Approval for Treatment, Marketing and Distribution in Malaysia
Immunosyn Corporation is currently marketing, distribution and patient treatment approval has been granted by the Ministry of Health Malaysia for SF-1019 in the Private Pay Heath Sector in Malaysia. The marketing name for SF-1019 in Malaysia will be R-1818. Argyll Biotechnologies, LLC, the licensor of SF-1019, Immunosyn?s strategic partner and its largest shareholder, has notified Immunosyn that the Ministry of Health Malaysia has approved the importation, marketing and distribution of SF-1019 in the Private Pay Health Sector throughout Malaysia for the treatment of Diabetic Mellitus, Diabetic Neuropathy, Diabetic Ulcers as well as other Chronic Inflammatory and Degenerative Diseases. The Ministry of Health has also given approval for treating physicians in Malaysia to prescribe and export SF-1019 to patients residing outside of Malaysia. ?Today marks an important chapter in our company?s entrance into the global markets and we are looking forward to commercially launching SF-1019,? said Stephen D. Ferrone, President and CEO of Immunosyn. ?Malaysia is the first country to grant regulatory marketing, treatment and distribution approval of SF-1019,? Ferrone added, ?Immunosyn hopes to make Malaysia a central distribution hub in order for patients worldwide to be able to receive the benefit of SF-1019.? Argyll Biotech has worked for several years on developing the manufacturing processes, protocols, safety procedures and guidelines for SF-1019. Immunosyn, together with Argyll Biotech, is working to finalize Distribution Management and Information Component Systems that will be implemented to define protocols to assure patient safety and regulatory compliance in Malaysia as well as throughout the world prior to treatment commencing. In addition, Argyll Biotech will apply for an import license from Malaysian authorities. These steps are expected to be completed during the fourth quarter of 2008. Argyll Biotech has advised Immunosyn that they plan to continue the process to obtain full regulatory approvals for the marketing of SF-1019 throughout Asia as well as in Europe and then the U.S. ?The healthcare spending of Malaysians is incredibly high, reflecting the trend of Malaysians towards a healthy lifestyle,? stated Douglas A. McClain, Jr., Chairman of the Board and CFO of Immunosyn. ?This is an exciting early-stage development as this puts revenue producing capabilities within short-term range for the company.? SF-1019 is a compound that was developed from extensive research into Biological Response Modifiers. This research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetes Mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders. Results from a recent study undertaken in Europe to evaluate the safety and efficacy of SF-1019 in the treatment of Diabetic Ulceration and its effect on Diabetic Polyneuropathy in Type 1 Diabetes Mellitus suggest that SF-1019 promotes wound healing and induces growth factors. Globally, according to Diabetes Atlas, third edition ? International Diabetes Federation, 2006 and www.diabetes.niddk.nih.gov: Approximately 246 million people have Diabetes Mellitus Estimated 50% (143 million) have Diabetic Neuropathy (DN) 1 in 6 (41 million) will develop a foot ulcer Malaysia has a population of just over 25,000,000 people. According to the Ministry of Health Malaysia, in 2008 nearly 17% of the general population of Malaysia had Diabetes Mellitus. The Ministry states in its
