Isis sees Kynamro delay; adds new drugs to pipeline

California, USA-based Isis Pharmaceuticals (Nasdaq: ISIS) announced yesterday that there will be a slight delay in the submission of the New Drug Application to the US Food and Drug Administration for Kynamro (mipomersen sodium), a first-in-class apo-B synthesis inhibitor currently in late-stage development for the reduction of low-density lipoprotein cholesterol, which is partnered with Genzyme, now part of France’s Sanofi (Euronext: SAN).

This additional time will allow Genzyme to complete preparation of additional technical documentation. The submission of the US NDA seeking approval of Kynamro for the treatment of homozygous familial hypercholesterolemia is now planned for the first quarter of 2012. In July of this year, Genzyme and Isis submitted a marketing authorization application to the European Medicines Agency seeking approval for Kynamro for the treatment of patients with homozygous and severe heterozygous.

A day earlier, Isis said it has added three new drugs to its development pipeline, ISIS-APOARx, ISIS-DGAT2Rx and ISIS-FVIIRx, which have potential in the treatment of various cardiovascular and liver conditions.