NEW YORK (CNN/Money) -
ImClone Systems may never escape its ties to the tarnished companies investigated for corporate wrongdoing.
But unlike, Enron, WorldCom, and Adelphia Communications, ImClone stands apart in one crucial way. Shares of the biotechnology company have nearly tripled over the last six months, rising 184 percent since Sept. 23.
Not bad for a money-losing company strung by a regulatory setback and hit by an insider trading scandal that spread from the company's CEO to Martha Stewart.
ImClone's comeback is only a partial one. The New York-based company still has no drugs on the market and is expected to lose money well into the future. Its shares are off 79 percent from the all-time high.
But the stock, which closed at a three-and-a-half-year low of $6.11 six months ago, finished at $17.37 Thursday, giving this apparent scandal survivor a $1.2 billion market value.
Analysts credit the recent gains to one thing: Erbitux. The same experimental cancer treatment that two years ago stirred so much optimism among patients, doctors and investors has begun to do so again, this time in Europe.
Erbitux is undergoing trials being conducted by ImClone's European partner, Merck KGaA, which is unrelated to Merck & Co. Merck KGaA is testing Erbitux in 330 colon cancer patients and plans to present those results at an American Society of Clinical Oncology meeting in late May in Chicago.
"Based on preliminary inklings, they are confident that the data is positive," said Jason Zhang, an analyst at Independent Research Group. Zhang's employer does no investment banking with ImClone.
ImClone (IMCL: Research, Estimates), which did not return a phone call requesting comment, has provided no specific updates on the European trials. But optimism is evident.
Patrick Mooney, who follows the company for investment bank Thomas Weisel, upgraded ImClone to "buy" from "market perform" last month amid anticipation over encouraging European results.
A positive outcome could lead to a European application for Erbitux. And one day, ImClone is expected to reapply to the Food and Drug Administration, whose December, 2001 refusal to consider Erbitux's initial application sparked the stock's tumble.
"It's very likely to be approved," said Jim McCamant, an analyst at brokerage Morris & Cabot Dakin, said of the FDA process. McCamant owns ImClone shares.
A company with a past
ImClone would presumably like the May trial results to answer questions the FDA had when it refused to review ImClone's Erbitux application.
Soon after that refusal, investigators began looking into whether Samuel Waksal, who resigned as ImClone's CEO last May, tried to illegally profit by selling ImClone shares ahead of the FDA news.
Waksal three weeks ago settled charges stemming from attempted insider trading and agreed to pay more than $800,000 in fines. Under the deal with the Securities and Exchange Commission, Waksal agreed to never again run a public company.
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That deal came a week after the former ImClone CEO pleaded guilty to charges that he failed to pay sales taxes on $15 million in art. And that was after Waksal last year already pleaded guilty to six counts of securities fraud and obstruction of justice.
Then there's Martha Stewart, the home decorating entrepreneur. A friend of Waksal's, Stewart sold nearly 4,000 ImClone shares just before the FDA news. She denies having any insider knowledge, saying she had an advance agreement with her broker to sell when the shares hit a certain price. A congressional panel passed the matter on to the Justice Department, but no charges against Stewart have resulted.
Bristol's role
ImClone has said that pre-clinical trials have shown that Erbitux, designed to be used in combination with chemotherapy, "provides an enhanced anti-tumor effect in animals."
Bristol-Myers Squibb in 1999 believed enough in the drug's promise to commit $2 billion for a 20 percent share in the company. ImClone received a $60 million cash payment from Bristol earlier this month.
The FDA had no commissioner when it refused to consider the application for Erbitux because of problems with how the trials were conducted. Since then, Mark McClellan has taken over at the FDA, a development that analysts say may speed up the overall drug approval process.
Jason Zhang, the analyst from Independent Research Group, remains cautious about ImClone, which has not said when it will release its fourth-quarter results. Analysts surveyed by First Call expect fourth-quarter loses to widen to 55 cents a share from 45 cents a year ago.
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"My sense is that before we see the data, it is very hard to predict," Zhang said.
Investors, or course, are trying. And ImClone, with the help of time, has been distancing itself from last year's scandals. The company is now run by Samuel Waksal's brother, Harlan, a man who fortunately for ImClone has stayed out of the news.
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