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Our Products
Existing Biopharmaceuticals
We have identified several existing and commercially available protein-based biopharmaceuticals for which a substantial market exists. Prolong Pharmaceuticals believes that a PEGylated version of these products can garner a substantial portion of the market. This market includes erythropoietin (EPO; off-patent in 2004 OUS and 2013 US) and interferon-beta (off-patent in 2003) and G-CSF (off-patent in 2008). The loss of patent protection and the growing demand for reasonably priced versions of these products suggest that Prolong should quickly garner substantial market share. The Company's market analysis suggests that sales of additional PEG-products could increase the size of the worldwide PEGylated biopharmaceutical market to over $25 billon by 2010.
The Company estimates that the time to market for its PEGylated versions of existing biopharmaceuticals will be significantly less than that of a completely new biopharmaceutical because both PEGylation and the underlying drugs have already been highly investigated.
Prolong Pharmaceuticals' PEG-EPO
Erythropoietin, or EPO, is a biopharmaceutical that stimulates the pre-cursors of red blood cells, thus providing a solution for anemia that was never before possible. Erythropoietin, developed and marketed by Amgen as EPOGEN®, and licensed to Johnson and Johnson and marketed as PROCRIT®, has been the most financially successful biopharmaceutical ever introduced. Amgen estimates its EPO sales for 2003 to be between $3.2 billion and $3.4 billion, while Johnson and Johnson estimates its global Procrit® sales for 2003 to be $3.6 billion.
The worldwide demand for erythropoietin-based products (2004 global sales of $10.7 billion) is unprecedented in the history of biopharmaceutical industry. The composition of matter patent for erythropoietin has expired. Consequently, several biopharmaceutical companies have already received approval to sell biogeneric versions of erythropoietin in Europe and Asia, with many more targeting this marketplace.
Prolong Pharmaceuticals has developed a PEGylated version of erythropoietin (EPEG) that, in animals, is clinically superior to and requires fewer injections than non-PEGylated erythropoietin. Moreover, an added benefit of PEGylation is that less protein (as compared with the unmodified protein) can be administered to achieve the desired therapeutic effect. This, in turn, results in lower raw material costs since the amount of protein per dose is substantially reduced. The Company believes that the superior clinical performance of EPEG, coupled with lower manufacturing costs, will enable Prolong to quickly penetrate the erythropoietin market and supplant competitors in this space.
We are currently negotiating marketing rights for EPEG and other products with a number of foreign companies. The company's strategy is to complete foreign clinical trials prior to US licensing.
Novel Protein Therapeutics
While it is the Company's intention to address the existing biopharmaceutical market, Prolong Pharmaceuticals recognizes enormous potential in this nascent industry to collaborate with developers of novel protein therapeutics to create second-generation products utilizing our expertise in PEGylation. While at Enzon, Dr. Abuchowski successfully PEGylated as many as 50 different proteins. Prolong is therefore planning to acquire the rights to many of these and other proteins via joint venture, licensing, R&D relationships, and strategic acquisition. The Company believes that its efforts in this area will lead to a significant and diverse product portfolio.
Examples of some of the many products being pursued are:
- PEG-uricase for the treatment of hyperuricemia due to gout or
following chemotherapy
- PEG-arginase for treatment of melanoma and Hepatocellular carcinoma
- PEG-protein for the treatment of hypovolemic shock.
- PEG-peptide antibiotic to treat Staphylococcus infections
- PEG-streptokinase for myocardial infarcts
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