As of last month -------------------------------------------
GSK Zanamivir Strategy and Response to Novel H1N1-Relenza Rotadisk/Diskhaler: Now, GSK can produce 49 million treatment courses this year, with a goal of 90 million per year. All of the inhaled products GSK can produce for this year has already been sold and accounted for.
To meet the potential increased demand for zanamivir, GSK is exploring an alternative presentation, the Rotacap/Rotahaler, for which production is more rapidly scalable. GSK is in negotiations with FDA and others about investing in the Rotacap/Rotahaler presentation.
With its current equipment, GSK could produce 20 million treatment courses of Rotacap/Rotahaler in 2009. With more investment in tools and starting materials, it could produce 50 million courses by mid-2010. The maximum capacity would be approximately 100 million courses per year using GSK facilities only. Unlike the Rotadisk/Diskhaler, other manufacturers could produce the Rotacap/Rotahaler. If both presentations were produced, GSK could potentially provide 60 million treatment courses this year, and a maximum of 190 million courses per year.
Nebulized Zanamivir: At the onset of the current H1N1 outbreak, FDA contacted GSK about the appropriate regulatory mechanism to provide nebulized zanamivir for U.S. patients on a compassionate-use basis. GSK determined the most expedient approach is through an emergency IND, in which the individual-treating clinician acts as the principal investigator for a single patient. GSK has documentation based on limited data on how to treat. However, the supply of nebulized zanamivir is extremely limited. It was manufactured when GSK was actively developing the IV formulation. GSK feels it should be available worldwide for compassionate-use provided that appropriate regulatory mechanisms are in place. The remaining clinical trial material has been earmarked for compassionate-use. GSK has no intention to restart the manufacturing of zanamivir solution.
IV-zanamivir remains on hold. GSK will consider a clinical development proposal from a third party for influenza antiviral drug development if it includes a clinical development plan that is reasonable, feasible, scientifically robust, and likely to lead to registration and approval. If the clinical development plan does not meet these criteria, GSK would not support a trial, execute the trial, or provide the drug. However, GSK would not prohibit a third party from sourcing the product from another licensed manufacturer.
