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10-Q: VIRAGEN INC
Recent Developments
In February 2004, we filed a patent application with the British Patent Office covering the use of natural, multi-subtype alpha interferon for human treatment and prevention of avian influenza virus, commonly known as avian flu.
Avian influenza is an infectious viral disease of birds caused by type A influenza strain. The type A influenza group of viruses have certain characteristics that make them of particular concern to the human population. They have a tendency to undergo mutation, resulting in new variants for which no vaccine is available. In addition, such viruses have the potential to combine with viruses from other species, leading to pandemics due to the resulting difficulties in developing effective treatments or preventative measures.
While no studies are currently planned or ongoing, we believe that Multiferon is a prime candidate for evaluation in avian influenza studies. We are contacting those international research organizations which are conducting studies in this area and offering samples of our product for in vitro and human evaluations.
In November 2003, we entered into an agreement with Pentafarma S.A. (Pentafarma) to distribute our natural human alpha interferon, Multiferon, exclusively in Chile. Headquartered in Santiago, Pentafarma is a specialized leader for the distribution of healthcare products related to dialysis and nephrology and is a wholly-owned subsidiary of Fresenius Medial Care, the worlds largest, integrated provider of products and services for chronic kidney failure. Pentafarma believes that Multiferon may offer benefits to a growing segment of its dialysis patients and intends to initially evaluate the use of Multiferon in dialysis patients diagnosed with chronic hepatitis C. The agreement provides that Pentafarma shall take all measures necessary to achieve regulatory approval of Multiferon in Chile.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. On an on-going basis, we evaluate our estimates, including those related to inventories, depreciation, amortization, asset valuation allowances, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.
Inventories. Inventories consist of raw materials and supplies, work in
process and finished product. Finished product consists of purified
natural human alpha interferon. Our inventories are stated at the lower of
cost or market (estimated net realizable value). Raw materials and
supplies cost is determined on a first-in, first-out basis. Work in
process and finished product costs consisting of raw materials, labor and
overhead are recorded at a standard cost (which approximates actual cost).
Excess/idle capacity costs are expensed in the period in which they are
incurred. If the cost of the inventories exceeds their expected market
value, provisions are recorded currently for the difference between the
cost and the market value. These provisions are determined based on
estimates. The valuation of inventories also requires us to estimate
excess inventories and inventories that are not saleable. The
determination of excess or non-saleable inventories requires us to
estimate the future demand for our product and consider the shelf life of
the inventory. If actual demand is less than our estimated demand, we
could be required to record inventory reserves, which would have an
adverse impact on our results of operations.
Recent Developments
In February 2004, we filed a patent application with the British Patent Office covering the use of natural, multi-subtype alpha interferon for human treatment and prevention of avian influenza virus, commonly known as avian flu.
Avian influenza is an infectious viral disease of birds caused by type A influenza strain. The type A influenza group of viruses have certain characteristics that make them of particular concern to the human population. They have a tendency to undergo mutation, resulting in new variants for which no vaccine is available. In addition, such viruses have the potential to combine with viruses from other species, leading to pandemics due to the resulting difficulties in developing effective treatments or preventative measures.
While no studies are currently planned or ongoing, we believe that Multiferon is a prime candidate for evaluation in avian influenza studies. We are contacting those international research organizations which are conducting studies in this area and offering samples of our product for in vitro and human evaluations.
In November 2003, we entered into an agreement with Pentafarma S.A. (Pentafarma) to distribute our natural human alpha interferon, Multiferon, exclusively in Chile. Headquartered in Santiago, Pentafarma is a specialized leader for the distribution of healthcare products related to dialysis and nephrology and is a wholly-owned subsidiary of Fresenius Medial Care, the worlds largest, integrated provider of products and services for chronic kidney failure. Pentafarma believes that Multiferon may offer benefits to a growing segment of its dialysis patients and intends to initially evaluate the use of Multiferon in dialysis patients diagnosed with chronic hepatitis C. The agreement provides that Pentafarma shall take all measures necessary to achieve regulatory approval of Multiferon in Chile.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. On an on-going basis, we evaluate our estimates, including those related to inventories, depreciation, amortization, asset valuation allowances, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.
Inventories. Inventories consist of raw materials and supplies, work in
process and finished product. Finished product consists of purified
natural human alpha interferon. Our inventories are stated at the lower of
cost or market (estimated net realizable value). Raw materials and
supplies cost is determined on a first-in, first-out basis. Work in
process and finished product costs consisting of raw materials, labor and
overhead are recorded at a standard cost (which approximates actual cost).
Excess/idle capacity costs are expensed in the period in which they are
incurred. If the cost of the inventories exceeds their expected market
value, provisions are recorded currently for the difference between the
cost and the market value. These provisions are determined based on
estimates. The valuation of inventories also requires us to estimate
excess inventories and inventories that are not saleable. The
determination of excess or non-saleable inventories requires us to
estimate the future demand for our product and consider the shelf life of
the inventory. If actual demand is less than our estimated demand, we
could be required to record inventory reserves, which would have an
adverse impact on our results of operations.
Die aber sicher auch!!
Bird Flu Hits U.S.; GenoMed Believes It Has Cure for the Human Disease
ST. LOUIS, Feb 9, 2004 /PRNewswire-FirstCall via COMTEX/ -- GenoMed Inc. ("the
Company" or "GenoMed") (National Quotation Bureau`s Pink Sheets Symbol GMED)
announced today that its treatment approach to viruses, which tones down the
host`s immune response rather than trying to kill the virus, should be effective
against the bird flu.
In humans, some strains of bird flu kill by causing lung failure. At autopsy,
the lungs of people who die of bird flu resemble those of people who have died
from SARS or influenza A infection, two other lethal viruses in the news this
past year.
The lung is invaded by immune cells called macrophages, and the lung`s tiny air
sacs get filled up with fluid. Relatively little virus is present. What kills
people is therefore an overly exuberant immune response to an entirely new
virus, not proliferation of the virus itself.
GenoMed has identified a very early step in the immune response which can be
turned off safely and effectively using already existing drugs. The result is
fast recovery from viral disease, in other words, a cure.
This approach has already produced prompt recovery from another frequently
lethal viral disease, West Nile virus encephalitis. Seven out of eight patients
(88%) with West Nile virus encephalitis were cured in an average of 24 hours
this past September. This case series, although small, represents the best
results so far against West Nile virus encephalitis. These results will be
published in the Pharmacogenomics issue of Current Topics in Medicinal
Chemistry, a well respected, peer-reviewed medical journal.
For an independent assessment of GenoMed`s West Nile virus results, please see
the recent article by Steve Mitchell, UPI Medical Correspondent, available at:
http://washingtontimes.com/upi-breaking/20031204-040206-6908…
A safe, effective cure for a viral disease makes killing the reservoir for the
virus unnecessary. So a cure for West Nile virus encephalitis makes it less
critical to kill mosquitoes. If GenoMed`s approach also cures bird flu, then
there will be little reason to slaughter poultry. The same is true for the SARS
virus and civet cats in China: a cure makes culling unnecessary.
GenoMed`s "universal vaccine" against most viral diseases involves blocking
angiotensin II, using drugs already known to be extremely safe since they have
been used in hundreds of millions of patients worldwide since 1980.
Angiotensin II gets the immune response started and keeps it going. Angiotensin
I-converting enzyme (ACE), the enzyme which produces angiotensin II, is
expressed on macrophages when they become activated. All immune cells, including
macrophages, contain receptors for angiotensin II.
Blocking angiotensin II production with a suitable ACE inhibitor, or the action
of angiotensin II at its receptors with an angiotensin II receptor blocker
(ARB), should therefore tone down the host`s immune response. GenoMed has seen
this approach work for several autoimmune diseases over the past year and a
half.
The patient`s blood pressure guides whether an ACE inhibitor or an ARB is used.
ARB`s at low doses can tone down the immune system without lowering blood
pressure at all.
Said Dr. David Moskowitz, GenoMed`s Chief Medical Officer and CEO, "It is
impossible to eradicate a virus`s entire animal reservoir. We can`t kill all the
birds in the world. Nor is it ethical to quarantine populations for a
transmissible virus like SARS when a cure may exist, as it now does. GenoMed`s
treatment approach lets us live with new viruses without having to devise a new
vaccine against each new strain. This may be bad news for vaccine companies but
wonderful news for public health."
Dr. Moskowitz continued, "Anyone can test our approach for themselves; the trial
is completely free from our end. This message is especially important for people
getting sicker rather than recovering as fast as expected from a flu-like
illness."
Dr. Moskowitz concluded, "The Internet now makes it possible for anybody to
enroll in our flu trial at any time of day or night anywhere in the world,
simply by going to our website (www.genomedics.com) and clicking on `Flu trial.`
We`d like people to enter a working email address so that we can follow up with
them. Then they`ll be able to download an informed consent to discuss with their
physician. The patient`s own physician will prescribe the medication. A family
member could easily do this for a child getting worse with the flu, for
example."
The drugs GenoMed uses are safe enough to allow for their preventive use, and
are available in every corner drug store around the world. Most general
practitioners are quite comfortable using them to treat high blood pressure.
Bird Flu Hits U.S.; GenoMed Believes It Has Cure for the Human Disease
ST. LOUIS, Feb 9, 2004 /PRNewswire-FirstCall via COMTEX/ -- GenoMed Inc. ("the
Company" or "GenoMed") (National Quotation Bureau`s Pink Sheets Symbol GMED)
announced today that its treatment approach to viruses, which tones down the
host`s immune response rather than trying to kill the virus, should be effective
against the bird flu.
In humans, some strains of bird flu kill by causing lung failure. At autopsy,
the lungs of people who die of bird flu resemble those of people who have died
from SARS or influenza A infection, two other lethal viruses in the news this
past year.
The lung is invaded by immune cells called macrophages, and the lung`s tiny air
sacs get filled up with fluid. Relatively little virus is present. What kills
people is therefore an overly exuberant immune response to an entirely new
virus, not proliferation of the virus itself.
GenoMed has identified a very early step in the immune response which can be
turned off safely and effectively using already existing drugs. The result is
fast recovery from viral disease, in other words, a cure.
This approach has already produced prompt recovery from another frequently
lethal viral disease, West Nile virus encephalitis. Seven out of eight patients
(88%) with West Nile virus encephalitis were cured in an average of 24 hours
this past September. This case series, although small, represents the best
results so far against West Nile virus encephalitis. These results will be
published in the Pharmacogenomics issue of Current Topics in Medicinal
Chemistry, a well respected, peer-reviewed medical journal.
For an independent assessment of GenoMed`s West Nile virus results, please see
the recent article by Steve Mitchell, UPI Medical Correspondent, available at:
http://washingtontimes.com/upi-breaking/20031204-040206-6908…
A safe, effective cure for a viral disease makes killing the reservoir for the
virus unnecessary. So a cure for West Nile virus encephalitis makes it less
critical to kill mosquitoes. If GenoMed`s approach also cures bird flu, then
there will be little reason to slaughter poultry. The same is true for the SARS
virus and civet cats in China: a cure makes culling unnecessary.
GenoMed`s "universal vaccine" against most viral diseases involves blocking
angiotensin II, using drugs already known to be extremely safe since they have
been used in hundreds of millions of patients worldwide since 1980.
Angiotensin II gets the immune response started and keeps it going. Angiotensin
I-converting enzyme (ACE), the enzyme which produces angiotensin II, is
expressed on macrophages when they become activated. All immune cells, including
macrophages, contain receptors for angiotensin II.
Blocking angiotensin II production with a suitable ACE inhibitor, or the action
of angiotensin II at its receptors with an angiotensin II receptor blocker
(ARB), should therefore tone down the host`s immune response. GenoMed has seen
this approach work for several autoimmune diseases over the past year and a
half.
The patient`s blood pressure guides whether an ACE inhibitor or an ARB is used.
ARB`s at low doses can tone down the immune system without lowering blood
pressure at all.
Said Dr. David Moskowitz, GenoMed`s Chief Medical Officer and CEO, "It is
impossible to eradicate a virus`s entire animal reservoir. We can`t kill all the
birds in the world. Nor is it ethical to quarantine populations for a
transmissible virus like SARS when a cure may exist, as it now does. GenoMed`s
treatment approach lets us live with new viruses without having to devise a new
vaccine against each new strain. This may be bad news for vaccine companies but
wonderful news for public health."
Dr. Moskowitz continued, "Anyone can test our approach for themselves; the trial
is completely free from our end. This message is especially important for people
getting sicker rather than recovering as fast as expected from a flu-like
illness."
Dr. Moskowitz concluded, "The Internet now makes it possible for anybody to
enroll in our flu trial at any time of day or night anywhere in the world,
simply by going to our website (www.genomedics.com) and clicking on `Flu trial.`
We`d like people to enter a working email address so that we can follow up with
them. Then they`ll be able to download an informed consent to discuss with their
physician. The patient`s own physician will prescribe the medication. A family
member could easily do this for a child getting worse with the flu, for
example."
The drugs GenoMed uses are safe enough to allow for their preventive use, and
are available in every corner drug store around the world. Most general
practitioners are quite comfortable using them to treat high blood pressure.
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