A Game-Changing Solution for Type 2 Diabetes Management

Valeritas
Written by Samita Sarkar

“Medicine only works if patients take it,” says John Timberlake, CEO and President of Valeritas, a diabetes management device manufacturer.
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In the summer of 2012, Valeritas launched its flagship product, the V-Go Wearable Insulin Delivery Device. The product was designed around the needs of the patient with Type 2 diabetes, who is able to receive insulin through this small, easy-to-use wearable device over a 24-hour period at a preset basal rate as well as on demand around meals by clicking two buttons.

Because the Bridgewater, New Jersey-based company really wanted to focus on the patient’s needs, its product is not an electronic pump, but instead a mechanical delivery device. Batteries and programming are not required for use of the product, which is disposed of at the end of each 24-hour period after each use. This makes V-Go more affordable for patients, who are able to have it reimbursed through their healthcare provider as if it were a drug at the pharmacy rather than a device with high deductibles. It is also covered by Medicare Part D, otherwise known as the “prescription drug benefit”: a government program to subsidize the costs of prescription drug insurance premiums for beneficiaries.

“We are focused on improving health and simplifying the lives of people with diabetes. Our mission is to enable patients to take their insulin in a very discreet and simple manner,” Timberlake tells us. “Thereby you will maximize the results of that medicine, and allow the patient a better experience and quality of life.”

V-Go is a game changer for diabetes management, no longer requiring that patients inject themselves three, four, or even five times a day. V-Go is the only FDA-approved, mechanically based basal and bolus insulin delivery product of its kind.

V-Go is also approved in the European market, although it is not yet available there. At the moment, Valeritas does not want to build infrastructure outside of the United States, but is open to partnerships with distributors who are interested in selling and commercializing the product in Europe.

“We are currently commercializing the product around the United States through our direct sales force. They promote the products to physicians who prescribe insulin to patients. Our sales force also supports physicians’ offices by educating their staff about how to train and support patients using V-Go,” explains Timberlake.

Once physicians are aware of the product, they can recommend it to adult patients with Type 2 diabetes (or adult Type 1 patients who do not have fluctuating basal rates) as a convenient alternative to insulin injections. The product is distributed through wholesalers, who then sell it to retail pharmacies around the country.

To ensure patients truly understand the disease and the importance of taking insulin, Valeritas also partnered with dLife®, a premier online resource and community, to help new users through an online educational program, V-Go Life™. “The vast majority of our patients who opt into our customer service participate in the program. V-Go Life™ is a subgroup of dLife® where patients who enroll can get general diabetes information and learn how to manage it,” says Timberlake.

Over three months, enrolled patients receive weekly communication with articles, quizzes, recipes, videos, diet and exercise tips, and more. After three months, the communication drops to a more infrequent basis. The program helps Valeritas with its twofold company goals: to improve the lives of people with diabetes, and to increase awareness about the disease and how to manage it.

Valeritas has created an incredible product with the potential to internationally change how patients deal with Type 2 diabetes, and the company is just getting started.

The core technology behind the Valeritas V-Go is called h-Patch (or “hydraulic patch”). Much more convenient than a traditional syringe, the h-Patch is an energy source that delivers the drug in a very precise manner. The simple, disposable, controlled delivery platform is currently being used only with V-Go, and Valeritas would like to expand and leverage the product to deliver other drugs as well, most likely though licensing or manufacturing agreements.

The team’s innovative R&D department is also working on two new products: the V-Go Link™ and V-Go Pre-Fill™, both of which are focused around the h-Patch technology. V-Go Link™ provides connectivity from the V-Go to smart phones and other devices, which then can be linked to other diabetes management platforms. It is a semi-disposable snap-on component to the V-Go with Bluetooth one-way communication from that link to a smart device. This is important for helping patients and doctors monitor the diabetes on a periodic basis allowing for regimen and behavioral changes without resorting to micromanagement.

“The Type 2 patient doesn’t want to be measuring all day long and changing their dosage at each meal and our data shows that they don’t need to be to reduce their glucose; they just need to be taking some insulin every time they eat. What the V-Go Link™ does is basically snap on to the V-Go and track when the patient has put on their V-Go and when they start delivering the insulin by pushing the ‘start’ button, as well as when they take insulin around meals,” Timberlake clarifies.

The goal of the V-Go Link™ is to collect data to provide information to both the patient and the doctors to see how much and when they are using their insulin, if they are following doctor’s recommendations, and matching that with their sugar data to then make behavioral or dosage modifications on a periodic basis.

The new product will be particularly significant because of the nature of Type 2 diabetes, a very different disease than Type 1. “Type 2 patients have a lot of other health issues, such as high blood pressure, high cholesterol, depression, or anxiety. They take a lot of medicine. The therapy must be very simple, and there is a social aspect to the disease—the patient doesn’t want to inject in public,” adds Timberlake.

He informs us that three out of four Type 2 patients who are prescribed mealtime injections don’t take their insulin medication out of the house. Therefore, when they go out to eat, they simply do not take it. With V-Go technology, combined with the soon-to-be-released V-Go Link™, these patients will find their disease much easier to accommodate in a safe and effective manner.

Valeritas is now seeking diabetes management collaborators who would like to partner with the company in its V-Go Link™ technology. Potential partners include companies who work with both insulin and glucose providers and utilize their data to help patients and doctors achieve better results. In a partnership, doctors who buy these diabetes management collaborators’ data sets will also get the V-Go Link™ data.

Valeritas’ other R&D development, the V-Go Pre-Fill™, is a pre-filled insulin cartridge that will eliminate the filling step and not require any EZ Fill refrigeration. The EZ Fill device is Valeritas’ current transfer device, which moves the insulin from the vial to the V-Go within about 20 seconds. But after developing this technology, Valeritas still wanted to go above and beyond, eliminating one more step for the patient.

“The next generation, which is really a true leap frog, is going to this pre-fill version,” Timberlake elaborates. “The Pre-Fill™ uses all of our current technology’s patient benefits and with a pre-fill cartridge, so that the patient doesn’t have to transfer insulin; they just snap the cartridge in.” This will make V-Go not only more convenient, but also more economical than its competition.

As of now, patients have two copayments a month—one for the V-Go product and one for the insulin—the same as they would have if they were not using V-Go and instead had to pay for pens or syringes for two different types of insulin.

While currently the V-Go is on par with competitors in terms of the number of copayments a patient requires, the V-Go Pre-Fill™ will reduce a patient’s number of copayments and therefore reduce their out-of-pocket healthcare costs.

“Our current therapy has no incremental cost on the copayment to the individual, but when we move to the Pre-Fill™, we can eliminate a copayment because it will be co-packaged,” says Timberlake.

Adding the Pre-Fill™ product will greatly expand Valeritas’ patient population. Timberlake anticipates that combined with the Pre-Fill™, V-Go will become a patient’s first option if they find diabetes pills to be ineffective for them, skipping the syringe injection step and moving right to the V-Go product. Launching Pre-Fill™ will also lead to mutually beneficial partnerships with insulin companies.

While both V-Go Link™ and Pre-Fill™ will incorporate h-Patch technology, Valeritas also has noncore technologies—the Mini-Ject and Micro-Trans needle-free injection systems—that it is actively looking to sell. Going forward, Valeritas will be investing in h-Patch with full force and will no longer be focused on these alternate delivery mechanisms.

As sales representatives are responsible for informing physicians about Valeritas’ flagship product, the company will continue to hire exceptional sales reps as the business grows. When seeking out candidates, Timberlake looks to hire those with three prime qualities: character, passion, and a proven history of performance.

“You cannot train or teach character and passion. That is something a person has to have, and it’s very important, especially with a small company. Anybody who works at Valeritas, even if they are not in sales—our R&D, finance, manufacturing—they have a very strong passion for what we do, and they truly believe that we are improving the lives of people with diabetes. I want people who want to get up to go to work every day and believe that they are making a difference for the patients,” says Timberlake.

By facilitating insulin delivery and encouraging diabetes awareness, Valeritas is changing the way that patients in the United States manage their condition.

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