United Press International - Friday, 24 August 2001

Brazilian Health Minister Jose Serra asked the public health laboratory to manufacture a generic version of Nelfinavir, trade name Viraceptan, an AIDS drug, which he said could lower the price of the drug by 40 percent.

"Roche is extremely surprised to hear the news of this government announcement," Roche said in a statement. "We have been in a long relationship with the Brazilian government as part of a well established program to manage HIV and AIDS in Brazil."

However, an industry insider told United Press International that the Brazilian announcement might have been made to put a lull in the negotiations and grab some media attention for Serra, who wants to be the next president of Brazil.

Nelfinavir is one of a new class of anti-HIV drugs called protease inhibitors. These drugs work by blocking a part of HIV called protease. When protease is blocked, HIV makes copies of itself that can't infect new cells. Protease inhibitors are almost always used in combination with at least two other anti-HIV drugs.

The standard dose of Nelfinavir is 750 mg. Brazil and Roche have been in the midst of negotiations for supplying the drug for 2002. Currently, Roche has been supplying the Brazilian government a supply of Nelfinavir, at a cost more than 50 percent lower than the U.S. wholesale acquisition cost, Roche said.

Earlier this year Roche had offered to cut the price of Nelfinavir by 13 percent but Brazil rejected the offer and they continued negotiating. Roche has supplied the pediatric formulation of Nelfinavir for children with HIV/AIDS in Brazil for free.

Brazil is believed to have the highest number of people with HIV/AIDS in Latin America, about 500,000, and about 100,000 are currently being treated in urban clinics opened and operated by the government with funding assistance by the World Bank, according to Shannon Herzfedlt, vice president for international pharmaceuticals, Pharmaceutical Research and Manufacturers of America, in Washington.

"We are hopeful that this negotiation will be resolved quickly and that both Brazil and Roche will reach an agreement," Herzfedlt said. "Brazil has never violated a patent and the president has courageously addressed AIDS and sought to provide the clinics which are so important in administering Nelfinavir and the other drugs in the AIDS drug cocktail."

Those prescribed Nelfinavir must take it three times a day with meals, and they must take if every day for the rest of their lives. "Skipping a dose can make a person worse, the virus is very fierce and if a dose is skipped than the virus can become more resistance to the drug," Denise Zolg, director of corporate relations, of Agouron Pharmaceuticals, the U.S. firm that first developed the drug.

"In fact, after a few years the drugs often have to be changed because of the resistance built up by the virus."

Also critical in dealing with HIV/AIDS drugs is that the level of quality be high, consistent and be sustainable because the drugs must be administered every day, according to Zolg. "There is not a very large margin of error when it comes to AIDS drugs, screw up a dosage of the active ingredient and the virus could mutate and the person may not be able to be treated by drugs again," Zolg said.

The approximate retail cost of Nelfinavir in the United States is $8,280 a year for the standard dose. In the United States, the cost of the drug is picked up by Medicaid or insurance programs; in addition, the federal government provides states with funds to help subsidize the drug.

"For the remaining 3 to 5 percent of those not covered under government or insurance programs the drug companies provide the drugs for free on a case-by-case basis," Zolg said. "Our company has never turned a patient away." In Brazil, the government purchases the drug from Roche and distributes almost all of it free of charge to those being treated at the clinics, Herzfedlt.

"We thought we were close to reaching an agreement for Viraceptan based upon a further substantial additional discount in 2002," Roche said. "Therefore, we prefer to not publicly disclose these exact figures and we remain committed to out offers to the Brazilian government." Nelfinavir was developed by Agouron Pharmaceuticals and the La Jolla, Calif.-based company entered into a partnership with Roche to manufacture and distribute the drug worldwide, except North America, Canada and Japan, in 1997. In May 2000, Agouron was acquired by Pfizer. (Reported by Alex Cukan in Albany, N.Y.).

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