ISIP--looking for a bounce tomorrow
<<Isis Shares Plunge as Crohn's Disease Drug Fails (Update4) (Adds closing share price.)
Carlsbad, California, Dec. 15 (Bloomberg) -- Isis Pharmaceuticals Inc. shares lost nearly two-thirds of their value after a late-stage study of the company's drug for Crohn's disease showed it wasn't effective against the bowel inflammation disorder.
Isis called off plans to seek U.S. Food and Drug Administration approval of the drug, known as ISIS 2302. The company also said it aims to halve its spending rate, saving $30 million to $35 million over the next year, by confining its efforts to a handful of drugs for which the first stage of human studies have begun, or are soon to start. ''We just had an all-employee meeting,'' said Debby Jo Blank, executive vice president for Isis. ''We are all in a state of shock -- we know we need to have a substantial reduction in our workforce but we don't want to do it precipitously; we've only been living with this Crohn's data for two days.''
Company officials will meet beginning Friday to come up with a formal restructuring plan and determine which programs it will retain, and where employees will be fired, Blank said.
Shares in the unprofitable California biotechnology company fell 9 29/32, or 64 percent, to close at a 52-week low of 5 19/32 in Nasdaq trading of 7 million, 22 times the stock's three-month daily average. The stock was the biggest percentage loser on U.S. markets. ''This is basically an early stage company now -- you have to think of it that way,'' said Laurence Blumberg, president of Blumberg Capital Management, which manages a health-care hedge fund. ''Until we see efficacy from this drug the stock should be in the mid-single digits.''
Disables Genetic Instructions
Isis develops drugs based on antisense technology, an approach that aims to disable the genetic instructions for a disease. Antisense technology designs drugs that reverse the bits of DNA code involved in a particular disease, like a mirror image. When the sections of reverse code and DNA meet, they bind together and neutralize the DNA's harmful activity.
Blumberg said he shorted Isis shares three weeks ago because he thought the Crohn's study results would be disappointing, based on earlier research using antisense technology for other inflammatory diseases.
Isis won FDA approval last year for an injected antisense drug called Vitravene, which fights a relatively rare AIDS- related eye disease. The approval was considered a triumph for the field of antisense, which had been met with skepticism and encountered repeated setbacks during the development process.
Antisense Technology's Future
Analysts and investors were divided today over whether Isis' failure in Crohn's disease cast doubt on the potential of antisense technology. ''I don't think there is much value to the antisense platform,'' said Blumberg. ''It is very likely from this study that IV forms of antisense aren't going to be effective.''
Jim McCamant, editor of the Medical Technology Stock Letter. McCamant said the market reaction was ''overdone,'' though. ''We have overwhelming evidence that (antisense) works at this point,'' said McCamant, who said he was maintaining his buy rating on Isis stock, and called the share price a buying opportunity.
The company is also working on topical and oral versions of antisense for conditions including hepatitis, psoriasis, and cancer.
Some of Isis' difficulties may be attributed in part to the nature of working with a new type of therapy that is still not thoroughly understood, and to the stubborn nature of Crohn's disease, analysts said. And because antisense has yet to be validated by a raft of successful products, the defeat of Isis' most advanced compound may take on a greater import with investors, they said. ''It's very bad for the company and it's very bad for antisense, but we shouldn't write antisense off,'' said Steven Delco, an analyst with Miller, Tabak Roberts Securities. ''It's clearly a case of don't throw the baby away with the bathwater; I still believe in the (antisense) platform, and Isis owns that platform.''
Delco lowered his rating on Isis to a ''hold'' from a ''long- term buy'' because of the drug's failure.>>
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