• 2/25/2005
  • Andrew Pollack
  • New York Times (nytimes.com)

Chinese biotechnology companies have long copied American drugs for use in their home markets. But one Chinese imitator may now save a novel cancer treatment from oblivion after it was abandoned by its American developer.

Shanghai Sunway Biotech, a biotechnology company in Shanghai, has licensed worldwide rights to the therapy from Onyx Pharmaceuticals, based in Emeryville, Calif., people at both companies said.

It is a sign that China is plowing ahead in certain areas of medicine that are regarded more cautiously in the United States.

The therapy uses a virus that has been genetically modified to attack cancer cells but avoid normal cells. The treatment, called Onyx-015, elicited great interest among cancer researchers a few years ago when it showed the ability to shrink tumors in midstage clinical trials.

But there were challenges delivering the therapy to tumors because the immune system attacks the virus. Some scientists also considered the treatment a form of gene therapy, a technique that fell into disfavor after the death of a teenager in a gene therapy trial at the University of Pennsylvania.

Onyx stopped work on the virus treatment in 2003 to devote its money to a more conventional cancer drug that is now in late stage trials with Bayer, the German pharmaceutical company. Onyx could not find a partner willing to pay for further development of the virus therapy.

Unbeknownst to Onyx, however, Sunway researchers duplicated its approach after reading a paper published by Onyx scientists in 1996. Sunway has taken the treatment through clinical trials in China and thinks it is close to winning approval to sell it for head and neck cancer.

“They cloned our work after our paper came out,” said Frank McCormick, founder of Onyx and the main inventor of the technology. He said Onyx had known nothing about Sunway’s activities all these years.

Onyx’s technology was not protected by patents in China because the company had not applied for them. But Sunway now says it wants to develop and sell the treatment in countries where Onyx does have patents, including the United States.

So Sunway has licensed the rights, according to Dr. McCormick and to Hu Fang, the president of Sunway. Dr. Hu said his company was paying $1 million up front, and might pay up to $10 million more if the drug won approval in the United States and Europe, plus royalties on sales. A spokeswoman for Onyx confirmed that an agreement had been reached but would not provide financial details.

“They weren’t fazed by the negative publicity around gene therapy in the U.S.,” said Dr. McCormick, who is now director of the cancer center at the University of California, San Francisco. “They just had a different attitude.”

The first and only approval of a gene therapy by any regulatory agency in the world happened in China in 2003.

That therapy, developed by SiBiono GeneTech, based in Shenzhen, uses a virus to deliver to tumors a gene called p53 that helps kill cancerous cells. SiBiono’s approach is very similar to one being tested in late stage clinical trials by Introgen, a company in Austin, Tex.

Even if the Onyx therapy wins approval in China, Sunway will need to conduct clinical trials in the United States to get approval in this country and to conform to tougher American manufacturing standards.

Dr. Hu said his company had made some improvements to the Onyx therapy to make it more effective. Dr. McCormick agreed, and said he was happy his work had been imitated. “I was a bit shocked at first,” he said. “But since we haven’t been able to find anyone in the U.S. to support the project, it’s better than having it die on the vine. Over all, I’m actually delighted.”

He said he expected to go to China soon to celebrate the first approval anywhere of the therapy he invented.