332:. Schlessinger testified in court that the idea of combining the anti-EGFR antibody that his lab had developed with chemotherapy in cancer treatment was his own idea. However, the Weizmann Institute scientists provided extensive documentation that they had been developing this idea using an antibody against EGFR that Schlessinger's laboratory had developed and generated, and that he had given them for these studies. Schlessinger claims to have initiated the idea of this use in combination therapy, but had not documented his research and ideas as thoroughly, leaving him forced to rely on his recollections of the events that led to the patent filing some 17 years before Yeda mounted their challenge.
224:(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.
210:
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, Samuel Waksal pleaded guilty to various charges, including
247:
The FDA's
February 2004 announcement of approval for use of Erbitux for treatment of colorectal 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
239:
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, nor the company's outside directors reported Waksal's actions to proper authorities or made any moves
335:
The court ruled that Yeda are the sole owners of the disputed patent in the U.S., while Yeda and Sanofi-Aventis co-own the 866 Patent's foreign counterparts. Following the ruling, ImClone and Sanofi-Aventis agreed to settle the dispute with Yeda, for $ 120 million, with each company paying Yeda $ 60
266:
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."
234:
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
351:
On
September 10, 2008, an undisclosed company and CEO offered to take over ImClone for $ 70 a share, financing approach was not disclosed. The offer was conditional on the results of a due diligence review of ImClone's business and technology by the undisclosed party, to be completed September 28,
209:
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 had done the same. John B. Landes,
363:
On
October 6, 2008, ImClone agreed to be acquired by Eli Lilly for $ 6.5 billion ($ 70/share). On November 24, 2008, ImClone was formally acquired by Eli Lilly, with all NASDAQ IMCL shares tendered for $ 6.5 billion ($ 70/share). ImClone is now a fully owned subsidiary of
240:
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
258:
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.
283:
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.
296:
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.
359:
upped its offer to take over ImClone to $ 62 a share. In addition, Bristol threatened to take the offer to the share holders for a proxy battle with the intention of replacing the current Board of Directors headed by Carl Icahn.
235:
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
279:, on February 12, 2004. In May 2001, while ImClone was still seeking approval for the drug (then known as IMC-C225), the CBS news program "60 Minutes" aired a story about two cancer patients' struggles to obtain
502:"Statement by Robert Temple, M.D., Associate Director for Center for Drug Evaluation and Research, Food and Drug Administration Before the Committee on Government Reform, U.S. House of Representatives"
752:
Aboud-Pirak E, Hurwitz E, Pirak ME, Bellot F, Schlessinger J, Sela M (Dec 21, 1988). "Efficacy of antibodies to epidermal growth factor receptor against KB carcinoma in vitro and in nude mice".
1203:
595:
562:
1148:
255:
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.
1196:
336:
million. In return, ImClone were also granted a worldwide license to technology covered by the 866 Patent, and agreed to pay a small royalty on Erbitux sales to Yeda.
409:
2015:
2020:
328:, claimed to have come up with this concept alongside Schlessinger when they worked together there years earlier, and Yeda challenged the Aventis patent in the
1212:
1189:
1995:
1985:
1980:
2010:
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1644:
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714:
529:
2005:
317:
antibodies in combination with chemotherapy, to slow the growth of certain tumors. This is the so-called '866' patent, which was filed in 1989 by
231:("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.
840:
787:
585:
697:"US Patent #6,217,866 : Monoclonal antibodies specific to human epidermal growth factor receptor and therapeutic methods employing same"
348:
offered to take over ImClone for $ 60 a share cash. The offer was made by letter addressed to ImClone's chairman of the board, Carl Icahn.
2000:
552:
248:
a standard chemotherapy treatment, irinotecan, 22.9% of patients responded and tumor growth was delayed by approximately 4.1 months.
501:
156:, and became a fully-owned subsidiary of Eli Lilly and Company on November 24, 2008. Prior to the acquisition, it was traded on the
195:
2025:
1109:
ImClone Systems Incorporated Announces Decision by The FDA Not To Accept For Filing The ERBITUX Biologics License Application.
818:
1001:
198:
that numerous executives sold their stock before the announcement of the decision after the close of trading on December 28.
940:
1069:"Lilly's CYRAMZA™ (ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy"
908:
873:
417:
734:
719: "Monoclonal antibodies specific to human epidermal growth factor receptor and therapeutic methods employing same."
438:
1959:
314:
164:. Imclone lost its separate identity in 2014 when its former ImClone research and manufacturing sites were renamed
72:
67:
1108:
221:
125:
1990:
1827:
1175:
1366:
306:
1105:, "U.S. House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations", June 13, 2002
965:
305:
Yeda Research and Development, a company set up to commercialize and market the products of research at the
1585:
1050:
191:
848:
519:
469:
1942:
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372:, was approved by the FDA for gastric cancer. Lilly acquired the drug through its purchase of ImClone.
177:
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1371:
1316:
794:
650:
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993:
Deep Value: Why Activist Investors and Other Contrarians Battle for Control of Losing Corporations
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1321:
321:, issued in 2001, and on which Joseph Schlessinger was listed as first-named inventor.
236:
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Joseph Schlessinger's former colleagues at the Weizmann Institute, in particular
280:
214:, and on June 10, 2003, was sentenced to seven years and three months in prison.
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Ultimately a new clinical trial and FDA filing prepared by Imclone's partner
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773:
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369:
340:
Takeover offer from Bristol-Myers Squibb, and subsequent bidding showdown
152:. On October 6, 2008, it accepted a $ 6.5 billion acquisition offer from
841:"ImClone and Sanofi-Aventis Settle Patent Litigation with Yeda Researc…"
1932:
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524:
293:
228:
182:
ImClone's stock price dropped sharply at the end of 2001 when its drug
39:
1882:
1752:
1525:
1490:
1351:
1326:
470:"Dr. John Mendelsohn, 82, Researcher Who Led Top Cancer Center, Dies"
276:
183:
368:. In 2014 a drug developed by ImClone, tumor angiogenesis inhibitor
1762:
1757:
1640:
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141:
504:. U.S. Food and Drug Administration. June 20, 2001. Archived from
140:
company dedicated to developing biologic medicines in the area of
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1610:
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1478:
1443:
1381:
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651:"ImClone seeking new CEO with biotech experience - Oct. 25, 2006"
310:
1922:
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144:. It was founded in 1984 and had its corporate headquarters in
53:
1937:
1907:
1842:
1331:
1261:
1246:
751:
557:
309:
in Israel, challenged the Aventis-owned patent, licensed by
275:
The FDA approved the aforementioned colorectal cancer drug,
1717:
1019:"Eli Lilly Agrees to Buy ImClone Systems for $ 6.5 Billion"
619:"Eli Lilly Agrees to Buy ImClone Systems for $ 6.5 Billion"
674:
292:
On October 25, 2006, a group led by billionaire investor
874:"Bristol-Myers offers $ 4.5 billion to buy out ImClone"
300:
1149:
ImClone Founder Waksal Sentenced to 7 Years in Prison
1139:
ImClone Founder Pleads Guilty to Avoiding Sales Taxes
941:"Icahn says he has $ 70-per-share offer for Imclone"
553:"Dying Patients Find Experimental Drugs Hard to Get"
416:. Bloomberg Businessweek. Snapshot. Archived from
1972:
270:
2016:Pharmaceutical companies disestablished in 2014
1159:'I will be back,' Stewart vows after sentencing
244:to refer to the ongoing misconduct as "wacky."
2021:Biotechnology companies disestablished in 2014
1103:An Inquiry into the ImClone Cancer-Drug Story.
788:"Court ruling on Yeda vs Aventis/Imclone case"
1213:Pharmaceutical companies of the United States
1197:
194:(FDA) approval. It was later revealed by the
1996:Pharmaceutical companies established in 1984
1986:Pharmaceutical companies based in New Jersey
1981:Biotechnology companies of the United States
1601:
2011:Biotechnology companies established in 1984
1204:
1190:
1176:FDA Approves Erbitux for Colorectal Cancer
586:"For some, untested drug is a last chance"
171:
1051:"FDA approves Cyramza for stomach cancer"
287:
1129:A Closer Look at Martha Stewart's Trades
1073:Eli Lilly and Company Investor Relations
989:
735:"ImClone goes up against patent dispute"
2006:Companies formerly listed on the Nasdaq
1016:
616:
583:
445:. Eli Lilly and Company. Archived from
196:U.S. Securities and Exchange Commission
14:
1973:
996:. John Wiley & Sons. p. 173.
729:
727:
725:
550:
467:
1185:
903:
901:
867:
865:
819:"ImClone settles drug patent dispute"
1057:. U.S. Food and Drug Administration.
871:
584:Foreman, Judy (September 23, 2003).
404:
402:
722:
301:Yeda/Aventis/Imclone patent dispute
148:, and its research headquarters in
24:
1491:Pharmaceutical Product Development
990:Carlisle, Tobias E. (2014-08-18).
966:"Bristol-Myers Boosts Imclone Bid"
909:"ImClone gets second takeover bid"
898:
862:
25:
2037:
2001:1984 establishments in New Jersey
1091:
520:"Controversial Compassionate Use"
399:
1960:List of pharmaceutical companies
315:Epidermal growth factor receptor
160:stock exchange under the symbol
1061:
1043:
1010:
983:
958:
933:
833:
811:
780:
745:
703:
689:
667:
598:from the original on 2012-10-05
565:from the original on 2013-12-26
532:from the original on 2013-12-26
222:Martha Stewart Living Omnimedia
1017:Pollack, Andrew (2008-10-06).
872:Saul, Stephanie (2008-07-31).
643:
617:Pollack, Andrew (2008-10-06).
610:
577:
551:Levine, Jeff (June 20, 2001).
544:
512:
494:
461:
431:
13:
1:
2026:2008 mergers and acquisitions
1367:Institute for OneWorld Health
1119:ImClone Stock Sales Disclosed
825:. 11 Dec 2007. Archived from
410:"ImClone Systems Corporation"
392:
307:Weizmann Institute of Science
271:Compassionate use controversy
190:, failed to get the expected
1586:West Pharmaceutical Services
847:. 2012-07-09. Archived from
675:"Technology Transfer Israel"
468:Thomas, Katie (2019-01-18).
192:Food and Drug Administration
7:
375:
87:; 40 years ago
10:
2042:
1392:McNeil Consumer Healthcare
205:, was arrested in 2002 on
178:ImClone stock trading case
175:
1955:
1898:Smith, Kline & French
1710:
1594:
1449:Northwest Biotherapeutics
1434:Merrimack Pharmaceuticals
1219:
121:
109:
99:
81:
60:
45:
35:
27:Biopharmaceutical company
439:"Eli Lilly US Locations"
1153:San Francisco Chronicle
1075:. Eli Lilly and Company
766:10.1093/jnci/80.20.1605
355:On September 23, 2008,
264:The Wall Street Journal
172:Insider trading scandal
146:Bridgewater, New Jersey
73:Pharmaceutical industry
1823:Leiner Health Products
1267:Amneal Pharmaceuticals
555:. WebMD News Archive.
414:Company Insight Center
313:, for the use of anti-
288:Carl Icahn acquisition
1991:Eli Lilly and Company
1377:Johnson & Johnson
366:Eli Lilly and Company
166:Eli Lilly and Company
154:Eli Lilly and Company
116:Eli Lilly and Company
68:Biotechnology company
1671:Jazz Pharmaceuticals
1661:Horizon Therapeutics
1531:Sarepta Therapeutics
1506:Proteon Therapeutics
1501:Procter & Gamble
1414:Melinta Therapeutics
1307:Bristol Myers Squibb
528:. CBS. May 3, 2001.
357:Bristol-Myers Squibb
346:Bristol-Myers Squibb
253:Bristol-Myers Squibb
1878:Repros Therapeutics
1793:Forest Laboratories
1778:Cutter Laboratories
1496:Prasco Laboratories
1237:Acorda Therapeutics
1227:Abbott Laboratories
1178:, February 12, 2004
1115:, December 28, 2001
972:. 23 September 2008
508:on August 20, 2001.
382:Accounting scandals
319:Rhone-Poulenc-Rorer
281:"compassionate use"
251:In September 2001,
188:monoclonal antibody
134:ImClone Systems LLC
101:Number of employees
32:
1838:Miles Laboratories
1828:Martek Biosciences
1651:Endo International
1571:Ventria Bioscience
1337:Danco Laboratories
1143:The New York Times
1133:The New York Times
1123:The New York Times
1023:The New York Times
970:The New York Times
913:The New York Times
878:The New York Times
754:J Natl Cancer Inst
623:The New York Times
474:The New York Times
449:on 20 October 2018
344:On July 31, 2008,
186:, an experimental
30:
1968:
1967:
1951:
1950:
1783:DNAPrint Genomics
1272:Avax Technologies
1003:978-1-118-74796-4
443:R&D Locations
220:, the founder of
138:biopharmaceutical
131:
130:
16:(Redirected from
2033:
1599:
1598:
1546:Tec Laboratories
1419:Melior Discovery
1404:Kinetic Concepts
1347:Galena Biopharma
1206:
1199:
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1055:FDA NEWS RELEASE
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845:Business Library
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793:. Archived from
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212:securities fraud
203:Samuel D. Waksal
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1893:Schering-Plough
1803:ImClone Systems
1706:
1590:
1439:Myriad Genetics
1429:Merck & Co.
1387:Janssen Biotech
1357:Gilead Sciences
1215:
1210:
1165:, July 17, 2004
1155:, June 10, 2003
1145:, March 3, 2003
1135:, July 15, 2002
1125:, July 15, 2002
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760:(20): 1605–11.
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387:Corporate abuse
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262:In April 2007,
237:James Greenwood
207:insider trading
180:
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126:www.imclone.com
102:
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1703:(Canada, 2010)
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1092:External links
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915:. 2008-09-10.
897:
861:
851:on 9 July 2012
832:
829:on 2008-10-13.
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741:. 2006-09-14.
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1566:Upsher-Smith
1397:Ortho-McNeil
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1113:BusinessWire
1112:
1077:. Retrieved
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947:. 2008-09-10
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795:the original
782:
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681:December 25,
679:. Retrieved
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602:December 25,
600:. Retrieved
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447:the original
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418:the original
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36:Company type
1873:Parke-Davis
1556:Trevena Inc
1424:Mentholatum
1232:AbbVie Inc.
1079:14 November
56:: IMCL
31:ImClone LLC
1975:Categories
1933:ViroPharma
1833:Massengill
1561:Ultragenyx
1292:Bioverativ
1036:2020-02-21
976:2020-05-13
951:2020-05-13
926:2020-05-13
891:2020-05-13
855:2020-05-13
804:2009-09-23
711:US 6217866
660:2020-04-09
636:2020-04-09
525:60 Minutes
487:2019-11-21
453:19 October
424:2013-12-25
393:References
294:Carl Icahn
229:Merck KGaA
40:Subsidiary
1883:Qualitest
1753:CancerVax
1536:Sheffield
1526:RespireRx
1521:Regeneron
1372:Intercept
1352:Genentech
1342:Eli Lilly
1327:CytoSport
1317:Ceragenix
1031:0362-4331
921:0362-4331
886:0362-4331
739:USA Today
677:. YEDARND
631:0362-4331
482:0362-4331
48:Traded as
1763:CoTherix
1758:Cephalon
1641:Covidien
1631:Allergan
1621:Alkermes
1541:Spectrum
1409:McKesson
1302:Biovista
1282:BioCryst
1097:Articles
596:Archived
563:Archived
530:Archived
376:See also
142:oncology
61:Industry
1918:Trubion
1768:Covance
1748:Bradley
1697:, 2013)
1695:Ireland
1691:Perrigo
1687:, 2013)
1685:Ireland
1677:, 2012)
1675:Ireland
1667:, 2014)
1665:Ireland
1657:, 2014)
1655:Ireland
1647:, 2007)
1645:Ireland
1637:, 2015)
1635:Ireland
1627:, 2011)
1625:Ireland
1617:, 2013)
1615:Ireland
1611:Actavis
1581:Viatris
1479:Hospira
1469:Ovation
1464:Organon
1459:NovaBay
1444:Moderna
1382:Ethicon
1312:Century
1297:Biovest
1257:Alnylam
1252:Alexion
1242:Advaxis
1220:Current
774:3193478
370:Cyramza
311:Imclone
277:Erbitux
184:Erbitux
122:Website
90: (
82:Founded
18:ImClone
1943:Zonite
1923:Upjohn
1858:Nuvelo
1853:Nereus
1848:Naurex
1773:Cubist
1743:Biolex
1728:Amylin
1595:Former
1576:Vertex
1484:Searle
1474:Pfizer
1287:Biogen
1277:Baxter
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352:2008.
158:NASDAQ
136:was a
111:Parent
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1938:Wyeth
1928:Verus
1908:Tanox
1888:Rib-X
1863:Ortho
1843:Mylan
1798:Genta
1733:ARIAD
1711:Other
1551:Titan
1516:Quark
1362:Ionis
1332:CytRx
1322:Combe
1262:Amgen
1247:Alcon
798:(PDF)
791:(PDF)
558:WebMD
105:1,128
1813:King
1808:ISTA
1788:Epix
1738:Barr
1718:Alza
1081:2014
1027:ISSN
998:ISBN
917:ISSN
882:ISSN
770:PMID
683:2013
627:ISSN
604:2013
571:2013
538:2013
478:ISSN
455:2018
162:IMCL
92:1984
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1913:TAP
1868:OSI
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762:doi
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