Oxygen Carriers Enzyme Carriers Other Drug Carriers

Oxygenix is developing the world's first cell-type Oxygen Carrier, OXY-0301. It will also develop new protein-based drugs using its unique formulation technology exploited through OXY-0301. 　Development of Oxygen Carrier, OXY-0301 　Development of new protein-based liposomal drug Oxygenix's leading product candidate, OXY-0301, is an Oxygen Carrier that contributes to the stable supply of safe erythrocyte products. At present, almost all erythrocyte derivatives, which are essential for human health care, are prepared using donated blood from volunteers. Effective measures must be taken as soon as possible to deal with decreases in the amount of donated blood in an aging society with fewer young generation who would be volunteers. Oxygenix believes that the development of OXY-0301, which effectively utilizes expired donated blood, can contribute to the society. Because of its unique features such as the possibility of long-term storage at room temperature and its use in patients without blood-type matching test, the applications listed below are expected for OXY-0301. Expected applications 1. Transfusion in the event of emergency 2. Transfusion for massive bleeding patients Natural erythrocyte product OXY-0301 3 weeks storage in refrigerator Long-term storage at room temperature Depending on blood groups (ABO, Rh+-, etc.) Universal compatibility The characteristics listed above differentiate OXY-0301 from natural erythrocyte products. Taking advantage of these features, OXY-0301 can be used in the case of unexpected massive bleeding during elective surgery. It can also be transfused immediately without checking blood groups of the recipient in case of emergency. 3. Treatment for ischemic diseases Size of OXY-0301 is about 1/30 of an erythrocyte. Because of this rather small size, OXY-0301 efficiently delivers oxygen to ischemic areas where conventional erythrocyte products cannot reach. This is a unique approach, categolized in oxygen therapeutics. Cerebral infarction is an example of ischemic diseases. OXY-0301 can provide unique oxygen therapeutics which keeps delivering oxygen into infracted sites. The therapy is expected to alleviate aftereffect of cerebral infarction and bring better recovery. In Japan, nearly 320,000 patients are transported by ambulance due to cerebral infarction every year. The approximate number is 1 million in the US and Europe. OXY-0301 is expected to satisfy this unmet medical needs through oxygen therapeutics. 4. Stock-pilling in case of catastrophes Because natural erythrocyte products can be stored only for 3 weeks in a refrigerator, they cannot be stockpiled in case of catastrophes. OXY-0301, which can be stored for much longer time at room temperature, is expected to be available anytime. It is also anticipated that OXY-0301 can be useful in areas where healthcare services are limited. Good healthcare services, including blood transfusion, are available only in a small number of countries at present. Some areas in Africa, Southeast Asia, Latin America, inland of the Eurasian Continent (West Asia) and China and small isolated islands have difficulties in establishing and maintaining system for natural blood products. The incidence of infections associated with blood transfusion is also very high. OXY-0301 would contribute to the society in these countries and regions. Agreement with Nipro Corporation for future commercial production Oxygenix has signed a partnership agreement with Nipro Corporation in May 2006 in preparation for future commercial production. With this agreement, Oxygenix will receive strong support for all processes, from manufacturing to marketing, from Nipro using its extensive and strong global network. According to the agreement, Nipro will start designing a GMP plant to manufacture OXY-0301 in 2007 and producing OXY-0301 as an investigational new drug in 2009. Both Oxygenix and Nipro will move toward mass production and commercialization step by step. The two companies will closely cooperate to establish a solid global business strategy. (top of page) At present, most global blockbusters are low-molecular-weight compounds. However, almost all of these compounds were well developed till the end of the previous century, and pharmaceutical companies have experienced in increasing difficulties in developing new drugs for this decade. Oxygenix will develop new protein-based drugs taking advantage of the unique formulation technologies which have been accumulated inhouse during development of OXY-0301. Advantages of Oxygenix's formulation technology 1. Effective product lifecycle management Product lifecycle management consists of establishing and implementing strategies to maximize sales life-time of drugs. By utilizing Oxygenix's formulation technologies, its patented period would be extended and it will lead to maximize the value of the product. 2. Increases in success-rate Oxygenix' unique formulation technologies can help reducing the risk of adverse reactions and it will lead to increase the drug developmental success-rate effectively. Building a solid R&D pipeline, centered on protein-based drugs Various liposome preparations with low-molecular-weight compounds and macromolecular micelles have been studied for more efficient delivery, and some of them are already on the market. However, no protein-based liposome preparations have been commercialized due to the greater complexity in their developments. Many problems were remained regarding the preparations include the following:     (1) Capability to encapsulate proteins efficiently in liposomes     (2) High production cost     (3) Difficulty in scaling up for liposome production. Oxygenix has a GMP production facility for clinical trials and the technology required for manufacturing protein-based liposome preparations, and it has overcome many of those difficulities. Oxygenix plans to effectively utilize its assets to establish the world-leading position in the field of protein-based liposomal drugs.