A Novel Inexpensive Process for Preparation of Polymeric Microspheres

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The technology patented by SpheriTech and described in this application isnot only novel but provides an inexpensive and efficient means formanufacture of polymeric microspheres.Page 3 of44The most important objective is to identify a range of polymers and linkagetechnologies for the three target markets. Identification of specific protocolsand technical know how is essential for the success of this work. Ultimatelythis will lead to large scale production of specialist polymeric microspheres foreach chosen market sector.In biocatalysis the worldwide market for the competing technology ismeasured in the region of $25 billion (Biocombinatorial Approaches for DrugFinding, Springer Berlin Heidelberg. ISBN 978-3-540-22092-3). $50 billion ofthe $800 billion global commodity, specialty, and fine chemicals markets arereadily addressable by bioprocesses. Another $200 billion has been identifiedas potentially addressable by biological app~oaches in the next 1 0 to 20 years(Chemical & Engineering News, Volume 79, Number 21).Peptide based drugs are already a major section of the pharmaceuticalportfolio. Sales of the top ten peptide based drugs total over $2000mannually and the top five of these are in the late stages of patent protection.The highest value market sector in peptides is in the area of prostate cancertherapy and since these were developed almost concurrently by majorpharmaceutical companies they are all nearing the end of their patent life.Leuprolide (Bayer AG, Sanofi-Aventis and others) came off patent in 2005and already there are 5-6 generic drug manufacturers showing interest. DrDon Wellings, the founder and CEO of SpheriTech has consulted on thesynthesis of Leuprolide for three individual companies that cannot be namedfor reasons of confidentiality.Affinity chromatography, used in the purification of biopharmaceuticals is thehighest contributor to the cost of manufacture. lmmobilised Protein A (anatural protein capable of binding to various classes of immunoglobulin [lg]molecules, excreted by various bacterial strains) for example is used for thepurification of monoclonal antibodies. The market size for Protein A media in2007 was estimated to be $49 million and the market size in 2013 isestimated to be $70 million based on an average annual growth rate of 6% inantibody production.More detailed market research is covered in Part C of this application.SpheriTech plans to obtain a significant market share within each marketsector in 3-4 years.