SF-1019 Receives Approval for Treatment, Marketing and Distribution in Malaysia
August 12 2008 - 9:00AM
Business Wire
Immunosyn Corporation (OTCBB:IMYN) announced today that 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 �Clinical Practices Guideline for Management of
Diabetic Foot� that, �Diabetic foot complications pose a
substantial problem in the Malaysian diabetic population. They are
a major source of morbidity, a leading cause of hospital bed
occupancy and account for substantial health care costs and
resources.� In a report released in August, 2004, the Ministry
noted, �The prevalence of foot ulceration in patients attending a
diabetic outpatient clinic in Malaysia has been reported as 6%.
Foot complications have been found to account for 12% of all
diabetic hospital admissions which in turn made up 17% of all
hospital admissions at Hospital Kuala Lumpur, Malaysia.� In
addition to its own residents, Malaysia has a Health Tourism
Industry which according to the Association of Private Hospitals
Malaysia has an annual growth rate of 25 � 30% per year. The
association attributes this growth rate to many factors including,
but not limited to, the choice of world class infrastructure
facilities, combined with high qualified, experienced practitioners
and competitive, affordable pricing. About Immunosyn Corporation La
Jolla, CA-headquartered Immunosyn Corporation (OTCBB:IMYN) plans to
market and distribute life enhancing therapeutics. Currently, the
company has exclusive worldwide rights from its largest
shareholder, Argyll Biotechnologies, LLC, to market, sell and
distribute SF-1019. Argyll Biotechnologies, LLC has initiated the
process for regulatory approval of SF-1019 in several countries and
preparations for clinical trials are underway in both the US and
Europe. (For more information on Immunosyn and SF-1019 go to
www.immunosyn.com). The above news release contains forward-looking
statements. These statements are based on assumptions that
management believes are reasonable based on currently available
information, and include statements regarding the intent, belief or
current expectations of the Company and its management. Prospective
investors are cautioned that any such forward-looking statements
are not guarantees of future performance, and are subject to a wide
range of business risks, external factors and uncertainties. Actual
results may differ materially from those indicated by such
forward-looking statements. For additional information, please
consult the Company�s most recent public filings and Annual Report
on Form 10-KSB for its most recent fiscal year. The Company assumes
no obligation to update the information contained in this press
release, whether as a result of new information, future events or
otherwise.