Roche receives clearance from the U.S. Food and Drug Administration for the new Accu-Chek® Nano SmartView blood glucose monitoring system

Innovative, small, no code device will be available to people with diabetes in the U.S. in first 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 its Accu-Chek® Nano SmartView blood glucose

monitoring system. The new Accu-Chek Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, preand postmeal markers and average glucose calculation. The Accu-Chek Nano meter uses Accu-Chek® SmartView test strips and will be available to customers in the first half of 2012.

 

“We are very excited to bring this latest blood glucose monitoring technology to the United States,”said Luc Vierstraete, Global Head of Roche Diabetes Care. “The Accu-Chek Nano meter is the newest advancement in Roche’s more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers, and continues our promise to enabling optimal diabetes management. This new system will help us to further leverage and enhance our position in this important market.”

According to the 2011 National Diabetes Fact Sheet published by the Centers for Diseases Control and Prevention, more than 25 million people in the US live with diabetes. However, seven million are currently undiagnosed and 1.9 million new cases of diabetes were diagnosed in people aged 20 years and older in 2010. It is also estimated that 79 million people live with pre-diabetes in the US.

“The Accu-Chek Nano blood glucose meter will appeal to those who prefer a small, discreet meter with maximum performance and is Roche Diabetes Care’s latest innovation aimed at enabling diabetes success for our customers and their health care team,” said Marc Gibeley, Head of Roche Diabetes Care North America. “It is easy-to-use and will help people with diabetes regularly check their blood glucose levels before making informed therapy and lifestyle adjustments. We look forward to its launch later this year.”

 

Roche Diabetes Care Roche Diagnostics GmbH

Sandhofer Straße 116

D – 68305 Mannheim

Global Communications Phone +49 621 759 9561

Fax +49 621 759789561

http://www.accu- chek.com

About the Accu-Chek Nano SmartView system

The Accu-Chek Nano SmartView blood glucose monitoring system offers a small, sleek and discreet design with easy-to-use operating buttons on top of the meter. It is the first single-strip no code meter in the Accu-Chek product family. This means it does not require any coding previously needed to calibrate the meter to the respective test strips and will use the maltose-independent Accu-Chek SmartView test strips. The Accu-Chek Nano SmartView system is part of the same product line as the Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems that have already been launched successfully in many markets in the EMEA, Latin-American and APAC region.

 

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 medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.

 

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. It encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – contributing to an improved medical outcome. For more information: www.accu-chek.com.

 

For more information please contact

Ute Volkmann

Roche Diabetes Care

Todd Siesky

Roche Diabetes Care

Roche Diagnostics Roche Diagnostics

Phone: +49 621 759 9561 Phone: +1 317 521 3966

E-Mail: ute.volkmann@roche.com E-Mail: todd.siesky@roche.com

or visit

www.accu-chek.com

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

 

Pure Play Diabetes Technology Companies Offer Little To No Value For Investor

The first blood glucose meter came to market in doctors’ offices in 1965. Within a minute of placing a drop of blood on a paper strip, a color reading was produced. The doctor compared this color to a color chart and came up with the blood glucose reading. The first digital readout came in 1970 with in home meters being produced starting in 1975. From 1975 until 2005, there were not too many updates to the at home blood glucose monitor: the device grew to be more accurate and smaller over time. Additionally meters are now available that enable physicians to download the readings onto their computers instead of patients having to write it down in a log. Enter the continuous glucose monitor in 2005.

The continuous glucose monitor is a device that that tracks blood glucose readings in real time. Typically attached to the stomach is a needle to draw minute amounts of blood. This links up to an electronic device that stores the data. The simple argument as to why this technology will be a breakthrough is because patients, mostly Type 1 Diabetics, will be able to monitor the highs and lows of their glucose levels, theoretically enabling them to better manage their condition. There are several reasons that the potential market for this device might be less than industry insiders and investors have come to believe. First, the patient has to feel that it is important enough to them to monitor their condition full time that they are willing to have these items attached to their body. Additionally, the patient still has to calibrate the device twice a day with a reading from a traditional glucometer. Also, insurance companies are on the fence about whether or not to cover the device. While commercial insurance companies have largely come around, there has been no national decision by Medicare and it is unlikely that Medicaid will ever take it up. That being said, CGM claims many Type 1 diabetes patients as fans. Many people swear by it and perhaps that’s what has driven up the valuation of the only pure play public company with a device currently on the market, Dexcom (DXCM). Though far from its $25 high in 2005 at $9 currently, the company’s market capitalization is 20% higher at $600 million now then it was in 2005 as a result of a tripling in the company’s shares outstanding. The company has an accumulated deficit of over $400 million. While I don’t think Dexcom is a bad company, it has become clear over the years that to get an increase in sales, the company has to spend incrementally more money. Though sales have increased from $2 million in 2006 to about $69 million in 2011, net loss has stayed about the same at around $45 million. The company has to spend a large amount of money to market its product because its primary competitor is Medtronic (MDT), a company with a great amount of resources. Medtronic has the only fully integrated product in the United States that combines an insulin pump with continuous glucose monitoring, making DXCM’s sale a difficult one. As a result, we think DXCM’s 8.5x Price/Sales multiple is not warranted without further evidence that the market is larger than current sales levels reflect.

* Numbers In Millions

The next big pure play in the diabetes technology market is Insulet (PODD), the maker of the OmniPod, the lightest insulin pump on the market. The clear competitive advantage that it has is being the only wireless pump in the United States. Type 1 diabetics have caught on to this product as well over the past few years. Similarly to Dexcom, while sales increased from $4 million in 2006 to about $135 million in 2011, net loss increased from $32 million to $64 million in the same respective period. A big part of this spend has gone into increasing awareness of the product and attempting to effectively compete with Medtronic. We think that while Insulet will continue to gain market share until Medtronic develops a tubeless pod system, sales will likely not accelerate further until the company receives FDA approval for a product that integrates the insulin pump with CGM, like Medtronic has on the market. While the stock topped out at $27 in 2007, market capitalization is at its high with the share count nearly tripling over the past four years. One particularly questionable move that the company made earlier in 2011 was the acquisition of Neighborhood Diabetes, a diabetes products supplier. Our thoughts are that the company made this large and non-core acquisition to thwart off any potential acquisition attempts. While the company was a pure play insulin pump company, a large med tech might have been interested in purchasing it. PODD trades at 8x price/insulin pump sales, similar to DXCM, compared to 2x sales for the average med-tech company. Additionally, over the past 6 months, executives have sold over 120,000 shares.

In conclusion, while we favor the fact that these products make the lives of diabetics easier in some cases, we do not think the current valuations are supported by fundamentals or realistic expectations for future demand. Medtronic, one of the largest Med-Tech companies in the world, currently dominates the space and companies including Johnson & Johnson (JNJ) & Roche (RHHBY.PK) are increasing their presence within the space. We think that the barriers to entry are somewhat low given that the IP for both products is based on established technology. We recommend investors stay away from the space until valuations rationalize considerably.

Kitty Castellini Wins Roche Diabetes Care’s Diabetes Heroes’ Torchbearer Challenge Roche to make $10,000 donation in Castellini’s name to South Jersey JDRF Chapter

Indianapolis, Dec. 2, 2011

INDIANAPOLIS—Roche Diabetes Care, makers of ACCU-CHEK products and services, is pleased to announce that Diabetes Living Today® Founder, President and CEO Kitty Castellini is the winner of Roche’s inaugural Diabetes Heroes’ Torchbearer Challenge.

Roche launched the online Diabetes Heroes program earlier this year to highlight and recognize historic and present-day individuals who have made important contributions to help others live full lives with diabetes. The site contains three groups: Trailblazers, Torchbearers and Everyday Heroes.

Trailblazers are scientists and researchers who have made important historic discoveries about how diabetes is diagnosed and treated. Torchbearers are present-day researchers, advocates and online community leaders who continue to blaze new trails in helping people with diabetes to live healthy, active lives. To increase the visibility of this very important group of modern-day heroes, Roche produced online video profiles of each Torchbearer and encouraged people to visit the site and “like” their favorite by Nov. 14, 2011, World Diabetes Day. Castellini received the most likes and as a result Roche will donate $10,000 in her name to the South Jersey JDRF Chapter.

“A diabetes hero is an ordinary person who finds the courage and strength to persevere and endure in spite of the overwhelming obstacles of diabetes,” said Castellini.

The Diabetes Heroes site remains active and will continue to promote the incredible work being done by Kitty and her colleagues to assist people living with diabetes. Visitors to the Diabetes Heroes website may also add their own Everyday Hero by visiting the site and adding their own hero to the growing list.

 

For more information about Diabetes Living Today®, please visit http://diabeteslivingtoday.com. To learn more about the Diabetes Heroes website, please visit http://www.accu-chek.com/microsite/heroes/index.html.

###

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 30 years, Roche has been committed to helping people with diabetes live lives that are as normal and active as possible and has been helping healthcare professionals manage their patients’ condition in an optimal way. Today, the ACCU-CHEK portfolio offers people with diabetes and healthcare professionals innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management—from blood glucose monitoring through information management to insulin delivery. The ACCU-CHEK brand encompasses blood glucose meters, infusion pumps, lancing and data management systems. For more information, please visit 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 medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.

 

About Kitty Castellini

Kitty Castellini, Founder, President and CEO of Diabetes Living Today®, has more than 47 years of experience with diabetes. Castellini is recognized as a national thought leader about diabetes by pharmaceutical companies, research institutes and those living with the disease. She is an active advocate for cure-focused research and fundraising. In 2007, the U.S. Congress acknowledged Castellini’s impressive work in helping others who suffer from diabetes through her writing, fundraising and interviews. The State of New Jersey Senate honored her for her exemplary service, steadfast commitment and praiseworthy history of inspired leadership on behalf of her fellow citizens.

 

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

 

For further information, please contact:

Todd Siesky
Public Relations Manager 

Roche Diabetes Care

Indianapolis, IN

(317) 521-3966 O 

(317) 361-7637 C

todd.siesky@roche.com