Important ISIS Pharma Data Coming at AHA Meeting – November 16-20, 2013 Print
By Brian Wilson - Lead Contributor   
Friday, 15 November 2013 10:16
A number of pharmaceutical companies developing products for cardiovascular indications will be presenting clinical trial data at the upcoming American Heart Association (AHA) Scientific Sessions 2013 convention in Dallas, Texas at the Dallas Convention Center. This meeting will take place between Saturday, November 16th and Wednesday, November 20th.

Most of the releases will come from big pharma or foreign pharma developers, although ISIS Pharmaceuticals (NASDAQ: ISIS) is small enough such that the event should have a material effect on share price. ISIS-ApoCIII, one of their most important drug candidates, is a drug based on the company’s antisense platform. The inhibition target is a protein called apoC-III, which plays a central role in the regulation of triglycerides in the bloodstream. The protein has a direct correlation with high triglycereides, inflammation, and undesirable side effects which lead to increased cardiovascular risk.

The compound is being developed for hypertriglyceridemia, which should not too difficult to breach given that triglycerides (a straightforward biomarker) can be reduced with statistical significance. Investors may be concerned that the link between the hypertriglyceridemia and cardiovascular risk indication is very shaky after the FDA’s response to Amarin’s recent sNDA for Vascepa, although its worth noting that ISIS is targeting a very different patient population.

ISIS’ ApoCIII inhibitor is designed for patients with familial chylomicronemia (FCS) – a genetic condition and orphan disease that causes patients to have triglyceride levels >2,000 mg/dL. Only a few hundred people in the United States would have the condition, based on incidence rates. However, these patients currently have no effective options available. The indication will also target patients with TG >880 mg/dL . Note that these triglyceride concentrations are exceptionally high, which allows ISIS more leeway in terms of its risk/reward profile.

Another very important factor is pricing power, which may allow this ApoCIII inhibitor to sell for Kynamro-level price or higher. As is the case with many orphan drugs, it may eventually be possible for ISIS to sell the drug at roughly $200,000 per patient per year after FDA approval. Because of this huge commercial potential, the upcoming phase II data will be a big deal.

Other news for ISIS

Earlier today, ISIS Pharma also announced a $5 M milestone payment from GlaxoSmithKline for the creation of ISIS-GSK4Rx – a drug candidate that is being developed for a “mystery” ophthalmologic indication. While Glaxo has the right to exclusively license the compound in Phase II development, it was also agreed that ISIS Pharma would be entitled to a double-digit royalty rate on all sales of the drug.

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