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Categories: Lantus Apidra ClikSTAR SoloSTAR Insulin Diabetes Drugs

ClikSTAR® A New Reusable Insulin Pen for Use with Lantus® and Apidra® Approved in EU and Canada

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).

About ClikSTAR®
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.

About SoloSTAR®
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.

About Lantus®
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® .

About Apidra®
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.

About Diabetes
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.

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 (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Contact: Anna Radjanova, Tel: +33 (0)6 07 28 61 63, E-mail: anna.radjanova@sanofi-aventis.com

Source: Sanofi-aventis

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