Dragon’s Generic Therapeutics Program is focused on commercializing biologic drugs in markets that are not protected by existing gene patent protection. These markets include China, Central and Eastern Europe, the Middle East, South America, and ASEAN countries. To date, markets outside of North America and the European Union have had very limited access to EPO because of its high cost. Dragon believes that the EPO market in these countries will expand considerably with the availability of a more affordable product. On expiry of the EPO gene patent in 2004, Dragon will expand its distribution base to include North America and the European Union.
Reduced Time to Commercialization
Dragon’s product development strategy minimizes R&D costs and time to initial commercialization by establishing production and initial regulatory approvals in China. The overall new drug development process required to support SDA registration in China is similar to the process required by the FDA. However, the SDA requires fewer numbers of patients in Phase III clinical trials, thereby allowing for substantial reductions to both the time and cost of new drug development.
Dragon chose to validate its technology platform and business strategy with the development and commercialization of its first generic product, Epoetin Alfa, or EPO. Since the Company’s inception in 1998, Dragon has become one of the world’s largest capacity and lowest cost EPO producers, and is now poised to become a leading world supplier of EPO.
EPO is indicated for the treatment of severe anemia associated with chronic renal failure and in cancer patients undergoing chemotherapy. Anemia occurs in 90% of kidney dialysis patients and in up to 60% of cancer patients. EPO also has application in the treatment of surgical patients to increase the yield of autologous blood prior to surgery and reduce the need for blood transfusions during surgery, and in HIV patients undergoing treatment with Zidovudine.
Since the introduction of EPO in 1989, it has become the world’s fastest growing drug in terms of annual sales, with global sales in excess of $6 billion in 2001. The market opportunity for generic EPO will see tremendous growth following the 2004 expiry of key EPO patents in major developed world markets. EPO sales in non-patent protected, developing world markets are also anticipated to expand significantly over the next few years with the increasing availability of affordable, high quality generic product.
Dragon’s EPO has received regulatory approval for use in chronic renal failure in China, Egypt, India and Peru. Additional regulatory applications are in progress for this indication in numerous key, non-patented markets.
In 2001, Dragon initiated pivotal multicentre Phase II/III clinical trials in patients with anemia related to surgery and to chemotherapy. The surgery trial was completed and an application for a New Drug License for this indication was submitted to the Chinese SDA late that year. We expect to complete the chemotherapy trial and file our regulatory submission with the SDA during 2002.
Following the success of our flagship product, EPO, we are now applying our technology platform in the following product pipeline.
|PROTEIN||ACTION & INDICATIONS|
|Slow-Release EPO*||Stimulates red blood cell production in anemia due to kidney failure, surgery and cancer therapy. Requires fewer injections than conventional EPO.|
|Granulocyte-Colony Stimulating Factor||Stimulates white blood cell production in leukopenia related to chemotherapy.|
|Human Insulin||Regulates glucose levels in diabetes|
|Thrombopoietin||Stimulates platelet production in thrombocytopenia related to chemotherapy.|