Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance -- Studies Presented at ISPOR Meeting Underscore Potential Cost Savings for Improved Diabetes Control --

NEW ORLEANS, May 22, 2013 /PRNewswire/ -- Hemoglobin A1C levels increased over a four-year period for commercially-insured patients with Type 2 diabetes, while modest improvements in A1C control has been shown to improve health outcomes and can lead to substantial healthcare cost savings, according to two studies presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18th Annual International Meeting.

The two studies, sponsored by Valeritas, makers of the V-Go® insulin delivery device, and conducted in collaboration with HealthCore, a clinical outcomes research company, reviewed data about commercially insured patients being treated for Type 2 diabetes. The first study found that diabetes control, as measured by levels of hemoglobin A1C, worsened among the studied patient population between 2008 and 2011, and the second study suggested that modest improvements in A1C control may lead to substantial cost savings.

Both studies used administrative claims data from the HealthCore Integrated Research DatabaseSM (HIRDSM), associated with a large national health insurer. The studies were jointly designed by Valeritas and HealthCore.

"These studies demonstrate that we, as health professionals, need to help patients better manage their Type 2 diabetes as poor A1C control may have serious human and economic consequences," Matthew Nguyen, PharmD, Vice President, Medical Affairs, Integrated Healthcare Management. "Even modest improvements in hemoglobin A1C levels can have a profound impact on health care spending."

Valeritas sponsored the studies, which underscore the need for innovative approaches to glycemic control. The first study presented at the ISPOR meeting examined medical and pharmacy claims of nearly a quarter of a million individuals for the years 2008 through 2011 who had continuous health plan enrollment for at least one year, and were taking medications for the treatment of diabetes. For those who had A1C readings available, 48.2 percent had an A1C level of less than 7 percent – a marker of good diabetes control -- in 2008. By 2011, that figure fell to 44.5 percent. Those with A1C levels in excess of 9 percent jumped from 15.3 to 17.7 percent over the same period.

The second study assessed the economic impact of A1C changes, using a combination of administrative claims from the HIRD and cost data from previously published literature. Multiple scenarios were estimated, which suggested broad cost savings at the health plan level. For example, if half of the patients with an A1C greater than 9 percent had modest improvements in diabetes control (reduction in A1C of >/= 1 percent), the estimated cost savings at the health plan level over a one-year timeframe could be in excess of $50 million across all patients in the health plans investigated in the study.

"At the health plan level, these data suggest that most patients do not have adequate diabetes control and the cost savings from even modestly better glycemic control can be very substantial, making concerted efforts to improve patient outcomes a win-win proposition for all," said Dr. Nguyen.

About Diabetes

In order to fuel the human body's cells with glucose, or sugar, insulin is required. While the body continuously produces insulin, people with Type 2 diabetes, the most common form of diabetes, either do not produce enough insulin, or their bodies cannot use the insulin adequately. When there is not enough, or insulin is not used properly, glucose builds up in the blood instead of going into the body's cells. If not controlled properly, diabetes can increase the risk of heart disease, blindness, amputations, stroke, and high blood pressure.

The number of patients diagnosed with diabetes in the United States is alarming and continues to grow. According to the American Diabetes Association, nearly 26 million people in the United States have diabetes,2 with approximately 4.8 million depending on daily insulin injections to help them control and manage their diabetes.3 However, more than half of insulin users do not achieve their recommended target glucose levels for various reasons, including injection pain, or the embarrassment of injecting medication in public.

About the V-Go® Disposable Insulin Delivery Device

The V-Go® is a simple, fully disposable device for the delivery of basal-bolus insulin therapy in adults with Type 2 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 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.

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 the 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. The 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 the 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 mimics 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.

Valeritas' development portfolio also includes the h-Patch™ technology for the delivery of other compounds beyond insulin, the Mini-Ject™ Pre-Filled Needle-Free Delivery System, and the Micro-Trans™ Microneedle Transdermal Delivery Patch. These technologies, not commercially available, when combined with certain compounds, are designed to provide unique products that allow precise dosing in previously difficult to treat conditions.

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 manufacturing in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, visit www.valeritas.com and follow Valeritas on Twitter @Valeritas_US

About HealthCore, Inc.

HealthCore, based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint, Inc. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the "real world" safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to www.healthcore.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.

References

1. Rosenfeld, C., and Grunberger, G. Effectiveness of V-Go for Patients with Diabetes in a Real-World Setting: A Long-Term, Prospective, Observational Registry (SIMPLE). Date to be presented at the American Association of Clinical Endocrinologists Annual Meeting. May 1 – 5, 2013. Phoenix, Arizona. 2. American Diabetes Association, Diabetes Basics. http://www.diabetes.org/diabetes-basics/diabetes-statistics/?loc=DropDownDB. Published 2012. Accessed November 5, 2012.
3. National Diabetes Information ClearingHouse. National Diabetes Statistics. 2011. http://diabetes.niddk.nih.gov/dm/pubs/statistics/#fast. Accessed November 5, 2012.

SOURCE Valeritas, Inc.



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