Sanofi sets up cholesterol drug showdown with Amgen
Sanofi and Amgen have posted results for their new injectable cholesterol drugs within 24 hours of each other.
Both drugs are looking to block the protein PCSK9 that increases LDL cholesterol, and the race is now on between the firms to develop the new medicines.
Analysts expects the new class of drugs, including those in earlier stages of development at Merck and Bristol-Myers Squibb, to generate annual future sales of up to $20 billion.
Amgen’s drug is currently in Phase Ib whilst Sanofi and Regeneron’s drug has just completed Phase II.
Sanofi and partner Regeneron said they expected to start Phase III in the second quarter of this year.
But whilst behind in the development race, Amgen may have an edge with AMG 145 as it can be injected just once a month, whilst Sanofi’s SAR236553 is administered every fortnight.
Both drugs are injectable fully human antibodies that target the PCSK9 proprotein, a known factor that increases the level of LDL (or bad cholesterol).
The blocking of the PCSK9 pathway is a potentially novel mechanism for lowering LDL-cholesterol, and all the firms involved will be banking on its future success.
Headline results from Sanofi’s Phase II trial showed that SAR236553, injected twice a month, showed a significant drop in LDL by as much as 73% in patients who were also taking Lipitor.
Meanwhile, once-monthly injections of Amgen’s drug cut levels of cholesterol by up to an additional 66% in patients already taking statins in its study.
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