Merck Aims to Be First to the Finish Line With Generic of Lantus

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U.S. pharmaceutical company Merck & Co. Inc. (NYSE:MRK) announced Monday that it’s partnering with Samsung Bioepis to create a generic version of Sanofi SA’s (NYSE:SNY) best-selling insulin drug, Lantus, according to a Reuters report.

The agreement between Merck and Samsung Bioepis threatens to annihilate Sanofi’s January victory against Eli Lilly & Co. (NYSE:LLY) in a patent infringement suit over the diabetes medicine. Eli Lilly was dealt a 30-day Food and Drug Administration delay that paved the way for Sanofi’s own generic version, the promising U300. As a result of the lawsuit, it’s unlikely the Eli Lilly-made generic of Lantus will appear before 2016, but if Merck’s version of the drug, known as MRK-1293, sneaks through the approval process ahead of Lantus’ patent expiry date, then it has the potential to pose a very real threat to Sanofi’s market share, per FierceBiotech.

“The relevance of today’s announcement to Sanofi is the potential for greater price erosion and market share loss from two ‘generic’ Lantus,” analysts at Bernstein said in a research note, per Reuters. “We currently model the ‘generic’ erosion of Lantus in our Sanofi model in the mid-2016 timeframe. This erosion could accelerate more quickly now that a second player is likely to enter in the 2016 timeframe.”

Currently, the drug makes the French pharmaceutical company approximately $7 billion per year, and sales rose 20 percent in 2013. Lantus is a long-acting human insulin analog that improves patients’ glycemic control in adults and children with type 1 diabetes as well as adults with type 2 diabetes, according to Sanofi’s website for the drug. The French drugmaker’s patent on the drug doesn’t expire until 2015.

It’s still unclear whether Sanofi and its legal team will move to sue Merck over its generic version.

The collaboration between Merck and Samsung Bioepis builds upon an earlier agreement made a year previous to develop and commercialize biosimilar candidates. The terms of the collaboration agreement between Merck and Samsung Bioepis states the companies will collaborate on clinical development and manufacturing of the drug, but Merck will commercialize it, given that the treatment is approved.

Merck’s collaboration with Samsung Bioepis is indicative of the company’s desire to focus on diabetes as an area of growth, along with plans for biosimilar drugs for Crohn’s disease and rheumatoid arthritis. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of disease” said Matt Strasburger, senior vice president of Diabetes and Global Health at Merck, according to a recent press release.

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