Palmisano says MCHM now has university lab and clinical evidence its platform
technology and commercial formulations "work" -
and is focused on partnering opportunities
SAN FRANCISCO, Jan. 10 /PRNewswire/ -- Robert J. Palmisano, president and
chief executive of MacroChem Corporation (Nasdaq: MCHM) told investors
attending the JP Morgan H&Q 20th Annual Healthcare Conference here today that
his company "is in the strongest technical and clinical position it has ever
been in," following clinical and university lab studies validating its
technology last year - and expects 2002 to be the year it rewards shareholder
faith and patience.
MacroChem specializes in formulating drugs that address large and unmet
medical needs, based on its patented absorption-enhancement technology,
SEPA(R). SEPA temporarily neutralizes the drug-absorption-barrier effect of
the outer layer of skin, the stratum corneum. MacroChem is focusing its
development efforts on three patented SEPA-containing preparations for markets
collectively exceeding 130 million patients worldwide.
"Final analysis of Phase 3 results for Topiglan(R), a topical gel for
erectile dysfunction, revealed that we achieved statistical significance for
both of our primary end points among the subset of patients who conformed to
the trial protocol," Mr. Palmisano told conference attendees. "Results
indicated that Topiglan enabled even men with severe ED to have successful
intercourse."
"A recently completed Phase 1 pharmacokinetic study showed that a
SEPA/testosterone gel for hormone replacement therapy delivers about twice as
much testosterone through skin as an unenhanced gel," he said.
"And in November of last year, a University of California San Francisco
study demonstrated that EcoNail(TM), our SEPA-enhanced econazole nail lacquer,
delivers more than ten times the amount of antifungal through nail as likely
to inhibit organisms responsible for onychomycosis (nail fungus)."
According to Mr. Palmisano, these three accomplishments last year have
validated the clinical potential of its platform technology - validation that
the company lacked until the company's successful testing efforts in 2001. The
company will now use that validation to commercialize the products based on
its SEPA technology, Mr. Palmisano said.
"Our most immediate goal is to enter into partnering agreements for our
nail fungus and hormone replacement products," Mr. Palmisano said.
Mr. Palmisano said the company is making good progress on reformulating
its Topiglan erectile dysfunction product, to improve tolerance and efficacy,
prior to an expected return to Phase 3 testing later in the year.
"When we return to testing, we will recruit patients more typical than the
population in our first Phase 3 trial," he said. "In that trial, 54% of the
men participating had severe ED. By comparison, among men participating in
four of the double-blind trials of Viagra, 37% had severe ED." (1)
Mr. Palmisano said that tests during the last quarter suggest that
subsequent Topiglan clinical trials need not prohibit oral-genital contact, as
was restricted in the first study.
"In addition to clinical and scientific advances during the past year, we
have significantly reorganized and optimized our management team, and focused
them on accelerating the development of our products to the point where
they're maximally interesting to prospective licensees," he said.
"Our principal objective for 2002 is simple: Validate our technology with
partnering agreements for EcoNail and SEPA-enhanced testosterone, from major
pharmaceutical companies, on terms that reward our shareholders for the
patience they've shown for so long," he said.
"In addition, we will make the Topiglan formulation and trials-planning
changes necessary to optimize partnering for this unique erectile dysfunction
treatment," he said.
"It's our intention to return to Phase 3 with a superior product by the
third quarter of 2002, and partner it before the end of 2003. Even though we
expect there will be at least three Viagra-class oral products at that time,
we expect consumer and commercial demand for a safe, effective topical to be
even greater than today, due to promotion attracting significant numbers of
men who are not candidates for any Viagra-class drug."
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
(1) FN Cappelleri et al., Urol. 54:346,1999
Contact:
Mike Seely - Investor Access Corp.
(203) 353-8200
SOURCE MacroChem Corporation
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Related links:
http://www.macrochem.com
CONTACT:
Mike Seely of Investor Access Corp.,
+1-203-353-8200
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