Sanofi to End R&D on Diabetes, Cardiovascular Drugs

Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.

The announcement was made Monday by Paul Hudson, the company’s new chief executive officer, who said during a media call that “we as a company have probably done more than almost any other companies combined, to innovate and to transform lives in diabetes and cardiovascular. Now we need to be efficient and move our resources to areas of opportunity, unmet needs and to grow our pipeline.”

Lantus, the originator insulin glargine, is under pressure from follow-on competition, given the commercialization of Boehringer Ingelheim’s Basaglar, the first FDA-approved insulin glargine follow-on, which launched in 2016 after a lengthy patent litigation with Sanofi.

In addition, insulin as a whole has been in the center of a debate for more than a year about high drug prices. Lantus, along with Novolog and Humalog, have shown highly synchronized price increases, coinciding with some of the largest growth in drug costs. And patients have traveled to Capitol Hill to testify how the rising prices have forced them to skip doses or go without.

However, a company spokesman said Monday that Sanofi will retain a proposed biosimilar of insulin aspart (NovoLog) in its pipeline as a registration phase molecule. Data on SAR341402 was presented in 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions last June. While insulins are currently regulated as drugs and follow-ons in the US context, they will become regulated as biologics and biosimilars in March 2020.

The Wall Street Journal (WSJ) noted Monday that diabetes has been a key driver for Sanofi since 2004, when Aventis and Sanofi-Synthelabo merged. Aventis had launched Lantus 4 years prior. By 2004, it was already the most widely prescribed insulin in the country.

Lantus represents that largest share of Part D spending on insulin, according to an analysis by the Kaiser Family Foundation.

Sanofi is shifting to focus on immunotherapies in cancer treatment; the company will buy biotech Synthorx for $2.5 billion. Sanofi has fallen behind in the race to develop immunotherapies, according to the WSJ report.

In addition, it wants to focus on dupilumab (Dupixent), a drug for severe chronic rhinosinusitis with nasal polyposis, severe asthma, and moderate-to-severe atopic dermatitis. Sanofi thinks the drug could eventually generate $10 billion.