Sanofi, the French pharmaceutical giant which manufactures the long-acting insulin Lantus, announced Monday that it would no longer be investing in research for new drugs to treat diabetes. The manufacturer also told investors it would no longer be investigating new treatments for cardiovascular health.
“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” chief executive officer Paul Hudson told reporters on a conference call, reported Marketwatch. “As tough a choice as that is, we’re making that choice.”
Hudson, who moved to Sanofi from Novartis just a few months ago in September, announced the move as part of a strategic effort narrow Sanofi’s focus onto a smaller range of more profitable activities, such as manufacturing drugs to treat rare diseases and various forms of cancer.
The news boosted flagging Sanofi share prices, which were up 6% by midday.
Lantus remains a key element of the US insulin market, but faces competition
Lantus is the trade name for insulin glargine, created by the pharma manufacturer Aventis in Germany, which Sanofi acquired in 2004. It was approved for the U.S. market in 2000, and it remains Sanofi’s highest-selling product by volume, prescribed 239 million times to 1.7 million patients in the U.S. alone. In fact, Lantus is actually the largest pharmaceutical export from Germany as a whole. In 2018, the firm reported in its 2018 earnings, Lantus brought in €3.565 billion ($3.952 billion) in total revenue, down 19% from the previous year.
However, the patent for Lantus expired in most international markets in 2015, opening a pathway for competition from other manufacturers, most notably Eli Lilly, which quickly brought Basaglar and Abasaglar to the field.
The introduction of these biosimilars and the increased competition has had positive effects for people with diabetes, according to research published in JAMA. The study, published in March, proved that the introduction of Basaglar measurably reduced reimbursement rates and overall resulted in savings of more than $70 million for Medicaid. Lantus is so critical that in 2016, it was second in overall expenditure for Medicare and Medicaid.
Sanofi faced another setback in the diabetes market in November, when a federal appeals court concurred with a ruling from the U.S. Patent and Trademark Office that two of Sanofi’s patents on Lantus were invalid. The case was brought as a patent infringement lawsuit in 2017 from Sanofi, as it maneuvered to block Mylan, another of its global competitors, from bringing a generic version of Lantus to market.
Under the current state of patent law, makers of new drugs are provided 20 years of exclusivity for their inventions, which typically does include some of the time it takes to develop and market the products. In the case of Lantus, this patent expired in 2015, but the firm has filed 70 secondary patent applications over the last two decades, extending its monopoly protection by several decades.
This story will be updated as more news emerges.