The rise and fall of ImClone Systems

Biotech company ImClone System Inc. faces questions over the failure to get cancer drug Erbitux to market, both at its annual meeting on Tuesday and at a congressional hearing later in the week.

Here are key dates in the history of the company:

1984 - ImClone Systems Inc. founded by Sam and Harlan Waksal as a drug discovery company.

1986 - ImClone opens labs in Manhattan.

1991 - ImClone becomes a publicly traded company.

1993 - ImClone completes purchase of rights to molecule C225, which was discovered in the early 1980s by Dr. John Mendelsohn and his colleagues at the University of California San Diego. C225 would later be given the brand name Erbitux.

March 2000 - ImClone stock reaches all-time high of $78.75 amid a boom in biotech stocks and encouraging results from early trials of Erbitux.

May 2000 - Sam Waksal presents case of Shannon Kellum at the American Society of Clinical Oncology (ASCO). After other treatment failed, Kellum took Erbitux and had two large tumors the size of grapefruits reduced to the size of a pea and surgically removed.

The results were the talk of ASCO meeting and sparked new interest in the drug and the company.

February 2001 - FDA grants Erbitux "fast-track" approval, which allows a company to seek regulatory approval for a potentially life-saving drug based on small trial as opposed to traditional trials.

May 2001 - ImClone releases late stage data on Erbitux at ASCO, showing the drug helped 22.5 percent of patients who failed to respond to all other treatments. The results lead one Sloan-Kettering physician to call the results "knock-your- socks-off exciting."

July-August 2001 - ImClone lends money to the Waksals so that they can exercise stock options to acquire 2.1 million shares at about $8 a share. The stock was trading publicly for more than $40 each.

September 19 - Bristol-Myers Squibb Co. agrees to pay ImClone up to $2 billion for a 20 percent stake in the company and for rights to sell cancer drug Erbitux in the U.S and Canada. The tender offer valued ImClone at $70 per share.

Bristol-Myers forecasts on conference call announcing the deal that Erbitux will be approved in early 2002.

October 29 - ImClone executives and directors sell a combined 2.1 million company shares to Bristol-Myers for $150 million. Sam Waksal sells 814,674 shares and Harlan Waksal sells 776,450 shares or just more that 20 percent of each of their holdings.

October 31, 2001 - ImClone submits a completed drug application for Erbitux, from which point the FDA has 60 days to decide to accept or reject the filing.

December 6, 2001 - Stock trades at $75.45, its highest level since its all-time high in March 2000 as investors anticipate approval of Erbitux by early 2002.

December 12, 2001 - ImClone, Bristol-Myers meet with FDA on Erbitux, their last meeting with regulators before receiving official news the FDA would not review Erbitux.

December 27, 2001 - Family and close friends of Sam Waksal sell almost $3 million worth of stock, including Sam's daughter Aliza Sells and Martha Stewart, the home style guru and friend of Sam Waksal. The stock closes at $58.30.

Aliza's share sales were not revealed until March 2002 and the rest were not revealed until early June.

December 28, 2001 - ImClone announces that the U.S. Food and Drug Administration rejects the application for Erbitux saying the trials did to satisfy requirements. The stock fell 15 percent in the following day's trading.

January 4, 2002 - An industry newsletter called the Cancer Letter publishes details of the FDA's refusal-to-file letter for Erbitux, showing the agency raised concerns about potential for new trials, incomplete justification for the proposed dose of Erbitux, incomplete reporting of deaths that occurred within 30 days of the last treatment with Erbitux, and several protocol violations.

January 7, 2002 - First of several shareholder lawsuits filed against ImClone, claiming management misled investors about Erbitux's prospects for reaching the market in early 2002. ImClone stock closed at $35.83.

January 9, 2002 - ImClone CEO Sam Waksal acknowledges at a biotechnology conference the company may need to conduct new trials of Erbitux because key data was not collected saying, "We put together a faulty package and we screwed up."

January 18, 2002 - The House Energy and Commerce Committee launches probe into ImClone's conduct surrounding the handling of the Erbitux application. ImClone stock closes at $21.15.

January 24, 2002 - Bristol-Myers CEO Peter Dolan says on an earnings conference call that his company will consider actions to protect shareholders following Erbitux setbacks.

January 25, 2002 - U.S. Securities and Exchange Commission and the U.S. Justice Department launch probe into ImClone.

February 5, 2002 - Bristol-Myers demands restructuring of Erbitux deal with ImClone, including the ouster of ImClone's senior management. ImClone says it will review proposal. ImClone's stock closes at $16.98.

February 14, 2002 - Sam Waksal notifies the securities and exchange commission for the first time of 50 trades he made in ImClone stock going back as far as 1992, transactions that should have been reported within months of their execution.

February 26, 2002 - ImClone, Bristol-Myers meet with FDA about Erbitux. FDA agrees to reconsider Erbitux application if supported with solid data from the drug's trials in Europe.

March 5, 2002 - ImClone, Bristol-Myers agree to restructure their $2 billion deal. Bristol takes charge of the Erbitux application.

May 16 - ImClone's European partner, Merck KGaA, refuses to expand their Erbitux trials in a way that would support ImClone and Bristol-Myers' U.S. application. ImClone and Bristol say they will conduct their own, new, trials.

May 22, 2002 - Sam Waksal resigns as CEO of ImClone, citing distractions caused by shareholder lawsuits and intense media focus into his private affairs. ImClone delays annual meeting with shareholders by nearly three weeks to June 11.

June 4, 2002 - Congressional investigators issue subpoena for Sam Waksal to appear at June 13 hearing looking into the company's development and promotion of Erbitux.

June 10, 2002 - ImClone stock trades at $6.55, a three-year low.