Interim Analysis Suggests that Delivery of Insulin via Valeritas' V-Go® Shows Promise in Improving Glycemic Control for Patients with Type 2 Diabetes Previously Taking Long-Acting Insulin

BRIDGEWATER, N.J., May 15, 2014 /PRNewswire/ -- Valeritas, makers of the V-Go® Disposable Insulin Delivery Device, announced interim analysis data from SIMPLE, a prospective observational study, today that suggest patients with Type 2 diabetes who switched to V-Go therapy from their previous baseline treatment of long-acting insulin with or without oral medications experienced significantly improved glycemic control and a reduction in total daily insulin dose. The interim results, part of a planned interim analysis performed as part of the twelve month study, were presented at the American Association of Clinical Endocrinologists (AACE) 23^rd annual scientific and clinical congress.¹

V-Go is a simple, fully-disposable device that delivers a continuous basal rate of insulin for 24 hours with on-demand mealtime dosing. It is designed to be easy to use and assist with blood glucose control in adult patients who require insulin.

"This prospective observational study enables us to obtain data about the actual clinical benefit of V-Go therapy when used in patients previously receiving long-acting insulin in a real-world setting," said Kristine Peterson, Chief Executive Officer. "These interim results are promising, suggesting improved glycemic control by switching patients to V-Go from their long-acting insulin regimen."

Patients with Type 2 diabetes and a baseline A1C greater than 7 percent were enrolled. Study participants were then switched from one of five baseline treatments (5 cohorts) to V-Go for their basal and mealtime insulin delivery.¹ One cohort (the basal cohort) included patients previously treated with a long-acting insulin (with or without oral anti-diabetic medication).

The primary objective of the observational study was to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for all patients combined as well as each of the individual cohorts. Patients in the study were followed on their previous therapy for up to 6 weeks before initiating therapy with V-Go. The study, observational in nature, had no mandated or forced titration instructions to guide insulin therapy with the exception of recommended starting doses for V-Go basal rate options.¹

The interim analysis included 40 patients in the basal cohort with continuous V-Go use for a minimum of 6 months, an average age of 59 years and diabetes for 14 years. At the time of this interim analysis, mean A1C levels for the study participants reduced from a range of 8.5% – 10.2% to a range of 7.7% - 8.3%, depending on the initial V-Go basal dose.  In an extended analysis of the overall group, patients in the basal cohort exhibited statistically significant improvements in A1C from baseline to 3 months, 6 months and 9 months of continuous V-Go use, with a p-value of less than 0.001.  Five hypoglycemic events occurred (<70 mg/dl). No severe hypoglycemic events were reported. Initiating V-Go therapy after long-acting insulin therapy may be an effective and safe strategy to lower glucose.

About the V-Go® Disposable Insulin Delivery Device
V-Go® is a simple, fully disposable device for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. V-Go provides a continuous preset basal rate of insulin and allows for on-demand dosing at mealtimes.

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.  V-Go is not electronic, making it easy to operate and use.

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 committed to developing and commercializing innovative treatment solutions that contribute to clinical and humanistic outcomes for patients, with an initial focus on the treatment of Type 2 diabetes. Valeritas' portfolio is headlined by V-Go® Disposable Insulin Delivery Device, which is being commercialized and reimbursed in a specialty pharmaceutical model and is distributed through retail pharmacy.

V-Go meets an adult Type 2 diabetes patient's insulin needs by providing a treatment that is simple, convenient and easy to use. V-Go is designed to mimic the insulin pattern of the body (when used according to the Instructions for Patient Use) by providing a continuous preset basal rate of insulin over 24 hours and on-demand bolus dosing at mealtimes.

In March 2011, Valeritas received EU CE Mark approval for V-Go. In November 2012, Valeritas was named Life Science Company of the year by the New Jersey Technology Council for its targeted mission and focus on the development of technology to improve the lives of people with Type 2 diabetes. Its Executive Management Team was further recognized for the ability to effectively develop and commercialize devices at high volumes. In addition, Valeritas received the 2012 Scrip Financing of the Year award for raising $150 million in Series C financing in September 2011.

Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D and operations in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, visit www.valeritas.com

Disclosure Notice:
This press release contains forward-looking statements, which may include statements about regulatory submissions and the timing and potential for FDA review and approval of such submissions, the efficacy and safety of Valeritas' product candidates, market opportunities for V-Go® and the clinical importance of V-Go, as well as any other financial projections. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as "believes", "expects", "may", "should" or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. The forward-looking statements contained in this press release are based on our current expectations, and those made at other times will be based on our expectations when the statements are made. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. The forward looking statements contained herein are made only as of the date of this press release and Valeritas undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

ART-677 rev: A ©Valeritas, Inc. 2014

References
1. Grunberger, G. et al. Initiating V-Go® in Patients Using Long Acting Insulin. Presented at the American Association of Clinical Endocrinologists Annual Meeting. May 15, 2014. Las Vegas, Nevada.

SOURCE Valeritas, Inc.