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Sanofi, Eli Lilly Agree to Settle Lantus Patent Litigation

SanofiSNY came up with two important announcements related to its diabetes drugs, Lantus and lixisenatide (EU trade name: Lyxumia).

Lantus Biosimilar Could Hit U.S. Markets by 2016 End

Sanofi announced a settlement agreement with Eli Lilly and Company LLY to resolve the patent litigation related to its best-selling diabetes product, Lantus SoloSTAR (insulin glargine). Shares of Sanofi and Eli Lilly were down 1.7% and 5.1%, respectively.

Sanofi has granted Eli Lilly a royalty-bearing license under which the latter can manufacture and sell Basaglar (the biosimilar version of Lantus) in the Kwikpen device globally. On the other hand, Eli Lilly has agreed not to sell Basaglar in the U.S. before Dec 15, 2016. The settlement, however, does not cover Lantus sold in vials, Toujeo or any combination product.

While the remaining terms of settlement were kept confidential, both companies decided to end the patent infringement lawsuit and related disputes across the world.

We remind investors that Eli Lilly and its partner Boehringer Ingelheim had gained tentative approval for Basaglar last August, pending the outcome of the patent litigation. Due to the ongoing patent litigation, the FDA could not grant final approval until the end of the 30-month stay period in mid-2016 or a favorable court ruling, whichever occurred first.

Eli Lilly said that with the companies entering into a settlement agreement, it now plans to request for final FDA approval for Basaglar with launch expected on Dec 15, 2016.

The news comes as a relief for Sanofi since it has put off the biosimilar threat to Lantus till the end of 2016. Lantus SoloSTAR, a pre-filled injectable pen version of Lantus, accounted for 61.7% of Lantus' U.S. sales in 2014. However, we note that Lantus is already facing biosimilar competition from Eli Lilly in the UK and some eastern EU countries.

Type II Diabetes Drug Lyxumia under FDA Review

In a separate press release, Sanofi announced that its new drug application (NDA) for Lyxumia has been accepted for review by the FDA. Lyxumia, an investigational once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist, is being developed for the treatment of adults with type II diabetes.

Sanofi informed that the NDA filing includes results from the ELIXA study, which is the first completed long-term cardiovascular outcomes study for a GLP-1 receptor agonist. We remind investors that Sanofi had in-licensed the drug from Zealand Pharma.

Given that Sanofi is currently looking to make up for the loss of revenues in the diabetes segment with the launch of new products like Toujeo and Afrezza, Lyxumia's approval would be a huge boost for the company.

Sanofi is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. REGN and Medivation, Inc. MDVN , each carrying a Zacks Rank #1 (Strong Buy).

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REGENERON PHARM (REGN): Free Stock Analysis Report

SANOFI-AVENTIS (SNY): Free Stock Analysis Report

LILLY ELI & CO (LLY): Free Stock Analysis Report

MEDIVATION INC (MDVN): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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