FDA Approves Apidra SoloSTAR

FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen

- Apidra SoloSTAR is a Convenient Insulin Delivery Device to Help Patients with Diabetes Improve Glycemic Control

BRIDGEWATER, N.J., February 26, 2009 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra, which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.

The approval of Apidra SoloSTAR follows the approval and launch of Lantus SoloSTAR (insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus and Apidra to help manage their blood sugar will now have two pen delivery devices to make administration of their insulins convenient. Basal-prandial insulin regimens that combine once-daily Lantus as a basal insulin analog with rapid-acting Apidra at mealtime can closely mimic normal physiologic insulin secretion.

"Patients with diabetes have to contend with the challenges of carbohydrate counting, regular blood sugar monitoring and careful administration of their insulin," said Angela Moskow, Vice President, Metabolism Marketing, sanofi-aventis, U.S. "Apidra SoloSTAR represents another innovation introduced by sanofi-aventis that offers patients a convenient option for administering their Apidra."

The Apidra SoloSTAR and Lantus SoloSTAR pens are the result of over four years of intensive development, and were designed in dialogue with patients, nurses and doctors to meet their needs and the high standards of the industry.

Apidra SoloSTAR and Lantus SoloSTAR are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very different types of insulins (rapid-acting vs. long-acting). The differentiation of the Apidra SoloSTAR and Lantus SoloSTAR was shown in a specific comparative study. Nevertheless, before using Apidra SoloSTAR or Lantus SoloSTAR, patients should carefully examine the labeling on the pen, to ensure they are using the correct one. Apidra SoloSTAR operates with a low injection force and two studies found that this delivery device required less injection force than the Novo Nordisk FlexPen and the Eli Lilly Humulin Humalog pen.

Apidra SoloSTAR is expected to be available in pharmacies this year.

www.Apidra.com

www.Lantus.com

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, approximately 40 percent of those diagnosed are not achieving the blood sugar control target of A1C <7 percent recommended by the ADA. The A1C test measures average blood glucose levels over the past two- to three-month period.

Apidra works fast and offers flexible insulin dosing to help manage mealtime blood sugar levels. It should be administered within 15 minutes before or within 20 minutes after the start of a meal. Along with exercise, a basal insulin, and a proper meal plan, Apidra is proven to help reduce A1C levels in adults and children (4 years and older) with type 1 diabetes and adults with type 2 diabetes. Apidra can be administered using an insulin pump, vial and syringe, the OptiClik reusable insulin delivery device, the Apidra SoloSTAR prefilled disposable insulin pen or intravenously under proper medical supervision in a clinical setting.

Apidra SoloSTAR is a prefilled, disposable insulin pen that is easy-to-use. Apidra SoloSTAR eliminates the need for the patient to change cartridges.

Apidra 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 can be kept at room temperature, as long as it remains below 77 degrees F [25 degrees C], away from direct heat and light, and can be used for up to 28 days.

Apidra is from the maker of Lantus, the number one prescribed insulin.*

Lantus is the only 24-hour insulin approved exclusively for use once a day. 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 is easy-to-use and requires a few straightforward steps to use it properly. Lantus SoloSTAR 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.

Prescription Apidra is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra should normally be used with a longer-acting insulin. Apidra may also be infused subcutaneously by external insulin infusion pumps. Do not use Apidra during a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine.

OptiClik is a reusable insulin delivery device for use with a 3-mL Apidra cartridge (U-100).

Apidra SoloSTAR is a prefilled disposable insulin pen.

Tell your doctor about all other medicines and supplements you are taking. Glucose monitoring is recommended for all patients with diabetes.

Possible side effects may include low blood sugar; injection site reactions, such as changes in fat tissue at the injection site; and allergic reactions, such as itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to insulin, including anaphylactic reactions.

If the pump or infusion set does not work right, you may not receive the right amount of insulin. Hypoglycemia, hyperglycemia, or ketosis can happen. Problems should be identified and corrected as quickly as possible.

www.Apidra.com

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.

OptiClik is a reusable insulin delivery device for use with a 3-mL Lantus cartridge (U-100).

Lantus SoloSTAR is a prefilled disposable insulin pen.

The syringe must not contain any other medication or residue. You should not use Lantus if you are allergic to insulin. Lantus is long-acting insulin you inject just once a day, at the same time each day. You must test your blood sugar levels while using insulin such as Lantus.

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.

www.Lantus.com

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 .

(C) 2009 sanofi-aventis U.S. LLC

* Based on TRx data from IMS Health, National Prescription AuditTM (Next Generation Prescription Methodology). Time period: May 2003 to September 2008.

CONTACT: U.S. - Carrie Melia, sanofi-aventis,, +1-908-981-6486 Carrie.melia@sanofi-aventis.com

Web site: http://www.sanofi-aventis.com/http://www.sanofi-aventis.us/

Ticker Symbol: (NYSE:SNY),(NYSE:SNY)

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Posted: February 2009

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Apidra (insulin glulisine) FDA Approval History

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