How Agenix Chairman sees the Hepatits B market in China

StephenW

Extracted from:
Agenix Limited (ASX:AGX) Chairmans Address to Shareholders at 2011 Annual General Meeting
http://abnnewswire.net/press/en/70343/Agenix_Limited_%28ASX:AGX%29_Chairmans_Address_to_Shareholders_at_2011_Annual_General_Meeting.html


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.

StephenW

摘自：
Agenix有限公司（ASX：AGX）主席的讲话在2011年年度股东大会的股东



铅药物AGX - 1009旨在帮助满足中国大量未得到满足的医疗需求

Agenix自2005年以来一直与乙肝在中国市场参与。中国已经在世界上乙肝患者的数量最多，估计有1.2亿人携带表面抗原（HBsAg）。估计，20亿中国人患有慢性乙型肝炎，30万人死于疾病或并发症每年。

2009年它被估计，肝炎乙在中国治疗（不包括香港香港，澳门和台湾）市场是一个31％的年度增长2008年和2009年间率$ 227.4万，仅在医院里，就有和$ 460跨整个市场万美元，和化合物56年度增长率％2006年和2009年之间。

中国乙肝药物市场2008年和2009年之间的数量增长了31％，与2006年 - 2009年47年复合成长率为百分之。

在中国最畅销的乙肝药物“阿德福韦1.09亿美元的销售额，虽然其他药物”拉米夫定“和”恩替卡韦“的销售额大于$ 84万。

由于改善获得药物和蓬勃兴起的中产阶级，Datamonitor公司预测，B型肝炎的药物在中国市场将在2019年达到701.5亿美元，仅在医院里，就有一个的总价值。 IMS Health公司将整体市场1.3亿美元的数字。这是一个巨大的市场和Agenix熟悉它是如何工作的。

AGX - 1009是Gilead公司的FDAapproved泰诺福韦“前体药物”Viread具有相同的活性化合物的专利泰诺福韦“的前体药物”。它具有相同的活性成分，泰诺福韦，但包含了不同的分子侧链，滴，药物接近人体所需的活动网站。

在肝脏疾病方面，Gilead公司的Viread是现在最规定的在美国和欧洲的慢性乙型肝炎治疗后接受监管部门的批准，于2008年在这些地区。

我们期待这是有可能发挥出同样的方式在中国，葛兰素史克公司的销售权，以Viread，当它接收到来自中国国家食品和药品监督管理局（SFDA）在2014年的某个时候可能的批准生产和销售。

患者产生耐药性，以现有的主要乙肝病毒随着时间的推移和慢性乙型肝炎患者的药物，那么需要改变下一代疗法。在拉米夫定的情况下，大约80％的患者经过5年发展的阻力。在阿德福韦的情况下，近30％的患者经过5年发展的阻力。

Agenix定位提供与我们的主导产品的候选人，AGX - 1009，属于同一类称为核苷酸类似物逆转录酶抑制剂药物Viread在这个庞大的医疗市场竞争非常强。他们的工作，阻断病毒复制的酶。 AGX - 1009将是这个市场每天一次的治疗。

在10月，Agenix进入两个重要协议，与我们在中国的战略合作伙伴：

首先是与中国的药理学和军事医学科学院学院毒理学研究所和覆盖工作，以完成我们的肝炎乙药物，AGX - 1009重要的临床前毒理学试验，我国应用在2012年年中前开始人体临床试验。

第二个是与中国医学科学院医药生物技术研究所（IMB）在北京的合作协议。本谅解备忘录，很可能导致未来的管道产品Agenix作为正式文件，我们可以探讨如何正在开发潜在的新的候选药物的开发和商品化的共同利益和合作领域，我们的战略合作伙伴IMB。我们在比尔和梅林达盖茨基金会的罕见公司，只有几个其他组织的，有这样一个与国际海事局的协议。