Healthcare Industry News:  metabolic disease 

Biopharmaceuticals Endocrinology Drug Delivery

 News Release - July 30, 2007

SoloSTAR(R), the First Prefilled Disposable Insulin Pen for Lantus(R), is Now Available in the United States

SoloSTAR(R) provides diabetes patients with an easy-to-use option for taking Lantus(R) (insulin glargine [rDNA origin] injection), the number one prescribed insulin

BRIDGEWATER, N.J., July 30 (HSMN NewsFeed) -- Sanofi-aventis announced today that Lantus® SoloSTAR®, a new, disposable insulin pen is now available. The SoloSTAR® pen offers people with diabetes a more convenient option for taking their insulin than through traditional methods. The SoloSTAR® pen is prefilled with Lantus® (insulin glargine [rDNA origin] injection), the only 24-hour insulin approved exclusively for use once a day, for the treatment of hyperglycemia in people with type 1 or type 2 diabetes.

SoloSTAR® is the only prefilled disposable insulin pen that allows patients to administer doses from 1 up to 80 units, in one injection. SoloSTAR® offers a 25% greater maximum capacity than other insulin pens.

"Lantus® has been proven to help lower blood sugar levels and can help patients reach their goals," said Stephen N. Davis M.D., FRCP, Mark Collie Professor of Medicine, Molecular Physiology and Biophysics, Chief of Diabetes, Endocrinology and Metabolism, Vanderbilt University, "Now, with the addition of the Lantus® SoloSTAR® pen, patients will find that the new pen is easy to use and will make Lantus® delivery even more convenient."

SoloSTAR® operates with a lower injection force and a recent study found that SoloSTAR® required 31% less injection force than the Novo Nordisk FlexPen and 54% less force than the Eli Lilly Humulin/Humalog pen. Similar results have been observed in a second study.

"Insulin pens are underutilized in the United States as compared to other countries, even though they may offer more convenience and flexibility for people with diabetes," said Angela Moskow, associate vice president, Diabetes Marketing, sanofi-aventis. "Lantus® SoloSTAR® demonstrates sanofi-aventis' commitment to designing devices based on insights from people with diabetes, to help meet their lifestyle demands. We are excited to offer this new device."

Lantus® SoloSTAR® is also available in Australia. Previously, Lantus® SoloSTAR® was introduced in France and Germany in 2007, and is expected to be introduced in other countries in the near future.

About Diabetes

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin - the hormone needed to convert glucose (sugar) into 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 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 percent recommended by the American Diabetes Association (ADA). The A1C test measures average blood glucose levels over a two- to three-month period.

The Importance of Insulin

In 2006, a team of leading diabetes experts from the ADA and the European Association for the Study of Diabetes (EASD) created a "consensus algorithm" to help guide treatment decisions for type 2 diabetes. For patients who are unable to achieve the ADA's recommended blood sugar control target (A1C<7%) with diet, exercise and the oral medication metformin alone, the consensus algorithm recommends, as one approach, considering insulin as a second-line option.

The consensus algorithm notes that insulin is an effective treatment for lowering blood sugar levels, 8 but by the time many patients with type 2 diabetes begin treatment with insulin, they usually have had diabetes for more than 10 to 15 years.

As part of an overall diabetes treatment plan that includes diet, exercise and oral medications, insulin is proven to help reduce A1C levels. Keeping blood sugar under control may help reduce the risk of developing diabetes- related complications over time.

About Lantus® and Lantus SoloSTAR®

Lantus® is the only 24-hour insulin approved exclusively for use once a day. Most insulins have a "peak of action," which refers to the time at which insulin reaches its maximum effect in the body. With Lantus®, the insulin is released into the bloodstream at a relatively constant rate throughout the day and night; therefore it has no pronounced peak.

Lantus® SoloSTAR® uses a simple, intuitive design with easy-to-read display features and requires only a few steps to use it properly. SoloSTAR® is small, discreet and eliminates the need for the patient to change cartridges.

Lantus® SoloSTAR® should be kept in cool storage (36 degrees F - 46 degrees F [2 degrees C - 8 degrees C]) until first use. Once in use, it should be kept at room temperature, as long as it remains below 86 degrees F [30 degrees C], away from direct heat or light, and can be used for up to 28 days.

OptiClik®, a reusable insulin pen option for use with Lantus® 3-mL cartridges, is also available in the United States.

Important Safety Information for Lantus®

Prescription Lantus® is for adults with type 2 diabetes or adults and children (6 years and older) with type 1 diabetes who require long-acting insulin for the control of high blood sugar. Lantus® SoloStar® is a disposable insulin delivery device (insulin pen). Needles and the SoloStar® pen must not be shared.

DO NOT DILUTE OR MIX LANTUS® WITH ANY OTHER INSULIN OR SOLUTION. It will not work as intended, and you may lose blood sugar control, which could be serious. Do not change your insulin without talking with your doctor. The syringe must not contain any other medication or residue. You should not use Lantus® if you are allergic to insulin. Lantus® is a long-acting insulin you inject just once a day, at the same time each day. You must test your blood sugar levels while using an insulin such as Lantus®.

The most common side effect of insulin, including Lantus®, is hypoglycemia, which may be serious. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works.

Please visit http://www.Lantus.com for full prescribing information.

About Sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. 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 financial 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 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, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.


Source: sanofi-aventis

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