Hi Dave,
I looked into Macrochem (MCHM) a few weeks ago, checking up on the "competition."
MCHM published that they will "not" go to clinical trials with their EcoNail (SEPA is the transdermal agent). Instead they hope a partner ( I guess with deep pockets )can be found to "validate" their technology. I haven't figured out what that means.
Today, their CEO at a brokerage presentation also reiterated plans to "outlicense" EcoNail. As I read this, I figure they stand to make a small fraction in royalties IF EcoNail ever makes it to market.
So its only in the preclinical, research stage, at the university lab level.
In effect, to bud in and answer your question, DMX is probably at the same stage with Fungoff. I don't think they are getting ahead of us. In fact, as Wolf pointed out, DMX has a nail penetration study published more than a year and a half ago. DMX stands to make large % of revenue on Fungoff, like Pennsaid, unless they "outlicense". <g>
My understanding of SEPA is that it is systematic. The active ingredient drug will get into the blood stream. Ends up in the lungs where it is metabolised. But I stand correction on this.
Their lead product Topiglan, apparently had troubles in Phase III. SEPA formulation and active agent caused burning, etc. Major ouch! So they are currently reformulating and doing another Phase III. This is their plan, but I am willing to bet that the FDA will have the final say, especially when reformulated, it may need phase II again.
Their website also list pain management as another indication where its transdermal product provides benefits, but I cannot find (yet) if there is an actual product being worked on.
The more I DD MCHM, the more I feel their management is screwed up. I should shut up here, it would take many paragraphs to explain.
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I got the following in my email this morning. Sorry no link. I'm sure there is a link, I just haven't looked.
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(Applies to: JPM MCHM)
Macrochem CEO Tells JP Morgan H&Q Meeting of Company Goals: Outlicense
Nail Fungus, Hormone Drugs, Return ED Drug to Phase 3 in 2002
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, 2002 /PRNewswire via COMTEX/ -- 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: macrochem.com
(1) FN Cappelleri et al., Urol. 54:346,1999
Contact:
Mike Seely - Investor Access Corp.
(203) 353-8200
MAKE YOUR OPINION COUNT - Click Here
tbutton.prnewswire.com
SOURCE MacroChem Corporation
CONTACT: Mike Seely of Investor Access Corp., +1-203-353-8200
URL: macrochem.com
prnewswire.com
Copyright (C) 2002 PR Newswire. All rights reserved.
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KEYWORD: California
INDUSTRY KEYWORD: CHM
MTC
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