Magic Pill? “This is the kind of situation that can change your life …”

by Travis Johnson, Stock Gumshoe | February 4, 2009 11:47 am

Nice headline, eh? That’s the first part of a quote from Porter Stansberry[1] that rides atop the new ad letter for Stansberry & Associates’ Phase 1 Investor newsletter (that’s the one that normally retails for $5,000 — they call it their “most expensive and sophisticated advisory service”). Here’s the rest of the lead-in:

“On March 30, FDA[2] results we’ve waited 2 years to receive could make you $195,600, overnight

“‘This is the kind of situation that can change your life… where a $10,000 stake can allow you to literally quit work, forever.’ – Porter Stansberry, Founder, S&A Research”

Forgive me for a moment as I wipe a little tear of joy from my cheek — are the good times back? I used to see ads like this all the time for biotechs and IPOs and tech companies, promises of huge wealth, of being able to quit your job, of massive returns from an investment tip. Being a teaser junkie, I like to call those the “good old days.”

But lately, it’s all been about dividend yields, and bear market strategies, and gold[3]. Sure, they might be great ideas … and we all have a tendency to batten down the hatches, cash our dividends[4] or bury our gold coins[5], and sit in the corner with a bottle of whiskey during times like these … but I, for one, am glad to see a teaser that tells us we can get filthy stinking rich. Refreshing, if nothing else.

Of course, the question is: How are we going to get rich?

This teaser is for Phase 1 Investor by Rob Fannon[6], and this service has focused largely on biotech companies in the past. Today is no different.

“On March 30th, there’ll be an announcement of FDA results for a new drug that could create the single biggest return of any investment we’ve ever found, in 10 years.

“‘All eyes are on the data,’ says Business Week. ‘It could be a multi-billion dollar drug, and so far, all the numbers have been positive.’ BioWorld writes: ‘It could be the largest pharmaceutical market ever.'”

OK, so that tells you pretty much all you need to know: This is a teaser built on the fact that Rob Fannon thinks the FDA will issue a positive opinion on a drug on March 30, and that this will cause the company that owns that bring you huge returns.

How about the details … like, what’s the drug? That’s why you come to your friendly neighborhood Stock Gumshoe, of course.

They tease that the drug is close to announcing Phase III results:

“… the drug has successfully cleared both Phase 1 and 2 FDA clinical trials… and is just weeks from the announcement of Phase 3 results… the last trial before it could launch on a scale potentially unseen since the release of penicillin.”

Which means that the March 30 information must be those clinical trial results, not the actual FDA approval — to the best of my knowledge that just about always takes at least six months, at the bare minimum. Great results can certainly help handicap an FDA decision, but they’re no guarantee of approval … nor are companies strictly limited to one Phase 3 trial, they sometimes have to go back for further research on safety or efficacy, depending on results or the FDA’s response.

But that’s neither here nor there — I certainly know far less about biotech investing than does Rob Fannon (or probably Porter Stansberry, too, for that matter), so let’s just find out what they think …

Here’s the part that really gets the drool flowing:

“And while most people have no idea what will happen… we’ve been able to access early results directly from the company, and they’re even better than we hoped.

“In short: as of Dec. 15, 2008, early clinical results suggest the drug is safe… has a near-perfect success rate… has a 500% efficiency… and finally, get this: will target 45% of the U.S. population – almost 1 out of 2 Americans.

“As one FDA expert puts it: ‘If results on March 30th turn out even half as good as we expect… this could be the best-selling drug in the history of medicine.'”

But it gets better, too. They do sprinkle in there that “people will remember where they were on March 30” bit that we see so often in ads like this, but there’s more:

“Quite simply, we expect approval for a new drug unlike anything to ever go public in the 81-year history of modern biotech. It’s a drug that simply hasn’t existed, in any useable form… until the company I’m telling you about invented it….

“The drug could help so many people a neuroscience writer in Dallas went as far as to say recently, ‘The FDA should lower requirements and speed up approval.’

“It’s been described by even conservative health writers with words like: ‘runaway bestseller’… ‘blockbuster potential’… and ‘sell like gangbusters.’ Forbes[7] wrote of the ‘magic pill,’ and went on to say: ‘If approved, it could be a billion-dollar drug.'”

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So … in case you haven’t guessed, this is an obesity[8] drug (that’s not a secret, they go into it later on in the ad).

And they even quote someone who said she was in one of the trials:

“As one patient in the Phase 3 trial recently said, ‘I’ve lost 21 pounds (10% of my body weight) in 10 weeks. I couldn’t be happier. I’m excited, because I wouldn’t mind being able to wear a single digit size by next summer!'”

So … what is this wonder drug?

It pretty well has to be Lorcaserin, and the drug company that’s developing it is Arena Pharmaceuticals (ARNA)

This is far from being an “under the radar” company, of course — obesity drugs are second only to cancer and Alzheimer’s drugs at garnering mass attention, it seems to me, and, like Alzheimer’s, there hasn’t been a really effective and safe drug yet … which means investors believe that the first really good one could be an incredible blockbuster.

And maybe that will be true, i have no idea. I do know that ARNA has taken off this morning, probably in at least some part because of this massive ad campaign from the Stansberry & Associates folks — and it has been a very volatile stock, so I’d be cautious about assuming that it will go straight up between now and March 30, even assuming the news released then is as positive as hoped.

Here’s what else I can share with you, being as I am that kid who barely got through chemistry class:

Here’s the Forbes article where they called it a potential billion-dollar drug[9] (from Fall ’07).

lorcaserin[10]-son-of-phen-fen-is-probably-a-victim-of-truthiness/" target="new">Here’s the blog where that patient’s experience was posted as a comment (from last March).

Here’s the link to their presentations page[11] — that’s where you can see the December 15 “direct from the company” info that is teased, that’s when the company held its Analyst Day to share information with investors and analysts. They’re also participating in a conference next week.

The quote about a “near-perfect success rate” could come from this quote from the analyst day presentation: “Almost every patient lost weight.” So that’s certainly pretty good. And they didn’t say much about serious side effects or other safety issues that ought to be a concern.

Other info? They have been saying that they expect the first results from the BLOOM trial (one of the their Phase III trials) to be released at the end of March, so March 30 is a reasonable estimate. What that means for a potential timeline for FDA approval I don’t really know, but positive results would obviously be better than negative results, and the data they’ve released thus far doesn’t seem to be terrifying anyone. Their other major Phase III trials is expected to be ready to release results in September, and they say that they’re on track to file an application for drug approval by “late 2009.”

So this March 30 tease is all about getting in early, before the official results of the first Phase III trial are released, and hoping that over the coming year or two the drug will proceed through the remainder of its trials, receive relatively expedited FDA approval, and hit the market.

Might happen, I have no idea — certainly there’s a lot of demand for weight loss[12] drugs, and relatively few of them available that are safe or effective. There have been cautionary tales in this sector, notably Fen-Phen and its long tail of liability after being pulled from the market; and there are competitors who are also trying to take this prize, including Amylin and Vivus (which had some results out recently[13]), but I know even less about any of those competitors than I do about Arena.

So there you have it: looks like the folks at Phase 1 Investor would like you to subscribe, and in return they’ll probably tell you to buy shares in ARNA … and I’m sure they’ll also provide a lot more information than I have here. Now, at least, if you’re interested you can do a little research on your own. If it sounds like a fun ride (even beyond the crazy jump in the stock this morning), let us know with a comment below.

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