Macrochem (NASDAQ:MCHM)
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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/