Chinese Drug Company Kunming, WHO in Dispute Over Malaria Drug, Wall Street Journal Reports

Chinese drug company Kunming Pharmaceutical, which produces an artemisinin monotherapy to treat malaria, and the World Health Organization are in a dispute over its drug "that touches on money, national pride and the dilemmas of treating infectious diseases," the Wall Street Journal reports. According to WHO, artemisinin should be used only in combination with other antimalarials to prevent malaria parasites from developing resistance to the drug, and the agency says that by manufacturing and selling its monotherapy, Kunming is jeopardizing global health, the Journal reports. However, Kunming and other Chinese pharmaceutical companies have said that they believe WHO is "overestimating the risk of resistance and underestimating the urgent need for treatments," the Journal reports. In addition, Chinese companies "resent being boxed out of part of a market for a drug Chinese scientists invented," according to the Journal.

Background
Kunming since the late 1980s has been producing its monotherapy, decades after Chinese scientists isolated artemisinin as a promising remedy for malaria. The company says it is China's largest manufacturer of artemisinin-based drugs. Kunming often used private channels to distribute its drug, rather than distributing it through public health agencies like WHO. The only fixed-dose, combination therapy for malaria approved by WHO is Novartis' artemisinin-based combination therapy Coartem, which was developed by Chinese scientists in the early 1990s. Novartis -- a Swiss company then called Ciba-Geigy -- in 1994 bought the rights to sell Coartem outside of China. The company paid "a few" million dollars and agreed to pay a 4% royalty on annual sales, one of the Chinese negotiators said. The demand for Coartem increased when WHO in 1990 began recommending that artemisinin be used only in combination with other antimalarials. According to some Chinese producers of artemisinin-based drugs, when the demand for the drug led to a global shortage of artemisinin a few years ago, they were pressured to supply raw materials to Norvatis instead of selling their own drugs. "Some people think we sold our country to Novartis," Liu Tianwei, who works for a unit of an investment company involved in the licensing deal, said. Several companies, including some in China, in 2006 agreed to halt sales of marketing of artemisinin monotherapy and to begin selling only ACTs after WHO in January 2006 singled out 18 pharmaceutical companies that still were selling the drug as a monotherapy. However, some Chinese companies have declined to stop their sales of monotherapy because they, like Kunming, believe that "Chinese scientists, using indigenous knowledge, developed a world-beating drug only to see the nation's companies blocked from getting a piece of the action," according to the Journal.

Kunming Wants To Sell Monotherpay, ACT on Own Schedule
Kunming recognizes the value of ACTs and has its own ACT, called Acro, but the company wants to introduce Acro on its own schedule and does not want to pull its artemisinin monotherapy while the drug is still selling well, the Journal reports. Kunming in 2004 sold about $5 million worth of its monotherapy, according to Yu Zelin, Kunming's general director of international trade. Although the company would not provide more recent figures, it said that it sold several million doses of the monotherapy in 2006. Being forced to halt sales of its monotherapy would not be "fair to China," Yu said, adding, "We have developed the drugs ourselves. We have made so much effort. We will sell the monotherapies." Yu also said that "worries about resistance ... are not fully based on solid science." WHO officials say Acro is a promising drug and are encouraging Kunming to submit laboratory and clinical data so the drug can be prequalified by the agency and made eligible for purchase by U.N. agencies. According to Arata Kochi, head of WHO's Malaria Department, Kunming executives are undermining their company "by selling monotherapies when they have a combination drug with great potential in the pipeline." However, Kunming wants to avoid the possibility of having to spend years trying to receive WHO approval for Acro and instead wants to continue distributing the drug through commercial channels, the Journal reports. Kochi and WHO staff in October 2006 met in Beijing with Chinese government officials and representatives of Kunming and three other drug companies. Kochi said that WHO is encouraging governments in developing countries to ban artemisinin monotherapies. Kunming did not agree to stop sales of its monotherapy, but Yu says the company eventually will stop selling its drug when sales of Acro increase. Kochi said that he believes Chinese companies soon will see the demand for monotherapy diminish, but it is unknown if they will allow WHO to examine their ACTs (Zamiska/McKay, Wall Street Journal, 3/6).