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MacroChem Highlights Topical Erectile-Dysfunction Drug Study, Topical Testosterone Drug at Annual Meeting (PR Newswire)... who avoided Viagra due to prior surgery for a benign brain tumor,...- Jun 28 10:00 AM ET

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Posted on: 06/28/2001

"Yahoo - MacroChem Highlights Topical Erectile-Dysfunction Drug Study, Topical Testosterone Drug at Annual Meeting"
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Thursday June 28, 10:00 am Eastern Time

Press Release

SOURCE: MacroChem Corporation

MacroChem Highlights Topical Erectile-Dysfunction Drug Study, Topical Testosterone Drug at Annual Meeting

CEO Announces Last Patient Has Completed Double-Blind Phase 3 ED Trial, Data Checking Now Under Way

Shows Videotaped Interviews With Topiglan Investigators, Satisfied Patients and Partners

Says Company in Talks on Topical Testosterone That Shows Vast In-Vitro Performance Advantage Over Currently Marketed Products for Hypogonadal Men

BOSTON, June 28 /PRNewswire/ -- MacroChem Corporation (NASDAQ: MCHM - news) told investors gathered at its annual meeting here today that the last patient has completed its Phase 3 home trial of Topiglan®, the company's late-stage topical gel for treating erectile dysfunction.

Topiglan contains alprostadil, an erectile-dysfunction drug widely known for its safety and efficacy when injected, and SEPA®, MacroChem's patented drug-absorption-enhancement agent that temporarily neutralizes the skin's traditional barrier function. Unlike the active ingredients in Viagra® and Viagra-class drugs, alprostadil is largely free of any potential systemic or drug-interaction risks.

Robert J. Palmisano, president and chief executive officer of MacroChem, told investors that the company will require up to three months to prepare and analyze the data collected from its 30 trial sites before announcing the results.

"During that period of time, we will be intensifying our communications with prospective marketing partners, domestically and internationally," Mr. Palmisano said. "We will also be planning the next pivotal trial, along guidelines we've discussed recently with the FDA."

  • Videotape Probes Attitudes of Doctors, Patients in Open-Label Extension of
  • Trial
  • The company has been in communications with investigators with patients

who have enrolled in the "open label" extension of the pivotal Topiglan trial,
Mr. Palmisano said. In this extension, all patients who complete the
double-blind trial, in which some patients receive placebo, now receive
Topiglan, if they elect to continue in the "open-label" (unblinded) extension.
"We originally planned to offer them 20 doses a month for six months,"
Mr. Palmisano said.

"However, after visiting with several of the investigators and learning first-hand of patient interest in the open-label study, we decided to extend their free-dose period to one year," he said.

The company showed shareholders a videotape of interviews with investigators and patients participating in the open-label trial. In that tape, one patient with a history of failure and side effects on oral ED drugs claimed consistent success and no side effects with Topiglan. Another, who avoided Viagra due to prior surgery for a benign brain tumor, and medically managed hypertension, reported successful intercourse and great satisfaction despite some local burning when first using the drug.

"Obviously, we don't know the results of the double-blind trial, and the opinions of the patients and physicians on this tape might not be representative of the mass of patients studied," Mr. Palmisano told investors. "But it's exciting to hear how happy these couples are with our product so far."

  • Company Reactivates Testosterone Program to Compete in Potential
  • $1 Billion Market
  • MacroChem announced to shareholders that it has reactivated a dormant

investigational program on SEPA-enhanced testosterone, and hopes to be able to
announce a partner for that product later in the year. Although current U.S.
sales of testosterone products total about $300 million, by 2010, that number
could increase to $1 billion or more, depending upon changes in prescribing
practices and patients.

"When the company put this project on hold to concentrate on Topiglan, it had obtained an IND to conduct a clinical trial with its formulation," Mr. Palmisano said.

"Testosterone was initially prescribed almost exclusively for patients who were profoundly hormone-deficient," Mr. Palmisano said. "Patches were in vogue, despite the fact that it meant men had to stick adhesive devices as big as six by six inches on various parts of their body. It didn't seem worth the effort to develop a topical gel, and then to persuade partners to market it."

Since then, one testosterone gel has come to market, and others are in development -- not just for profound hypogonadism, but for a larger population of men with less profoundly depressed hormone levels. And several companies are developing topical gels for women suffering from low libido. One research firm has forecast a market of $600 million just for women by 2010.

"Laboratory in-vitro studies have demonstrated our SEPA-enhanced gel might enhance skin absorption of testosterone four to ten times over unenhanced gels like those currently marketed," Mr. Palmisano said.

"To get enough absorption, current gels require application over a man's chest, stomach and upper arms," he said. "We believe our product could deliver as much testosterone when applied over as little as a quarter -- or less -- of that area. And since many men with erectile dysfunction also suffer from low testosterone levels, we see a definite synergy in being able to partner such a product."

MacroChem is negotiating with one partner prospect to begin a clinical trial as early as late third quarter, or it could elect to proceed alone. MacroChem specializes in formulating drugs that address large and unmet medical needs. The company develops proprietary drugs based on its patented absorption-enhancement technology, SEPA®. SEPA temporarily neutralizes the absorption-barrier effect of the outer lipid layer of mammal skin, known as the stratum corneum.

To the extent that this press release discusses matters relating to the development of future products, these 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.

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SOURCE: MacroChem Corporation

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