Relenza Zanamivir influenza treatment drug kit
Object No. 2005/161/1
Zanamivir was the first of a new class of drugs called neuraminidase inhibitors. These drugs are a first line of defence against all strains of influenza virus. Once a new virus emerges it takes about six months to develop a vaccine, so neuraminidase inhibitors can slow the spread of infection and reduce morbidity and mortality in the early stages of an epidemic. These drugs target an enzyme on the surface of the influenza virus and prevent the virus particles from leaving infected cells. They are effective against all types of flu, reducing the severity of symptoms and shortening the length of the illness. They also reduce the risk of secondary bacterial infection and have minimal side effects. Zanamivir is as significant in the battle against viruses as penicillin was in the battle against bacteria. Zanamivir is a significant Australian innovation that took a novel approach to the treatment of an age-old disease. The Spanish flu pandemic of 1918 killed about 30% of the world's population. Without neuraminidase inhibitor drugs it is likely that any new flu pandemic would do the same. Sandra McEwen 2005
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Summary
Object Statement
Influenza treatment drug kit, 'Relenza' (zanamivir), powder / metal / plastic / cardboard / paper, designed by Biota Holdings, Notting Hill, Victoria, Australia, made by GlaxoSmithKline Australia Pty Ltd, Boronia, Victoria, Australia, 2004
Physical Description
The blue and white cardboard packet contains 20 doses of Relenza in five rotadisk blister packages. Each rotadisk is 4cm in diameter and holds four doses of Relenza in powder form. Four rotadisks are stacked inside a white plastic cylindrical screw-cap bottle. One rotadisk is loaded into a diskhaler that is used to deliver the drug. The diskhaler is blue and beige and carries a sticker that says RELENZA Diskhaler GlaxoSmithKline P18662A. An information sheet provides step by step instructions for use of the diskhaler.
DIMENSIONS
Height
111 mm
Width
111 mm
Depth
55 mm
PRODUCTION
Notes
Zanamivir is a drug that was created by scientific researchers in Australia. The scientists identified a part of the influenza virus that does not change, no matter how many times the virus mutates. They then created the Zanamivir molecule that locks into the unchanging part of the influenza virus particle, rendering it inactive and preventing the virus from spreading throughout a person's body. By immobilising virus particles, Zanamivir gives the body's immune system a chance to destroy them. Three Australian scientists, Dr Peter Colman, Professor Mark von Itzstein and Dr Graeme Laver, contributed to the development of Zanamivir and shared the 1996 Australia Prize for their research effort. Dr Laver, at the Australian National University, first crystallised, neuraminadase, a protein which occurs on the outside of all influenza molecules. In 1983, Dr Colman of the CSIRO, announced that he and his colleagues had identified a part of neuraminadase as the unchanging molecular target. They described the exact shape of the site. In 1986, using the CSIRO group's information, Professor von Itzstein and a colleague, Dr Wen-Yang Wu at the Victorian College of Pharmacy, began making blocking molecules that would fit neatly into the neuraminadase site. By early 1990, Professor von Itzstein and Dr Wu had developed Zanamivir. In animal trials it successfully blocked influenza infections in ferrets. Their research was supported financially by a small Melbourne-based company called Biota Holdings which had, in 1986, acquired the intellectual rights related to the discovery of Zanamivir. In 1990 Biota Holdings reached an agreement with the giant UK-based pharmaceutical company Glaxo-Wellcome to develop, test and market the anti-influenza drug. The drug underwent clinical trials between 1993 and 1998. In 1999 approval was granted by various regulatory bodies to market Zanamivir as Relenza in Australia, Sweden, USA and the European union. Relenza was launched in Australia in May 1999 and in the USA and UK in September 1999.
HISTORY
Notes
Two months after Relenza was released, another drug designed to block the action of neuraminadase was released worldwide. Its design is extremely similar to that of Zanamivir and was based on the original Australian research. It was developed by the Californian company, Gilead, together with the Swiss company, Hoffman-La Roche. That drug contains Oseltamivir and is marketed as Tamiflu. It is administered as a tablet rather than as an aerosol like Relenza. Although Oseltamivir was created six years after Zanamivir, it was fast tracked through clinical stages to catch up with Relenza. Relenza was rejected by the United States FDA (Food and Drug Administration) in March 1999 but subsequently approved in July 1999. Thus it was on the market for only two months before Tamiflu was launched. Subsequent failure by GlaxoSmithKline to market Relenza effectively lead to a legal dispute between Biota and GlaxoSmithKline. In 1990 Biota licensed Glaxo, on a world wide exclusive basis, for development and commercialisation of Zanamivir. Biota agreed to receive a royalty rate of 10% of net sales in Australia, New Zealand, Indonesia, and South Africa in exchange for marketing rights in those countries. The royalty for sales in the rest of the world was set at 7% of net sales. GlaxoSmithKline registered Relenza in 70 countries between 1999 and 2002, and launched it in about 30 countries during 1999 to 2000. Glaxo merged with Wellcome in 1995 to create Glaxo Wellcome and then again in 2000 with SmithKlineBeecham to create GlaxoSmithKline. During 2000 and 2001, GlaxoSmithKline cut back support programs and promotions for Relenza. In 2005 Biota sued GlaxoSmithKline for failing to properly promote and market Relenza. Relenza's market share declined markedly in 2001 after GlaxoSmithKline withdrew support for Relenza. Major flu epidemics in Japan and the USA in 2003 increased the sales of Tamiflu to US$330 million. In 2005, with the threat of an Asian bird flu pandemic, developed countries are stockpiling Tamiflu while sales of Relenza continue to fall.
SOURCE
Credit Line
Gift of Biota Holdings, 2005
Acquisition Date
15 June 2005
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