Washington Editor

The National Institutes of Health and an Australia-based company have signed an international agreement allowing U.S. scientists to study human embryonic stem cells listed as acceptable by President Bush.

The agreement, known as a memorandum of understanding (MOU), specifies that NIH scientists and its contractors can study the six stem cell lines held by ES Cell International Pte. Ltd., of Melbourne, Australia, without signing over intellectual property rights. In September, the NIH entered a similar agreement with the Wisconsin Alumni Research Foundation (WARF), which owns five lines and holds the patent to a technique used to develop stem cell lines. (See BioWorld Today, Sept. 6, 2001.)

Speaking of the WARF agreement several months ago, Secretary of Health and Human Services Tommy Thompson said it would serve as model for companies or academic organizations seeking to negotiate a research agreement with owners of the 72 existing stem cell lines approved by Bush for government-funded research.

ES Cell and WARF are among the 14 organizations worldwide that own approved lines. The NIH does not require MOUs from each of the organizations, but recommends them to help hasten the research process.

Under its agreement with the NIH, ES Cell retains commercial rights to its materials and will receive a fee to cover its handling and distribution expenses in supplying the cell lines. Also, ES Cell has agreed to make stem cell lines available for use by nonprofit institutions that receive NIH grants.

Meanwhile, the NIH will retain ownership to any new intellectual property that might arise from the research, and NIH scientists are allowed to publish their research results.

In a prepared statement, Robert Klupacs, ES Cell’s CEO, said the agreement with the NIH was of major importance to ES Cell. “It will ensure that we are able to distribute our cell lines widely via the NIH’s considerable network of stem cell researchers while maintaining our primary focus, which is on the development of therapeutic products.”

He referred to NIH researchers and those in their collaborative networks as among the best in the world and stated, “We look forward to distributing our cells and providing training to researchers where required.”

The NIH spends about 85 percent of its budget next year proposed to top $27 billion on research grants. Since August, the government has received nine research applications that involve the use of human embryonic stem cells. None of the applicants has received word on funding, as the review process is still ongoing.

Regarding the remaining 12 organizations holding stem cell lines, NIH said it is engaged in discussions with each of them to “facilitate access on equitable terms and conditions.”

The other entities are BresaGen Inc., of Athens, Ga., four lines; CyThera Inc., of San Diego, nine lines; Geron Corp., of Menlo Park, Calif., seven lines; Goteborg University, of Goteborg, Sweden, 19 lines; Karolinska Institute, of Stockholm, Sweden, six lines; Maria Biotech Co. Ltd.-Maria Infertility Hospital Medical Institute, of Seoul, Korea, three lines; MizMedi Hospital Seoul National University, of Seoul, Korea, one line; National Centre for Biological Sciences/Tata Institute of Fundamental Research, of Bangalore, India, three lines; Pochon CHA University, of Seoul, Korea, two lines; Reliance Life Sciences, of Mumbai, India, seven lines; Technion University, of Haifa, Israel, four lines; and University of California at San Francisco, two lines.

For more information on the stem cell lines and to view the NIH registry, visit the website at www.nih.gov.