CHESTERBROOK, P.A., Dec. 20, 2016 – Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada’s authorization for the sale of the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for the treatment of patients age two and older living with diabetes. The OneTouch Vibe™ Plus is the first and only insulin pump integrated with Dexcom G5® Mobile CGM technology, combining accurate and precise insulin dosing technology from Animas with the most accurate CGM sensing technology from Dexcom. This system will enable patients to see their glucose reading at all times either on their pump or using the Dexcom G5® App on their smart phone, and to deliver the precise amounts of insulin they may need from the pump.
The Dexcom G5® Transmitter collects blood glucose readings from the Dexcom sensor and wirelessly sends them to the patient’s OneTouch Vibe™ Plus Insulin Pump screen and compatible smart device using the Dexcom G5® Mobile System and app. This will enable patients using the pump and their caregivers to access CGM data wherever it is most convenient for them, and to make informed diabetes management decisions. In addition to the primary smart device, glucose data can be shared with up to five people utilizing the Dexcom Follow App.
“People living with diabetes will no longer have to pull out their pump to read their glucose readings. By having constant access to glucose readings on their pump and now their smart devices, the OneTouch Vibe™ Plus will give people with diabetes greater flexibility and discretion,” said Brian L. Levy, MD, FACE, Chief Medical Officer of JJDCC and Vice President of Worldwide Clinical Affairs for LifeScan, Inc. “This unique connectivity combined with the OneTouch Vibe™ Plus System’s patented technology that delivers insulin with exceptional accuracy and precision will help patients—even the most insulin-sensitive patients—stay in their target glucose range.”
In addition to being the only Dexcom G5® integrated system cleared by regulatory authorities, it also remains the only integrated system approved for children as young as age two. The enhanced connectivity enables parents and caregivers to continuously access their children’s blood glucose to help make treatment choices. “This system will offer kids living with diabetes a sense of freedom and will provide loved ones and caregivers with an insulin delivery and monitoring system that they can trust,” says John Wilson, Worldwide Vice President of Insulin Delivery, Animas Corporation.
Animas is evaluating launch timing for the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System in the U.S. and Canada.
With this approval, the OneTouch Vibe™ Plus Insulin Pump – and all Animas Corporation insulin delivery products moving forward – will join the iconic OneTouch® family of diabetes solutions. In the U.S., OneTouch® brand products are recommended by more endocrinologists and primary care physicians than any other brand[1]. Globally, more than 15 million people depend on OneTouch® brand products to help them manage their diabetes.
About Johnson & Johnson Diabetes Care Companies (JJDCC)
With a shared vision of creating a world without limits for people with diabetes, the Johnson & Johnson Diabetes Care Companies are a collaboration of Johnson & Johnson companies dedicated to diabetes and includes LifeScan, Inc., a world leader in blood glucose monitoring; Animas Corporation, maker of innovative insulin delivery systems; Calibra Medical, Inc. developer of the OneTouch Via™ on-demand insulin delivery system; and the Johnson & Johnson Diabetes Institute, LLC, a global initiative to improve care and better outcomes worldwide through education and training programs. In the U.S., Lifescan, Inc. is the leading blood glucose monitoring company and OneTouch® brand products are recommended by more endocrinologists and primary care physicians than any other brand1. Globally, more than 15 million people depend on OneTouch® brand products to help them manage their diabetes. For more information visit: www.OneTouch.com.
Important Safety Information
OneTouch Vibe™ Plus System is intended for the delivery of insulin and continuous glucose monitoring (CGM) for the management of insulin-requiring diabetes in persons age 2 and older. The OneTouch Vibe™ Plus System’s CGM, the Dexcom G5® Mobile Sensor and Transmitter, is indicated for detecting glucose trends and tracking patterns in persons age 2 and older and is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. Interpretation of the CGM results should be based on trends and patterns seen with several sequential readings over time. The OneTouch Vibe™ Plus System is intended for single patient use and requires a prescription.
Note: Insulin pump therapy is not recommended for people who are unwilling/unable to see their healthcare professional regularly, who are unwilling/unable to test their blood glucose 4-6 times per day, who are pregnant, who are suffering from certain medical conditions or taking certain medications, or who are vision/hearing impaired such that important information (e.g. alerts, warnings, and alarms) cannot be received. Please contact your healthcare provider to determine if insulin pump therapy and continuous glucose monitoring are recommended for you.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Animas Corporation, any of the other Johnson & Johnson Diabetes Care Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Johnson & Johnson Diabetes Care Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
[1] Global Brand Equity Insights Study, February 2015.
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