|
ImClone Systems Incorporated (NASDAQ: IMCL) is a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and is headquartered in New York City. It is traded on the NASDAQ stock exchange under the symbol IMCL. NASDAQ in Times Square, New York City. ...
Biopharmaceuticals are medical drugs (see pharmacology) produced by biotechnology. ...
See cancer for the biology of the disease, as well as a list of malignant diseases. ...
This article is about the year. ...
Midtown Manhattan, looking north from the Empire State Building, 2005 New York City (officially named the City of New York) is the most populous city in the state of New York and the entire United States. ...
NASDAQ in Times Square, New York City. ...
Insider trading scandal ImClone's stock price dropped sharply at the end of 2001 when its drug Erbitux, an experimental monoclonal antibody failed to get the expected Food and Drug Administration (FDA) approval. It was later revealed by the U.S. Securities and Exchange Commission that numerous executives sold their stock before the announcement of the decision after the close of trading on December 28. Year 2001 (MMI) was a common year starting on Monday (link displays the 2001 Gregorian calendar). ...
Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of colorectal cancer. ...
Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ...
“FDA†redirects here. ...
The U.S. Securities and Exchange Commission, commonly referred to as the SEC, is the United States governing body which has primary responsibility for overseeing the regulation of the securities industry. ...
is the 362nd day of the year (363rd in leap years) in the Gregorian calendar. ...
Its founder, Samuel D. Waksal, was arrested in 2002 on insider trading charges for informing friends and family to sell their stock, and attempting to sell his own. His daughter, Aliza Waksal, sold $2.5 million in shares on December 27. His father, Jack Waksal, sold $8.1 million in shares over the 27th and 28th. Company executives followed the suit too. John B. Landes, the general counsel, sold $2.5 million in shares on December 6. Ronald A. Martell, the vice president for marketing and sales, sold $2.1 million in shares on December 11. Four other executives sold shares in the following weeks as well. Later, founder Waksal pleaded guilty to various charges, including securities fraud, and on June 10, 2003, was sentenced to seven years and three months in prison. Samuel D. Waksal (born September 8, 1947 in Paris, France) is an American immunologist and businessman who founded the biopharmaceutical company ImClone Systems in 1984. ...
Also see: 2002 (number). ...
Insider trading is the trading of a corporations stock or other securities (e. ...
December 27 is the 361st day of the year in the Gregorian calendar (362nd in leap years). ...
For a discussion of the legal actions for securities fraud in the United States under the Securities Exchange Act of 1934 and SEC Rule 10b-5 promulgated thereunder, see the Wiki entry for the Private Securities Litigation Reform Act. ...
is the 161st day of the year (162nd in leap years) in the Gregorian calendar. ...
Year 2003 (MMIII) was a common year starting on Wednesday of the Gregorian calendar. ...
Martha Stewart, the founder of Martha Stewart Living Omnimedia (Waksal had dated Stewart's daughter) also became embroiled in the scandal after it emerged that she sold about $230,000 in ImClone shares on December 27, just a day before the announcement of FDA decision. Although Stewart maintained her innocence, she was found guilty and sentenced on July 16, 2004 to five months in prison, five months of home confinement, and two years probation for lying about a stock sale, conspiracy, and obstruction of justice. Martha Stewart (born Martha Helen Kostyra on August 3, 1941) is an American business magnate, author, editor and homemaking advocate. ...
Martha Stewart Living Omnimedia Inc. ...
is the 197th day of the year (198th in leap years) in the Gregorian calendar. ...
Year 2004 (MMIV) was a leap year starting on Thursday of the Gregorian calendar. ...
Ultimately a new clinical trial and FDA filing prepared by Imclone's partner Merck KGaA ("German Merck," not to be confused with the US company of similar name) resulted in an FDA approval of Erbitux in 2004 for use in colon cancer. Merck KGaA is a German based pharmaceutical company. ...
A Congressional hearing on improprieties at ImClone, held in October 2002, unveiled a culture of corruption dating back to 1986. This was the year that ImClone CEO Waksal first forged the signature of the company's general counsel John Landes (one of the three original employees of the company) for financial gain. Nonetheless, Landes defended Waksal's illegal actions at the hearings before the Subcommittee on Oversight and Investigations, portraying the forgery as "a good-faith misunderstanding," to which Representative James Greenwood replied "My children know better than that, Mr. Landes." Further questioning about this and subsequent forgeries on Waksal's part revealed that neither Landes, the chief legal officer of the company, or the company's outside directors reported Waksal's actions to proper authorities or made any moves to have Waksal removed as CEO. Instead, testimony revealed that they initiated their own internal investigation, which was never concluded. The decades-long tolerance for Waksal's fraud, starting from the company's earliest days, provoked Representative Peter Deutsch to refer to the ongoing misconduct as "wacky."
The FDA's February 2004 announcement of approval for use of Erbitux for treatment of colrectal cancer reported that conclusions were drawn from a trial involving 329 patients, of which 10.8% responded when Erbitux was used by itself, delaying tumor growth by 1.5 months. When used in conjunction with a standard treatment irinotecan, 22.9% of patients responded and tumor growth was delayed by approximately 4.1 months.
In September 2001, Bristol-Meyers Squibb committed $2 billion (including a $1 billion up-front cash payment) for less than 20% of ImClone due to what was called at the time the drug's "blockbuster" potential.
In January 2006, the company was put up for sale but failed to find any buyers, likely due to the fact that Erbitux by that time faced significant competition in the medical marketplace. ImClone directors withdrew the sale of the company in mid-2006.
In April 2007, The Wall Street Journal reported that "Bristol-Myers Squibb Co. and ImClone Systems Inc. said their cancer drug, Erbitux, failed to significantly prolong the lives of people with pancreatic cancer in a new study, marking yet another setback in the drug industry's efforts to find a better treatment for this deadly disease."
Compassionate use controversy The FDA approved the aforementioned colorectal cancer drug, Erbitux, on February 12, 2004. In May 2001, while ImClone was still seeking approval for the drug (then known as IMC-C255), the CBS news program "60 Minutes" aired a story about two cancer patients' struggles to obtain "compassionate use" of the drug. One ultimately succeeded; the other failed despite repeated pleas to ImClone officials. It was alleged in the story that ImClone was arbitrary in who received the drug and had no written criteria for compassionate use.
Carl Icahn acquisition On October 25, 2006, a group led by billionaire investor Carl Icahn acquired a majority of stock thereby giving him control of the board. Within hours of the announcement, interim CEO Joseph Fischer resigned, and Icahn announced that other members of the Board of Directors would not be re-elected. Carl Celian Icahn (born February 16, 1936) is an American billionaire financier, corporate raider, and private equity investor. ...
See also In 2002, media celebrity Martha Stewart was investigated for alleged insider trading, after selling 3,928 shares of ImClone Systems on December 27, 2001. ...
Accounting scandals, or corporate accounting scandals are political and business scandals which arise with the disclosure of misdeeds by trusted executives of large public corporations. ...
Corporate abuse refers to incidents that involve unethical behavior on behalf of a corporation; a case of corporate abuse may be a scandal, fraud, or negligence toward the corporations employees and/or the local community. ...
External links and references
Articles - Dying Patients Find Experimental Drugs Hard to Get., "WebMD Medical News," June 20, 2001
- Statement by Robert Temple, M.D., Associate Director for Center for Drug Evaluation and Research, Food and Drug Administration., "The Committee on Government Reform, U.S. House of Representatives," June 20, 2001
- For some, untested drug is a last chance., "The Boston Globe", September 23, 2003
- An Inquiry into the ImClone Cancer-Drug Story., "U.S. House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations", June 13, 2002
- Controversial Compassionate Use., "60 Minutes", May 3, 2001
- ImClone Systems Incorporated Announces Decision by The FDA Not To Accept For Filing The ERBITUX Biologics License Application., BusinessWire, December 28, 2001
- ImClone Stock Sales Disclosed, The New York Times, July 15, 2002
- A Closer Look at Martha Stewart's Trades, The New York Times, July 15, 2002
- ImClone Founder Pleads Guilty to Avoiding Sales Taxes, The New York Times, March 3, 2003
- ImClone Founder Waksal Sentenced to 7 Years in Prison, San Francisco Chronicle, June 10, 2003
- 'I will be back,' Stewart vows after sentencing, AP, July 17, 2004
FDA
Data |
Feeds |
Contact