Flu Drug Maker Agrees To License

The manufacturer of a drug used to inhibit the effects of the bird flu virus will negotiate with generic drug companies to increase production, two senators said Thursday.

Tamiflu is the most effective drug in treating bird flu, a virus that has killed more than 60 people since late 2003, all of them in Asia. Most human cases have been linked to contact with sick birds. But health officials warn the virus could mutate into a form that can be easily passed between humans, possibly triggering a global pandemic which could kill millions.

Swiss-based Roche Holding AG will meet with four companies and maybe more in coming weeks, all in an effort to work out licensing agreements that would allow other companies to produce Tamiflu, which is in great demand throughout the world.

"The bottleneck on Tamiflu has basically been broken," said Sen. Charles Schumer, D-N.Y., who announced the agreement along with Sen. Lindsey Graham, R-S.C.

The two senators met Thursday with George Abercrombie, head of Roche Pharmaceuticals in North America.

Abercrombie did not meet with reporters, but the company issued a statement in which he said the company had already announced that it was willing to meet with companies that may be able to assist in manufacturing additional supplies.

"We continue to take the steps necessary to protect the health of people on a worldwide basis, and to make Tamiflu available wherever it is needed for both seasonal influenza and pandemic stockpiling," he said. "We already have expanded dramatically our own production capability and continue to make significant investments both internally and with partner companies."

He said Roche has a team in place dedicated to assessing the ability of other companies to either produce or provide capabilities in Tamiflu production.

"We want to be sure that they can produce substantial amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety and regulatory guidelines," he said.

Generic manufacturers cannot legally sell the patented drug in the West and parts of Asia. Roche holds the patent. Companies would need a sub-license from Roche to make the drug, Schumer said.

The determination of who gets the sub-license will be made in cooperation with the U.S. government and other governments around the world, the senators said.

Schumer said he contacted Roche two days ago, and he asked company officials to find other drug companies that they would grant a license to. Roche, in return, asked the senator to find some companies that would be willing and able to take on the job.


"We've called some of the leading generic drug companies in the United States, who told us that, with Roche's cooperation, they could make Tamiflu within a month, without Roche's cooperation, within three months," Schumer said. "Roche has agreed to meet with these companies as soon as possible."

Those four companies are Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories and Ranbaxy Laboratories. Each believe they can produce Tamiflu if given the chance, the senators said.

Schumer did not say how much Roche would charge companies for a license to produce the drug. Nor did Roche make any mention of money in its press release.

"It's a win for Roche because they will be stepping up to the plate as a world citizen and be doing the right thing, and at the same time, they're going to make a little more money because they are going to get a licensing fee, though they made it clear to us that was not their No. 1 consideration," Schumer said.

Graham was recruited by Schumer to help with negotiations because Roche has manufacturing facilities in South Carolina. He said he was amazed they could work out such a potentially sweeping protection in such a short time.

"God, I wish we could do that in other areas," Graham sighed.

In related developments:

  • A 48-year-old man who succumbed after handling his neighbor's sick chickens became the 13th person to die of the disease in Thailand, Prime Minister Thaksin Shinawatra said Thursday, citing new lab results confirming the diagnosis. Taiwan also reported the island's first incidence of the lethal virus.
  • A human pandemic of bird flu can be avoided, provided rich nations channel funds to poorer countries to help them report and contain the disease in birds, an official at the Paris-based World Organization for Animal Health said. "In our opinion, the first line of defense is to mobilize resources and tackle the problem in the bird rather than focusing on anti-virals and vaccines," Alejandro Thiermann, head of the group's standard-setting committee for terrestrial animals, said Wednesday. He noted that it was still very rare for humans to become infected.
  • Europe's top health officials meet Thursday for talks on how to thwart the spread of bird flu, as Prime Minister Tony Blair scheduled similar meetings with British politicians and the country's largest farmers' union. Other countries across Europe were already slaughtering suspect birds. Veterinary officials killed poultry in a small village in central Russia on Thursday, and Germany ordered farmers to keep poultry indoors as a precaution. British farmers were taking similar measures. As EU ministers meet Thursday afternoon, Blair will hold private talks with British government ministers and the head of the National Farmers Union.
  • Authorities at Shanghai's two airports will start checking travelers' bags for animal products, the Shanghai Daily newspaper said as countries in the region step up vigilance against the disease.
  • Serbia on Thursday ordered that all poultry and pigs be kept indoors, and banned the sale of live birds to minimize the risk of bird flu spreading in Europe. The Agriculture Ministry said the measure was taken "to prevent contacts of poultry and pigs with wild birds." All animal feed must also be kept indoors, the ministry said. People are also barred from taking domestic fowl or pigs to open water, as well as to "live bird displays." The H5N1 strain of bird flu was found last week in neighboring Romania and in Turkey.
  • The Philippines announced new measures to keep the country free of bird flu. The country will host about 7,000 athletes and officials from 11 next month for the 23rd Southeast Asian Games. Health officials said thermal screening will be conducted at the airport in Manila, and athletes entering with a fever will be isolated and examined. The country has so far been free of the virus.
  • The World Health Organization also announced China had destroyed 91,100 birds near a farm in the country's north. The birds were slaughtered after 2,600 chickens and ducks died of the H5N1 virus in a breeding facility in a village in the Inner Mongolia region.
  • Taiwan on Thursday confirmed the island's first case of deadly bird flu. The Agricultural Council said birds smuggled in from China on a Panama-registered freighter tested positive for the H5N1 virus strain.
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