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CONSTELLATION TECHNOLOGIES LIMITED — Regulatory Filings 2007
Oct 1, 2007
64712_rns_2007-10-01_9627a713-4da9-4290-8fc2-a89e96d2ff4b.pdf
Regulatory Filings
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Company Announcement
2 October 2007
Agenix Receives Approval for New Anti-HBV Drug in China
Agenix has received approval in China for its anti-hepatitis B virus drug, YouHeDing (adefovir dipivoxil), from the State Food and Drug Administration of the People’s Republic of China (“SFDA”).
Hepatitis B is an inflammation of the liver caused by the hepatitis B virus (“HBV”). Chronic hepatitis B may cause liver cirrhosis which can lead to fatal liver cancer. The disease is recognized as being endemic in China and many other parts of Asia. There is no cure for chronic HBV, with patients usually requiring medical treatment for life.
Mr Jonathan Zhang, CEO of Agenix Bio-Pharmaceutical (Shanghai), stated: “The patient population for HBV in China is staggering. Of the total population in China of 1.3 billion people, 10% or 130 million are HBV carriers. Of these, at least 30 million, and possibly as many as 40 million, are chronic HBV patients. China is believed to account for at least 34% of global chronic HBV patients. Each year 2-3 million HBV carriers are diagnosed with chronic HBV and require immediate medical treatment.”
“YouHeDing is the first China developed and patented triclinic structured adefovir dipivoxil drug, and was awarded as a scientific breakthrough by the Chinese Ministry of Science and Technology in its 10[th] 5-year development plan,” Mr Zhang said.
Agenix is projecting annual revenue from the sale of YouHeDing in China alone to grow to RMB320 million per annum (A$50 million per annum) as the sales and marketing network is progressively rolled out, with earnings before interest and tax projected to exceed RMB160 million per annum (A$25 million per annum) at the peak of the rollout.
The above projected revenue could prove conservative, as the market for medical expenditures on anti-HBV treatment in China is itself growing very rapidly as socioeconomic changes take place and affordability of ethical medical treatments replaces traditional Chinese medicines. Expenditure on medical treatments for HBV in China had a market growth rate in 2006 of 44%.
Jonathan Zhang and his management team in China have been establishing the staff and infrastructure ready for the market launch of YouHeDing. As well as the head office in Shanghai, representative offices have been established in Beijing and
Guangzhou. Also, initial marketing and sales staff for the direct sales force in key regional areas have been recruited and discussions are well-advanced regarding product distribution in other areas of China.
Mr Neil Leggett, Agenix CEO and Managing Director stated: “The approval of YouHeDing in China is an exceptional milestone for shareholders. But it is only part of the story. YouHeDing also has sales potential in other Asian countries. It is also the first of what we believe will be a broad pipeline of anti-viral products, each capable of generating significant revenue. In 2008 we will have two new products commence Phase I clinical trials in China (an additional anti-HBV drug and an anti-colon cancer drug). It is probable that two more potential products will commence clinical trials in China in 2009. Our strategy is to have multiple revenue-generating products on market simultaneously.”
“Furthermore”, Mr Leggett said, “our anti-viral treatment pipeline has the potential to keep growing through our research collaboration agreement with PLA No.2 Military Medical University, one of the major medical universities in China specializing in pharmacology."
Mr Ravi Govindan, Chairman of Agenix, stated: “There has been much anticipation around the approval of YouHeDing. Now that this has occurred, investors will start to appreciate the significance of the growth platform which Agenix has established in China. This is the birth of a Chinese bio-pharmaceutical powerhouse with revenue, GMP manufacturing capability and a deep product pipeline.”
Mr Leggett added: “When taken together with our ThromboView® product, which successfully completed a Phase II deep vein thrombosis clinical trial last year, and recently commenced a Phase II pulmonary embolism trial at seven centres in the USA and Canada, shareholders should see substantial value accretion from here on. Our expert US consultants continue to advise us that ThromboView® has the potential to generate end user sales of over US$500 million per annum.”
“Recent M & A deals in the antibody space worldwide have attributed values in the hundreds of millions of dollars to companies which in my opinion are far less advanced in the clinic than we are with ThromboView®. Also, our Agen Biomedical subsidiary was a pioneer in the antibody space in Australia and we believe was the first Australian company to take a monoclonal antibody from the research bench into the clinic,” Mr Leggett said.
END
For more information contact:
Mr Neil Leggett CEO and Managing Director Agenix Limited Ph: + 61 408 151270
Agenix Limited [ASX: AGX, OTC (NASDAQ): AGXLY ] is a biotechnology company based in Brisbane, Australia. Through its wholly owned subsidiaries, Agen Biomedical Ltd and Agenix Bio-Pharmaceutical (Shanghai), the company has a strategic goal of building and developing a pipeline of therapeutic and imaging products.
Agenix Biopharmaceutical (Shanghai) has ownership interests in two associated Chinese life sciences companies. One, Shanghai Rui Guang Bio-Pharma Development Co., Ltd, is a biopharmaceutical company which has a pipeline of antiviral drugs in development. Its lead product candidate, a hepatitis B virus drug, has successfully completed Phase III clinical trials in China and has received China State Food and Drug Administration approval for market launch in China. The second, Shanghai Yi Sheng Yuan Pharmaceutical Co., Ltd, has a GMP certified manufacturing facility which has the capacity to produce 150 million tablets per annum (based on a 5-day working week at 8 hours per day).
Agen Biomedical’s lead candidate is its high-technology blood clot-imaging agent, ThromboView[®] ,which has been undergoing human clinical trials in the United States, Canada and Australia. ThromboView[®] uses radio-labelled antibodies to locate blood clots in the body, and could revolutionise the global clot diagnostic imaging market. A Phase II pulmonary embolism clinical trial has just commenced in the United States and Canada. ThromboView[®] is being developed with the assistance of the Australian Federal Government through its START scheme. ThromboView[®] is a registered trademark of Agen Biomedical Ltd.