Sanofi-Aventis (France)’ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award

PARIS, February 14 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the Chicago Athenaeum Museum of Architecture and Design has awarded a 2007 GOOD DESIGN(TM) Award for the new SoloSTAR(R) disposable insulin injection pen for people with type 1 and type 2 diabetes.

“LANTUS(R) SoloSTAR(R) and APIDRA(R) SoloSTAR(R), the results of over four years of intensive development, have been designed in dialogue with patients, nurses and doctors and meet the high standards of the industry,” said Paul Jansen, Global Head Medical Devices, sanofi-aventis.

“We are proud to receive this prestigious GOOD DESIGN Award for SoloSTAR(R) as a recognition of our strong commitment to people with diabetes”, Gilles Lhernould, Senior Vice President Industrial Affairs sanofi-aventis added.

For some people with diabetes, self-injection can be a barrier to acceptance of insulin therapy. “SoloSTAR(R) is a marriage of sleek, handsome design styling with easy, but advanced sophisticated technology for dispensing insulin to people with diabetes,” says Christian K. Narkiewicz-Laine, President Chicago Athenaeum Museum of Architecture and Design. “SoloSTAR(R) represents a design for social good and for humanitarian concerns”.

When choosing a specific insulin pen for an individual patient, clinicians consider the patient’s insulin regimen, lifestyle, and other factors that may affect the ability to use a particular device, such as manual dexterity and visual acuity. Therefore certain characteristics of a given insulin pen may make it preferable for patients. The outstanding design of SoloSTAR(R) using breakthrough technology contributes to making this patients’ and clinicians’ choice easier.

SoloSTAR(R) provides a delivery option that may be more acceptable and more convenient to use in comparison with other delivery systems, thus may promote patient compliance, which could help achieve and maintain glycemic control.

A recent survey of LANTUS(R) SoloSTAR(R) use in everyday clinical practice, involving more than 2000 people with diabetes (16% with manual dexterity problems and 15% with poor eyesight not corrected by glasses) showed that more than 95% of participants declared to be “satisfied” or “very satisfied” with using SoloSTAR(R) to inject insulin, irrespective of diabetes type or previous device experience.

Healthcare professionals involved in teaching the people in this survey how to use LANTUS(R) SoloSTAR(R) found SoloSTAR(R) to be easy learn and easy to use for people with diabetes.

SoloSTAR(R) also operates with a lower injection force and a recent study found that SoloSTAR(R) required 31% less injection force than the Novo Nordisk FlexPen(R) and 54% less force than the Eli Lilly Humulin/Humalog pen.

“Insulin injection with SoloSTAR(R) brings flexibility, satisfaction for the patients, and an opportunity for earlier initiation of insulin therapy which may contribute to better long term glycaemic control”, Denis Raccah, Professor of Endocrinology, University Hospital Sainte Marguerite, France, added.

About SoloSTAR(R)

SoloSTAR(R) is a new, easy-to-use disposable pen for administration of LANTUS(R) and APIDRA(R). SoloSTAR(R), allows to administer doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR offers a 25% greater maximum capacity than other insulin pens. Consequently, the administration until 80 units of insulin can be done with only one injection.

SoloSTAR uses a simple, intuitive design with easy-to-read display featured and requires only a few steps to use it properly. SoloSTAR(R) is small, discreet and eliminates the need for the patient to change insulin cartridges. Easy-to-use and easy-to-inject, SoloSTAR(R) reduces the injection force by 30% or more in comparison to other most broadly available pens in its class.

Lantus(R) SoloSTAR(R) and APIDRA(R) SoloSTAR(R) were approved by the EMEA in September 2006; LANTUS(R) SoloSTAR(R) was approved by the FDA in April 2007. LANTUS(R) SoloSTAR(R) and APIDRA(R) SoloSTAR(R) are launched in France, UK, Italy, Spain, Germany, Netherlands, Slovakia, Slovenia, Sweden, Norway, Austria, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Australia, Lithuania, Lebanon, and South Africa. LANTUS(R) SoloSTAR(R) is launched in the US, Canada and Switzerland. The preparation for launches in other countries is planned during 2008.

The elegant exterior design of Lantus(R) and Apidra(R) SoloSTAR(R) and its ease of use due to advanced technology is the result of the collaboration with DCA Design International Ltd. in Great Britain DCA Company.

About sanofi-aventis’ pen portfolio

Sanofi-aventis having 85 years of innovation in the diabetes is committed to offering people with diabetes an integrated system of insulin products and delivery devices. In addition to the SoloSTAR(R), the pen portfolio available for LANTUS(R) and APIDRA(R) includes the OptiSet(R) disposable pen, the OptiClik(R) and OptiPen(R) Pro reusable pens, and the Autopen(R) 24 from Owen Mumford.

About LANTUS(R) (insulin glargine [rDNA origin])

LANTUS(R) is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients (6 years of age and older) with type 1 diabetes mellitus. LANTUS(R) demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.

About APIDRA(R) (insulin glulisine [rDNA origin])

APIDRA(R) is a rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adult patients with type 1 and type 2 diabetes. APIDRA(R) offers patients mealtime dosing flexibility-it can be taken 15 minutes before or within 20 minutes after starting a meal. APIDRA(R) is also flexible for use in patients with a variety of body types, from lean to obese.

About Diabetes

Diabetes is a chronic, evaluative widespread disease in which the body reduces or does not produce or properly use insulin - the hormone needed to convert glucose (sugar) into energy. More than 240 million people worldwide are living with the disease. It is estimated that near 250 million people worldwide have diabetes, the number is expected to reach some 380 million within 20 years. It is estimated more than 20 million Americans have diabetes, including an estimated 6.2 million who remain undiagnosed. At the same time, approximately half of those diagnosed are not achieving the general blood sugar control standard of A1C <7% recommended by the American Diabetes Association and the European Association for the Study of Diabetes (ADA/EASD). The A1C test reflects average blood glucose levels over a two- to three-month period.

Without proper insulin production and action, glucose remains in the blood, leading to chronic hyperglycaemia (raised blood sugar). This can result in short and long-term complications, many of which, if not prevented and left untreated, can be fatal. All have the potential to reduce the quality of life of people with diabetes and their families.

The most common long-term complications are:

- Diabetic nephropathy (kidney disease), which may result in total kidney failure and in the need for dialysis or kidney transplant.

- Diabetic eye disease (retinopathy and macular oedema), damage to the retina of the eye which can lead to vision loss.

- Diabetic neuropathy (nerve disease), which can ultimately lead to ulceration and amputation of the feet and lower limbs.

- Cardiovascular disease, which affects the heart and blood vessels and may cause fatal

- complications such as coronary heart disease (leading to a heart attack) and stroke.

Diabetes is the fourth leading cause of death by disease globally. Every year, 3.8 million people die from diabetes-related causes.

About GOOD DESIGN

The Museum’s historic GOOD DESIGN program was founded in Chicago in 1950 by Edgar J.Kaufmann, Jr. with the participation of some of America’s most important designers. Every year the jury meets in New York and select products and graphics worthy of the GOOD DESIGN Award for design distinction. GOOD DESIGN remains the oldest and most important Awards program worldwide.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York .

References:

For easy to inject

Owens DR. Comparison of insulin pen devices reveals lower injection force of Solostar(R) compared with novo Flexpen(R) and lilly(R) disposable pen; Diabetes Technology Meeting 25-17 October 2007, San Francisco, CA, USA. Journal of Diabetes Science and Technology, March 2008; Abstract OWEN70184; In press.

Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin. Drug Deliv. (2007) 4(2):165-174.

For easy to use and patient’s satisfaction

Carter J et al. Usability, participant acceptance and safety of SoloStar in an observational survey in everyday clinical practice; Diabetes Technology Meeting 25-17 October 2007, San Francisco, CA, USA. Journal of Diabetes Science and Technology, March 2008; Abstract CART70119; In press.

CONTACT: Contact: Anna Radjanova, MD, Tel: +33-6-07-28-61-63, E-mail:
anna.radjanova@sanofi-aventis.com

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