Others like her may not be so fortunate. The reason has little to do with medicine but rather with a nasty corporate fight. On one side is CellPro Inc., a small Seattle biotech company that has given some 5,000 desperately ill patients like Tully a second chance at life. On the other is Baxter International, a giant pharmaceutical company that has accused its tiny rival of infringing on one of its patents. It wants CellPro to yank the therapy off the market or hand over its profits on the treatment. But doing so would bankrupt the company, according to CellPro’s executives, stranding thousands of potential patients. That’s because only CellPro makes the product - and Baxter itself is at least a year from receiving regulatory approval for its own.
The stakes in the controversy are huge. Some 25,000 patients receive bone-marrow transplants each year for diseases ranging from AIDS to lymphoma to breast cancer. And that number is growing by 30 percent annually, as doctors learn more about how diseases can be treated with aggressive transplant therapy. CellPro’s product uses a unique technology to remove cancerous cells and to specifically select healthy, immune-building cells from bone marrow extracted from a patient. The marrow is re-implanted following radiation and chemotherapy. The process may reduce the risk of recurrence and moderate the often severe side effects of such therapy. ““If this technology passes all the tests,’’ says biotech analyst Rich van den Broek at Hambrecht & Quist, ““it could become a $100 million business in a very short time.''
CellPro won approval of its treatment for certain types of cancer from the Food and Drug Administration last December. Clinical trials for using the technology to treat other diseases are underway at scores of medical centers in the United States and Europe. Emory University, for example, is using it to try to save children dying of leukemia; other researchers believe it could help bring cures for lupus and, as in Tully’s case, multiple sclerosis. Dr. Kent Holland at Emory calls it ““one of the biggest breakthroughs in transplant therapy in the last decade.’’ Four U.S. senators and the president of the American Cancer Society recently encouraged Secretary Donna Shalala of the Department of Health and Human Services to force Baxter to extend a license to CellPro in the public interest.
It’s unclear which company is in the right. Earlier this spring, a federal judge ruled that CellPro had knowingly used technology patented by Johns Hopkins University and licensed by Baxter. (Many medical researchers, on the other hand, disagree with the court’s verdict - as did the jury in the case, which the judge overruled.) Baxter also accuses CellPro of using ““scare tactics’’ to try to steal the drug company’s rights to the treat- ment. ““CellPro is saying this technology won’t be available to cancer patients, and that’s not true,’’ says John Osth, presi- dent of Baxter’s immunotherapy division. ““We’re not asking for their product to be taken off the market until ours can replace it.''
That would be cold comfort for CellPro, especially if it’s forced to yield a big chunk of its sales revenues to Baxter. What’s more, CellPro executives argue that allowing their products to remain on the market only until Baxter comes up with its own is really just a clever way for the drug company to cash in on CellPro’s clinical trials without incurring any costs. Clearly, both sides are playing a savvy game of phar- maceutical hardball here, and the outcome is anyone’s guess. ““We’ll prevail on ap peal,’’ promises CellPro president Rick Murdock, whose commitment to CellPro’s product is nothing less than messianic. And small wonder. Diagnosed a year ago with a rare type of lymphoma and given less than two years to live, Murdock became CellPro’s first human test case. That he today appears to be cancer-free is a testament to the human dimension of what otherwise would be just another business squabble.
