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What’s the “Miracle on Mount Ararat” Drug?

What's teased as the solution to "The Next Pandemic" by Bill Patalon?

By Travis Johnson, Stock Gumshoe, February 3, 2016

[ed. note: This article originally ran on October 6, 2015. The ad is circulating again and generating questions here at Stock Gumshoe, and it appears unchanged. The article that follows is also unchanged and has not been updated. The stock being teased by Money Morning is essentially unchanged in price from when this article was first published]

—from October 6, 2015—
Bill Patalon is pitching the latest cure for “MDR Pathogens” in an ad for his Private Briefing service and, as we’ve grown to expect from Money Map Press, it’s wildly over the top in hinting at dramatic, fantastic, miraculous results for shareholders (and patients)…

… but the actual investment being teased, according to all the clues provided, is much more mainstream and, well, kinda boring.

Which might be a good thing, in the end. But let’s dig through the ad and see what they’re talking about.

They start, of course, with freaking us out:

“Unfortunately, a pandemic has crossed our borders.

“Deadly and highly contagious superbugs known as MDR Pathogens are spreading rapidly throughout our cities and small towns.

“At this very moment, infectious disease specialists from the CDC are closely monitoring for MDR Pathogen outbreaks in eight major metro areas.

• Atlanta • Chicago
• San Francisco • Baltimore
• Denver • Nashville
• Portland • Minneapolis

“And I can tell you that, whether or not you live near these cities, or know someone who does, it’s critical you pay close attention to what you are about to hear.”

So yes, I silently congratulated myself for living far from the madding crowds in all those metro areas… but wait, even if I don’t live there I’m in trouble? Oh, jeez, what is it?

“What we’re facing is a superbug that can be spread through both direct contact with an infected person, as well as through the air.

“MDR Pathogens can be transmitted easily with a handshake, by bumping into someone at the checkout line at the grocery store…

“And because it’s airborne, just by being in the same room as a carrier.

“Once activated inside victims, these superbugs go to work quickly.

  • Skin lesions can develop and rapidly spread all over the body.
  • Lungs can fill up with fluid.
  • Kidney and liver failure can follow nearly instantaneously.”

Oh My GOD! How could I not spend $19.95 a month to learn about this? I can feel my skin getting itchy already!

“According to the CDC, 33% of the country now has an MDR Pathogen precursor lurking inside them. That means…

  • If you were to walk into a restaurant, mall, or airport and look at the person standing to your left and right…
  • One of you could suffer an MDR Pathogen attack, at any moment, without warning.
  • And chances are, none of you are showing a single symptom… yet.

“I’ve investigated this dangerous situation, and I’m going to share with you everything I’ve uncovered.

“Because already, deadly MDR Pathogen outbreaks have been reported in 41 states.”

Deep breath, deep breath.

OK, so what are they talking about?

MDR Pathogens are what are also commonly called (especially by attention-seeking article writers), “Superbugs” — the MDR stands for “multiple drug resistant,” and it’s mostly just another way to refer to the growing ranks of bacterial infections that are resistant to several different kinds of antibiotics. One that gets a lot of attention is Methicillin-resistant Staphylococcus aureus (MRSA), which is definitely terrible but also quite treatable in most people (I’ve had MRSA infections, as have my kids), but there are other varieties as well — Clostridium Difficile is one that has seen a few outbreaks and lots of press attention lately. Some are very systemically frightening, particularly when they spread through health care settings where the infections can be very hard to root out entirely and where the individuals who contract the infection are already often in a weakened condition.

So… is this all a spiel for another of the “next generation antibiotics” stocks?

Kind of seems that way — antibiotics were mostly ignored for many years by big pharma, given the expense of developing them and the generally good performance of generic antibiotics for most patients… but now that the bugs have continued to mutate, and the infections that are resistant to all, or nearly all, antibiotics have proliferated, there’s a big push for the next big thing — antibiotics that use some entirely different approach, or that fight the worst of the MDR Pathogens particularly well. That push comes both from big pharma and from little development-stage biotechs, and they’ve also gotten some help from the regulators in terms of extra carrots for antibiotics developers (longer patent lives, R&D grants, contracts for stockpiling strategic drugs, etc.)

Of course, there’s also a balancing act — most folks with regular old strep throat will be cured just fine with one of the old, boring antibiotics, even good ol’ Penicillin, so this new wave won’t replace all the cheap generics that are sold in huge volumes… the next wave in antibiotics will need to be pretty expensive because there will probably be restrictions on its use, either by the payers who’d rather use generics first or by the doctors who wish to preserve the “big guns” for the worst cases in order to avoid another wave of resistant pathogens.

And yes, drug resistance is a very big deal in the big picture — and a dangerous side effect of our love affair with antibiotics, a love affair that means we demand prescriptions from our doctors whenever we have a sniffly nose… and, disturbingly, that we pump our livestock full of antibiotics in part to help them grow fatter, faster.

But turn down the volume a little bit — most of these infections and illnesses are still eminently treatable almost all the time, and most people who have these infections have no long-term problems… it’s a big deal, and it’s worth taking precautions particularly if you’re in any way at risk, but it’s not the Spanish Flu that’s going to take out whole cities, and you don’t have to act like Donald Trump and avoid touching people in public. Check out the CDC’s page on drug resistance, it’s sobering but not nearly as alarmist as ads like Money Map’s… according to the CDC, about two million people in the United States get some sort of drug-resistant infection or disease each year, and about 23,000 die as a direct result (those are 2013 numbers, I believe). So about one half of one percent of us (0.6%) will get some sort of this infection this year, and 1.1% of those infected will die. That’s less than half the number of folks who die from pneumonia each year (50,000+), just by way of comparison — though some of that number overlaps, too, and in most cases (though not all), the people at risk are facing other risks, too… they’re already hospitalized for something, or they have compromised immune systems, etc.

This is not a new issue, of course, though it continues to grow in importance as bacteria evolve to fight us and evade our drugs… but the real question, now that we’ve gotten past a little bit of panic about these deadly outbreaks, is will it make us rich?

We’ve seen similar pitches many times for the past several years (I think the most recent was from Dave Lashmet over at Stansberry last year but I might be forgetting some), and there have been some high-profile buyouts of these “new antibiotics” companies over the years as well, including Durata Therapeutics and Cubist Pharmaceuticals in just the past year.

One of the attention-getting “outbreak” stories was in the headlines for a while, and you might remember it — the NIH facility in Bethesda had an outbreak of antibiotic-resistant infections in 2011, and the teaser describes it this way:

“In 2011, an MDR Pathogen was activated inside a 43-year-old woman in New York City, who had been an unknowing carrier.

“Her infection was so severe that doctors didn’t have strong enough medicine to save her.

“So they immediately transferred her to the National Institutes of Health (NIH) outside of Washington D.C.

“When she arrived at the NIH, doctors quickly diagnosed the presence of an MDR Pathogen and placed her in ‘enhanced contact isolation.’

“Hospital staff took extreme precaution to wash and sanitize anything that was near the patient.

“And they disposed of all gowns and gloves after they were in the isolation area.

“After four weeks of treatment, the patient recovered and she went back home to New York.

“It was an apparent victory over the MDR Pathogen.

“But the celebration was short-lived.

“Three weeks later, a second patient was infected, a 34-year-old male, who had never crossed paths with the woman from New York.

“Then a 27-year-old woman contracted it.

“A total of 18 people were infected before it was contained.

“11 of them died.

“This particular NIH outbreak had a 61% mortality rate.

“And the NIH is one of the leading medical facilities in the world.

“This happened there.

“Imagine how equipped your local hospital is right now to deal with such a threat.”

They harp on that “61% mortality rate” a few times in the ad, so I couldn’t resist noting that yes, it’s true that 11 people of the 18 who were infected in this special hospital died… but they were in terrible shape anyway, or they wouldn’t have been at this hospital, and five of them died from other things, not from the infection. There’s a story on the NIH website about it here. It would not have spread this same way inside, say, a shopping mall.

Not that a 30% mortality rate sounds all that much better, but still.

So I’ll stop talking about the big picture — Doc Gumshoe wrote a nice overview of antibiotic resistance for us a couple years ago, and Dr. KSS has covered many of the “new antibiotics” stocks for the irregulars from time to time. Let’s just move on and see which stock is being teased by Bill Patalon.

As you expected, he’s pitching a company that has developed a new antibiotic — and he thinks the rewards should be fantastic. Here’s another bit of inducement:

“If you have the opportunity, in the early stages, to purchase stock in a pharmaceutical company that has developed a new antibiotic, the rewards can be immense.

“Take Pfizer. With a market cap of over $200 billion, it is an enormous drug company.

“And yet, after they released the antibiotic Zithromax, their stock shot up 405%.”

That’s true, Pfizer did indeed “shoot up” by 400% or so over a few years in the late 1990s — but while perhaps some of that is from Zithromax, it’s worth noting that Pfizer got approval for Zithromax in the same year that they got approval for Lipitor, which had a record $70 billion in sales in its first ten years and I think is still the best-selling drug of all time (Humira may have caught up by now, not sure about that). Correlation doesn’t mean causation — Pfizer didn’t quintuple in value over a couple years because of Zithromax. Zithromycin was a $1 billion drug for a few years (annual sales), Lipitor was a $5-10 billion drug every year for almost 15 years before the patent expired.

And this will make more sense as a comparison when we get down to the “big reveal” in a moment, but Pfizer was not a $200 billion company before Zithromax (and before Lipitor, more accurately) — it was a $25 billion company in the mid 1990s and, thanks largely to Lipitor (and a ludicrous PE of 75), became a $300 billion company for one brief shining moment in the Summer of 2000. It’s been bouncing around near $200 billion over the past few years, with performance pretty similar to the health care index most of the time (or, indeed, the S&P 500), though it has lagged lately.

But anyway… some hints about our specific stock being teased today? Here’s what I excerpted from the pitch:

“I want to stress this, recent developments are now causing the leading minds in the medical community, as well as world governments, to have hope.

“There has been a breakthrough.

“A team of prominent doctors with specialized training from MIT, Harvard, and Yale believe they’ve uncovered a medical miracle.

“The cure that could stop a pandemic has been found in the soil of Mount Ararat….

“It has already been transformed into an emergency treatment that saved 82 lives in Detroit, stopping a potential citywide MDR Pathogen outbreak.

“And, in a nationwide trial, doctors cured 147 people and prevented similar emergencies in four other U.S. cities….

“This drug has been rushed through the FDA’s approval process in a unanimous 9-0 vote for treating MDR Pathogens.

“And one biotech firm controls it…”

Exciting, right?

This “Miracle on Mount Ararat” drug is, we’re told, a result of Eli Lilly’s efforts decades ago to search the world for new bacterial samples — this apparently led to the samples (from Borneo) that led to the development of vancomycin… but also this soil sample from near Mount Ararat (which was, for folks who haven’t read all the Indiana Jones-style adventures focused on exploring Ararat, the legendary landing spot for Noah’s Ark… it’s in Turkey. And yes, there are several other possible Ark locations, and some folks who’ve claimed to have found it in the past — if you listen to the mainstream archeologists who are very skeptical of the Ark searches, nearly every expedition for Noah’s Ark, most of them led by evangelicals, has claimed to have found it.)

Not that Ararat or the Ark really has anything to do with the drug, of course — that’s just a nice attention-getting hook the copywriters can use to perk up your ears a bit.

Like in the latest email I got on the ad this morning…

“This company has already been awarded six patents for its discoveries. It is perfectly positioned to see its revenues rise 4,809% in less than two years.

“So we’re looking at a situation that is the equivalent of turning every $10,000 you invest into $490,900.

“I want you right there, at the beginning, as all of this develops.

“So I’m offering you one more chance to get Bill Patalon’s time-sensitive investor briefing on this discovery, called The Mount Ararat Miracle – It Will Save Millions of Lives and Deliver a 4,809% Windfall.”

What makes this “Mount Ararat Microbe” and the drug developed from it so special? Here’s a bit more from the ad:

“This Mount Ararat microbe has a tiny tail that it can insert into the membrane of the MDR Pathogen without fully entering the cell. Without setting off its internal alarms….

“That makes this Mount Ararat microbe the perfect delivery vehicle for a quick-acting antibiotic that can slip into these superbug cells and eliminate them.

“So hiding inside the soil of one of the holiest places on the planet is the secret to safely outsmarting the MDR Pathogen.

“The team that acquired the rights to this Mount Ararat microbe founded a small biotech firm.

“They immediately began developing a drug that could harness it.

“After five years, they accomplished what they set out to do.

“A treatment now exists.”

Well, that’s all true — but it’s also old news. This is the story of the development of Cubicin, daptomycin, by Cubist Pharmaceuticals… and that drug, which was indeed developed, originally by Eli Lilly about 30 years ago, using samples from near Mount Ararat in Turkey, has been approved since 2003 and is nearing the end of its patent protection (I think that’s still in the courts, but several of the patents were thrown out last year and that might mean generic competition as soon as 2016… certainly there will be generic daptomycin sold by 2020). It’s an interesting story of persistence that created a powerful drug and a valuable company, you can see a synopsis of it here if you’re curious.

But you can’t invest directly in Cubist anymore — it was bought by Merck, in a deal announced less than a year ago and consummated earlier in 2015 — an oft-derided deal, as it happens, thanks to the Cubicin patent litigation.

So did they really go through this whole Mount Ararat story to convince us to buy shares of Merck (MRK), a $140 billion megacap pharmaceutical company? Merck may be a fine stock that’s a bit beaten down by the general pharma pricing panic of recent weeks (Morningstar thinks it’s got 30% upside to “fair value”, for example), but there’s no way on earth that it’s going to turn $10,000 into $490,900 in the next decade. It’s probably a lot less likely than most of the small cap biotechs to lose half its value overnight… but that size and diversification comes with the implicit realization that it’s just too big to have any chance at growing by 1,000% in any reasonable timeframe (like, less than 20 years).

Could it possibly be a different company?

Well, they say that “the company’s Senior Vice President of Scientific Affairs” was called in to Congress, and that “This Small Lab” made five specific recommendations to prevent “MDR Pathogen” outbreaks… and that, again, is a reference to Cubist, whose Senior VP Barry Eisenstein did provide testimony to a Congressional hearing with those five recommendations, many of which were or are being followed to some degree… in 2008.

One of those recommendations dealt, apparently, with distribution and “market pull” …

“Congressional Recommendation #5: Create ‘market pull mechanisms’ where pharmaceutical partnerships can deliver this drug to the entire world.

“This biotech firm quickly reached distribution agreements with Novartis, Astra Zeneca, and Merck.

“This miracle drug has united the major pharmaceutical companies. It’s hard to find a historical precedent for something this big.

“And thanks to this joint mission, it will now be able to reach 70 countries.”

So, again, that matches Cubist — which did partner Cubicin with Novartis and AstraZeneca and Merck, before being acquired by Merck this year. That’s not all that unusual, though the scope may be outside the norm — they had marketing partnerships with several other pharma companies, too. Novartis owned marketing rights to Cubicin to Europe and Australia, AstraZeneca in China and lots of smaller countries, Merck in Japan, etc.

How, though, does that turn into a “4,809% windfall?”

The ad says that there’s huge demand for a stockpile of millions of doses of this “MDR Pathogen Cure” — 50 million doses just in Europe and the US. And that this will lead to $5.9 billion in sales ($118.56 per dose).

Which would be pretty impressive, if not a record-breaking blockbuster. But then they stretch it out to say that the “Mount Ararat Miracle is a $51.7 billion opportunity” — because there are 437 million doses required to “stop this deadly superbug strain, worldwide.”

Which is, of course, absurd. Cubicin had about $1 billion in sales last year, mostly in the US. And, as you’ve probably noticed, drug sales in other countries are far, far less lucrative — there are few places where pricing is anywhere near as high as it is in the US, largely because most large countries have price controls or single-payer health systems who negotiate prices. That number could rise, and Cubist (now Merck) has other antibiotics in development — and one more recently approved, Zerbaxa — but I’d guess they probably won’t get even another $5 billion in revenue from Cubicin before it loses patent protection, and Zerbaxa, though it’s got at least ten years of patent life (maybe 16 or 17) may be a smaller annual seller than Cubicin was.

Where does that put Merck? Well, if they were able to reach that $51.7 billion sales number because the world’s governments suddenly decide to stockpile 437 million doses of Cubicin in the year before Cubicin loses patent protection… and they do it all in the US, where Merck owns full rights to Cubicin, and pay full retail prices, then Merck would have a fantastic year.

Which is sort of like saying, “if Apple sold a billion iPhones this year instead of 220+ million, the stock would have a fantastic year.” It’s not going to happen, even if you can theoretically draw out a long string of logic for why it maybe could possibly happen. If the world suddenly needs 50X as much Zerbaxa or Cubicin as it will consume this year, it will be because of some real, immediate global infection crisis — and the prices would collapse, because Merck would be under tremendous pressure not to profiteer.

How about Zerbaxa? Well, that’s hinted at in the ad as well:

“For Klebsiella pneumoniae [one of the ESKAPE antibiotic-resistant pathogens] they developed a drug from a slow-growing fungus called Acremonium. It was used to treat 1,068 patients in an international double-blind, randomized trial.”

That is indeed a match for Zerbaxa, which was approved by the FDA last December primarily for complicated urinary tract infections.

There are other ESKAPE pathogens tossed out as clues, too:

“They also have a drug that can stop Pseudomonas aeruginosa. After being used to treat 979 patients, the FDA fast-tracked its approval.”

Huh. That’s Zerbaxa, too. Was called CXA-201 before it got a name, but the same antibiotic used in a different indication.

And no matter what the teaser pitches, I don’t see how we get to the kind of horror-show, zombies walking the streets world where this sets a new record for antibiotics and sells 90 million doses for $21.1 billion in annual revenue, as teased.

So yes, after all that this whole convoluted pitch is for Merck (MRK), all based on the drugs they acquired from Cubist — and really, other than Cubicin, those drugs were all bought by Cubist, which hasn’t developed any more new drugs on their own that have advanced as far as clinical trials as far as I can tell… and Merck just laid off 120 folks at Cubist’s R&D operation, so they’re probably not counting on them discovering any other new stuff anytime soon, from Mount Ararat or anywhere else.

Merck’s sales over the last four quarters were about $40 million, down a bit from the previous year and generally trending down for a couple years (partly because of the loss of patent protection for some of their drugs). Analysts, who are all fully aware that Merck now owns Cubist, are projecting that Merck will return to growth in 2016 with a boost in sales of about 2% from this year’s level… and earnings growth of almost 10%, which they expect to level out as earnings grow at about 6-7% a year for the next several years. Cubicin and Zerbaxa will provide some of the revenue growth to supplant declining products, as happens at pretty much every big pharma company — they all have to constantly supplement their R&D pipeline with new research or acquisitions to replace drugs that either lose out to competitors or lose patent protection and go generic.

That’s not going to provide anyone with 4,809% returns. You can argue that Merck should maybe deserve to trade at a slightly better valuation (it trades at about 15X earnings now, with a dividend yield around 3.5%), or even that it should snap back to the mid-$60s area where it traded early in the year… but you can’t construct much of an argument, using mainstream metrics and forecasts, that it’s going to see $100 anytime in the next year or two… not unless we see rampant inflation.

So… wanna buy Merck (MRK)? Wanna buy me a drink for saving you from reading through that whole misleading, Godforsaken ad? Either one’s OK with me… but I wouldn’t hold your breath looking for 4,809% returns. Maybe you’ll find that from some of the other early stage antibiotics that are being developed, if those companies get bought out for huge returns after making grand clinical trial success announcements… but, of course, some of those will not be approved and will go down in flames, one expects. Let us know what you think with a comment below.

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7 years ago

You had way too much fun with this one Travis. Definitely one of your better efforts.

👍 37
7 years ago
Reply to  fischershaw

Hey Gumshoe glad I found you