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news.Biozyme Laboratories has received approval from the UK's Medicines and Healthcare Products Regulatory Agency to import base material and manufacture its biopharmaceutical drug for human use in clinical trials.
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Immunosyn holds the exclusive license for worldwide marketing rights of the drug, SF-1019, while Biozyme Laboratories has agreed to manufacture SF-1019.
The license approvals currently granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) include a ‘manufacturer’s authorization-investigational medicinal products’ as well as ‘manufacturer’s/importer’s licence’ for manufacturing investigational medicinal products for use in humans for Phase I, II and III clinical trials. If a company successfully completes these trials it can apply for a full license to distribute throughout the European Union.
Stephen Ferrone, CEO and president of Immunosyn, said: “The fact that SF-1019 has garnered manufacturing and import approval from the MHRA so rapidly is exciting news as every milestone we achieve in this process brings us that much closer to producing revenue for our shareholders.”