Clinical Profile concerns spur a big sell-off : ISIS shares down 14.6% to $9.40 on volume of 10.6M shares

The Mipomersen Phase 3 study in patients with Heterozygous Familial Hypochesterolemia, a genetic disorder, met its primary endpoint but investors were worried about potential side effects such as liver enzyme elevations. The trial goal was met as Mipomersen met its primary endpoint with a highly statistically significant 28% reduction in LDL-cholesterol after 26 weeks of treatment compared to a 5% reduction with the placebo. Isis’ partner Genzyme intends to seek approval in the U.S. and Europe in the first half of 2011.

Mipomersen works by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the blood stream. Isis is a leader in the discovery and development of microRNA (or antisense) therapeutics for treating a wide variety of diseases and the Company holds 1600 patents worldwide.

Isis has 22 drugs currently in development and three are in Phase 2: 113715 which inhibits PTP-1B an insulin synthesizer for the treatment of Type 2 diabetes, OGX-011 which inhibits clusterin and is overexpressed in response to cancer treatments and LY2181308 which inhibits survivin another overexpressed protein in cancer.

ISIS stock is 81 % institutionally owned with big holders in order as of 9/30/09: Fidelity, Federated, Vanguard,Barclays and State Street. The XBI ETF has an overweighted position of about 4% and the IBB has a less than 1% holding. Holdings should be reviewed at month to see who was selling

The ISIS market cap is now under $1B and technical damage to the stock is fait accompli so barring a bear market in biotech the stock should stay in a $9-10 trading range.

Stockholder equity is $306M and ISIS investors have invested $682M (Retained Earnings negative) since inception net of partnership revenues of $1.6B .ISIS is positioned as a “direct route from gene to drugs”.

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