www.macrochem.com/. Contact: Bernard Patriacca - VP/CFO (781) 862-4003 DATASOURCE: MacroChem Corp. CONTACT: Bernard Patriacca, VP/CFO of MacroChem, +1-781-862-4003 Web site: http://www.macrochem.com/

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