Valeritas Announces New Findings From Observational Study Suggesting That Delivery Of Insulin Via V-Go® May Improve Glycemic Control And Reduce Total Daily Insulin Dose For Patients With Type 2 Diabetes

CHICAGO and BRIDGEWATER, N.J., June 22, 2013 /PRNewswire/ -- Valeritas, makers of the V-Go^® insulin delivery device, today 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.^{1, 2}

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.

"Like all diabetes providers, we see many patients in our diabetes clinic who are not achieving recognized treatment goals. We strive to understand the barriers that limit each patient's treatment, in an effort to help such patients improve their outcomes. Not too surprisingly, we have identified many different factors that contribute to the less than ideal treatment metrics including busy work schedules, forgetfulness, needle phobia, inconvenience, and simply not fully embracing their disease," said David M. Harlan, M.D., Co-Director of the Diabetes Center of Excellence at the University of Massachusetts Medical School. "We saw the potential for the V-Go to help such patients and have been using the V-Go with increasing frequency. We've been very pleased with our patients' early results. V-Go has been well accepted by most patients, and they've achieved improved glycemic control."

The SIMPLE study, "Effectiveness of V-Go for Patients with Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry," compares 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 percent. Study participants are switched from one of five baseline treatments to the V-Go for their basal and mealtime insulin delivery.¹

"We are very encouraged by the consistency in results between our SIMPLE study and the independent University of Massachusetts experience," said Kristine Peterson, Valeritas Chief Executive Officer. "Both analyses indicate that V-Go helps patients with Type 2 diabetes better manage their blood glucose, with a potential reduction in total insulin dose."

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 percent. Study participants are then switched from one of five baseline treatments to the V-Go for their basal and mealtime insulin delivery.¹

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.¹

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 percent to 8.8 percent 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 percent to 8.1 percent; 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.

University of Massachusetts Report Design and Results

At the American Diabetes Association Annual Session, UMass diabetes specialists report their "real world" initial patient experience using the V-Go for insulin delivery. Their abstract describes outcomes achieved in the first 21 patients with diabetes they treated using the V-Go device. Prior to initiating the V-Go, all patients had elevated A1C levels. 7 patients discontinued using the V-Go for various reasons. Of the 14 who continued the device, outcomes were impressive. All started with elevated A1C levels ranging from 8.0 percent to 14.8 percent with a mean of 10.7 percent. With an average follow up of 58 days (range 45-150 days), glycemia control dramatically improved with subsequent A1C levels ranging from 7.0 percent to 11.1 percent, with a mean of 8.3 percent (pre-V-Go to V-Go P= 0.001). Interestingly, total daily insulin requirements also significantly decreased.²

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,³ with approximately 4.8 million depending on daily insulin injections to help them control and manage their diabetes.⁴ 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.

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

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. Effectiveness of V-Go for Patients with Diabetes in a Real-World Setting: A Long-Term, Prospective, Observational Registry (SIMPLE). Data presented at the American Diabetes Association's 73rd Scientific Sessions. June 21-25, 2013. Chicago.

2.    Omer A, Powell R, Lock J, Malkani S and David M. Harlan. Disposable Insulin Pump to Improve Diabetes Treatment. Data presented at the American Diabetes Association's 73rd Scientific Sessions. June 21-25, 2013. Chicago.

3.    American Diabetes Association, Diabetes Basics. http://www.diabetes.org/diabetes-basics/diabetes-statistics/?loc=DropDownDB. Published 2012. Accessed November 5, 2012.

4.    National Diabetes Information Clearing House. National Diabetes Statistics. 2011. http://diabetes.niddk.nih.gov/dm/pubs/statistics/#fast. Accessed November 5, 2012.

SOURCE Valeritas