标题: How Agenix Chairman sees the Hepatits B market in China [打印本页] 作者: StephenW 时间: 2011-10-31 16:36 标题: How Agenix Chairman sees the Hepatits B market in China
Lead drug AGX-1009 aims to help meet large unmet medical needs in China
Agenix has been involved with the hepatitis B market in China since 2005. China has the largest number of hepatitis B patients in the world, with an estimated 120 million people carrying the surface antigen (HBsAg). An estimated, 20 million people in China suffer from chronic hepatitis B, and 300,000 people die from the disease or its complications every year.
In 2009 it was estimated that the market for hepatitis B treatments in China (excluding Hong Kong, Macao and Taiwan) was $227.4 million in hospitals alone and $460 million across the whole market, with an annual growth rate of 31 per cent between 2008 and 2009, and a compound annual growth rate of 56 per cent between 2006 and 2009.
The Chinese hepatitis B drugs market grew by 31 per cent by volume between 2008 and 2009, with a 2006 - 2009 compound annual growth rate of 47 per cent.
The highest selling drug in China for hepatitis B was 'Adefovir' with sales of $109 million, although other drugs ' Lamivudine' and 'Entecavir' had sales of greater than $84 million.
Due to improved access to medication and a burgeoning middle class, Datamonitor forecasts that the hepatitis B drugs market in China will reach a total value of $701.5 million in 2019 in hospitals alone. IMS Health puts the overall market figure at $1.3 billion. It is a huge market and Agenix is familiar with how it works.
AGX-1009 is a patented tenofovir 'prodrug' with the same active compound as Gilead's FDAapproved tenofovir 'prodrug' Viread. It has the same active ingredient, tenofovir, but contains a different molecular sidechain that drops away as the drug nears its site of desired activity in the body.
Within the area of liver disease, Gilead's Viread is now the most-prescribed treatment for chronic hepatitis B in the US and Europe after receiving regulatory approval in 2008 in those geographies.
We expect this is likely to play out the same way in China where GSK has the marketing rights to Viread and when it receives manufacturing and marketing approval from China's State Food and Drug Administration (SFDA) sometime likely to be in 2014.
Patients develop resistance to the major existing HBV medications over time and chronic HBV patients then need to change to a next generation therapy. In the case of lamivudine, around 80% of patients develop resistance after 5 years. In the case of adefovir, almost 30% of patients develop resistance after 5 years.
Agenix is positioned to offer very strong competition in this large medical market with our lead product candidate, AGX-1009, which belongs to the same class of drugs as Viread known as nucleotide analogue reverse transcriptase inhibitors. They work by blocking an enzyme the virus requires to replicate. AGX-1009 will be a once-a-day therapy for this market.
In October, Agenix entered into two important agreements with our strategic partners in China:
The first was with China's Institute of Pharmacology and Toxicology of the Academy of Military Medical Sciences and covers the work to complete important pre-clinical toxicology tests for our hepatitis B drug, AGX-1009, ahead of our application in mid 2012 to start human clinical trials.
The second was a cooperation agreement with the Institute of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences in Beijing. This MoU may well lead to future pipeline products for Agenix as it formally documents how we can explore areas of mutual interest and cooperation in the development and commercialisation of potential new drug candidates under development by our strategic partner IMB. We are in the rare company of the Bill and Melinda Gates Foundation and only a couple of other organisations to have such an agreement with IMB. 作者: StephenW 时间: 2011-10-31 16:38