GSK provides H1N1 update
GSK says it is making rapid progress in developing an adjuvanted vaccine for influenza A(H1N1). The drugmaker has also significantly increased production of its anti-viral influenza treatment Relenza and has developed an innovative respirator mask, designed to protect the wearer from inhaling airborne influenza virus.
GSK says it is making rapid progress in developing an adjuvanted vaccine for influenza A(H1N1). The drugmaker has also significantly increased production of its anti-viral influenza treatment Relenza and has developed an innovative respirator mask, designed to protect the wearer from inhaling airborne influenza virus.
GSK says the candidate A(H1N1) vaccine will consist of two vials - pandemic (H1N1) 2009 antigen and GSK's AS03 adjuvant system - which will be combined before administration. The US FDA and EMEA will assess a generated data package, including safety information, according to predefined criteria before approving the vaccine.
The company is in discussions with regulatory authorities to develop appropriate clinical development plans. The total population studied in clinical trials will be limited owing to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.
GSK is on track to meet orders for 195 million doses of the H1N1 vaccine and first supplies will be available from September, including 50 million doses to the WHO. The company has allocated 20% of production at its Canadian manufacturing site to developing countries and is operating a tiered-pricing policy for the vaccine.
GSK plans to increase its annual production capacity of the influenza anti-viral Relenza to 190 million courses of treatment by the end of 2009. This represents a threefold increase to its previous capacity of 60 million courses.
Production capacity of Relenza in its standard Diskhaler format will be increased from 60 to 90 million courses. A further 100 million courses a year of additional capacity will be available as Relenza Rotacaps/Rotahaler. This alternative Relenza treatment has been granted temporary approval by Swedish regulators and hence within the EU, for distribution during a pandemic.
The Rotacaps/Rotahaler is already manufactured by GSK for other inhaled products and offers a rapid increase in capacity for Relenza. GSK is in discussion with a number of international regulatory authorities to secure further approvals.
The company also intends to donate two million courses of Relenza to the WHO, on which Australian developer Biota has agreed to waive royalties. Biota receives a minimum 7% royalty on global sales of Relenza from GSK and holds patent coverage in the major markets until at least December 2014.
GSK's Actiprotect disposable respirator mask includes an antiviral coating and has been shown to inactivate all influenza strains, including previous strains of H1N1 and H5N1. It has not yet been tested against the pandemic (H1N1) 2009 strain.
Actiprotect has been approved for use in Europe and certain international markets and last month the FDA approved it for occupational use in the US. The US National Institute of Occupational Safety and Health has certified the mask as an N95 respirator (filters at least 95% of airborne particles). GSK currently has limited manufacturing capacity for the mask.