Lantus® ClikSTAR® and Apidra® ClikSTAR® launches scheduled to begin in October 2009 -
Paris, France – September 30, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that ClikSTAR®, a new reusable insulin pen, for administration of the 24-hour insulin analog Lantus® (insulin glargine [rDNA] injection) or/and the rapid acting insulin analog Apidra® (insulin glulisine [rDNA origin] injection), will be available in Europe and Canada in October 2009. ClikSTAR® recently received regulatory approval in EU and Canada.
ClikSTAR® was designed to provide the state-of-the-art performances of the SoloSTAR® pen, in a reusable form.
“Easy-to-use pens such as ClikSTAR® bring high degree of flexibility and comfort to patients and may offer an opportunity for earlier initiation of insulin therapy. This may contribute to better glycaemic control,” said Professor Alfred Penfornis, Head of the Endocrinology and Diabetology Service, Besançon, France.
“ClikSTAR® is the result of over four years of intensive development and testing of pens, designed in close collaboration with patients and conceived to fulfill patients’ needs,” explained Jean-Philippe Santoni, Senior Vice President, Industrial Development and Innovation, sanofi-aventis. “The ClikSTAR® delivery system is precise, easy to use and reliable, addressing both patients' expectations and medical needs”.
Sanofi-aventis, the developer, manufacturer and marketer of ClikSTAR®, is currently building a significant manufacturing capability to support the worldwide launch.
ClikSTAR® will be launched in Canada, Greece, the Netherlands, and Switzerland, in October 2009.
With the introduction of ClikSTAR® in addition to SoloSTAR®, sanofi-aventis offers now a full range of devices to simplify usage of insulin for patients, by better addressing their different needs and lifestyles.
ClikSTAR® is currently being reviewed by the U.S. Food and Drug Administration (FDA).
ClikSTAR® is the new easy to use reusable pen for administration of Lantus® and Apidra® and all other sanofi-aventis insulins. ClikSTAR® has been designed with the help of nearly 2,000 patients and 500 healthcare professionals and comes in two colours. Its usage is easy to learn for patients of all ages with an easy cartridge changing and a low injection force.
ClikSTAR® allows to administer doses from 1 up to 80 units, in one injection, in one unit increments, with the possibility to dial back at any time.
The results of a study comparing ClikSTAR® to other pens will be presented during the 2009 Wold Diabetes Congress in Montreal.
SoloSTAR® is an easy-to-use disposable pen for administration of Lantus® and Apidra®. SoloSTAR® allows to administer doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR® offers a 33% greater maximum capacity than other disposable insulin pens, up to 80 units of insulin in one injection.
Lantus® 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 and older) with type 1 diabetes mellitus. Lantus® demonstrates a peakless and sustained concentration/time profile over 24h thus reducing the risk of hypoglycemia and allowing a constant and high efficacy over 24h with one single daily injection. Lantus® is the number one prescribed insulin worldwide. Once prandial insulin is required, Apidra® is the logical partner to Lantus® .
Apidra® is rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adults, adolescents and children with diabetes. Apidra® offers patients mealtime dosing flexibility - it can be taken shortly (0-15 min) before or soon after the meal.
Apidra® is also flexible for use in a wide range of patients from lean to obese.
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, about 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c <7 percent recommended by the ADA. The HbA1c test measures average blood glucose levels over the past two- to three-month period.
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 (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
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