MACROCHEM CORP NEW

Seit dem 21.01. vom multimonatstief auf ueber 1,80$ gestiegen... Timing war perfekt ! Gruss

MacroChem Updates Shareholders on Clinical Trial Progress For Three Development-Stage Products Tuesday January 20, 12:35 pm ET Letter to shareholders available online at http://media.corporate-ir.net/media_files/nsd/mchm/reports/shareholder_let.pdf LEXINGTON, Mass., Jan. 20 /PRNewswire-FirstCall/ -- MacroChem Corporation (Nasdaq: MCHM - News) has announced in a letter to shareholders that it expects to begin clinical testing of EcoNail(TM), its topical treatment for fungal infections of the nail, in the first quarter of 2004. In addition, the letter from MacroChem president and CEO Robert J. DeLuccia updated shareholders on progress made in advancing the company's two other development-stage products: Topiglan®, a topical cream therapy for erectile dysfunction, and Opterone(TM), a cream treatment for male testosterone deficiency. ADVERTISEMENT MacroChem is a specialty pharmaceutical company developing topical medications based on its proprietary skin-absorption enhancer, SEPA®. Its products combine SEPA with known pharmaceuticals, and are targeted at improving care of millions of patients with unmet medical needs. "In June of last year, we initiated a Phase 2 study in erectile dysfunction (ED) patients using our new cream formulation of Topiglan®, a topical ED treatment containing SEPA, and alprostadil," Mr. DeLuccia said. Alprostadil is an established ED therapy used today as an injection, and as an intraurethral suppository. MacroChem reports that this Topiglan study has nearly completed patient enrollment, and that it anticipates data later this quarter. In December, MacroChem announced that it had initiated a dose- proportionality clinical study of Opterone(TM) (SEPA + testosterone), the first absorption-enhanced topically administered cream to treat male testosterone deficiency. According to Mr. DeLuccia, results of that study are expected to be available in the first half of 2004. This trial will be followed by additional studies which, if successful, could allow for a U.S. regulatory filing in the first half of 2005. The planned initiation of an EcoNail patient trial follows a pre-IND (Investigational New Drug) meeting held with the FDA near the end of last year. Pending favorable outcome for this study, which will commence following IND filing and clinical site preparation, MacroChem believes an efficacy trial could begin in 2005. EcoNail combines SEPA with econazole in a lacquer designed to be brushed onto infected nails. More than 30 million Americans have fungal infections of toenails, but less than a quarter currently receive drug treatment, due to perceived safety risk and low efficacy of available medications. "These clinical trials highlight our commitment to shift from a traditional drug delivery company to a specialty pharmaceutical company that develops and brings to market innovative healthcare products," explains Mr. DeLuccia. "In addition to these clinical trials, over the past year, we have filed patents covering our SEPA-based creams and a new generation of skin absorption-enhancers with improved characteristics." "We have also advanced a number of potential new products using both our SEPA enhanced-absorption technology and our MacroDerm(TM)-based technology, which retards penetration of pharmaceutical actives through the skin," Mr. DeLuccia said. He also reported in the letter to shareholders that experiments are being conducted by MacroChem and university researchers on potential uses of the company's technologies in dermatological drugs, cosmeceuticals and other products for which transdermal technologies can provide important therapeutic innovation and commercial value. "I think you'll agree that these efforts represent substantial progress in each of our strategic goal areas set forth earlier this year," he said. "First, to accelerate each product in our portfolio to its next value-creating development milestone; second, to exploit and expand our technology to develop new products with both high therapeutic value and commercial potential; third, to build the Company via licenses, collaborations and partnerships; and last, to develop a capacity, at the appropriate time, to market certain of our products ourselves." The letter to shareholders described in this announcement is available online at http://media.corporate-ir.net/media_files/nsd/mchm/reports/shareholder_let.pdf and on the company's web site, www.macrochem.com. With the exception of historical information contained in this press release, the matters described herein are forward-looking statements and are subject to various risk factors that could cause actual results to differ materially from those expressed in the forward-looking statements. The relevant risk factors are set forth in MacroChem's annual report on Form 10-K as filed with the SEC and include, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, and patents and licenses. Visit our web site at: http://www.macrochem.com Contact: Bernard Patriacca - VP/CFO (781) 862-4003