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Study Supports Valeritas’ V-Go® Can Improve Glycemic Control in Type 2 Patients When Using an Easy to Follow Physician-Driven Insulin Titration Algorithm

November 26, 2018

BRIDGEWATER, N.J., Nov. 26, 2018 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of V-Go® Wearable Insulin Delivery device, a simple, all-in-one, wearable insulin delivery option for patients with diabetes, today announced the publication of a manuscript titled “Evaluation of a Weekly Physician-Driven Bolus Titration Algorithm in Patients with Type 2 Diabetes Prescribed V-Go® Wearable Insulin Delivery Device for Basal-Bolus Therapy,” in a special Bolus Insulin issue of Annals of Diabetes, Metabolic Disorders & Control, an international, peer-reviewed journal.

The published manuscript describes in detail the retrospective analysis conducted by Dr. Sandip Mehta of Texas Star Adult Medicine and the Texas Health Research & Education Institute. Results of the study support the view that V-Go can safely improve glycemic control of patients with type 2 diabetes using an easy to follow physician-driven titration algorithm.

In the proof-of-concept study, Dr. Mehta evaluated the safety and efficacy of a physician-driven insulin titration algorithm in adult patients diagnosed with type 2 diabetes who were prescribed V-Go. At weekly intervals, the bolus doses of insulin were titrated based on 2-hour post meal blood glucose averages. Up titration occurred when averages exceeded 170 mg/dl and down titration occurred when averages were below 100 mg/dl. Following initiation of V-Go, the bolus dose was actively titrated (either up or down) for the first three weeks of therapy after which insulin dosing remained fairly stable. Basal doses were adjusted after bolus dosing was optimized. Clinical outcomes were evaluated after four months.

After four months of V-Go use with insulin dose adjustments, 67% of patients achieved an A1C level less than 7.5% compared to 13% at baseline on prior regimens. Moreover, a significant decrease in A1C of 1.6% was found compared to baseline (8.7% to 7.1%; p<0.001) and the prevalence of hypoglycemia decreased to 7% by month four from a baseline of 23%. Mean body weight did not change from baseline to study end.

Commenting on the announcement, Valeritas CEO, John Timberlake, stated, “Titration of insulin is an important step to improving glycemic control. We are heartened by the impressive results demonstrated by combining a straightforward insulin titration algorithm with the simplicity of V-Go in patients with type 2 diabetes to maximize results.”

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, affordable, all-in-one basal-bolus insulin delivery option for patients with type 2 diabetes that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours, and it 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 Marlborough, Massachusetts.

More information is available at www.valeritas.com and our Twitter feed @Valeritas_US, www.twitter.com/Valeritas_US.

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. Statements or claims made by third parties regarding the efficacy or functionality of V-Go as compared to other products are statements made by such individual and should not be taken as evidence of clinical trial results supporting such statements or claims. As with all research, study design limitations should be considered when interpreting the results and whether or not the results can be applied to a general population. Refer to the full findings in the referenced published disclosure or contact Valeritas Medical Information at med-info@valeritas.com for additional information. 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.

Investor Contacts:Lynn Pieper Lewis or Greg ChodaczekGilmartin Group646-924-1769 ir@valeritas.com

Media Contact:Kevin KnightKnight Marketing Communications, Ltd.206-451-4823 pr@valeritas.com

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