US Ambassador to Israel Richard Jones speaks at the Fulbright Israel anniversary symposium on US-Israeli scientific and technological cooperation. (Photo: Kobi Koenicks)Tens of thousands of Americans who suffer from severe and seemingly untreatable gout may soon find relief for their pain in Puricase, a drug that breaks down the uric acid deposits that cause gout.
The breakthrough is the result of a joint initiative between the Israeli subsidiary of an international pharmaceutical company and a California-based pharmaceutical company whose CEO did her post-doctorate work at the Weizmann Institute of Science.
The drug has already received approval from the US Federal Drug Administration, and in about a year, the companies involved will apply to market the drug in Israel, the US and around the world. Before it becomes available, it must pass the final phase III stage of clinical trials, which are set to begin this week.
Clinical trials held so far have found that two injections of Puricase per month significantly reduced the swelling and pain associated with gout after three months of treatment. Merry Sherman, the CEO of Mountain View Pharmaceuticals, the California company that initiated the deal, showed ISRAEL21c digital photographs of an elderly woman with gout. Before taking Puricase in a clinical trial, one of her fingers was grossly swollen, but after three months of injections it appeared only slightly larger than her other fingers.
“It’s almost normal after 25 years of incurable suffering,” Sherman told 21c at a Fulbright Israel anniversary symposium on US-Israeli scientific and technological cooperation, which took place last week in Jerusalem. Sherman, who received her PhD in biochemistry in 1966, did her post-doctorate fellowship at the Weizmann Institute in Rehovot and has directed research in endocrine biochemistry at Memorial Sloan-Kettering Cancer Center in New York.
An estimated 30,000-60,000 Americans suffer from gout, which the US National Institute of Health calls “one of the most painful rheumatic diseases.” According to the NIH, gout accounts for about 5 percent of all cases of arthritis and results from deposits of uric acid in connective tissue or the joint space between bones, causing swelling, redness, heat, pain and stiffness in the joints.
The number of patients with treatment-resistant gout may be increasing, according to a 2003 US Department of Health and Human Services call for research on diseases such as gout. It said that gout, which primarily affects men, is increasingly affecting elderly women as well, and that more than 10 percent of people who receive kidney and heart transplants develop gout within three years of treatment with a drug that prevents tissue rejection.
Sherman said her company would not have been able to manufacture the drug it developed without the $800,000 it received in funding from the Israel-US Binational Industrial Research and Development Foundation (BIRD). The funding enabled Mountain View to collaborate with Bio-Technology General (Israel) Ltd., the Kiryat Weizmann subsidiary of a New Jersey-based company now called Savient Pharmaceuticals. (Savient has since sold its Israel subsidiary to Ferring Pharmaceuticals, headquartered in Switzerland, in order to fund the advancement of Puricase.)
The bi-national fund will receive a 150-percent return on its 1998 loan once the drug goes to market, Sherman said. Had the collaboration been unsuccessful, the money would have become a grant that would not need to be repaid. This funding method facilitates collaboration between companies in America and Israel by removing the risk factor that would otherwise accompany such cooperation, Sherman said.
“This is something that [Bio-Technology] wouldn’t have undertaken without this money from BIRD,” she said. “We were this unknown company. That’s why BIRD was so critical – in taking away the risk.”
Sherman and several speakers at the Fulbright conference urged an increase in funding for collaborative projects and for bringing American post-doctorate fellows to Israel. “The point is there’s not enough money,” said Sherman. “There needs to be more of this.”
Alan Leshner, the CEO of the American Association for the Advancement of Science and the executive publisher of Science magazine, said that of all countries in the world, Israel has what is “probably the highest investment in science” when calculated as a percentage of gross domestic product. Israel invests about 4.5 percent of its GDP in research and development, while the United States invests a little more than 2.5 percent,” he said. The problem, though, is that the amount of real money is “quite small.”
Leshner told ISRAEL21c that “Israeli science is tremendously well-respected in the world” – but that the country has not done a good job of attracting scientists from other countries to collaborate with Israelis.
He suggested that Israel make the best use of its limited funds by focusing on research in specific fields. “The point about having priorities is particularly important in a small country,” he said. “There has to be some kind of recognition of points of emphasis.”
Access to money is a constant problem for collaborative research, scientists said. David Stern, president of the Boyce Thompson Institute for Plant Research, a private institution located on the Cornell University campus in Ithaca, New York, said the two bi-national funds dealing with agricultural research – the United States-Israel Binational Science Foundation and the United States-Israel Agricultural Research and Development Fund – are “long on excellence yet critically short on funding.”
He said the fruits of collaborative efforts can be both profitable and useful for both countries, citing a project on heat physiology in which scientists from Israel and Florida discovered that cows become pregnant more often if they are inseminated in cooler weather.
But in order to reap the profits, said Stern, grant-providing funds must allocate enough time for the research to lead to a marketable product. The cycles can sometimes take about 10 years – as with Puricase, the anti-gout drug.
“In the biological field, it takes a long time for payback,” said Sherman.
Stern said that often scientists tend to function on a different time frame than those who fund them.
“There has to be a long-term vision,” he said. “Research runs on long cycles.”