Roche considers licensing companies to make oseltamivir
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《英国医生杂志》
With the gradual spread of avian influenza from East Asia to Europe, many countries were this week seeking supplies of the antiviral drug oseltamivir (Tamiflu), which lessens the effects of flu when taken at an early stage of the illness.
Cipla, an Indian company which specialises in generic drugs, said last week that it would make its own generic version of the drug. Cipla said it could market the drug by December and could make a million 10 capsule courses of treatment by next July, a report in New Scientist says ( 2005;188: 14).
A spokesperson for Roche, the manufacturer of oseltamivir, said that the company would discuss sublicensing to increase supplies of oseltamivir, provided the companies could meet stringent manufacturing requirements. Making oseltamivir is a year long process involving many steps, some of them possibly explosive, she said. "We're looking for companies to approach us so we can assess their capabilities," she added.
Two US senators said that Roche had agreed to talk with four companies. The Roche spokesperson said the company had received many requests from companies and governments to scale up production, and it would be considering them.
Roche has been challenged by Gilead Sciences, which developed oseltamivir and licensed it to Roche. In June 2005, Gilead sent a message to Roche terminating the agreement by which Roche manufactured oseltamivir.
In documents filed with the US Securities and Exchange Commission, Gilead Sciences say that Roche has performed poorly in the five years during which it had been licensed to market oseltamivir and that Gilead was acting to protect its shareholders. It also says that health professionals and patients need improved access to information about the drug and to the drug itself.
Gilead charged that Roche had failed to commercialize the drug through promotion and marketing, including a failure to launch it in markets where the drug had been approved, and that Roche had failed to properly calculate and pay royalties to Gilead.
A Roche spokesperson told the BMJ that the dispute was in arbitration.
The two drugs most effective in treating ordinary flu and bird flu are both neuraminidase inhibitors—oseltamivir, an oral pill, and zanamivir (Relenza), an inhaled medication, made by GlaxoSmithKline. A report in Nature last week raised the possibility that a prophylactic regimen of oseltamivir might lead to partial resistance to the drug, however ( 2005;437: 1107). The article suggested that governments should consider stockpiling zanamivir as well as oseltamivir.
Anne Moscona, professor of pediatrics at New York-Presby-terian Hospital and author of a New England Journal of Medicine review ( 2005;353: 1363-73), told the BMJ, "These drugs are remarkably effective if given early... but we need new flu anti-virals that attack the virus at different points in its life cycle." (See p 975.)(Janice Hopkins Tanne)
Cipla, an Indian company which specialises in generic drugs, said last week that it would make its own generic version of the drug. Cipla said it could market the drug by December and could make a million 10 capsule courses of treatment by next July, a report in New Scientist says ( 2005;188: 14).
A spokesperson for Roche, the manufacturer of oseltamivir, said that the company would discuss sublicensing to increase supplies of oseltamivir, provided the companies could meet stringent manufacturing requirements. Making oseltamivir is a year long process involving many steps, some of them possibly explosive, she said. "We're looking for companies to approach us so we can assess their capabilities," she added.
Two US senators said that Roche had agreed to talk with four companies. The Roche spokesperson said the company had received many requests from companies and governments to scale up production, and it would be considering them.
Roche has been challenged by Gilead Sciences, which developed oseltamivir and licensed it to Roche. In June 2005, Gilead sent a message to Roche terminating the agreement by which Roche manufactured oseltamivir.
In documents filed with the US Securities and Exchange Commission, Gilead Sciences say that Roche has performed poorly in the five years during which it had been licensed to market oseltamivir and that Gilead was acting to protect its shareholders. It also says that health professionals and patients need improved access to information about the drug and to the drug itself.
Gilead charged that Roche had failed to commercialize the drug through promotion and marketing, including a failure to launch it in markets where the drug had been approved, and that Roche had failed to properly calculate and pay royalties to Gilead.
A Roche spokesperson told the BMJ that the dispute was in arbitration.
The two drugs most effective in treating ordinary flu and bird flu are both neuraminidase inhibitors—oseltamivir, an oral pill, and zanamivir (Relenza), an inhaled medication, made by GlaxoSmithKline. A report in Nature last week raised the possibility that a prophylactic regimen of oseltamivir might lead to partial resistance to the drug, however ( 2005;437: 1107). The article suggested that governments should consider stockpiling zanamivir as well as oseltamivir.
Anne Moscona, professor of pediatrics at New York-Presby-terian Hospital and author of a New England Journal of Medicine review ( 2005;353: 1363-73), told the BMJ, "These drugs are remarkably effective if given early... but we need new flu anti-virals that attack the virus at different points in its life cycle." (See p 975.)(Janice Hopkins Tanne)