There are millions of Americans with Type II diabetes and many of them take multiple daily injections of insulin, using two injection pens – one for mealtime insulin and one for insulin throughout the day. But studies have found that people with Type II diabetes are willing to skip insulin injections if they have to inject the drug in public.
“If you’re a Type II patient, you read it in magazines, you see it on TV, you see it in movies, you hear it from primary care doctors – [your diabetes] is your fault,” Valeritas (NSDQ:VLRX) CEO John Timberlake told Drug Delivery Business News.
The stigma surrounding Type II diabetes can make people feel uncomfortable taking their medications in a restaurant or at work, the chief executive explained. There are other reasons why a person might miss their insulin, like accidentally leaving their insulin pens at home or suffering from a debilitating fear of needles.
These are the kinds of patients Valeritas is hoping to help with its insulin delivery device, V-Go.
The publicly-traded medical technology company has designed a disposable, lightweight drug-delivery device that a Type II diabetes patient can wear throughout the day and eliminate the need for multiple daily shots of insulin.
The product’s competitive edge is its simplicity and usability, according to Timberlake.
“I can swim in it, I can shower in it, I can exercise in it, I can sleep in it – I can do anything,” he explained.
To use V-Go, patients transfer their insulin into the device, pull the adhesive off and place it on their midsection or their arm. Once the device is flush against their body, they push the start button – one of just four buttons found on the device – and insulin begins to flow through their system.
The next time they have to think about the device, Timberlake said, is when they’re ready to eat. When they sit down to eat, users can give themselves additional insulin to cover their meals by pressing two buttons on the device.
An important aspect of the product’s design is the needle, which the user never sees – it is hidden in the device before the product is used and once the user is ready to discard the device, the needle retracts and is safely stored within the disposable product, eliminating the need for a separate sharp’s container.
Valeritas’ wearable insulin pump won 510(k) clearance from the FDA in 2010 and CE Mark approval in the European Union the following year.
Timberlake, who spent 15 years at insulin-maker Sanofi (NYSE:SNY), is intimately familiar with the process required to launch a drug. But commercializing a device is a whole different ball-game, he said.
“Where we made a mistake as an organization is we tried to launch this product more like a drug,” he said.
Valeritas didn’t have the money or the sales force to bring their device to every Type II diabetes patient in the U.S. The company began by sending out a small cohort of sales representatives to spread the word about Valeritas and each time the company raised additional funds, they added to their sales force.
But, as many of the sales reps soon discovered, the company was more successful when they focused their efforts on a “high touch” model. Instead of showing up once and leaving the doctor to figure out how to use V-Go, Timberlake and the Valeritas team began visiting the same doctors more frequently and guiding them through the training process.
“It is truly easier to train than two pens. If I’m teaching someone about basal and bolus injections, that’s two different insulins. When I was in the business, half the patients would mix them up. Especially if you mix up and go to bed thinking you’re taking 80 units of the long-acting insulin and it’s fast-acting, you’re going to end up in the emergency room. That is a nightmare,” Timberlake said. “So it truly is simpler. What we had to do, and what our research showed is, we couldn’t just tell [doctors]. We had to to show them.”
Valeritas has conducted a number of real-world analyses showing that its product helps patients get their blood sugar levels under control and that it helps lower patients’ total daily dose of insulin.
If doctors don’t know that their patients aren’t taking their insulin as prescribed, they will continue to escalate that patient’s total daily dose of insulin in an attempt to rein in their blood sugar levels, Timberlake explained.
In one retrospective analysis of 86 diabetic patients who switched from multiple daily insulin injections to Valeritas’ V-Go device, the company found that use of its device led to a 44% reduction in total daily insulin dose per patient.
Since Timberlake took over the corner office in Feb. 2016 and helped the company implement a new commercialization strategy, Valeritas has seen its revenues grow quarter-over-quarter. Last year, the company brought in $20.2 million, up 4% from 2016.
Looking ahead, Timberlake hopes to continue growing the company and expanding into additional products, like a Bluetooth-enabled accessory for the V-Go device that communicates data about a patient’s insulin use to their smartphone. Valeritas is also working on a pre-filled version of its V-Go insulin delivery patch.
“We’re just scratching the surface,” he said. “Fifty sales reps, two million type II diabetes patients that are on multiple daily shots – we have so much growth potential.”
