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[Brruno]

Monday July 10, 10:56 am Eastern Time
Company Press Release
SOURCE: MacroChem Corporation

MacroChem Will Initiate Phase 3 Home Trial of Its Erectile-Dysfunction Drug, Topiglan(TM)

Trial Will Test Topical Gel In More Than 400 Patients With ED
LEXINGTON, Mass., July 10 /PRNewswire/ -- MacroChem Corporation (Nasdaq: MCHM - news) announced today it will begin a pivotal Phase 3 clinical trial of its investigational topical impotence drug, Topiglan(TM), following favorable U.S. Food & Drug Administration review of its proposed trial protocol. This pivotal Phase 3 trial is the first pivotal trial of a topical ED therapy to be initiated in the U.S.

(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/NEM047)
``This Phase 3 home trial, which will begin later this month, represents a critical advance toward marketing approval of our potentially safer option for the 24 million impotent American men who have declined to use one of the three pharmacologic treatments currently available,`` said Alvin J. Karloff, chairman and chief executive officer of MacroChem.

``This trial also represents an important milestone for our shareholders, because Topiglan holds the potential for annual sales by marketing partners of more than $1 billion annually. The reduction of risk a successful Phase 3 trial represents to these potential marketing partners could lead to very substantial licensing fees, milestones and royalty payments to MacroChem,`` Mr. Karloff said.

``Topiglan has attracted considerable interest from physicians and prospective patients because, in Phase 1 and Phase 2 trials, it displayed no significant systemic side effects in patients, and pharmacologically, is unlikely to interact with any systemic drugs a patient may be taking,`` Mr. Karloff said.

Topiglan is a topical gel containing prostaglandin E1 (alprostadil) and a through-the-skin absorption-enhancing excipient known as SEPA®. Prior to Topiglan, alprostadil could be used to treat erectile dysfunction only if injected about a half-inch deep into the penis with a hypodermic needle (Caverject®), or inserted into the urethra as small suppository with a syringe-like device (Muse®).

According to the National Institutes of Health, more than 30 million American men suffer some degree of erectile dysfunction (ED). More than half of these men have ED due to a vascular form of the disease, which may lead them and their physicians to avoid use of ED drugs taken orally, with potential for systemic effects. According to a 1999 study by the American Association of Retired Persons, fewer than 6% of men with ED currently take a drug to treat their condition.

Study to be conducted at 20 sites

The double-blind, randomized and placebo-controlled Topiglan study will be conducted in 20 specialized centers around the U.S., according to Paul Schechter, MD, PhD, vice president of drug development and regulatory affairs at MacroChem.

``The study will involve more than 400 patients with a well-documented history of erectile dysfunction, and their partners,`` Dr. Schechter said.

``After a routine screening and examination visit, each couple will attempt to have sexual intercourse at least four times over the next four weeks, to determine their ability to have sexual intercourse without drugs, and to ensure their ability to keep good records,`` Dr. Schechter explained. ``Then, they will return and be randomized into groups receiving placebo gel or one of two different doses of Topiglan gel.``

During the next three months, participating patients will attempt sexual intercourse using the provided gel as directed, and keep records assessing the success of their intercourse attempts.

``Clinical trials in an office setting have demonstrated that Topiglan is well tolerated and causes erections deemed capable of vaginal penetration, among a population of men with moderate to severe erectile dysfunction,`` Dr. Schechter said.

``Now that the company has obtained the critical information demonstrating safety for the female partners of patients using Topiglan, we`re prepared to evaluate its effectiveness in a home setting,`` Dr. Schechter explained.

The MacroChem phase 3 study will begin the last phase of drug development prior to petition of the FDA for marketing authorization. The first, phase 1, typically evaluates a drug for side effects in normal individuals; Phase 2 trials usually seek evidence of effectiveness and safety in patients with the target disease or disorder. Phase 3 -- the last prior to submission of a New Drug Application (``NDA``) -- studies a prospective new drug under the most realistic conditions, to determine the safety and effectiveness that regulators, doctors and patients might expect if and when the drug is approved for routine prescription.

One of the lead investigators in MacroChem`s Phase 3 trial is Irwin Goldstein, MD, Professor of Urology at Boston University School of Medicine, immediate past president of the Society for the Study of Impotence, and one of the world`s best-known authorities on sexual dysfunction. Dr. Goldstein was also lead investigator in the preceding Topiglan phase 2 trial.

Men wishing to be considered for entry into the Topiglan Phase 3 trial should telephone [phone], and follow the recorded message.

Phase 3 Strategy: Reduce Risk for Licensee, Increase Reward for Shareholders

Initiation of Phase 3 trials for Topiglan represents a major commitment for a company the size of MacroChem, company chairman Karloff said.

``Results of our phase 2 trials prompted us to adopt a parallel licensing and development strategy for Topiglan,`` Mr. Karloff said.

``On one hand, we are in due diligence discussions with prospective licensees who would take on the product at its current stage,`` Mr. Karloff explained. ``Should we conclude a deal at this stage, we could turn administration of the forthcoming Phase 3 trial over to that company.

``On the other hand, we are prepared to complete this Phase 3 trial on our own,`` Mr. Karloff said. ``If successful, that trial would significantly reduce the risk for a prospective licensee -- and thus, enable us to justify the greater up-front fees, milestone payments and royalties generally associated with phase 3 products,`` he said.

``Either way, we are driving our product closer and closer to the potential of FDA approval and marketability,`` Mr. Karloff said.

According to MacroChem Vice President and Chief Financial Officer, Kenneth L. Rice Jr., the company has paid close attention to the investment required to complete this Phase 3 study.

``The cost of this trial is well within our current cash budgets,`` Mr. Rice said.

``We believe that the payback on this investment is likely to be attractive for MacroChem and its shareholders,`` Mr. Rice said.

MacroChem is a pharmaceutical company based in Lexington, MA that specializes in formulating drugs that can be administered through the skin. That address large and unmet medical needs. Following a capital infusion of more than $20 million in 1998, the company restructured itself from its contract R&D origins to develop proprietary drugs based on its patented absorption-enhancement technology, SEPA. In addition to Topiglan, MacroChem is developing EcoNail(TM), a SEPA-enhanced nail lacquer delivering antifungal agents through nails and surrounding tissues, for the 37 million Americans with onychomycosis, a fungal infection of the fingernails or toenails.

MacroChem is actively engaged in licensing discussions on its proprietary products, and seeks to acquire or inlicense compatible drug delivery technologies.

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 licenses and patents.

Caverject® is a registered trademark of Pharmacia and Muse® is a registered trademark of Vivus Corporation.

Visit our web site at: http://www.macrochem.com or http://www.mchm.com

[claudechabrol]

wäre ich an etwas längerfristitigem interessiert würde ich sie mir jetzt kaufen
aufgrund der gerigen marktkap. und dem aussichtsreichem produktportfolio würden mich kurse um 50-100e in sechs monaten
nicht wundern
mk: ca 150 mil
analy: 1strong buy
0
0
0
0
laut einem auch hier bei wo zu findenden artikels, ist mchm eines von 3 biotechs unter den 100 am schnellst wachsenden unternehmen

[Der Pharmer]

Sach ich doch:

Thread: MacroChem (MCHM, 900425) ***strong buy***

[gholzbauer]

Guter Bericht, man muß aber bedenken, daß die Konkurrenz nicht schläft. Pfizer (Viagra) hat immer noch einen riesigen Presserummel-Vorsprung, ICOS & Abbott kommen wahrscheinlich 2001 auf den Markt, Bayer 2002, dann sind da noch Vivus und Senetek, jedoch sollte der Markt groß genug sein für ein paar verschiedene Produkte. Angesichts der Mini-Marktkapitalisierung von Macrochem ist viel Luft nach oben. Ein guter Marketingvertrag wäre für Macrochem jetzt wichtig.

[gholzbauer]

Clinical Trial on MacroChem Topical Impotence Drug to Be Published By Urology, One of the Nation`s Top Journals for That Specialty Will Report That Topiglan(TM), Now in Phase 3 in-Home Trials, Performed Almost 6 Times Better Than Placebo in Phase 2 Office Trial, Including Men Who Failed Viagra(R), Muse(R), or Caverject(R)(1)
LEXINGTON, Mass., Jul 12, 2000 /PRNewswire via COMTEX/ -- MacroChem Corporation (Nasdaq: MCHM chart, msgs) announced today that Urology, one of the nations largest technical journals for urologists, has accepted for publication a major paper on the Phase 2 study of its investigational drug Topiglan(TM), a topical treatment for erectile dysfunction (also known as "ED" or "impotence").

The double-blind, randomized in-office study of Topiglan gel, performed in 60 men with moderate to severe erectile dysfunction, suggests the MacroChem drug, applied to the head of the penis less than an hour before intercourse, may someday enable millions of impotent men who cannot or will not take oral or invasive ED drugs to enjoy satisfying sexual relations.

The paper will report that Topiglan(TM) proved almost six times more effective than placebo gel in men with vascular-caused erectile dysfunction, the leading cause of male impotence.

The lead author on the paper is Irwin Goldstein, MD, Professor of Urology at Boston University School of Medicine. Dr. Goldstein is immediate past president of the Society for the Study of Impotence, and one of the nation`s most widely recognized authorities on sexual dysfunction.

"We are very pleased that this important scientific paper has been accepted for publication by such a prestigious journal," said Alvin J. Karloff, chairman, president and chief executive officer of MacroChem. "Acceptance by the expert editors of Urology indicates their support for the scientific controls, clinical procedures and conduct of the trial," Karloff said.

"This trial and our recently completed safety study in couples provided MacroChem with the critical safety and efficacy data essential to the start of our just announced Phase 3 in-home trial of Topiglan," said Paul Schechter,M.D., Ph.D., vice president drug development and regulatory affairs of MacroChem and a co-author on the paper.

Topiglan is a topical preparation of prostaglandin E1 (alprostadil) and a through-the-skin absorption-enhancing excipient known as SEPA(R). Prior to Topiglan, alprostadil could be used to treat erectile dysfunction only if delivered in a highly invasive manner, namely by injection into the penis with a hypodermic needle (Caverject(R)), or insertion into the urethra as small suppository, with a syringe-like device (Muse(R)).

According to the National Institutes of Health, more than 30 million American men suffer some degree of erectile dysfunction (ED). More than half of these men have ED due to a vascular form of the disease, like the patients in the Topiglan trial. According to a 1999 study by the American Association of Retired Persons, fewer than 6% of men with ED are currently taking a drug to treat their condition.

Details of Phase II Topiglan Study to Be Reported in Urology

"Sixty men, 97% of whom were impotent due to vascular disease, received either a placebo gel or Topiglan, after which their erections were repeatedly observed and measured by a lab nurse -- conditions under which many men would find it difficult to produce an erection," Dr. Goldstein said.

"Within 45 to 60 minutes of application, almost 40% of the impotent men receiving Topiglan produced erections judged sufficient for intercourse, versus less than 7% receiving a placebo gel," Dr. Goldstein said.

Dr. Goldstein went on to say that "These patients were difficult cases referred to me by other practitioners. Before being treated with Topiglan, some men in the trial could obtain an erection only with one or more vasodilators injected directly into their penises."

According to Dr. Goldstein, local side effects were transitory and described by the patients as mild to moderate burning, tingling, or warmth upon application by both active and placebo recipients. "The observed side effects are not an issue for use of the drug and should not interfere with its acceptance by a significant portion of the patient population," said Dr. Goldstein. No significant systemic side effects were detected during the trial. Systemic effects of alprostadil are unlikely because the body metabolizes 80% of any alprostadil that enters the bloodstream in a single pass through the circulatory system. As a result, Topiglan may provide a much safer alternative for those patients who cannot take other drugs for erectile dysfunction, because of cardiac conditions or medications.

Topiglan is the lead product of MacroChem, a Lexington, MA pharmaceutical company specializing in formulating drugs that can be administered through the skin. Following a capital infusion of more than $20 million in 1998, the company restructured itself from its contract R&D origins to develop proprietary drugs based on its patented absorption-enhancement technology, SEPA. In addition to Topiglan, MacroChem is developing EcoNail(TM), a SEPA-enhanced nail lacquer delivering antifungal agents through nails and surrounding tissues, for the 37 million Americans with nail infections.

MacroChem is currently engaged in discussions with leading pharmaceutical companies in the U.S., Europe and Japan for rights to develop and market Topiglan. MacroChem is also actively engaged in licensing discussions on its other proprietary products, and seeks to acquire or inlicense compatible drug delivery technologies.

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 licenses and patents.

[Forum]

Könnte sein, dass die eher geschluckt werden als man schauen
kann.

[Brruno]

Monday September 18, 1:16 pm Eastern Time
Press Release
SOURCE: MacroChem Corporation
MacroChem Reports Major Progress on Bringing First Topical Male Impotence Drug To Clinical Practice
Tells specialists Topiglan(R) has passed partner transfer, enhancer carcinogenicity tests.
Patients being enrolled at 20 sites across U.S. for 400-patient pivotal trial.
LEXINGTON, Mass., Sept. 18 /PRNewswire/ -- MacroChem Corporation (Nasdaq: MCHM - news) told sexual dysfunction specialists convened at the annual Society for the Study of Impotence meeting in Cleveland that it has made major advances in bringing Topiglan®, its topical treatment for erectile dysfunction, to the approximately 24 million American men still waiting for a safer, effective alternative to current ED drugs.

Topiglan is a gel containing an erection-inducing drug and SEPA®, MacroChem`s patented absorption enhancer that enables the drug to penetrate the skin of the penis.

``In the year since the last SSI meeting in Boston, we demonstrated the safety of Topiglan in female partners of men using Topiglan, passed a critical test evaluating the carcinogenicity of SEPA in transgenic mice, and initiated a pivotal phase 3 trial in more than 400 patients,`` said Howard Richman, DPM, senior director of regulatory affairs and quality assurance at MacroChem.

``We believe these steps increase our lead in the race toward marketing the first topical erectile-dysfunction drug,`` Dr. Richman said.

The Society for the Study of Impotence is a professional organization founded in 1994 to ``promote, encourage and support the highest standards of practice, research, education and ethics in the study of human sexual function and dysfunction.`` The membership consists predominantly of urologists but also includes internists, general and vascular surgeons, researchers in several fields, nurses, and psychologists.

MacroChem is a pharmaceutical company based in Lexington, MA that specializes in formulating drugs that can be administered through the skin - drugs with the potential to be safer and faster-acting than oral formulations. In addition to Topiglan, MacroChem is developing EcoNail(TM), a SEPA-enhanced nail lacquer delivering antifungal agents through nails and surrounding tissues, for the 37 million Americans with onychomycosis, a fungal infection of the fingernails or toenails.

SEPA safety package important to advancing Topiglan

MacroChem is particularly proud of the transgenic AC mouse challenge that our SEPA® drug-absorption enhancer passed, Dr. Richman told attendees.

``That study exposes our enhancer SEPA® at doses thousands of times greater than in Topiglan to mice specially bred to be sensitive to potentially cancer-causing agents,`` he explained. ``Those tests revealed no direct or dose- response tumor formation.``

SEPA is MacroChem`s patented drug-absorption enhancer that enables prostaglandin E1 in Topiglan - the active ingredient in Topiglan® - to penetrate the skin of the penis and enter into the penile blood vessels that support erection. Prostaglandin E1 is a natural component of ejaculate, but as a drug does not readily cross the skin barrier. Prior to Topiglan, men who wished to use prostaglandin E1 to obtain an erection had to inject it into their penises, or pass a small pellet of prostaglandin E1 into their urethras with a plastic catheter.

``We had no reason to expect any carcinogenic potential in SEPA, because it`s compounded from ingredients routinely used in the cosmetics and fragrance industries, on the FDA`s `generally regarded as safe` (GRAS) list,`` Dr. Richman said. ``But that`s not good enough for the FDA - the FDA needs to see safety when such agents are used as enhancers. This is just the latest in a multi-million-dollar investment in safety documentation we have made in SEPA and Topiglan.`` Absence of significant effects in partner trial enables initiation of phase 3 study

Dr. Richman told the specialists attending the SSI meeting that Topiglan had passed another critical test for a topical ED drug during the past year: A ``partner transfer`` challenge.

``Actually, this is the second study we have performed to demonstrate the safety of the female partner of a man who might use Topiglan,`` Dr. Richman said.

``The first study involved indirect administration of a Topiglan into the vaginas of female subjects,`` he explained. ``But we wanted to be assured that no clinically significant transfer takes place during actual intercourse - and so, we tested Topiglan against placebo in a randomized placebo-controlled vaginal-intercourse study - and passed that test, too.``

Now, Dr. Richman reported, MacroChem has embarked on a 20-site pivotal phase 3 home trial - one of the last before a drug can be submitted to the FDA for evaluation and possible marketing approval. About 460 men with varying degrees of erectile dysfunction will use Topiglan or a placebo, and record their ability to initiate and complete vaginal intercourse.

``We look forward to bringing the results of that trial to you as soon as possible - perhaps by next year`s SSI meeting,`` Dr. Richman told the attendees.

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, or licenses or patents.

Visit our web site at: http://www.macrochem.com or http://www.mchm.com

SOURCE: MacroChem Corporation


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