Valeritas Presents Data Showing Greater Reductions in A1c and Insulin Dose with V-Go® Wearable Insulin Delivery Device Compared to Insulin Pen Devices in Patients with Type 2 Diabetes

BRIDGEWATER, N.J., Feb. 16, 2017 -- Valeritas Holdings, Inc. (OTCQB:VLRX) today announced data showing greater reductions in A1c and insulin dose in patients with type 2 diabetes who used V-Go^® Wearable Insulin Delivery device compared to patients using insulin pen devices. The data were presented as an E-Poster at The 10^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), February 15 to 18, in Paris, France.

The study was a retrospective analysis based on electronic medical records from a multicenter diabetes system in the United States. Patients with A1c levels greater than seven percent and transitioning from basal only to basal and mealtime insulin were included in the analysis. The primary endpoint was to evaluate the difference in A1c change between V-Go and insulin pens.

One hundred seven patients (50 V-Go and 57 insulin pens) were evaluated. Baseline parameters were similar between the two groups. By 27 weeks, the changes in A1c levels were -1.96% with V-Go and -1.23% with insulin pens for a treatment difference at 27 weeks of 0.73; p=0.011, favoring V-Go. In addition, insulin dose and needle sticks were less with V-Go compared to insulin pens (56 vs 77 units/day; p<0.001 and 1.0 vs 3.6 sticks/day; p<0.001, respectively).

“This study is of particular relevance to European physicians and their patients as insulin pens are the primary delivery system for insulin for patients with type 2 diabetes in Europe,” said John Timberlake, President and Chief Executive Officer of Valeritas. “While we remain focused on continuing to grow our customer base and prudently increase our commercial footprint in the U.S., we welcome opportunities such as ATTP to present our compelling clinical data to European audiences as we continue to explore potential commercial partners to distribute V-Go in the region.”

About Valeritas Holdings, Inc.

Valeritas is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. Valeritas’ flagship product, V-Go^® Wearable Insulin Delivery device, is a simple, wearable, basal-bolus insulin delivery device for patients with type 2 diabetes that enables patients to administer a continuous preset basal rate of insulin over 24 hours. It also provides discreet on-demand bolus dosing at mealtimes. It is the only basal-bolus insulin delivery device on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in Shrewsbury, Massachusetts. For more information, please visit www.valeritas.com.

Forward Looking Statements

This press release may contain forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Valeritas technologies, business and product development plans and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue Valeritas’ business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize the V-Go^® Wearable Insulin Delivery device with limited resources, competition in the industry in which Valeritas operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and Valeritas assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Valeritas files with the SEC available at www.sec.gov.

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