News Release

Glucowatch Biographer reported to improve diabetes control in children

Study published in Pediatrics is first ever to demonstrate that

Business Announcement

Hill and Knowlton

Parsippany, NJ, and Redwood City, CA, April 24, 2003 -- A study published in the current issue of Pediatrics showed that children who wore the GlucoWatch Biographer had greater detection of hypoglycemic events, and reduced levels of the metabolic marker, HbA1c (also known as A1c), compared to those using conventional glucose monitoring. The study is the first to demonstrate that diabetes management with the Biographer and appropriate therapy could affect HbA1c levels--a key marker in the quest for better disease control.

"Detection of hypoglycemia and better glycemic control are both significant benefits associated with the use of the GlucoWatch Biographer," said Professor H. Peter Chase, M.D., Clinical Director Emeritus, Barbara Davis Center for Childhood Diabetes, University of Colorado and lead author of the study. Dr. Chase was named the American Diabetes Association's physician of the year in 2001.

"Management of HbA1c levels helps prevent and/or reduce serious complications of the disease that affect the eyes, kidneys and nerves. Further, it is essential to detect hypoglycemia before a severe episode happens that may result in a seizure or coma due to a critically low glucose level. Nighttime detection is of particular concern, since more than half of all severe hypoglycemic events in children happen during the sleeping hours." The study was originally presented at last year's 62nd Scientific Sessions of the American Diabetes Association (ADA).

In conjunction with the report, the journal also published a commentary by Leslie P. Plotnick, M.D., pediatric endocrinologist and an associate professor in the Department of Pediatrics at Johns Hopkins University. She wrote as part of her conclusion, "The biographer appears to be a valuable tool and important step in diabetes management for the child and family, and for the diabetes management team." An estimated 17 million people in the United States suffer from diabetes, approximately 150,000 of whom are less than 20 years of age. Every year, close to 13,000 new cases are diagnosed in children. The risk of developing diabetes is higher than virtually all other severe chronic childhood diseases. It is the fifth deadliest disease in the United States. The complications of uncontrolled diabetes include heart disease, stroke, high blood pressure and kidney disease. The device is marketed by Sankyo Pharma and manufactured by Cygnus, Inc.

About the GlucoWatch Biographer study

The study was conducted in 40 children with type 1 diabetes in poor glucose control (defined as HbA1c greater than 8% on at least two occasions in the previous nine months). Patients were randomized to two groups--one using the Biographer in addition to conventional glucose monitoring, and one using the conventional monitoring alone. Those in the Biographer group were asked to wear the device four times per week for three months and to perform blood glucose monitoring if the Biographer alerted them that glucose was at or below 70 mg/dL (confirmed as hypoglycemia), or at or above 300 mg/dL. After the initial three months, all subjects received Biographers and were followed for six months. HbA1c values were determined at 0, 1, 3, 6, and 9 months.

Hypoglycemia was detected more frequently in the Biographer group compared with the control group (P = 0.005), with the greatest relative increase in detection of hypoglycemia at night. Additionally, after the first three months of diabetes management, the group using the Biographer to monitor glucose levels in addition to conventional therapy had significantly lower average HbA1c levels than the control group (P < 0.05). The study authors also reported that the GlucoWatch Biographer was well tolerated by the subjects; only one subject experienced more than a mild skin reaction.

Additional study findings demonstrated that insulin dose changes were more frequent in the control group. Richard C. Eastman, M.D., Medical Director at Cygnus and an author on the published study, commented, "The GlucoWatch Biographer provides a large amount of glucose data. This in turn, when used by the healthcare team, can lead to potential improvements in glycemic control as demonstrated by blood glucose and A1c measurements. Changes in aspects of the treatment regimen other than insulin adjustment may explain why children wearing the Biographer had better control of their disease. These factors may have included treatment of hypoglycemia, glucose management at night, regimens for high-fat meals and high-glycemic foods, and the management of exercise. However, the information is only suggestive, since alterations in management were not quantified in the study."

About the GlucoWatch G2 Biographer

The study reported in Pediatrics was conducted with Cygnus' first FDA-approved glucose monitoring device, the GlucoWatch Biographer. Since then, the FDA has approved the second-generation GlucoWatch G2 Biographer, for use in adults (March 2002), and children and adolescents ages 7-17 (August 2002). The GlucoWatch G2 Biographer differs from the first generation Biographer, as well as conventional blood glucose monitoring devices, in several important ways:

  • It measures and displays glucose levels frequently, up to every 10 minutes, automatically and non-invasively, collecting glucose through the skin, not from blood.
  • It also creates an "electronic diary," storing up to 8,500 glucose values that can be reviewed at the touch of a button, or uploaded into a software program (GlucoWatch Analyzer), helping detect trends and track patterns in glucose levels.
  • In addition, users can set personal glucose alert levels, an alarm can sound if readings are below or above their alert levels, or likely to be too low within 20 minutes.

The device consists of two main parts: the durable Biographer, a watch-like device, is worn on a person's forearm, and the AutoSensor, a disposable component (attached to the back of the device) that allows for glucose monitoring for up to 13 hours. It detects trends and tracks patterns in patient glucose levels.

The GlucoWatch G2 Biographer is available in the United States (by prescription only) and in the United Kingdom. The Biographer is not intended to replace the common "finger-stick" testing method, but is indicated as an adjunctive device to supplement blood glucose testing to provide more complete, ongoing information about glucose levels. It is indicated for detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of Biographer results should be based on the trends and patterns seen within several sequential readings over time. Additional information about the GlucoWatch G2 Biographer can be obtained by calling the toll-free number, 1-866-GLWATCH, or by visiting http://www.glucowatch.com.

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Sankyo/Cygnus

Under the agreement announced July 9, 2002, Sankyo Pharma is responsible for marketing, managed care and government contracting, and distribution of the GlucoWatch G2 Biographer, in addition to promoting the product to healthcare professionals. Sankyo promotes the Biographer with a specialty sales force of 100 representatives, and utilizes its national sales force. Cygnus, the manufacturer of the GlucoWatch™ Biographer as well as the GlucoWatch™ G2™ Biographer, is responsible for research and development, regulatory and clinical activities.

About Sankyo

Sankyo Pharma Inc. is dedicated to developing and marketing important pharmaceutical products for the U.S. market. Sankyo Pharma has offices in New York and New Jersey with a Research Institute in California. A national sales force of 550 representatives promotes Sankyo Pharma products, and they are supported by dedicated managed care and field-based medical personnel.

Sankyo Pharma launched WelChol® (colesevelam HCI), a non-systemic lipid-lowering agent, in September 2000. Currently, WelChol is the number one prescribed agent in its category with 2002 sales in excess of $100 million dollars. In addition, Sankyo Pharma launched Benicar® (olmesartan medoxomil), an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, in April 2002. Sankyo co-promotes Benicar with Forest Laboratories, Inc.

Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is Japan's second largest pharmaceutical company, with annual worldwide sales of $4.5 billion. Sankyo has a long history of discovering new classes of drugs, including the statin class of lipid-lowering drugs, with its discovery of the first statin, mevastatin, and the co-discovery of lovastatin, the first statin to be marketed. Additionally, Sankyo discovered, co-developed and manufactures pravastatin sodium.

About Cygnus, Inc.

Cygnus (www.cygn.com and www.glucowatch.com), founded in 1985 and headquartered in Redwood City, California, develops, manufactures and commercializes new and improved glucose-monitoring devices. The Company's products are designed to provide more data to patients and their physicians, enabling them to make better-informed decisions on how to manage diabetes. Cygnus believes its product represents the most significant commercialized technological advancement in self-monitoring of glucose levels since the advent of "finger-stick" blood glucose measurement approximately 20 years ago.

Some of the statements in this news release are forward-looking statements that involve risks and uncertainties. These forward-looking statements include statements about Cygnus' plans, objectives, expectations, intentions and assumptions and other statements contained in this news release that are not statements of historical fact. Forward-looking statements include, but are not limited to, statements about Cygnus' ability to manufacture and commercially scale up the GlucoWatch Biographer, Cygnus' plans for commercialization alliances, Cygnus' ability to achieve market acceptance of the GlucoWatch Biographer, and Cygnus' plans for enhancements and possible manufacturing changes through the regulatory process. In some cases, you can identify these statements by words such as "may," "will," "should," "estimates," "predicts," "potential," "continues," "strategy," "believes," "anticipates," "plans," "expects," "intends" and similar expressions. Cygnus cannot guarantee future results, levels of activity, performance or achievements. Actual results and the timing of certain events may differ significantly from the results discussed in the forward-looking statements. Cygnus refers you to the documents Cygnus files from time to time with the Securities and Exchange Commission, including Cygnus' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, which contain descriptions of certain factors that could cause Cygnus' actual results to differ from Cygnus' current expectations and any forward-looking statements contained in this news release.

NOTE: "GlucoWatch" is a registered trademark and "G2" is a trademark of Cygnus, Inc.


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