September 18, 2014 11:14 PM ET

Healthcare Equipment and Supplies

Company Overview of Valeritas, Inc.

Company Overview

Valeritas, Inc. engages in developing and commercializing treatment solutions that contribute to clinical and humanistic outcomes for patients with type 2 diabetes. It offers V-Go, a disposable device for the delivery of basal-bolus insulin therapy in adults with type 2 diabetes. The company’s development portfolio also includes h-Patch, a disposable controlled delivery technology platform to deliver drugs into subcutaneous tissue; Mini-Ject, a pre-filled needle-free delivery system that delivers drugs ranging from small molecules to large proteins, fragile antibodies, and vaccines; and Micro-Trans, a micro needle transdermal delivery patch, which enables drug delivery into the dermis. It se...

750 Route 202 South

Suite 600

Bridgewater, NJ 08807

United States

Founded in 2006

Phone:

908-927-9920

Fax:

908-927-9927

Key Executives for Valeritas, Inc.

Chief Executive Officer and Director
Age: 54
President and Chief Commercial Officer
Chief Financial Officer
Age: 42
Executive Vice President of Manufacturing Operations and R&D
Age: 62
Vice President of Human Resources
Compensation as of Fiscal Year 2014.

Valeritas, Inc. Key Developments

Valeritas, Inc. Presents at Citigroup 2014 Global Healthcare Conference, Feb-24-2014 01:50 PM

Valeritas, Inc. Presents at Citigroup 2014 Global Healthcare Conference, Feb-24-2014 01:50 PM. Venue: Hilton New York, 1335 Avenue of the Americas (Between West 53rd - West 54th Streets), New York, NY 10019, United States. Speakers: Kristine Peterson, Chief Executive Officer and Director.

Valeritas, Inc. Presents at The JPMorgan 32nd Annual Healthcare Conference, Jan-15-2014 02:30 PM

Valeritas, Inc. Presents at The JPMorgan 32nd Annual Healthcare Conference, Jan-15-2014 02:30 PM. Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA 94102, United States. Speakers: Kristine Peterson, Chief Executive Officer and Director.

Valeritas, Inc. Announces New Findings from Observational Study

Valeritas announced new findings from a planned interim analysis of data from the SIMPLE study that suggests that patients with Type 2 diabetes who switched to the V-Go insulin delivery device from their previous baseline treatment experienced improved glycemic control and a reduction in total daily insulin dose with no significant change in weight. Additionally, an independent and separate report conducted by clinicians at the Diabetes Center of Excellence at the University of Massachusetts Medical School, suggests improvement in glycemic control and a reduction in total daily insulin dose for patients requiring insulin who switched to the V-Go device. Both sets of data were presented at the American Diabetes Association's 73(rd) Scientific Sessions. V-Go is a simple, fully-disposable device that delivers a continuous preset basal rate of insulin for 24 hours with on-demand mealtime dosing. It is designed to be easier to use and assist with blood glucose control in adult patients who require insulin. SIMPLE study design and results: The SIMPLE study compares the changes in baseline and endpoint A1C measures and observes glycemic control, insulin dose requirements and other parameters. The study enrolled patients with Type 2 diabetes and a baseline A1C greater than 7%. Study participants are then switched from one of five baseline treatments to the V-Go for their basal and mealtime insulin delivery. The primary objective of this observational study is to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go. Study participants are followed on their current therapy for up to 6 weeks before starting the V-Go insulin delivery device. The study has no mandated or forced titration instructions to guide insulin therapy with the exception of starting doses for V-Go basal rate options. The interim analysis of the observational study suggests that 89 patients had continuous V-Go use for a minimum of 3 months. At the time of this interim analysis, A1C levels for the study participants reduced from a mean of 9.0% to 8.8% during the 4 to 6 week run-in phase. After the run-in period and starting the V-Go, the interim results suggest that patient A1C levels further improved with a mean change from 8.8% to 8.1%; P<0.0001 from month 0 to month 3. There was a small but statistically significant decrease in body weight and the total daily insulin dose was reduced by 11.4 units on average. Overall, the incidence of hypoglycemia after 3 months of V-Go use was low with 90% of patients reporting no hypoglycemia. A total of 10 patients reported hypoglycemia with 7 patients having documented hypoglycemia (<70 mg/dl) and 2 patients reporting severe hypoglycemia (requiring third party assistance). Patients across the three major subgroups of baseline insulin therapy (basal insulin subgroup, premixed insulin subgroup, and the multiple daily injection subgroup) also demonstrated significant reduction in A1C levels consistent with the overall findings. The most robust decrease in insulin was seen in patients previously on premixed insulin or taking multiple daily injections where the 3 month decrease in total daily insulin dose was 23 units and 18 units, respectively.

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