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NOVEMBER 27, 2007

Alright, so there’s a new steroid on the market. I think that the name is supposed to vaguely rhyme with “libido” but I’m not totally sure. It would make sense, since it’s an absurdly long acting version of Testosterone, which at the recommended dose only requires one shot every twelve weeks. At this dose it will keep testosterone levels for a hypogonadal male in the normal range. It will give that hypogonadal (and hypothetical) male that I’m talking about a “new libido” …hence the name “Nebido” for this new drug.

I think.

A few weeks ago I had publicly predicted that the Hormone Replacement Market would continue to grow, and I suspected that prescribing guidelines would probably be relaxed a bit. I still think this is true, and I’m very happy to see new alternatives for Hormone Replacement Therapy (HRT) being developed and marketed.

However, this isn’t exactly a new steroid (testosterone), but in this form it’s going to be very new to the American HRT market. This drug has been available for a couple of years over in Europe already, released by Bayer Shering Pharma. Studies conducted by that company indicate that blood levels of testosterone provided by this drug will be within the normal range within 3 days of the first injection, will peak within the first week, and will maintain normal levels for 10-12 weeks. In the United States, the pharmaceutical company Indevus (traded as IDEV on the New York Stock Exchange), has licensed the drug for release into the American market. Currently, their other major product in that market is Delatestryl (Testosterone Enanthate).

Nebido is poised to take over a good deal of the American HRT market though, because it only needs to be used once every 3 months (4-5 injections per year). The market here is convenience and comfort for both the doctor and the patient. Doctors typically don’t want their patients to come into their office and walk out with a 10ml vial of testosterone and some needles, and go home to do the injections by themselves. On the other hand, patients don’t want to go to their doctor’s office every week or every other week to receive an injection.

Enter Nebido.

Basically, this drug is a 4 milliliter injection comprised of 1,000mg of testosterone undecanoate, packaged in an ampule (a sterile, single use glass container, which can not be closed once it’s been opened). Testosterone Undecanoate (TU) has been offered before, though, in various forms. Many people will be familiar with it’s most common form, which is an oral form called “Andriol” that contains 40mgs of TU in each capsule.

The injectable form of TU was previously on the market in both a multi-testosterone blend as well as alone by a veterinary company called Ft. Dodge. The Ft. Dodge version was available in a 50mg/ml size only, and I have to admit to having tried it out just prior to a Spring Break in Mexico many years ago.

As “new” as this drug is, it’s not a very creative effort by the company who brought it to the market. Essentially, they took a very long acting and slow releasing version of testosterone, put a huge dose of it in a container that can’t be resealed (so you have to shoot it all at once), and marketed it as a 12 week supply of HRT. This isn’t groundbreaking stuff, but they’re marketing it very aggressively, doing studies on it, and applying for new drug patents in numerous countries.

If money spent on advertising is any indication of how a product will do in the marketplace, this one will be a huge success. It’s also very expensive, depending on how you look at its price breakdown.

For 12 weeks of normal testosterone levels, this drug isn’t a bad buy. It’s costing about $300 from legitimate pharmacies, and about half of that on the black market. Again, seen as a twelve week supply of testosterone, $300 is not a bad price.

When you consider the fact that what you’re actually getting (physically, in that box of Nebido) is 4mls of testosterone dosed at 250mgs/ml, $300 is an absurd price to be paying. The cost to physically manufacture this product, including everything from the box to the active ingredients is under a dollar.

No, I’m not kidding.

Yes, this product will cost less than a dollar for its physical production – and the price will be roughly $300 by the time it reaches the pharmacy. Now, given the fact that this company had their stock drop by over a full dollar during a key quarter last year (fiscal 2006), it’s not surprising that they would need to come out with a product which provided them with a huge profit margin in the American HRT market. Remember, the American HRT market is one of the most rapidly expanding markets in the pharmaceutical field.

My advice?

Buy stock in Indevus but don’t actually buy their Nebido product. It’s a total rip off, and there’s better buys for the HRT patient.

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