It's been a big year for Vertex Pharmaceuticals (VRTX -0.59%) so far. The biotech company has grown its main cystic fibrosis (CF) business -- reporting billions of dollars in revenue from its portfolio of products. It's getting ready to apply for approval of its blood-disorders candidate. And Vertex shares have managed to gain 27% year to date -- even as the rest of the market moved into bear territory.
Now another piece of good news has emerged. Vertex plans to launch a phase 3 trial of its non-opioid pain candidate by the end of the year. Could this be the company's biggest news yet? Let's take a closer look.
The pain problem
So why is a pain candidate reason to sit up and take notice? Well, unfortunately, pain is a pretty common problem. About 17% of Americans experience severe levels of pain, according to a National Institutes of Health analysis. And pain treatments today are limited. There are everyday painkillers such as aspirin, acetaminophen, and ibuprofen. And there are opioid treatments for more severe pain, but they've been linked to addiction.
That means there's a need for more options. And Vertex may have a good one on the way.
Vertex's candidate -- VX-548 -- is a NaV1.8 inhibitor. NaV1.8 is a sodium channel that is involved in pain signaling within the nervous system, and VX-548 works by blocking the action of that channel. Vertex has successfully brought its drug through phase 2 for the treatment of acute pain. The trial included patients with pain following bunion surgeries or tummy tucks.
Phase 3 will include patients who've undergone those procedures and are suffering from moderate to severe acute pain. But it also will include a study of patients with other sources of this category of pain.
Vertex also plans to launch a phase 2 study of VX-548 in people with nerve pain due to diabetes.
A potential game-changer
Now, let's get back to our question: Is this Vertex's biggest news yet? I'll go out on a limb and say yes. That's because pain is such a common problem and the need for more remedies is so great. If Vertex reaches the finish line, VX-548 could be a game-changer for patients and for the company.
Today, it's too early to say exactly how much revenue Vertex could generate from its candidate. This would depend on how many indications regulators eventually approve. If VX-548 is developed as a treatment for a broad range of pain cases, the opportunity could be huge.
The global pain-management drug market, at a compound annual growth rate of 4.3%, is set to reach more than $105 billion by 2030, according to Precedence Research.
What does all of this mean for investors? Even if we set aside its pain management program, I'm optimistic about the company's future. Vertex is the leader in the CF market and expects to keep that position until at least the late 2030s. Its CF program has helped Vertex steadily grow annual revenue and profit into the billions of dollars.
Vertex has made enormous progress in its pipeline beyond CF, as well. If it meets its goal of applying for regulatory approval of its blood-disorders candidate this year and then wins approval, it could be looking at another blockbuster. Farther down the road, Vertex's candidate for type 1 diabetes could be a potential blockbuster too. That candidate is in a phase 1/2 trial right now.
Cheaper than years ago
If we add the pain-management candidate to the mix, it presents a great case for buying shares of this biotech company. Of course, Vertex isn't as cheap today as it was a year ago. But it's still cheaper than it was a couple of years ago. And today, revenue is higher than it was back then -- and it continues to climb.
We also have more visibility now regarding Vertex's prospects. That's because candidates have advanced through the pipeline, so there's reason to be more hopeful that some of these candidates may become successful products a few years down the road.
All this means that now is a good time to buy shares of Vertex -- or hold on if you're already a shareholder. The company, as a whole, remains attractive. And the latest big news makes things even better.