NEWS OF THE WEEK DRUG
DEVELOPMENT
GENENTECH'S CANCER TRIALS Lawsuit win saves one cancer drug, while another fails in clinical trials
G
ENENTECH FACED SIGNIF-
icant ups and downs in its cancer drug development efforts last week. It successfully defended itself in a lawsuit filed by Chiron over the breast cancer
drug Herceptin. But only a few days later, Genentech announced that one of its promising oncology products failed to show efficacy in clinical trials. Chiron originally sued Genentech in June 2000, alleging that Herceptin infringed a Chiron patent covering monoclonal antibodies that bind selectively to human breast cancer cells. Herceptin is a monoclonal antibody that blocks the overproduction of the HER2 protein by tumor cells. A California district court jury found Chiron's patent to be invalid. As a result, Genentech will not have to pay royalties to Chiron. Herceptin sales reached $182
REGULATION
FDA CONSOLIDATES DRUG REVIEW
IN BRIEF: STRONGER Aerogel materials, lightweight composites of glass and plastic, have been made 100 times stronger and almost totally impervious to liquids by University of Missouri-Rolla chemists, who cross-linked silica nanoparticles with polyisocyanate.
8
C&EN
/ SEPTEMBER
Biologies to be evaluated in FDA's main drug division
F
DA HAS ANNOUNCED THAT
it will shift the review of biotechnology drugs from its biologies division to its main drug division, the Center for Drug Evaluation & Research (CDER). Currendy, CDER oversees traditional pharmaceuticals made using chemical processes. The purpose of the consolidation is to shorten review times for new biologies—drugs derived from living organisms—and to make the review of biologies and traditional chemical drugs consistent. 16,
2002
"By carefully combining part of our present biologies review operations responsibilities with our drug review operation, FDA will be optimally positioned to uphold" its reputation for highquality evaluations, says FDA Deputy Commissioner Lester M. Crawford. The Biotechnology Industry Organization praises FDAs decision. "We are pleased with the Bush Administration's efforts to bring lifesaving drugs to patients faster alongside greater consis-
million in the first half of 2002, up 13-5% from last year, and total more than $1 billion since the drug's launch in September 1998. Chiron is expected to fight to prove its patent is valid. However, expectations for Genentech's next big product, Avastin, were dashed when the firm said the cancer drug did not meet the primary clinical end point ofprogression-free survival. The company was studying Avastin's effectiveness in relapsed metastatic breast cancer patients. Avastin, also a monoclonal antibody, binds to vascular endothelial growth factor, a secreted protein that stimulates the formation of new vessels supplying blood to tumors. Genentech is continuing clinical studies of the angiogenesis inhibitor in colorectal and lung cancers. The setback was a blow for Genentech—the company's stock fell nearly 10% the day after it announced the results—and for others developing much-promoted anti-angiogenesis drugs. — ANN THAYER
tency in the drug development and review process," BIO President Carl B. Feldbaum says. One catalyst for this consolidation was aJune hearing on the ImClone Systems scandal held by the House Committee on Energy & Commerce. After the hearing, the committee wrote a letter to Crawford saying, "There appears to be a different and better approach to the expedited review of cancer drugs in CDER" than in the biologies division. Larry Sasich, a pharmacist and research analyst at Public Citizen, says approval times for biologics may have been slower because their manufacture may be inherently very complicated to review. Ensuring the consistency of batches of biological drugs is much trickier than for conventional drugs, which are usually small molecules, he says.—B ETT E HILEMAN
HTTP: //PUBS. ACS.ORG/CEN
