FDA acts on one sepsis drug, holds up another - C&EN Global

No date has yet been set for another hearing on E5 by the panel, the Vaccines & Related Biological Products Advisory Committee. Both Centoxin and E5 t...
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News of the Week cal drawing package that provides images for querying structural databases; ISIS/Base, a program that translates a query into the appropriate language for each database and allows access to different types of databases in different locations simultaneously; and ISIS/Host, a package that brings scientific information on networked hosts to a workstation, manages data requests, routes requests to appropriate databases, and transfers requested data to the correct location. "A year ago, the technology required to bring together data from several sources did not exist/7 says MDL president and chief executive officer Steven Goldby. The agreement with CAS, he says, enables MDL to realize the full potential of ISIS. "We can now give scientists an easily accessible, coherent view of all their scientific information, whether the source is in-house or on-line, in the same building or on another continent/7 James Krieger

Wigington replaced by Callis as CAS director In a period of dramatic change for Chemical Abstracts Service (CAS), its director for more than five years, Ronald L. Wigington, last week was shifted to a newly created position of director of information technology for the American Chemical Society, the parent organization of CAS. Clayton F. Callis has agreed to serve as interim CAS director until a search committee finds a permanent replacement. Callis, retired from Monsanto since 1985, was a member of the ACS Board of Directors from 1977 to 1990, chairman of the board in 1982-83, and ACS president in 1989. He also served as chairman of the Society Committee on CAS and the Society Committee on Budget & Finance. This top management change follows the recent formation of the CAS Governing Board to oversee the business aspects of CAS operations (C&EN, July 29, page 45). Formerly, those operations were overseen by ACS committees and the board. In addition, CAS has just set up a joint 6

September 9, 1991 C&EN

marketing is still to be decided by FDA; that could take several months. However, the agency does not have a record of going against advisory panel recommendations. The advisory committee asked Xoma to complete an analysis of a second E5 Phase III human clinical trial. Xoma says it had no indication prior to the meeting that the committee would not act. No date has yet been set for another hearing on E5 by the panel, the Vaccines & Related Biological Products Advisory Committee. Both Centoxin and E5 treat gramnegative sepsis caused by bacterial infection. They are vying for a major biopharmaceutical market, and they could be the first therapeutic prodWigington: new position uct for either firm receiving approvventure with Molecular Design that al in the U.S. will change the character of accessGram-negative bacteria cause ing much of CAS's database (see about two thirds of more than previous story). 400,000 cases of sepsis reported annuAccording to ACS executive direc- ally in the U.S. With sepsis, release of tor John K Crum, Wigington in his endotoxin by bacteria causes a rapid new position will assist Crum in a cascade effect. This can lead to septic variety of special assignments of shock and organ failure with mortalcrucial strategic importance. Con- ity rates as high as 75% in more adtinuing to work at CAS headquar- vanced cases. mAbs act to bind and ters in Columbus, Ohio, Wigington neutralize the endotoxin. will "remain largely associated with With an estimated U.S. market of information service activities/' as much as $500 million annually at Crum says. stake, Centocor and Xoma are agA native of Topeka, Kan., Wiging- gressive competitors. Xoma holds a ton, 59, joined CAS in 1968 as direc- patent covering the use of mAbs to tor of research and development, a treat sepsis and is currently suing post he held for 16 years. He served Centocor for violating it. as director of ACS Washington operCentoxin has been approved in ations from 1984 to 1986, and as di- Europe and currently is marketed in rector of CAS operations since then. five countries. Having linked up Ernest Carpenter with marketing partner Pfizer, Xoma could be in a more powerful position if it wins E5 approval. Centoxin is produced from a hybrid mouse-human cell line, whereas E5 is a murine antibody. Both products have undergone randomA Food & Drug Administration ad- ized placebo-controlled trials and visory committee has recommended have been shown to reduce mortaliapproval for a monoclonal antibody ty. Results for Centoxin's showing a (mAb) that fights sepsis, a some- greater decrease in mortality rates as times fatal bacterial infection. But at compared with those for E5 have the same meeting the committee de- generally made Centocor the favorlayed action on a competitive mAb. ite among analysts. The product receiving the positive The actions of the advisory comrecommendation was Centoxin, pro- mittee caused the stocks of both duced by Centocor of Malvern, Pa. companies to be very active. CentoAction was held up on E5 produced cor's rose $3.00 to $40^, and Xoma's by Xoma of Berkeley, Calif. dropped $5.00 to $151/z. Final approval of Centoxin for Ann Thayer

FDA acts on one sepsis drug, holds up another