FDA Approves Sanofi's New Diabetes Drug

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Feb 27, 2015

Sanofi S.A. (SNY, Financial) is a multinational pharmaceutical company headquartered in Paris, France. It is one of the world’s largest pharma companies in terms of prescription sales.

In 1973, the company began as subsidiary of a French oil company, Elf Aquitaine, when Elf Aquitaine took control of the Labaz group, a pharmaceutical company. In 1994, Sanofi was incorporated as a société anonyme, a kind of limited liability company, under the laws of France.

Sanofi is involved in the research and development, manufacturing and marketing of pharmaceutical drugs chiefly in the prescription market, along with the manufacture of over-the-counter medication. The company focuses on 7 primary therapeutic areas: diabetes, cardiovascular, internal medicine, central nervous system, oncology, thrombosis and vaccines.

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Source: By Sanofi de via Wikimedia Commons

Sanofi is the world's largest producer of vaccines through its subsidiary Sanofi Pasteur.

Sanofi’s diabetes successor to Lantus gains U. S. approval

Sanofi won U.S. regulatory approval for its new diabetes treatment Toujeo, which is a more potent successor to the Lantus insulin product, the drug maker’s top-selling product, which loses patent protection in 2015.

With sales of $7.2 billion in 2014, Lantus is the world's most prescribed insulin.

The U.S. Food and Drug Administration approved Toujeo, a long-acting form of insulin to help control blood sugar, for treating Type 1 and Type 2 diabetes. The company said that the treatment is expected to be available in April.

According to studies, patients using Toujeo have fewer drops in blood sugar while asleep than those using Lantus, an advantage that Sanofi is relying on to encourage patients and doctors to change to the new drug. Toujeo is instilled with insulin glargine, the same active ingredient that is present in Lantus, but at three times the concentration and with a technique of gradually releasing the insulin.

Sanofi has not disclosed pricing for Toujeo and has refused to divulge any possible discounting strategy in the market, which is seen as becoming more and more price responsive.

Will Toujeo be able to repeat Lantus’ success story?

The approval by the FDA is seen as a major step for Sanofi since analysts predict that Toujeo will garner $1 billion in sales by 2018. According to the company, Toujeo is a better drug for both physician recommendation and patient use.

Since Lantus would be losing patent protection and will lose exclusive rights in Europe in May, it was critical for Sanofi to get Toujeo in the market as soon as possible.

There is fierce competition among the diabetes companies, as there is constant development to create better and more innovative ways to treat a disease. Competitors are quick to produce drug programs that are remarkably similar to the winning class. That leaves the big pharmaceutical companies like Sanofi in a difficult state to develop innovative in-house successes, with pressure building on R&D to perform.

Sanofi has filed a lawsuit against Eli Lilly & Co. (LLY, Financial) in order to block a copycat competitor from coming to market, which Lily was ready to launch in Europe as soon as May.

Toujeo is still awaiting European approval.

Our Take

There are about one million new patients for basal insulin each year, but there is a slight concern if the Toujeo label will offer enough conviction for a switch from the established Lantus, which was a market blockbuster. Only time and the effectiveness of the drug can tell how Toujeo fares in the drug market.