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June 2001


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Rub-a-dub-dub... three women in my tub
Viagra faces stiff competition from this topical impotence drug

by Brian Hicks

You may have read about the alternatives: outrageous contraptions using everything from vibration to motor-powered suction machines... unappetizing brews and soups made from shriveled parts of poached endangered animals you and I would be hesitant to feed to a dog... mysterious powders made from deer antler, rhino horn, ground-up insects.

But the business of putting the sparkle back into a man’s eye has been changed forever. And you knew it was just a matter of time before even Viagra got some... competition... from other impotence drugs, that is.

Actually, more than one contender has risen to the challenge and will fight Pfizer for the lion’s share of the limp noodle market. (Pfizer’s Viagra now pulls down US$1 billion a year for the drug maker. For those of you doing the math at home — that’s US$2.7 million spent on the little blue pill every single day.)

Even though Viagra currently has a lock on the market, there’s still about 90% that’s left untapped.

Sure, Viagra is the drug to beat. But beating it might not be so difficult. Just think: you get the same unwanted effects from Viagra as you do from imbibing too much alcohol. And the reasons for taking each are pretty much the same (And considering Viagra costs about US$12.00 a pill, I’d rather buy a bottle of Ripple for US$3.50 and take my chances.)

Besides, since being approved in 1998, Viagra has lost more patients than it has gained (on a net basis). One of the reasons: those side effects.

Even though Viagra does US$1 billion in sales every year, there’s another US$9 billion just waiting for a safer, more effective drug.

I’ve found out the name of that drug... and it’s already been approved by the FDA.

The shot heard around the world
Before Viagra, there was CAVERJECT by Pharmacia & Upjohn. CAVERJECT was an impotence drug that was injected by needle into the side of the penis. That’s right — a needle rammed into the most sensitive part of the male anatomy.

Listen, I don’t care how good-looking she is. Even if she looks like Catherine Zeta-Jones, I’m not about to let a needle anywhere close, if you catch my drift.

And apparently a lot of impotent men felt the same way, as CAVERJECT found little market appeal.

But regardless of the pain, CAVERJECT was extremely effective — producing erections in 80% of impotent men who tried it. And it was all because of a substance called alprostadil — the active ingredient in CAVERJECT.

Well, the drug company I’m going to tell you about has taken alprostadil... and put it into a completely painless method of delivery.

But first, let’s get a little personal
When I started researching impotence, I noticed one thing: most of my older colleagues tended to shy away from the subject.

I mean, difficulty in “keeping up appearances” has to be every red-blooded man’s nightmare.

Estimates say that nearly 30 million American men (mostly over the age of 50) have some form of erectile dysfunction. That’s about one in every six men.

Don’t get me wrong — I feel for them. Even my libido — at the tender age of 32 — isn’t what it used to be:

A decade ago, when I was in college, I had enough testosterone running through my body to kill a Clydesdale horse.

(Heck, high school was even worse.)

I bring up the topic of my adolescence because it’s important. Because when it comes to sex, men tend to compare their prowess to when they were younger. You’ve heard it before: “When I was 18, I could have sex 10 times a day!”

But when you get to be your father’s age, having sex 10 times a day is like playing Russian roulette. In fact, the odds of surviving are better with a loaded gun to your head.

That’s why, since the dawn of marriage, man has sought a magical drug to lift what the body could not.

As recently as the late 1980s, many men experimented with a cocaine solution. Dripping dissolved cocaine into their urethra, some men experienced the best erections ever. The only problem was... the erection lasted for days — a very dangerous situation. Many contracted gangrene. The afflicted members finally turned black, shriveled up, and to the horror of their owners, fell off!

Possible Side Effects from Erectile Disfunction Drugs Under Development
Company (brand) Active Agent Side Effects
MacroChem (Topiglan) alprostadil minor warmth
Pfizer (Viagra) sildenafil headache, lowers, blood pressure, visual disturbance
Schering-Plough/Zonagen (Vasomax) phentolatime dizziness, lowers blood pressure
TAP Pharmaceutials apomorphine nausea, vomiting

But this catastrophe was a blessing. It prompted many biotech companies to begin developing a safe cure for impotence.

Anatomy of an erection
Just like other organs, as you get older, your penis begins to lose normal function. In a normal (younger) penis, blood flows through the blood vessels and into the corpus spongiosum (spongy tissue) around the penis. As the corpora swell, they press against the veins, keeping blood from leaving the penis. Full of blood, the corpora become rigid and erect, making the penis hard enough for vaginal penetration.

But as the years go by, men have a harder time achieving an erection. When a man has impotence, more times than not, it’s a hardening of the arteries. This condition won’t allow the blood vessels to dilate — inhibiting blood flow to the penis.

Although there are numerous things that can prevent vessel dilation from occurring naturally, a drug like alprostadil has a specific, direct effect on the vessels, allowing engorgement to occur.

Rub it here
MacroChem (MCHM:NASDAQ) is a Massachusetts drug technology company whose scientific claim to fame is its transdermal SEPA technology — a way to deliver drugs with a topical gel from the surface of the skin into the bloodstream.

SEPA compounds, MacroChem’s proprietary transdermal penetration enhancers, when properly combined with particular drugs, create pharmaceutical formulations (creams, gels, solutions, etc.) that enhance the delivery of the drugs via the skin.

SEPA technology allows the drugs to diffuse through the skin by making the outer layer (stratum corneum) more permeable to the drug molecule. Transdermal delivery offers an alternative to other methods of drug administration (injection, oral dosage, inhalation), and may allow selected drugs to be administered more effectively, at lower doses, with fewer side effects.

The biggest benefit of SEPA technology — you might’ve guessed — is that it can be used to deliver drugs that would otherwise have to be administered by more painful means.

SEPA is a natural for erectile dysfunction.

Buy MacroChem now
MacroChem’s impotence drug, Topiglan, is currently in pivotal Phase III trials. This after an excellent Phase II trial that showed Topiglan to be six times more effective than placebo in producing erections.

And, apparently, word has got around about it. There was a mad rush by hundreds to participate in the Phase III trials, and MacroChem had to beat men away with a stick.

MacroChem trades at a market cap of US$200 million, peanuts compared to where it would trade if Topiglan gets approved. Quite frankly, if Topiglan gets the go-ahead, not only will it quickly grab a portion of the market that doesn’t use Viagra, but it will most likely acquire patients that do use Viagra.

Early estimates for Topiglan call for around US$200 million in sales for the first year. This is based, in part, on what Vivus did when its impotence drug, Muse, went on the market. Muse was another ED drug that had to be inserted into the urethra (ouch!). Nonetheless, it was effective enough to generate sales of US$138 million in 1997.

Topiglan could easily surpass that.

Buy MacroChem (MCHM:NASDAQ) under US$10 a share.

Contact: MacroChem Corporation (MCHM:NASDAQ), 110 Hartwell Avenue, Lexington, MA 02421; Tel: 781.862.4003; Fax: 781.862.4338; Website: www.macrochem.com


In addition to providing Microcap analysis for Taipan, Brian Hicks is also the editor of the Cutting Edge, a monthly biotech and hi-tech newsletter and the Rogue Trader, a microcap trading service.




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