IMYN has License Approval in Europe
for it's Biopharmaceutical Drug - Immunosyn Corporation has approval from the MHRA to import base material and manufacture it's drug for human use in clinical trials. Immunosyn holds the exclusive license for worldwide marketing rights.
The "Medicines and Healthcare products Regulatory Agency," more commonly known as the MHRA, functions in the United Kingdom on behalf of the European Medicines Agency (EMEA) much like the FDA does in the United States. MHRA regulates which drugs are safe and effective for use in humans to treat specific ailments and conditions. The license approvals currently granted by the MHRA include a "Manufacturer's Authorisation -- Investigational Medicinal Products" (MIA (IMP)) as well as "Manufacturer's / Importer's Licence" (MIA) 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.
"The fact that it has garnered manufacturing and import approval from the MHRA so rapidly is exciting news," says Stephen D. Ferrone, CEO and President of Immunosyn, "as every milestone we achieve in this process brings us that much closer to producing revenue for our shareholders."
"This is another example whereby Immunosyn's shareholders strongly benefit from our unique relationship with our largest shareholder, Argyll Biotechnologies," stated David Criner, CFO of Immunosyn. "Under the terms of our exclusive license agreement, Argyll Biotechnologies is responsible for all regulatory approvals and clinical trials including those required by the MHRA and FDA together with their associated costs."
Under EMEA requirements, in order to obtain approval to manufacture a drug for use in humans, whether for clinical trials or for general use, an approved manufacturer must be able to demonstrate its ability to comply with the rules governing "Good Manufacturing Practice" (GMP) and apply directly to the MHRA for license approval. Following a series of manufacturing "scale-up" studies, Argyll Biotechnologies entered into an agreement with Biozyme Laboratories. As a result of this agreement, Biozyme applied for and received manufacturing and base materials import approval from MHRA for clinical trials for the Immunosyn Corporation.
