Valeritas to Present Results of the Prospective Pragmatic Multicenter Clinical Trial of V-Go® Wearable Insulin Delivery Device to the European Diabetes Community

Study demonstrated Clinical Efficacy and Lower Total Daily Insulin Dose in Patients with Type 2 Diabetes

Poster Presentation on September 13 during the European Association for the Study of Diabetes Annual Meeting

BRIDGEWATER, N.J., Sept. 05, 2017 -- Valeritas Holdings, Inc. (NASDAQ:VLRX) today announced it will present data demonstrating use of the V-Go^® Wearable Insulin Delivery Device provides clinical benefits in real-world use by patients with type 2 diabetes. Results will be presented during a poster presentation at the European Association for the Study of Diabetes Annual Meeting 2017 (EASD) taking place September 11-15 in Lisbon, Portugal.

“This study demonstrates that use of V-Go can provide significant and meaningful clinical benefits in patients with type 2 diabetes with decreased total insulin requirements compared to other insulin injection regimens,” said John Timberlake, President and Chief Executive Officer of Valeritas. “Presenting this important data in Europe, where V-Go has regulatory clearance, provides us the opportunity to communicate the benefits of V-Go while we explore options to commercialize V-Go to the European diabetes community.”

Poster Presentation 703: A Prospective Pragmatic Clinical Trial in Type 2 Diabetes to Compare the V-Go Insulin Delivery Device with Standard Treatment Optimization

Poster Session:  PS 051: Using technology in diabetes: from obesity to closed loop
Date and Time:  Wednesday, Sep 13, 2017, 12 p.m. to 1 p.m. CEDT

Exhibit Booth:  Please visit us at Stand H.05 in Hall 2 to learn more about V-Go.

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.

An experimental result, such as those derived from a clinical or non-clinical study is statistically significant if it is unlikely to have occurred by chance. The statistical significance of experimental results is determined by a widely used statistical method that establishes the p-value of the results, which is a statistical measure of the probability that the difference in results between treatment and control groups in a study could have occurred by chance. Under this method, the smaller the p-value, the greater the confidence that the results are significant, and a p-value of less than .05, reflecting a less than one-in-twenty probability that the result occurred by chance, is generally considered by the FDA to represent statistical significance.

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