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Genzyme to Sell Third Wave s Colon Cancer Test, Two Other Molecular Dxs with Similar Approach

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Genzyme has added Third Wave Technologies' UGT1A1 colorectal cancer test to its suite of recent pharmacogenomics-related products, and it plans to popularize and sell these tests using a shared marketing strategy.

"We're really promoting the personalized medicine aspect in both 2005 and 2006," Genzyme spokesperson Celeste Chenet-Monte told Pharmacogenomics Reporter this week. "Our pipeline for 2006 is really devoted exclusively to pharmacogenetic-type tests."

Genzyme this week began offering the UGT1A1 colon cancer solid-tumor test in North America in a preferred partnership arrangement with Madison, Wisc.-based Third Wave, the second of three pharmacogenomic tests Genzyme plans to introduce in 2005 and early 2006.

With a common marketing strategy for its expanded pharmacogenomic offerings, the Cambridge, Mass.-based diagnostic testing laboratory aims to clear a common stumbling block to clinical acceptance of personalized medicine: physician education.


"Our pipeline for 2006 is really devoted exclusively to pharmacogenetic-type tests."

Genzyme is using the same marketing mold for its epidermal growth factor receptor mutation test, and the company will follow suit with a BCR-ABL mutation diagnostic it intends to launch toward the end of January, said Chenet-Monte.

Based on intellectual property the firm licensed in October from the University of California at Los Angeles Jonsson Cancer Center, the BCR-ABL mutation diagnostic tests for secondary mutations in the ABL gene that are associated with resistance to Novartis' drug Gleevec, which is the first-line therapy for chronic myeloid leukemia. The test complements a BCL-ABL quantitative FISH test for CML detection.

For Third Wave's UGT1A1 test, Genzyme will tailor its physician-education program to support "the use of diagnostic tests to identify patients for therapy, and then to monitor those patients on therapy," said Chenet-Monte.

The company's 23 pathologists will travel around North America to speak with oncologists and pathologists personally and to deliver talks about the testing, Chenet-Monte said. "These talks are in the form of grand rounds, tumor boards, and what we call 'speaker's bureau' programs," she said. The firm will send its solid-tumor surgical pathologists to speak about the new diagnostic and colorectal cancer in general, while approximately 50 of its molecular geneticists will go on the road to popularize the tests at scientific conferences and other venues, she added.

The company will also print and distribute brochures targeted to physicians involved in the treatment of colorectal cancer, and it will advertise the test in relevant peer-reviewed publications, said Chenet-Monte.

Third Wave introduced the UGT1A1 test soon after the US Food and Drug Administration changed the label of the colorectal-cancer drug Camptosar to reflect the test's utility, and the diagnostic was quickly cleared by the FDA in a process that sets a precedent for followers. Currently, the blood thinner warfarin is in the early stages of relabeling, and although there are no clear successor diagnostics yet, further research in the field may soon reveal more candidates.

Beyond warfarin, "we haven't seriously looked at any other drugs," Larry Lesko, director of the FDA Office of Clinical Pharmacology and Biopharmaceuticals at the FDA's Center for Drug Evaluation and Research, told Pharmacogenomics Reporter in June. But that doesn't mean the process will come to a stop. "I don't [think] people realize that when you're living through an evolution or a revolution, you don't realize how much is going on," he said.

Sales of Camptosar, made by Pfizer, may prove to be a useful estimation of the upper limit of the annual market for a UGT1A1 test. Camptosar brought Pfizer first-quarter 2004 revenue of $212 million, up 132 percent compared to the same period in 2004, according to a company statement. Sales in the United States account for about half of the drug's worldwide sales, the company said.

"The market opportunity for a diagnostic like this test, and any other pharmacogenetic test, is very much an emerging one," Rod Hise, a Third Wave spokesperson, said in June. The company is working to position itself "to capture value when the market really does begin to accelerate," he said.

Fleshing Out a Marketing Mold

Beside UGT1A1, Genzyme is using the same marketing mold for its epidermal growth factor receptor mutation test, and the company will follow suit with a BCR-ABL mutation diagnostic it intends to launch toward the end of January, according to a company spokesperson.

On the EGFR mutation front, several recent studies, including one presented last month at the American Association for Cancer Research conference in Philadelphia, suggest that patients with tumors harboring certain EGFR mutations are more likely to respond to EGFR inhibitors such as AstraZeneca's lung-cancer drug Iressa and Tarceva, made by OSI Pharmaceuticals, Pfizer, and Genentech. Both Iressa and Tarceva are therapies for second-line treatment and beyond.

However, not enough data exist to draw strong conclusions about the relationship yet, according to Brian Holloway of AstraZeneca Pharmaceuticals in England, who led mutation research presented at AACR. In those studies, most of the EGFR-mutated tissue also tested positive in an EGFR FISH test, which was itself found to be a promising marker for patient survival on Iressa, and which made mutation testing unnecessary.

The number of patients receiving first-line non-small cell lung cancer therapy in the United States is approximately 69,000, and the number receiving second- or third-line treatment is approximately 41,000, Colleen Wilson, Genentech associate director of product communications, said in a July e-mail exchange with Pharmacogenomics Reporter.

In terms of looking for BCL-ABL secondary mutations as biomarkers that suggest CML drug response, Novartis, whose Gleevec is aimed at treating the disease, said that about 90 percent of patients initially respond to its drug. However, a small proportion respond only partially or not at all, and approximately five percent of initially responsive patients develop resistance to the drug every year.

Nearly 4,600 new cases of CML were projected to be diagnosed in the United States in 2005, according to the American Cancer Society, and about 25,000 US CML patients are currently in remission on therapy.

— Chris Womack ([email protected])

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