Sanofi/Genzyme And Isis Submit Kynamro For Lowering Cholesterol
This article was originally published in The Pink Sheet Daily
It’s been a long haul, but Sanofi’s Genzyme business unit and Isis have submitted their NDA for a drug that helps lower cholesterol levels in high-risk patients with a rare genetic cardiovascular disease that doesn’t respond well to statins.
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Aegerion submitted the lomitapide NDA Feb. 29 with 54-week data from a single-arm, open-label trial, hoping for priority review based on the lack of effective treatments for homozygous familial hypercholesterolemia. Meanwhile, Isis/Sanofi submitted their competing candidate mipomersen March 29 with two-year extension-study data.
The focus at Isis turns to the near-term prospects of an approval for the cholesterol drug Kynamro and to business development.
The two companies build on an existing partnership in spinal muscular atrophy to address another muscle-wasting disease. For the second time, they’ve arranged an option deal, with milestones built in both before and after licensing.