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Sanofi's Update on Lyxumia

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Pipeline updates are highly-awaited events in the pharma/biotech sector as they play an important role in deciding whether to invest in a particular company or not. These updates provide information on experimental drugs and sometimes give an insight on the commercial potential of the candidate once it is successfully developed and commercialized.

Several companies submit abstracts on their drugs at scientific meetings where the data can be showcased.  

The World Diabetes Congress 2013, held in Australia, has provided companies like Sanofi (SNY) to present data on their diabetes portfolio. Last week, Sanofi shared data on Lyxumia (lixisenatide) from a 24-week phase III study (n = 451).

The study evaluated the use of Lyxumia either before breakfast or the main meal of the day in patients suffering from type II diabetes, who have not derived sufficient benefit from metformin.

It was found that at either time of administration, Lyxumia was effective in lowering blood sugar levels. Comparable mean HbA1c reduction, an indicator of glucose level in the blood, was observed in both arms of the study - before breakfast (0.74%) and the main meal (0.65%). Additionally, mean change in body weight was also similar, in the main meal group (2.6 kg) and in the breakfast group (2.8 kg). Flexibility in timing of administration of the drug will be convenient for patients.

Lyxumia is currently available in several countries in Europe (including the UK, Germany, Spain), Japan and Mexico for use in combination with oral glucose-lowering medicines and/or basal insulin when these, in combination with lifestyle management, do not provide adequate glycemic control. In the third quarter of 2013, the drug generated sales of approximately €3 million.

However, Lyxumia is yet to be approved in the U.S. where Sanofi withdrew its new drug application for the drug in Sep 2013. Sanofi intends to resubmit the NDA in 2015, following the completion of the ELIXA cardiovascular (:CV) outcomes study.

Sanofi had in-licensed Lyxumia from Zealand Pharma.

Although Sanofi holds a strong position in the diabetes market, we note that the market is highly crowded with players like Novo Nordisk (NVO) and Eli Lilly and Co. (LLY).

Sanofi carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Bayer (BAYRY). The stock carries a Zacks Rank #2 (Buy).

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