Isis Expands Pipeline - Analyst Blog

Isis Pharmaceuticals, Inc. (ISIS) is working on expanding its cardiovascular pipeline. The company recently announced that it has added a new drug, ISIS-APOCIIIRx, to its development pipeline. The candidate is being studied for the treatment of hypertriglyceridemia, or high levels of triglycerides (TG).
 
Hypertriglyceridemia is an independent risk factor for cardiovascular disease and is also a trait of metabolic syndrome, which occurs in a large percentage of people with type II diabetes.
 
ISIS-APOCIIIRx is the third new drug to be added to the company's pipeline recently. Over the past few months, the company has been working on expanding its pipeline. In early December 2009, the company added two new drugs to its pipeline - ISIS-FXIRx and ISIS-SMNRx.
 
While ISIS-FXIRx is designed to treat clotting disorders without increased risk of bleeding, ISIS-SMNRx is being developed to treat spinal muscular atrophy, a neuromuscular disorder and the leading genetic cause of infant mortality.
 
Meanwhile, Isis and partner Genzyme Corp. (GENZ) could be in a position to file for U.S. Food and Drug Administration (FDA) approval for Isis ’ lead pipeline candidate, mipomersen, a phase III drug that is being developed for the treatment of familial hypercholesterolemia (FH).
 
The company recently reported positive phase III results on mipomersen from a study that was conducted in patients with homozygous familial hypercholesterolemia (hoFH). Results from a second phase III study, in patients with heterozygous FH, are due in the first quarter of 2010.
 
The companies could be in a position to file a New Drug Application (NDA) in the second half of 2010.
 
We currently have a Neutral recommendation on Isis. While we are pleased to see that the company is working on expanding its pipeline, we note that it will be several years before these candidates are successfully developed and commercialized.
 
In the meantime, we remain concerned about the company's dependence on mipomersen for future growth. With all eyes focused on the successful development and commercialization of this candidate, any development or regulatory hurdle would be a major setback for the company. A delay in gaining approval would weigh heavily on the stock.
Read the full analyst report on "ISIS"
Read the full analyst report on "GENZ"
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