Valeritas Wins Silver Medal and Announces Positive Results of Two Retrospective Study Analyses of the V-Go® Disposable Insulin Delivery Device in Poster Presentations at AMCP

BRIDGEWATER, New Jersey, April 21, 2016 /PRNewswire/ -- Valeritas Inc., announced today the results of two retrospective analyses of the clinical and economic benefits of the company's lead product, the V-Go^® Disposable Insulin Delivery device.  The results were disclosed today in poster presentations at the Academy of Managed Care Pharmacy's 28th Annual Meeting and Expo (AMCP 2016) in San Francisco, California.

The first of the two posters, titled Achievement of Individualized Glycemic Targets and Cost Effectiveness: Comparison between Two Insulin Delivery Methods in Patients with Diabetes, was awarded a silver medal by the Academy of Managed Care Pharmacy. It evaluated data from Diabetes America, a large specialized diabetes system across Texas. The objective of this analysis was to compare both the percent of patients that achieved individualized A1C targets and the direct pharmacy cost difference per patient/per month (PPPM) between V-Go and multiple daily injections (MDI) for the delivery of basal-bolus insulin therapy in patients previously administering basal-only insulin ± concomitant anti-hyperglycemic agents.

Ninety-two patients (46 V-Go, 46 MDI) were identified for inclusion.  At baseline, both groups had similar mean A1C values (9.98%) and were prescribed the same daily basal insulin dose (50 units/day).  After a mean of 27 weeks on basal-bolus therapy, overall 43% of patients on V-Go and 33% of patients on MDI achieved individualized A1C targets.  In patients achieving goal,  insulin doses were similar at 27 weeks to baseline for V-Go (53 vs 51 units/day) however, were significantly higher compared to baseline for patients using MDI (96 vs 59 units/day, p<0.001).  The mean direct pharmacy cost difference PPPM associated with the addition of prandial insulin and goal achievement was +$309 for V-Go and + $439 for MDI from baseline. 

"The delivery of basal-bolus insulin therapy can be administered by a variety of methods. We find V-Go to be a simple delivery method to introduce prandial insulin and in this analysis resulted in more patients achieving goal at a lower incremental cost to the payer compared to MDI," said Dr. Rosemarie Lajara, president, Diabetes America, Physician Associates, P.A. 

The second poster, titled Evaluating Cost of Therapy and Clinical Efficacy with V-Go^® in Patients with Sub-Optimally Controlled Diabetes From An Endocrine Specialty System, details the results of a study that evaluated the impact on glycemic control and other variables for patients with diabetes who were transitioned to V-Go and were managed at Northeast Florida Endocrine and Diabetes Associates, a large multi-centered endocrine practice in Jacksonville, Florida. 

Sixty patients with sub-optimally controlled diabetes were identified who had transitioned to V-Go therapy from previous therapies.  At baseline patients had a mean A1C of 9.6±2.08%, body weight of 95± 20.35kg, and total daily insulin dose of 82 u/day (0.86 u/kg). Additionally, 58% (N=35) were on concomitant anti-diabetes medications and 77% (N=46) were on multiple daily insulin injections.

Patients who switched to V-Go achieved significant A1C improvements with a reduction in total daily insulin dose and concomitant medications, and an improved pharmacy cost impact, which may improve affordability for patients. Switching to V-Go resulted in a mean A1C reduction of -1.2±1.6% (p<0.0001) and a 50% reduction of patients with an A1C≥ 9.0%. Despite the robust improvement in A1C the overall incidence of reported hypoglycemia was similar to baseline. Baseline cost of diabetes therapy was $950 per patient per month (PPPM) and was reduced to $866 PPPM in part due to a 22% (-19 u/day,-.21u/kg) reduction in total daily insulin dose and reduction in concomitant anti-diabetes medications.  This study validates similar findings of other real world assessments also based on previous observations of patients switching to V-Go. 

About the V-Go^® Disposable Insulin Delivery Device
V-Go is a small, discreet, wearable and easy-to-use disposable insulin delivery solution for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. V-Go enables patients to closely mimic the body's normal physiologic pattern of insulin delivery by releasing a single type of insulin at a continuous preset basal rate over a 24–hour period and also providing for on-demand bolus dosing at mealtimes. V-Go is mechanical and operates for 24 hours without electronics, batteries, infusion sets or programming. It is worn on the skin under clothing and measures just 2.4 inches wide by 1.3 inches long by 0.5 inches thick, weighing approximately one ounce when filled with insulin.

Important Risk Information: If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery device may result in hypoglycemia. The following conditions may occur during insulin therapy with V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. V-Go should be removed before any magnetic resonance imaging (MRI) testing.

About Valeritas, Inc.
Valeritas is a commercial-stage medical technology company focused on developing innovative technologies to improve the health and quality of life of people with Type 2 diabetes. Valeritas' flagship product, the V-Go^® Disposable Insulin Delivery device, is a simple, wearable, basal-bolus insulin delivery solution for patients with Type 2 diabetes that enables patients to administer a continuous preset basal rate infusion of insulin over 24 hours. It also provides on-demand bolus dosing at mealtimes.  It is the only basal-bolus insulin delivery system 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 a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, please visit www.valeritas.com.

Press Contact:
Marjie Hadad
MH Communications
[email protected]
+1-908-947-0378 

SOURCE Valeritas, Inc.

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