Sep 11, 2009 (CIDRAP News) – Officials from Roche today said the company is producing Tamiflu (oseltamivir) at near-capacity levels and is collaborating on dozens of research studies, focusing on groups such as pregnant women who are at higher risk of complications from pandemic H1N1 flu.
At a media briefing today, Roche executives also addressed news of antiviral-resistant novel flu cases and concerns about the availability of pediatric suspension Tamiflu in light of the disease's heavy burden on children.
Also today, the European Union approved Tamiflu use in a pandemic setting for children ages 6 to 12 months and for women who are pregnant or breastfeeding, the Roche officials said. In April the United States issued emergency use authorization for Tamiflu in children younger than 1 year old.
David Reddy, Roche's pandemic taskforce leader, told journalists that since 2004 Roche has boosted its Tamiflu production capacity from 28 million to 400 million courses per year. The company is currently making 33 million courses per month to meet the pandemic flu demand.
He said that as of July, governments had about 270 million courses in their stockpiles and that Roche has 110 million more stockpiled "It's unprecedented for a company to maintain this type of emergency capacity," he said.
Roche has been fielding questions about the supply of pediatric suspension Tamiflu, he said. He said knowing that it takes 25 times more production capacity to make the pediatric liquid suspension, Roche foresaw the need for oseltamivir options for children and has focused more on developing and ramping up production of pediatric-dose capsules that were approved by the US Food and Drug Administration in 2007.
However, the liquid suspension is often a better option when a child or adult can't swallow pills. Reddy said some healthcare providers recommend mixing the medication with food for those who are unable to swallow intact capsules.
So far the company has received 23 reports of oseltamivir-resistant pandemic H1N1 cases, Reddy said, adding that such reports are expected and that no significant clusters or community-level spread of the strains has been reported. Thirteen of the resistant cases were in people who receive postexposure prophylaxis, he noted, saying that it's possible some patients of those patients were already infected with the virus.
Even when patients show mild symptoms, Reddy said, they should receive the treatment dose rather than the prophylactic dose, in accordance with recognized antiviral guidelines.
Roche currently has 43 studies in progress with research collaborators, Reddy said. Many focus on vulnerable populations, such as obese or immunocompromised patients, and some of the trials are evaluating the benefits of combination treatment with other antivirals, such as zanamivir (Relenza), he added. Other studies are evaluating the effect of longer-duration or higher-dose treatment on viral shedding.
Businesses are still showing strong interest in obtaining the drug for their employees, Reddy said. An employer stockpiling program that the company unveiled in 2008 is still enrolling participants, he said. For an annual fee, companies can secure a supply of Tamiflu, which will be stored, secured, rotated, and kept current by Roche. If and when the company requests its supply, Roche will guarantee delivery within 48 hours in most instances.
GlaxoSmithKline also offers an employer stockpiling program for zanamivir. Both drugs have shown to be effective against the pandemic H1N1 virus.