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As the US government weighs its options on whether to commission a vaccine for the new H1N1 strain of influenza, pharma companies gear up for a possible epidemic.
Less than a week after the first major reports of outbreaks of the H1N1 influenza (dubbed “swine flu” by the media for its prevalence in pigs), two leaders in flu treatment and prevention-GlaxoSmithKline and Roche-got down to business working with the government to help get medication to the people hardest hit by the illness.
Roche was informed last Friday that swine flu was not resistant to its antiviral drug Tamiflu, which is approved to treat flu types A and B. “We heard from both the World Health Organization and the CDC that Tamiflu was active against the swine flu,” Roche spokesperson Terrence Hurley told Pharm Exec on Wednesday.
“When we became aware of the new flu outbreak, we proactively opened discussions with the authorities and contacted the WHO reference laboratory, which is responsible for creating the new seed strains for this strain of the virus,” said GSK spokesperson Sarah Alspach. “At this point, we are awaiting notification from WHO as to whether or not they want us to begin manufacturing a new vaccine.”
Roche explained that there are considerable stockpiles of Tamiflu around the world. “People tend to forget that countries have been stockpiling the drug for many years now,” Hurley said. “In fact, there are 85 countries that have reserves of Tamiflu. Several years ago, Roche donated five million treatment courses to the WHO, which are set to be deployed as soon as they give us the green light.”
The US government also has 50 million treatment courses in its strategic national stockpile, of which 11 million were recently released to individual states.
Roche sent half a million additional courses of Tamiflu to Mexico, beyond the half million the country already received to help treat the large number of people infected with H1N1. Mexico has become “ground zero” for the disease, with 159 suspected deaths attributed to the flu. Approximately 90 cases have been reported in the US, with only one casualty-a 23-month-old baby in Houston.
GSK supplied Mexico with 100,000 packs of its antiviral Relenza and an additional 170,000 doses of its seasonal flu vaccine, both of which were requested by Mexican authorities. There is no information available at this time stating that the seasonal vaccine will be affective against the new flu strain.
“It was a relatively mild flu season, which means there was more stock of Tamiflu in the system than would normally be,” Hurley said. “We have been in constant contact with the US government, and we have plans in place to increase our manufacturing of the drug.”
Tamiflu and Relenza are traditionally given between 24 and 48 hours after flu symptoms are first exhibited. The treatments can also be given as a preventative measure for people close to the patient.
Organizations like the CDC test antivirals against new strains every flu season. When they became aware of the new strain, they found that both Relenza and Tamiflu could treat the H1N1, albeit on a limited basis.
Unlike flu vaccines, which are updated annually, the antiviral formulations are consistent and do not change. GSK provides 75 million doses of seasonal flu vaccines annually, and is waiting to hear from the authorities if a new vaccine must be readied for H1N1.
“The health authorities have been very diligent in the US about how to prevent the flu, and I think we are sharing similar messages with our employees about how to watch for symptoms,” Alspach said. “I think at this point, these are the most responsible things we can be doing to prevent the spread of this flu.”