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Eli Lilly/Boehringer's Diabetes Drug Under FDA Review

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Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of a candidate once it is successfully developed and commercialized.

Earlier this week, Eli Lilly and Company (LLY) and partner Boehringer Ingelheim’s new drug application (:NDA) for a fixed-dose combination of their sodium glucose co-transporter-2 (SGLT2) inhibitor, Jardiance (empagliflozin) and metformin was accepted for review by the FDA.

The companies are looking to get the Jardiance/metformin fixed-dose combination approved for the treatment of type II diabetes in adult patients.

We remind investors that Jardiance was approved by the FDA in Aug 2014 as an adjunct to diet and exercise for improving glycemic control in adults suffering from type II diabetes. It is also approved in the EU.

According to information issued by Eli Lilly, an estimated 382 million people across the world suffer from type II diabetes accounting for about 90% to 95% of all adult diabetes cases in the U.S. alone.

We are encouraged by Eli Lilly’s progress with its diabetes pipeline. Eli Lilly needs to develop new products to make up for the loss of revenues from genericization of drugs like Cymbalta and Evista among others.

Last month, Eli Lilly gained tentative FDA approval for Basaglar (insulin glargine injection) for improving glycemic control in adults with type II diabetes and in combination with mealtime insulin in adults and pediatric patients with type I diabetes. Basaglar is another diabetes drug developed under the Eli Lilly-Boehringer collaboration.

However, we note that the diabetes market is highly crowded given the presence of companies like Novo Nordisk (NVO), Merck (MRK) and Sanofi (SNY).

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