Dr. Morse requested that the issue of supply be addressed.
Andrew Leone (GSK) indicated that at this point, GSK had reactivated all of its global sites. They have annual capacity of approximately 55 to 60 million courses of RELENZA ®. In the US, they have the capacity to produce approximately 1.6 million courses per month and is committed to producing throughout 2009. Thus, they anticipate ample supply for the upcoming influenza season.
Dr. Fiore indicated that there has not been a shortage in supply of oseltamivir through Roche and that the predominant drug in the US stockpile is also oseltamivir.
With respect to the issue of increasing resistance, Dr. Meissner requested information on the status of Peramivir and whether it was expected to be active against oseltamivir-resistant H1N1 season strain and the novel strain.
Dr. Fiore responded that the neuraminidase inhibitor, Peramivir, from BioCryst Pharmaceuticals is currently in Phase 2 trials and is currently available under an investigational new drug (IND). The advantage of this drug is that it can be given intravenously or intramuscularly. There are several thousand treatment courses available. It is active against the circulating influenza viruses. He thought it might have intermediate to full activity against the resistant seasonal H1N1s. The activity is different from zanamivir. Further information can be acquired from the FDA’s and manufacturers’ websites. Intramuscular Peramivir might come into play if severe infections are observed in the fall or winter for which the licensed drugs are not effective or cannot be used for some reason.