“This is an evolutionary fight…”

That’s Ken Frazier – chairman and CEO of pharmaceutical giant Merck – on live television back in March.

COVID-19 had already spread globally.

The World Health Organization (WHO) had just labeled it a “pandemic.” There were more than 190,000 confirmed cases and 7,807 deaths.

But Frazier wasn’t talking about COVID-19.

He was referring to a far more serious global health crisis. It kills about 700,000 people every year. By 2050, that number could climb as high as 10 million.

Right now, the world is focused almost exclusively on COVID-19. But as I’ll show you today, there is another pandemic bubbling beneath the surface.

And it’s one I want to put front and center on your radar. Because there is some great science biotech companies are doing to find a way to fight back.

Evolutionary Fight

As my readers already know, there are several reasons to be optimistic about COVID-19.

Last month, I shared new research from the Stanford University School of Medicine. It showed why the real COVID-19 mortality rate is likely on par with that of the seasonal flu… and possibly much lower.

But as the world gets COVID-19 under control, other global health crises are developing. Here’s Ken Frazier with more:

With these kinds of viral outbreaks, severe infections are often accompanied by bacterial infections, sometimes super-bacterial infections. You go back a decade to H1N1, nearly half of the 300,000 people who lost their lives died because of bacterial pneumonia. It’s important that we continue to develop new, powerful antibiotics to ensure that – with respect to this outbreak and future outbreaks – we have those things in our arsenal. […]

We want to make sure that we understand that this is an evolutionary fight between us and the bacteria.

Super-bacterial infections – or superbugs – are caused by bacteria that are resistant to today’s antibiotics.

Doctors call this antimicrobial resistance (AMR).

Roughly 700,000 people die each year from these super-bacterial infections. And researchers expect the annual death toll will hit 10 million by 2050.

This problem is far more deadly than COVID-19 will ever be.

And because of this new coronavirus, the spread of superbugs is likely to speed up.

“Nightmare Scenario”

One of the most common side effects for patients who contract COVID-19 is bacterial pneumonia.

Top medical journal The Lancet just published a study of 41 hospitalized COVID-19 patients. It found that one in 10 of them developed secondary infections.

And doctors are prescribing more antibiotics than normal to stop these infections.

Dr. Priya Nori works at a New York City hospital. As she put it, “We tend not to hold back on antibiotics in [COVID-19] patients.”

As doctors prescribe more antibiotics, bacteria become more resistant. And the problem of superbugs grows larger.

To make matters worse, intensive care units (ICUs) are hotbeds for superbugs. And in virus hotspots, such as New York City ICUs, researchers suspect the spread of COVID-19 is making the problem of superbugs more prevalent.

Dr. Bo Shopsin is an infectious disease expert from New York University’s Langone Health. As he put it, “It’s quite clear that COVID is transmitting in hospitals. And if it is, [resistant bacteria] are too.”

Dr. Neil Clancy is an infectious disease physician from the University of Pittsburgh. He put it even more bluntly: “In terms of a nightmare scenario, it’s quite scary.”

Void of Discovery

You may be wondering how this is possible.

I’m certain you’ve taken antibiotics at one time in your life. So has almost everybody reading this. And for much of recent history, these antibiotics have worked well enough.

After the discovery of penicillin in 1928, we saw an explosion of scientific discoveries in antibiotics. One after the other, scientists discovered new forms of antibacterial drugs to fight off bacterial infections… until 1987.

That’s when a void opened up in which we made no new advancements. This void has lasted more than 30 years.

image

We can see the consequences of this everywhere.

Today, a class of antibiotics called quinolones (more specifically fluoroquinolones) contains some of the most widely used antibiotics worldwide.

Over the last 15 years, bacteria have become resistant to quinolones. Quinolone antibiotics just don’t work as well as they used to.

It’s all in this next chart…

image

Between 2000 and 2004, bacterial resistance to treatment using quinolones was 3.5%. That means 96.5% of patients were able to recover using quinolone treatment.

But between 2013 and 2014, resistance levels jumped to 34.5%. Only 65.5% of patients were able to recover using quinolones.

And the trend continues today…

Throughout all my research in high technology, I’ve never seen this kind of “void of discovery” before. I can’t think of any other example of a technology that’s shown virtually no significant progress over the last 30 years.

But this also presents an interesting opportunity…

This Company Is Filling the Void

The world seems singularly focused on beating COVID-19. But behind the scenes, the world’s next public health crisis is already taking shape.

Fortunately, I’ve identified the one biotech company positioned to stop it.

This company designed its lead product candidate to treat a specific type of antibiotic-resistant bacteria. This superbug is responsible for about 400,000 hospitalizations in the U.S. each year, at a cost of $2.9 billion. Outside of hospitalizations, the cost is about $1.4 billion per year.

The company believes that the opportunity in Europe is about 60% of the potential U.S. business. That’s an extra $2.58 billion. For just the U.S. and Europe, we’re looking at a potential $6.88 billion opportunity.

In July 2018, this biotech company announced positive results for its Phase 1 clinical trials. [See the image below for a full summary of the major phases of biotech development.] And get this… This drug has been used for many years in Japan with few adverse side effects.

image

Because of this, the FDA allowed the company to skip Phase 2 trials and move directly into Phase 3. The company expects trial results for Phase 3 in the July-to-September quarter this year.

This will be the only oral antibiotic of its kind in the market. It will also have zero competition from generic drugs. The company’s intellectual property (patents) is protected through 2038.

At these levels, I predict investors will see returns of at least 1,000%.

This is a story I’ve wanted to share for some time. And with COVID-19 highlighting the need for new antibacterial therapies, I believe now is the right time.

Regards,

Jeff Brown
Editor, The Bleeding Edge