FDA Clears ACCU-CHEK Combo Systems

Media Release via Email

Indianapolis, 18 July 2012

FDA clears Accu-Chek Combo system – Roche’s new interactive insulin pump
system for people with diabetes

The system will be available in the United States in the second half of 2012

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food

and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy. The Accu-

Chek Combo system seamlessly combines a blood glucose meter with an insulin pump, which are able to

exchange data in both directions via Bluetooth wireless technology. The meter not only enables the user to

quickly test blood glucose levels: It allows for operating the insulin pump remotely and by means of an easy-

to-handle bolus advisor it provides support in defining the right amount of insulin. With this the Accu-Chek

Combo system not only supports a more targeted therapy management, but it also allows for a discreet

insulin administration without the need to touch the pump.

“We are very pleased to announce that our new insulin pump system will soon be available for people with

diabetes in the U.S.,” said Daniel O’ Day, COO Roche Diagnostics. “With this clearance we are now looking

forward to launch the second device in the U.S. this year, after the successful clearance of the Accu-Chek

Nano SmartView system in the first quarter. Both launches represent a significant milestone for our Diabetes

Care business.”

According to the 2011 National Diabetes Fact Sheet published by the Centers for Disease Control and

Prevention, more than 25 million people in the U.S. live with diabetes. It is also estimated that 79 million

people live with pre-diabetes in the U.S.

“The Accu-Chek Combo system clearly demonstrates Roche’s dedication to integrated diabetes management

solutions, combining the technical components for blood glucose monitoring, data management and insulin

delivery. This new system is designed to support insulin pump patients in managing diabetes easily and

discreetly in their everyday life,” said Luc Vierstraete, Head of Roche Diabetes Care.

F. Hoffmann-La Roche Ltd

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The Accu-Chek Combo system has been launched successfully in several European and APAC(Asia-Pacific)

countries already – including France, Germany, UK, and Australia.

About the Accu-Chek Combo system:

In addition to being discreet and easy-to-use, the Accu-Chek Combo system also features:

Bluetooth technology for two-way wireless communication between the smart meter and the insulin

pump;

A full-color display that brings to life blood glucose data, insulin dose information and pump settings;

A bolus advice function on the meter to allow users to easily calculate and deliver a bolus without

touching the pump;

Flexibility to adjust the basal rate to as low as 0.05 units per hour – in increments as precise as 0.01 units;

and

An insulin cartridge that holds up to 315 units of insulin, the largest capacity among pumps sold in the

U.S.

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and

a global leader for diabetes management systems and services. For more than 35 years, the

Accu-Chek brand has been dedicated to enable people with diabetes to live life as normal and active as

possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way.

Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products

and impactful solutions for convenient, efficient and effective diabetes management spanning from blood

glucose monitoring through information management to insulin delivery. The Accu-Chek brand

encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and

education programs – leading to an improved medical outcome.

For more information, please visit www.accu-chek.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with

combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech

company with truly differentiated medicines in oncology, virology, inflammation, metabolism and

CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a

pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing

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medicines and diagnostic tools that enable tangible improvements in the health, quality of life and

survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8

billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United

States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai

Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations

Tandem Diabetes Care™ Launches t:slim™ Insulin Delivery System

Tandem Diabetes Care™ Launches t:slim™ Insulin Delivery System

Tandem to start accepting orders on June 11, 2012

PHILADELPHIA, June 8, 2012 —Tandem Diabetes Care™, Inc. (“Tandem”) announced today at the 72nd Scientific Sessions of the American Diabetes Association that it will begin accepting orders for the t:slim™ Insulin Delivery System, the first insulin pump approved by the FDA with a touch screen, on Monday, June 11, 2012. The product will begin shipping in August 2012.

“Since the t:slim Insulin Delivery System received FDA clearance, we have been conducting user evaluations to further demonstrate its performance and reliability, as well as the readiness of our team,” said Kim Blickenstaff, CEO, Tandem Diabetes Care. “t:slim is proving to be easy to teach, easy to learn, and easy to use, and our 24/7 Customer Technical Support Team is also finding it easy to support.”

People interested in the t:slim Insulin Delivery System can begin the order process starting at 6:00am PDT on June 11, 2012.

More information is available online at www.TandemDiabetes.com, or by calling 1-877-801-6901. Tandem’s sales team is available Monday through Friday from 6:00am to 6:00pm PDT to accept orders.

The t:slim Insulin Pump has the footprint of a credit card and the look of a smart phone. Currently the smallest FDA-cleared insulin delivery system, t:slim is up to 25% slimmer than other 300 unit pumps.[1] Unlike other insulin pumps that have complex menus and require excessive button pressing, t:slim’s vivid, color touch screen is the window to an easy-to-use interface that places everything at the touch of a finger.

About Tandem Diabetes Care, Inc.

Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a privately held company with novel diabetes technologies. The Company offers a comprehensive, user-centric and integrated approach to product design, development, and customer care. Tandem Diabetes Care is based in San Diego, Calif.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim.

Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetesCorp.

t:slim and Tandem Diabetes Care are trademarks of Tandem Diabetes Care, Inc.

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[1] Compared to dimension sizes of the Medtronic MiniMed Paradigm® REAL-Time Revel®.

You’ve got mail: JDRF Announces Research Collaboration with Dexcom, Inc…..

JDRF Announces Research Collaboration with Dexcom, Inc. to Develop “Smart Transmitter” Technology to Accelerate Artificial Pancreas Studies

–Novel Transmitter Will Simplify Artificial Pancreas Research by Eliminating a Separate CGM component—

NEW YORK, April 24, 2012 – JDRF, the leading global organization focused on type 1 diabetes (T1D) research, announced today that it has partnered with Dexcom, Inc. (NASDAQ:DXCM), a San Diego, CA-based medical device company focused on developing and marketing continuous glucose monitoring (CGM) systems. The goal of the partnership is to accelerate the development of a novel wireless “smart transmitter” that would allow a CGM system to communicate directly with an artificial pancreas control device currently being used for research studies, instead of only with a CGM receiver.

JDRF will provide Dexcom up to $500,000 over 12 months in milestone-based funding to complete the development, testing, and manufacturing of a custom “smart transmitter” prototype, which will be used for studies within JDRF’s Artificial Pancreas Project academic research consortium. The direct communication capability enabled by the smart transmitter will be an important feature for artificial pancreas trials in outpatient (real-world) settings, as it would eliminate the need for a trial participant to carry multiple devices all wired together while testing an artificial pancreas system’s ability to manage glucose levels.

People with T1D are burdened with constantly having to determine the right amount of insulin to dose at the right time, multiple times every day. Yet even with diligent monitoring, a significant portion of the day is still spent with either high or low blood sugar, placing them at risk for devastating complications. The artificial pancreas under development will be an external device that people with T1D could use to do what their bodies cannot—automatically control their blood sugar around the clock. It will work by combining an insulin pump and a CGM, which provides glucose readings every 1-5 minutes, with sophisticated computer software that allows the two devices to “talk to each other” to determine and provide automatically the right amount of insulin at the right time. Currently, all in-hospital artificial pancreas studies use wires and cables to connect a CGM system and an insulin pump to laptop computers or smartphones, which act as the artificial pancreas controllers.

In current CGM systems, the transmitter sends real-time glucose levels from the sensor to a receiver. In comparison, Dexcom’s next generation of “smart transmitters” will have the ability to wirelessly transmit a glucose value directly to multiple devices, including several versions of an artificial pancreas controller.

“This robust wireless capability could greatly enhance the performance of closed-loop algorithms in outpatient studies, and we are proud to be working with JDRF on this exciting venture,” said Terrance Gregg, chief executive officer of Dexcom.

“In order for us to truly achieve real-life outpatient studies of artificial pancreas systems, we need systems that will allow people the freedom and ability to move around while also providing safety, monitoring, and data collection,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. “Dexcom’s ‘smart transmitter’ will allow the sensor to talk directly to multiple artificial pancreas control devices, and essentially eliminate the hassle of being encumbered by wires and other devices while trying to be active. Now that the first outpatient studies have started, the development of robust wireless connection capability is a key step toward accelerating the delivery of an artificial pancreas to all patients with T1D.”

About JDRF
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.6 billion to T1D research. More than 80 percent of JDRF’s expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. For more information, please visit www.jdrf.org.

*press release received via email*

You’ve Got Mail: Lilly Diabetes and Walgreens Launch Diabetes Hypoglycemia Awareness Campaign

Lilly Diabetes and Walgreens Launch Diabetes Hypoglycemia Awareness Campaign

Lilly Diabetes and Walgreens to Help Combat the

Growing Problem of Hypoglycemia Unawareness

 

Indianapolis – April 16, 2012 – Lilly Diabetes and Walgreens are educating people living with diabetes about one of the most common and misunderstood consequences of diabetes: hypoglycemia (low blood sugar). The companies today launched an awareness campaign at 43 Walgreens pharmacies throughout the Indianapolis area. Lilly Diabetes will provide take-home educational materials about hypoglycemia that pharmacists may use when counseling people with diabetes.

Hypoglycemia occurs when people experience an abnormally low level of blood sugar, which is the body’s main energy source.1 Symptoms may include shaking, sweating, tiredness, hunger, increased heart rate, confusion, blurred vision and / or headaches. It’s important to recognize and treat hypoglycemia, as it can get worse and people can lose consciousness.2

“At Lilly Diabetes, we understand that managing diabetes extends beyond medicines to tools and resources that provide real, personalized solutions to improve the quality of everyday life, which is why we’re excited to collaborate with Walgreens to tackle the important and sometimes overlooked issue of hypoglycemia,” said Steve Sugino, vice president of Lilly Diabetes. “This initiative will not only provide needed education, but will also ultimately help facilitate better discussions between pharmacists and people with diabetes that can lead to improved disease management.”

The Lilly Diabetes-Walgreens approach is designed to complement the care and guidance people with diabetes receive from their health care providers. The campaign will be launched in 43 Walgreens stores in the Indianapolis area and showcase Walgreens new approach to community pharmacy that includes making pharmacists more accessible for patient consultations. Based on customer feedback over the next six months, the companies will explore expanding the campaign in additional cities.

“Walgreens, with our dedicated and highly professional pharmacists, is continually looking for ways to enhance our services to best meet the needs of our customers, particularly when it comes to their health needs,” says Walgreens Indianapolis market pharmacy director Marcel Naddaf. “With the high incidence of diabetes and its potential complications, we’re pleased to collaborate with Lilly Diabetes to provide valuable information to our customers with diabetes to help them better manage their condition.”

 

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and our continued commitment to providing real solutions – from medicines to support programs and more — to make lives better. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company (NYSE: LLY)

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Walgreens

As the nation’s largest drugstore chain with fiscal 2011 sales of $72 billion, Walgreens vision is to become America’s first choice for health and daily living. Each day, Walgreens provides nearly 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with respiratory services. These services improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. The company operates 7,840 drugstores in all 50 states, the District of Columbia and Puerto Rico. Take Care Health Systems is a Walgreens subsidiary that is the largest and most comprehensive manager of worksite health and wellness centers and in-store convenient care clinics, with more than 700 locations throughout the country.

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1 Mayo Clinic, “Hypoglycemia.” http://www.mayoclinic.com/health/hypoglycemia/DS00198. Accessed on 12/12/11.

2 American Diabetes Association. “Living with Diabetes.” http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Accessed on 11/15/11.

 

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