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Valeritas Receives FDA 510(k) Clearance for the V-Go(TM) Disposable Insulin Delivery Device for Use with NovoLog®

March 1, 2011

BRIDGEWATER, N.J., March 1, 2011 /PRNewswire/ – Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the U.S. Food and Drug Administration has cleared the company’s V-Go Disposable Insulin Delivery Device for use with Novo Nordisk’s NovoLog® for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. In December 2010, Valeritas received FDA clearance for the V-Go’s use with Eli Lilly’s Humalog®.

“With the addition of NovoLog® to the V-Go label, we have demonstrated that the two most widely prescribed fast acting insulins in the United States can be used safely with the V-Go and thereby have increased healthcare professional and patient insulin options available for use with the V-Go Disposable Insulin Delivery Device,” said Valeritas CEO Kristine Peterson.

About the V-Go Disposable Insulin Delivery Device

The V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with diabetes. The V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes thereby providing an alternative to taking multiple daily insulin injections.

The V-Go is engineered to simplify basal-bolus insulin therapy for the millions of people suffering from Type 2 diabetes. The V-Go is small, lightweight, and worn under the patients’ clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. The V-Go is not electronic, making it easy to operate and use.

The V-Go is filled with insulin using a very simple point-of-care filling accessory – the EZ Fill (which will be included with each monthly supply of V-Go devices). A separate prescription for insulin is required for use with the V-Go. Humalog® and NovoLog® have both been tested by Valeritas, Inc. and found safe for use with the V-Go Disposable Insulin Delivery Device.

About Valeritas, Inc.

Valeritas is a medical technology company committed to the development and commercialization of innovative drug delivery solutions that contribute to clinical and humanistic outcomes for patients, with an initial focus on the treatment of diabetes. The Valeritas medical technologies portfolio is headlined by the h-Patch(TM) technology. The V-Go Disposable Insulin Delivery Device, designed for the simple delivery of basal-bolus insulin therapy via a preset basal rate and on-demand bolus dosing around mealtimes, is the first use of the h-Patch(TM) technology.

In addition to the V-Go, the Valeritas delivery technology portfolio includes the

h-Patch(TM) for the delivery of other compounds in addition to insulin, the Mini-Ject(TM) Pre-Filled Needle-Free Delivery System, and the Micro-Trans(TM) Microneedle Delivery System. These technologies, when combined with certain compounds, are designed to enhance the delivery of a variety of injectable drugs resulting in improved patient acceptance and outcomes.

Headquartered in Bridgewater, NJ, Valeritas operates its R&D and manufacturing in a state-of-the-art facility in Shrewsbury, MA. Valeritas’ primary investors include MPM Capital, Pitango Venture Capital, Abingworth, US Venture Partners, ONSET Ventures, ATV Capital, HLM Venture Partners, CHL Medical Partners, Kaiser Permanente Ventures, and Agate Medical Investments.

Information on Valeritas and the V-Go(TM) Disposable Insulin Delivery Device can be found at www.valeritas.com and www.go-vgo.com.

NovoLog is a registered trademark of Novo Nordisk A/S.

Humalog is a registered trademark of Eli Lilly and Company.

SOURCE Valeritas, Inc.


Source: newswire



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