BASEL, Switzerland, Nov. 9 - In a factory here on the banks of the Rhine, three floors of linked vats and pipes churn out a compound that until recently drew only scant attention. Across the street, workers in protective suits dry that compound to make a white powder, to be packaged and sold as Tamiflu.
Roche, the Swiss pharmaceutical company that makes the drug, opened the doors to its Tamiflu factory Wednesday to allay fears that it might be unable to meet demand for the antiviral drug in the event of a bird flu pandemic. "There's a shortage right now," said William M. Burns, head of Roche's pharmaceutical division. But he quickly added that the company plans to raise annual production capacity to 300 million courses of treatment by this time next year: a drastic increase from 55 million this year and more than 10 times the output capacity in 2003. "This is a capacity significantly larger than the cumulative number of orders we have," Mr. Burns said.
In response to international pressure, Roche also said Wednesday that in the less-developed countries, as defined by the World Bank, it would charge 12 euros ($14.12 at Wednesday's conversion rate) for a five-day treatment and 15 euros in the developed nations. It was the first time Roche had disclosed the price it will charge governments. For seasonal flu, the company charges 20 to 50 euros a course to the public.
Roche also confirmed that it was in talks with Vietnam to provide the finished active ingredients for Tamiflu. Local companies could then put them in capsules "perhaps more cheaply than we can," said Eugene Tierney, head of virology at Roche.
Of 150 requests for licenses, Roche said it has talked with eight possible partners; it expects to shorten the list this month. Roche, Mr. Burns said, has sent out questionnaires to help sift the "commercial opportunists" from those with "serious intent." Roche is trying to find out if "there are people out there that can help us in a serious way," he said.
Bird flu has so far killed 64 people in Thailand, Indonesia, Vietnam and Cambodia, and infected millions of poultry and other birds. Infection rates in humans could soar if the virus mutates to a form that can be transmitted from person to person, experts have warned.
Roche stood by earlier statements that making Tamiflu was complex, taking up to a year, including gathering the raw materials. Among the criteria to become a manufacturing partner, the company says, is the ability to produce large quantities quickly without interfering with Roche's own supply chain.
Companies like Cipla, an Indian generic drug maker that wants to produce the generic version of Tamiflu, called oseltamivir, could probably supply only small amounts, making little difference in a pandemic, Mr. Tierney of Roche said. Some analysts dispute this, saying it is no more complicated to make Tamiflu than many other drugs.
| Non-sequitor alert: it may not be 'more' complicated, but manufacturing pharmaceuticals on a large scale is a daunting operation and can be quite complex. Getting the requisite purity in raw materials and maintaining quality control throughout the process are the keys, and not just anyone can do that. |
Gilead Sciences, the American drug company that invented Tamiflu 11 years ago, says Roche has not done enough to manufacture and market the drug, and is trying to regain control; the two companies are in arbitration. Mr. Burns said Roche has had "good discussions" with Gilead aimed at settling out of court. Roche bought control of the patents for Tamiflu 10 years ago.
Analysts also say that ramping up production of shikimic acid, a basic material in the making of Tamiflu, presents a potential bottleneck. Roche relies on a relatively rare Chinese spice, star anise, to make around two-thirds of the acid. The spice, grown in the mountains of southern China, is in increasingly short supply. The Chinese broker that supplies most of it, Beijing Gingko, has received requests for it from generic drug companies, but has declined them, Mr. Tierney said.
Roche produces a third of the acid by fermenting E. coli bacteria. Jan Van Koeveringe, head of global technical operations at Roche, said the company hoped to reverse that proportion, but gave no timeline.
| That's genetic engineering and will definitely take time, but once they ramp it up they won't need star anise any more. |
|
