Apollo develops needle free and better performing biopharmaceuticals for many diseases, by combining its oral/transdermal delivery systems with natural human proteins to overcome challenges faced by first generation biopharmaceuticals.

Drugs based on therapeutic proteins are part of the global biopharmaceuticals market, with an estimated value of US$50 billion a year in 2005 and 10% annual growth rate. These biopharmaceuticals are a growing class of therapeutics for disorders and diseases ranging from inflammation and auto-immunity to cancer. Proteins and antibodies together represented approximately 57% of the new biopharmaceutical entities approved by the US Food and Drug Administration in 2005. The increasing rate of R&D growth in biopharmaceutical industry can be observed by the number of annual new molecular entity (NME) submissions to the US FDA, which in 2005, rose for a third year in a row to a new six-year-high.

Administration of most existing biopharmaceuticals requires injections, due to size and other physical limitations that prevent their successful delivery in tablet or cream form. Existing biopharmaceuticals have also not been effective in all patients and a number cause immune-related response with repeated use. Apollo has made significant advances in overcoming these limitations, and has developed proprietary technologies that enable biologic administration either in tablet or cream formulation. These forms of delivery are normally preferred over injections. Furthermore, the company's biopharmaceuticals are less likely to cause immune responses and more likely to be effective at lower doses. This is because Apollo's hcx™ proteins more closely mimic those in the human body.

Apollo has multiple products in development, and has chosen to focus on the development of drugs to meet the need for new or improved treatments for diabetes and autoimmune/ inflammatory conditions. These are being developed simultaneously for large world markets.

Administration of biopharmaceuticals such as interferon or TNF blockers topically or in a tablet will improve a patient's comfort and quality of life. Apollo's Oradel™ technology has considerable potential to successfully deliver biopharmaceuticals that have traditionally been administered by injections. It combines the ability to protect the therapeutic protein from the harsh stomach environment and actively promoting transport of the drug into the bloodstream.

Apollo's TransD™ technology breakthrough effectively delivers large water-soluble molecules across the skin and has the potential to be developed for the treatment of psoriasis, acne, urticaria, dermatitis and melanoma. The transdermal route of delivery is also ideally suited for direct delivery to sites such as ligaments, joints and muscles.

The biopharmaceuticals Apollo develops will also perform better because they use proteins that are uniquely human in composition and attachments, such as sugars or fats. By contrast, proteins used in existing biopharmaceuticals have attachments that may be foreign to the human body and cause an immune response, or be unable to function effectively inside the body. The differences are a consequence of being produced in non-human expression systems. Clinical experience and research are showing that the human nature of the attachments can have an impact on drug effectiveness.

Other companies modify their proteins chemically (pegylate) to improve biological half-life and efficacy as these proteins (normally expressed from bacterial and other non-human cell systems) can be rapidly cleared from the circulation without such modifications. In contrast, Apollo's human (hcx™) proteins do not need such artificial modifications as they contain naturally occurring human specific modifications. Thus our range of uniquely human proteins is potentially more efficient and is less likely to provoke side-effects compared to biopharmaceuticals from non-human sources.

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