Valeritas Presented New Data Demonstrating use of V-Go® Wearable Insulin Delivery Device Results in More Patients with Type 2 Diabetes Achieving Blood Glucose Targets

BRIDGEWATER, N.J., April 30, 2018 -- Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, last week presented positive findings from a new study during the poster presentations at the AMCP Managed Care and Specialty Pharmacy Annual Meeting held in Boston, Massachusetts.  The AMCP published these same results in an abstract two weeks prior to this meeting. 

The findings from the ENABLE (Effectiveness of V-Go Wearable Insulin Delivery for Basal-Bolus Therapy) study, demonstrated that patients who switched to V-Go from insulin pens or syringes experienced a greater reduction in A1C levels and insulin total daily dose (TDD).

“Insulin only works if patients take it and the current standard of asking patients to inject themselves multiple times a day has its challenges,” said John Timberlake, President and Chief Executive Officer of Valeritas.  “We believe V-Go provides patients a simple and convenient way to deliver basal-bolus insulin and the findings from this new study continues to support the use of V-Go for insulin delivery results in better glucose control.”

The ENABLE study is a real-world, retrospective, multi-center analysis evaluating the achievement of blood glucose targets in 283 patients with type 2 diabetes sub-optimally controlled (A1C ≥ 7.0%) on current insulin regimens that transitioned to V-Go for basal-bolus therapy. Baseline mean characteristics were A1C of 9.2%, weight of 221 lbs, and total daily dose (TDD) of insulin of 76 units per day (range 14 to 300).  After seven months of V-Go use, there were significant (p<0.0001) reductions in A1C and TDD. Twenty-three percent of patients achieved an A1C target of <7% with V-Go.  Achievement of an A1C target < 8% was achieved by 52% vs 24% (p<0.001) and a target of ≤ 9.0% was achieved by 76% vs 54% (p<0.001) with V-Go compared to prior insulin regimens, respectively.  The percent of patients poorly controlled (A1C > 9%) and at high risk for long-term complications decreased from 46% at baseline to 24% with V-Go use (p<0.001).

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 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. 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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