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Isis Turns in Good Test Results, Delays Market Entry

Carlsbad-based Isis Pharmaceuticals said Nov. 17 that its cholesterol-lowering drug mipomersen met all its goals in a late-stage trial, cutting levels of “bad” LDL cholesterol by an average of 25 percent in people genetically inclined to develop high cholesterol.

But the drug maker’s shares plunged almost 15 percent after the company said it would seek regulatory approval for the drug a year later than anticipated.

Shares of Isis, traded under the same name on Nasdaq, stood at $11.15 at midday Nov. 17, down from a pervious day’s close of $13.40.

Isis partner Genzyme of Massachusetts said it expects to apply for U.S. and European regulatory approval in mid-2011.

The drug maker presented the data at an American Heart Association meeting in Orlando, Fla. The 6.5-month trial tested the drug in 51 people with homozygous familial hypercholesterolemia, an inherited condition from both parents that often leads to cholesterol levels at four times the normal amount.

The trial, designed to test once-weekly injectable mipomersen on top of lipid-lowering statins or Merck & Co.’s Zetia, showed average improvements of 25 percent, compared with 3 percent in the placebo group, although the therapy lowered some patients’ LDL levels by as much as 80 percent.

“Mipomersen has the potential to change the standard of care for (homozygous familial hypercholesterolemia) patients,” said Frederick Raal, the study’s lead investigator.

About 12 percent of patients saw elevated liver enzyme levels, although the company said other tests to check for liver dysfunction returned normal results.

An ongoing Phase 3 study is also testing the drug in patients with heterozygous familial hypercholesterolemia, in which patients inherit a tendency toward high LDL from a single parent.

— Heather Chambers

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  February 8-14, 2010
SDBJ News
CONNECT Goes to Washington
Most high-tech entrepreneurs and innovators don’t have time to put on a tie and sit through a three-hour meeting about policy issues in Washington, D.C. They are too busy creating the next generation of digital mobile applications and lifesaving health care products, and creating jobs for the new innovation economy. There has not been a strong voice or presence in the nation’s capital to represent these innovators, who neither have the money nor bandwidth to lobby or educate representatives on their needs and interests — until now.
S.D. Companies Race to Build Gene Machines
Technology contenders in the race to decode a person’s entire genetic makeup for less than $1,000 have been making gains in recent months, signaling that the finish line isn’t far ahead.
Conference Focuses on Methods to Combat Cyber Attacks
The creative and destructive power of the Internet emerged as a major topic of the West 2010 military conference, sharing the stage with more time-honored topics such as ships and naval strategy.
Scripps Health Issues $220M in Revenue Bonds
Scripps Health, currently in the middle of a building spree intended to bring its aging health care facilities up to date while accommodating future population demands, sought help financing its projects through the public markets last week.
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