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As a physician, I find there are days when I really do feel like I fell down the white rabbit's hole into a strange hall at the FDA. Our friends at the FDA recently updated their 1996 draft guidance on "Developing Products for Weight Management". It's pretty boring but for the interested... here she be

I'd like to point out a couple of items that might be of interest to investors. Let's talk about a very interesting problem... the potential for drug companies to "invent disease". Here's a great concept. First you make a drug and get it patented... then you invent a disease with which you can use your drug to effect a cure. Sounds far fetched? Look no further than "social anxiety disorder". You may not realize this but social anxiety disorder is said to affect 10 million people in the US alone. But, I thank God as I wipe tears from my eyes, there is a treatment. It is Paxil CR (praise the Lord).

There's now a treatment for the scourge of Americana... 10 million people. They were dropping like flies, this is astounding. Well, maybe not. In the old days a nice martini would do just fine to limber up the limbic system. Now we have paxil CR (not plain paxil mind you, nosir... the generic paxil will not! I repeat... will not treat this problem).

Contrast that stance with the FDA's pronouncement on (drum roll)... THE METABOLIC SYNDROME.

Do a google search on it. You start with hits from the American Heart Assoc, Natl Lib of Medicine, The Mayo Clinic (the WFMC for those in the know). CMS/M'care has a nice diagnostic code for it... meaning doctors get reimbursed for dx'ing it and treating it.

BUT... the F&DA currently views metabolic syndrome as "not necessarily" a distinct disease entity. I think any physician reading this will blink twice and rub their eyes... here's what the F&DA says...

The term metabolic syndrome represents a cluster of laboratory and clinical findings that serve as markers for increased risk for cardiovascular disease and type 2 diabetes, and, depending upon the definition used, is prevalent in as much as 25 percent of the adult American population. The FDA does not necessarily consider the metabolic syndrome to represent a distinct disease entity. At present, there is no single etiological factor or central pathogenetic abnormality identified as mediating the constellation of excess visceral adiposity, abnormal lipids, elevated blood pressure, and insulin resistance that comprise the metabolic syndrome.

the number of D-I-S-E-A-S-E-S that perfectly fit that description is huge. I think of rheumatoid arthritis, lupus, any disease where the exact etiology is not yet defined. Why would one branch of the government define something as a distinct problem and another resist that name?

Money, money, money
Must be funny
In the rich man's world
Money, money, money
Always sunny
In the rich man's world
All the things I could do
If I had a little money
It's a rich man's world

As a doctor, it just un-Neves me that the F(n)DA would determine to not call a disease a disease for money reasons... but here we are. Then we've got the drug co's inventing medicines for the disease to come... and that is exactly what SNY is doing for Rimonabant and exactly why the FDA is resistant. There's also NVS and GSK with skin in this game. The key words are NAVIGATOR, DREAM... and of course CRESCENDO. Those are drug trial names.

The FDA, in their wisdom, did leave a door open for letting the metabolic syndrome be a disease and approving a drug to treat it... and I quote...
Ideally, such a drug intended to treat metabolic syndrome should NORMALIZE or improve all the components of the syndrome, independent of weight loss.... and ultimately be shown to present the development of type 2 diabetes and reduce cardiovascular morbidity and mortality

somebody needs to explain to me why in the name of God and all things holy such a drug needs to "cure" a problem but be sure and do it independent of weight loss... considering we're in an obesity epidemic. In fact, really, we do live down the rabbit hole when one of the greatest problems facing the poor in America is... obesity.

The FDA's new guidance on weight control does place greater emphasis on lifestyle modification. They also go into great depth about "unknown risks of drug treatment". This statement gives great insight into the current state of mind at the FDA... talking about "unknown risks of drugs" is an interesting comment coming from the drug approval guys and does not bode well for any investor who's' betting on any phase three study of any medicine... other than those that treat fatal conditions like metastatic cancer.

Well, let's talk Sanofi and the practice of drug companies training a recptive public on the disease they're gonna have... they are launching an ad campaign early to "train" the US of A on what "Metabolic syndrome" is. In the ad's, it's defined as "a cluster of risk factors: decreased 'good' cholesterol; elevated blood pressure, triglycerides (dietary fat molecules in the blood) and rising blood sugar levels; and a widening waistline."

So... we have the drug co's "training" the American public on the diseases we have. We've got the FDA cooperating on some but not others... for no good reason. We have hospitals being put to the test. Hospitals lose money educating patients on how to loose weight and control diabetes but make scads of money on amputations and other procedures required as those diseases worsen. One in seven adult Americans will get diabetes and 21 million Americans have already got it.

You've got a medicine coming out that may prevent or delay the onset of diabetes (via weight control?) and the FDA is building a wall to prevent it's approval in metabolic syndrome... and why is this? Insurance companies will sorta have to reimburse or it if it's treating metabolic syndrome... but will not have to do so if it's treating a cosmetic condition... obesity. Wait a minute.

So... we've got an epidemic of obesity. It's a crisis...

even the World Health Organization is in on the problem

but any drug that treats it is only treating a cosmetic condition. That is the current state of affairs.

allrighty then... drug companies almost inventing diseases to treat but an FDA resisting definitions of disease that every other government agency and all medical organizations accept. We've got hospitals losing money on disease prevention but making bundles by ignoring prevention and treating complications (The cruel contradictions of hospital medicine were wonderfully described in the New York Times's Jan. 9-12 series on diabetes...

oh lord...

the data surrounding Rimonabant is good and with SNY's recent swoon, I'm adding to my position. Current data suggests that treating obesity and getting results that rival bariatric surgery will prob require a cocktail of meds. One of the companies that is very actively pursuing this is AMLN. Byetta is getting substantial off label script use for weight reduction (don't tell the FnF&DA).

Amylin is an interesting company. They're best known for byetta, which is a diabetic treatment derived from the spit of Gila monsters (I ain't lyin...). Turns out Byetta "causes" weight loss in many of the diabetics that take it.

BUT... AMLN has a second molecule approved to treat diabetes.... Symlin. Interesting to note that Symlin, also known by its scientific name pramlintide, is based on a human hormone called amylin, which is where the company gets its name. Symlin is where it's at and it's in a combo cocktail with leptin that it really might do something special. Last year, AMLN bought the rights to Leptin from our friend... Amgen. Leptin is a very interesting molecule. Adding leptin to Symlin could be the winning combination for Amylin. In a study completed last year, fat rats on the Symlin-leptin combination lost 12 percent of their body weight. A similar result in a 300-pound man would cause him to shed to 36 pounds, just by taking drugs (no diet, no exercise). Amylin should be releasing the results of its Symlin-leptin study in humans in the second half of 2007.

As said, Symlin is already out on the market for diabetic treatment but watch the sales numbers for symlin very very carefully. I expect to see increasing off label use of the drug for weight loss.

Andrew Forman, the WRH guy I've got alot of respect for, asked the question How much of a premium do you want to pay for something that's five or six years away? Well... it's not 5-6 years away. It's now for symlin and if sales are unexpectedly good... it'll be because it's being used off label for weight loss

AMLN has lost 35% (give or take) of it's market value in the past year. There's no good way to value possibilities... maybe. Track the sales figures of Byetta and Symlin. If they beat expectations, it'll be, in some part, because of off label use and will bode well, indeed, for the company's prospects.

I expect to begin a position in AMLN this next week or two. I was short AMLN for the second half of 06. The more I've studied it, the warmer I've gotten about prospects.
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