Companies Involved in the Treatment of Swine Flu 11 comments
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Introduction
On June 11, 2009, the World Health Organization (WHO) declared the swine flu (swine influenza) outbreak as a global pandemic (worldwide outbreak of disease).
To date, 28,774 confirmed cases of swine flu have been reported in 74 countries across the world, including 13,000 confirmed cases in the U.S. The disease has caused 144 deaths throughout the world, including 27 deaths in the U.S. The origin of the swine flu outbreak can be traced to Mexico, where the virus has reportedly killed and infected 108 and 6,241 people respectively (data as of June 11, 2009).
Recently there have been sporadic cases of swine flu reported in countries throughout the world.
This report discusses the details of the disease, the estimates (by the World Health Organization) on the extent of the spreading of the disease, the companies who are currently selling products that are being used to treat this disease and companies that have new flu treatments in their pipelines, which may also be used to target swine flu disease.
Companies with Existing Treatments for Swine Flu
- Gilead Sciences, Inc./Roche Holding Ltd. (GILD/RHHBY.PK) - Tamiflu (oseltamivir)
- GlaxoSmithKline Plc./Biota Holdings Ltd. (GSK/BTAHY.PK) - Relenza (zanamivir)
Companies with Potential Vaccines and Treatments for Swine Flu
- Biota Holdings Ltd. (BTAHY.PK) and Daiichi Sankyo - CS-8958
- BioCryst Pharmaceuticals, Inc. (BCRX) - Peramivir Intravenous
- Novavax Inc. (NVAX) - swine flu vaccines by using Virus-like particle (VLP) technology
- MedImmune, a unit of AstraZeneca PLC (AZN) - needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology
- Novartis AG (NVS) - swine flu vaccine
- Sanofi-Aventis (SNY) - swine flu vaccine
- Baxter International Inc. (BAX) - swine flu vaccine
What Is Swine Flu?
Swine flu is a highly infectious, severe respiratory disease that most commonly occurs in pigs (swine). This disease is caused by the H1N1 strain of the Type A influenza virus (see explanation below).
Though swine flu frequently occurs in swine and causes high levels of illness, it has rarely been known to kill the swine. The 2009 flu outbreak is being referred to as ‘Swine Flu’ because the form of this virus bears the closest resemblance to the swine flu virus. The 2009 ‘Swine Flu’ is being caused by a modified H1N1 form of the Type A influenza virus, which is infecting humans and has been shown to be fatal in some cases.
The origin of this new strain of H1N1 virus is still unknown, although most hypotheses point to the swine as being the originator of this new mutated (undergone changes in its structural composition) virus strain.
There are 3 types of influenza virus: Type A, Type B and Type C.
Type A influenza virus can cause flu in humans, animals and birds. It is the most infectious type of influenza virus, and is responsible for regular outbreaks.
Type B influenza virus infects only human beings. It causes a less severe infection than the Type A virus and does not cause outbreaks.
Type C influenza virus is able to infect only humans and animals; however, the flu in humans caused by this type of virus is very uncommon, as compared to Type A and Type B. It does not cause outbreaks.
Further explanations (i.e., why Type A can cause an outbreak while Type B and Type C cannot), descriptions, differences and unique characteristics of each of the aforementioned types of influenza virus are discussed later in the report.
- The Type A influenza virus consists of two proteins called hemagglutinin (H protein) and neuraminidase (N protein). There are 16 types of H proteins (H1 to H16) and 9 types of N proteins (N1 to N9). Depending upon the combination of the types of H and N protein, there are various subtypes of the Type A influenza virus, like H1N1 (swine flu), H5N1 (avian flu) etc. The table below lists the various subtypes of the Type A influenza virus that have been found in humans, animals and birds.
- In Humans: H1N1, H1N2, H2N2, H3N2, H5N1, H7N2, H7N3, H7N7, H9N2, H10N7
- In Animals: Pigs: H1N1, H1N2, H3N2 Horses: H3N8, H7N7
- In Birds: H1N1, H1N8, H2N9, H3N2, H3N8, H4N3, H4N6, H5N1, H5N9, H6N1, H6N2, H6N5, H6N8, H7N1, H7N3, H7N7, H8N4, H9N2, H9N6, H10N7, H10N8, H11N6, H11N9, H12N5, H13N6, H14N4, H15N4, H15N9
The swine flu virus (the H1N1, H1N2 and H3N2 subtypes of the Type A influenza virus) seldom infects human beings. The previously reported human cases of swine flu were confined to those who had direct contact with pigs, like people working in the swine industry. However, the current outbreak of swine flu in the human population in Mexico and the U.S is caused by an entirely new and mutated strain of the Type A influenza H1N1 virus, which has never been detected before.
It is theorized that the virus responsible for the current ‘Swine Flu’ outbreak is actually a mixture of the 3 types of H1N1 virus that are found in birds, pigs and humans (see table above). This new strain of the H1N1 virus does not appear to infect pigs, but is infecting only humans. The major concern is its ability to spread from one person to another. The disease started in Mexico, crossed the U.S. border and now threatens to develop into a pandemic. The World Bank estimates that a worldwide flu pandemic could cost approximately $3 trillion.
Despite being different, the virus responsible for the current outbreak shares the same name as the swine flu virus because after the initial analysis of the first few cases, this virus had shown many similar characteristics as that of the swine flu virus. Further analysis subsequently has revealed that the virus also contains some elements of the bird flu and the human flu virus.
On June 11th, 2009, the World Health Organization (WHO) raised the alert to Phase 6, declaring the swine flu as a global pandemic. This is the first influenza pandemic since 1968. The WHO is a United Nations agency that works to strengthen health activities and improve health services internationally. It has a numbered alert level scale, ranging from Phase 1 to Phase 6, which measures the spread and severity of infectious diseases like swine flu. An increase in the number of phase indicates an elevated risk of mass outbreak. The details of the phase alerts are as follows:
Phase 1: There are various flu viruses that circulate among animals. A Phase 1 alert indicates that the virus is circulating amongst animals but it does not cause any human infections.
Phase 2: Indicates that a flu virus in animals can also cause human infections and therefore is considered as a potential pandemic threat, but with low risk.
Phase 3: Indicates that the flu virus causes infection in humans, but there is no report of human-to-human transmission.
Phase 4: Indicates that the virus has a persistent ability to pass from one human being to another and is able to cause outbreaks in certain communities. It denotes a significant increase in pandemic threat.
Phase 5: Indicates that the virus easily spreads from human-to-human and has affected at least two countries in one region of the world. It gives a strong pandemic alert signal.
Phase 6: Indicates that the virus spreads from one country to another country located in different regions of the world, denoting an outbreak of pandemic.
Transmission of the Swine Flu Virus
Swine flu is a highly contagious disease and can directly transmit from an infected human to a healthy person. The human-to-human transmission of the swine flu virus occurs through air. When a swine flu infected person coughs or sneezes without covering his/her mouth and nose, the virus containing bodily fluid in the form of respiratory droplets (drops of moisture expelled from the nasal passages, mouth and throat) enter the air. When this air is inhaled by healthy individuals, the virus enters into his/her body through the respiratory tract.
Sometimes the infection spreads by touching some objects with the virus on their surface and then touching the mouth or nose. It can be noted that the virus does not spread by eating properly handled and prepared pork (pig meat), which is cooked at 160°F temperature.
Structure and Classification of the Influenza Virus
Almost all the round shaped influenza viruses consist of two parts: inner core and outer envelope
Inner core: The inner core comprises of the virus’ genetic material called ribonucleic acid (RNA), which is responsible for the replication process of the virus. The RNA of the virus is found inside a protein called nucleoprotein (also called the structural protein of the virus) that helps in the viral replication process, as well as in selecting the proper host (such as a human, animal or bird cell) where the virus can attach itself and cause an infection.
Outer envelope: The outer envelope is made up of lipids (a type of fat) and proteins. In the Type A and the Type B influenza viruses, the two proteins (called surface proteins), namely H protein and N protein, are present in the lipid layer. In place of H and N surface proteins, the Type C influenza virus contains a different surface protein called glycoprotein 88 (gp88). The surface proteins help the virus to cause the infection in the host cell.
The classification of the influenza viruses into the three categories, namely Type A, Type B and Type C, is based on the type of nucleoprotein present in the inner core of the virus. The different types of influenza viruses have different nucleoproteins.
The Type A influenza virus can be classified into various subtypes, based upon the composition of the two surface proteins, H protein and N protein. As per the various combinations of the 16 types of H and 9 types of N proteins that have been identified till date, there are several subtypes of the virus, namely H1N1, H5N1 and others. All these subtypes can further be classified into different strains (the viruses belonging to the same subtype but with slight changes in the structure).
In contrast to the Type A influenza virus, the Type B and the Type C do not have subtypes, however, they also undergo small changes that results in the formation of a new strain of virus. The formation of subtypes and strains depend upon the ability of the virus to mutate. There are two specific ways by which the influenza virus mutates: Antigenic drift and Antigenic shift.
Antigenic drift – The Influenza viruses undergo small and steady changes in a part of the RNA that has the information of making the surface proteins (H protein and N protein in case of the Type A and B virus; gp88 protein in case of the Type C virus). These changes result in minor alterations in the structure of the surface proteins, resulting in the formation of new strains of the virus. This process is called antigenic drift. All types of influenza viruses (A, B and C) undergo antigenic drift.
Antigenic shift – This is a sudden and abrupt change in the virus that results in the formation of a new form of the virus. It is only the Type A influenza virus (and not B and C) that can undergo an antigenic shift. The Type A influenza virus is able to infect humans, animals as well as birds. Some animals, like pigs, catch the bird flu virus (the Type A influenza virus that normally affects birds), the human flu virus (the Type A influenza virus that normally affects humans) and the pig flu virus (the Type A influenza virus that normally affects pigs). As a result, inside a pig, all the three types of the A influenza viruses meet and can form an entirely new kind of the Type A influenza virus, which has a mixture of the surface proteins of the three original viruses.
This is what is theorized as the origin of the current swine flu outbreak. The causative Type A influenza virus is an entirely new virus and is a mixture of the three Type A influenza viruses that are found in birds, pigs and humans.
Reason Why Only the Type A Influenza Virus Causes Pandemics
Despite the fact that all the three types of influenza viruses can infect humans, it is only the Type A influenza virus that is capable of causing pandemics in the human population. Excluding the current swine flu pandemic (as declared on June 11, 2009 by WHO), the world has suffered three other flu pandemics, which are as follows:
The 1918 pandemic – This flu pandemic was the most severe one, which killed at least 675,000 people in the U.S. and 50 million people worldwide. It was caused by the H1N1 subtype of the Type A influenza virus. This virus originated in birds and mutated itself enough to acquire the ability to infect humans. The disease was first officially acknowledged in Spain in May 1918. In the early months of 1918 (the final year of World War I), a wave of flu appeared in the military camps all over U.S., France and Southern China. However, the news of the flu outbreak in these countries was censored for security reasons since these countries were involved in the war. The news of the outbreak spread around the world, only when the disease appeared in Spain, which was a neutral player in Word War I. Spain did not censor the news of the outbreak and the Spanish press documented the disease in detail.
The 1957 pandemic - This flu pandemic was moderately severe compared to the 1918 pandemic and it took 70,000 lives in the U.S. and killed 1 million to 2 million people worldwide. This was caused by the H2N2 subtype of the Type A influenza virus, which originated in birds, then eventually mutated and infected humans. This flu originated in China.
The 1968 pandemic – This flu pandemic was the least severe one amongst all three, causing at least 34,000 deaths in the U.S. and 700,000 deaths all over the world. It was caused by the H3N2 subtype of the Type A influenza virus, which also had a bird origin. This disease began in Hong Kong.
As opposed to Type B and Type C, the Type A influenza virus can cause a pandemic because it affects humans, pigs as well as birds. So along with undergoing a frequent and continuous antigenic drift, it has an ample chance of undergoing an antigenic shift, with different strains of the virus combining inside a host. An antigenic drift of the Type A influenza viruses is much easier to control than an antigenic shift.
An antigenic drift produces new strains of the subtypes of the Type A influenza virus. The human population has already been exposed to flu caused by these subtypes of the Type A influenza virus.
Thus, the entire genetic information of the virus is known, and has been used to develop preventive flu vaccines. The newly formed strain would be a result of an antigenic drift and just a slightly changed version of the subtype of the Type A influenza virus. Thus, the infections from these new strains can be controlled by using the already available preventive flu vaccines.
The only drawback is that the person needs to be vaccinated every year because as the virus undergoes an antigenic drift, a new strain is formed replacing the older strains against which the people had been previously vaccinated.
As a result, the immune system cannot recognize this new strain and an infection from this strain can occur in the body. This is why people often get infected with flu even though they have been vaccinated. It’s because a new strain has developed and is attacking the body.
To overcome this problem, the government keeps a constant watch on the possible strains of the viruses that might cause an infection in the next flu season (November to March) and notifies the vaccine manufacturers about these strains so that the manufacturers can include the specified strains in the vaccines that are to be produced for the next flu season.
An antigenic shift results in the formation of an entirely new Type A influenza virus, which has never attacked the human population before. Therefore, the complete genetic information about this virus is unknown and there is no preventive vaccine available against this newly formed virus. Since human beings are exposed to this virus for the first time, their immune system does not have the mechanism to resist the virus.
In addition, the new Type A influenza virus formed after an antigenic shift generally is highly contagious for humans because it becomes airborne and thus, can spread from person to person by just a cough or a sneeze. This significantly increases the chances of the disease turning into a pandemic. Thus, an antigenic shift of the influenza virus is significantly more dangerous and problematic than an antigenic drift.
Even though the Type B influenza virus, shares a very similar structure (in respect to the surface proteins) to the Type A, it is less dangerous and causes milder illnesses, as compared to the Type A influenza virus. This is due to the fact that the Type B virus exclusively infects humans, so there is no chance for it to undergo an antigenic shift.
Thus, the Type B influenza virus can only undergo an antigenic drift, which occurs slowly in this virus and can be treated with minor modifications to the existing vaccines.
The Type C influenza virus infects animals but rarely infects human beings. The surface protein composition of this virus is entirely different from the Type A and the Type B. It contains only one surface protein, the gp88 protein, as compared to the two (H protein and N protein) proteins in the two other types of influenza viruses. The gp88 protein is much more stable than the H and N proteins and rarely undergoes any variation. There has been no report of any antigenic shift in this virus and even though it undergoes antigenic drift, it does so at a very slow rate.
The lack of possibilities of an antigenic shift in the Type B and C influenza viruses makes it practically impossible for them to cause a pandemic.
How Does the Swine Flu Virus Work?
In order to cause a viral infection, the virus must first enter a human cell. For doing so, the virus must locate a site (known as a receptor), which it can bind to and attach itself. In case of swine flu, a sugar molecule called sialic acid, which is present in the mucous membrane, acts as the receptor for the virus. (The mucous membrane is a group of cells that covers and lubricates the various passages and cavities exposed to air, including the mouth, nose and inner portion of the eyelids).
Thus, the Type A influenza virus causing swine flu enters the human body through the mucous membranes of the mouth, eyes or nose.
The swine flu virus consists of two proteins called hemagglutinin (H protein) and neuraminidase (N protein) on its surface. The H protein of the virus attaches itself with sialic acid in the mucus membrane. This binding of H protein with sialic acid permits the entry of the virus into the human cell.
Once inside the human cell, the virus releases its genetic material, called ribonucleic acid (RNA), which starts the production of new copies of the swine flu virus inside the body.
The virus reprograms the human cell to make viral proteins. By using the viral proteins synthesized inside the human cell, the swine flu virus multiplies rapidly and new copies of the virus are produced. Thus, the infected cell essentially becomes a virus-producing factory.
These newly synthesized swine flu viruses leave the infected human cell with the help of N protein and go on to infect the adjacent healthy cells.
The Current Effective Treatments for Swine Flu
Based on the U.S. government's declaration on April 26, 2009, that swine flu is a public-health emergency, on April 27, 2009, the U.S. Food and Drug Administration (FDA) recommended the off-label use of the existing flu drugs, Tamiflu (oseltamivir) by Gilead Sciences, Inc./Roche Holding Ltd. (GILD/RHHBY) and Relenza (zanamivir) by GlaxoSmithKline Plc./Biota Holdings Ltd. (GSK/BTAHY.PK) for the treatment and/or the prevention of an infection with the swine flu virus.
The U.S. government has released 25% (12.5 million dosages) of these drugs from the National Stockpile as a response to the swine flu outbreak.
- Tamiflu: A pill, is approved as a treatment and a prevention of flu for individuals, who are over the age of 1, while Relenza, an inhaled drug, is approved for the treatment of flu for individuals who are over 7 years old and for the prevention of flu in individuals who are over 5 years old.
- Off-label use: A physician’s practice of prescribing a drug or medical device for indications beyond those approved by the FDA. For example – the drugs can be used beyond their approved age groups like Relenza can be given as a treatment for children under the age of 7, even though that is not included in its FDA approved label.
- National stockpile: The U.S. government piles few million antiviral drugs as part of public health preparedness for a pandemic. This is called National Stockpile. At present, the U.S. government has 50 million anti-viral treatments in its National Stockpile.
Both Tamiflu and Relenza seem to be effective in improving the symptoms of swine flu. Additionally, the use of these drugs also helps to stop the spreading of the swine flu virus. However, these drugs are most effective when taken at an early stage (within 48 hours of the start of flu-like-symptoms).
Disadvantages of the Current Effective Treatments
Both Tamiflu and Relenza cannot be used as preventive therapies for the entire population. Unlike a flu vaccine, these drugs do not provide long-term protection and can be used as a preventive therapy only in short-term situations for people who are at increased risk of complications from swine flu.
Additionally, these drugs should be administered within a stipulated time period (within 48 hours of the start of flu-like-symptoms). This is important because the late initiation of treatment can reduce the efficacy of the drugs.
Moreover, there are dangers of the individual’s development of resistance against these drugs, whereby these drugs will not be effective anymore.
No Vaccine Against Swine Flu
Currently, there are no vaccines available in the market, which can specifically give protection against swine flu. The currently approved flu vaccines like Afluria (made by CSL Limited), Fluarix (made by GlaxoSmithKline Biologicals, a subsidiary of GSK), FluLaval (made by ID Biomedical Corporation, a subsidiary of GSK), FluMist (made by MedImmune Vaccines Inc., a subsidiary of AstraZeneca Plc./AZN), Fluvirin (made by Novartis Vaccines and Diagnostics Limited, a subsidiary of Novartis AG/NVS) and Fluzone (made by Sanofi Pasteur Inc., a subsidiary of Sanofi-Aventis/SNY), will not be effective in preventing swine flu because these vaccines have been developed using the genetic information and details of the existing seasonal flu viruses.
Swine flu is caused by an entirely new virus that people have not been exposed to before. Mostly healthy adults are at risk of suffering from the serious complications of swine flu. The entire genetic information of swine flu is yet to be made available, hence, any effective vaccine development will at least take 4 - 6 months.
Upcoming Drugs for Flu: Potential Treatments of Swine Flu
CS-8958by Biota Holdings Ltd. (BTAHY.PK) and Daiichi Sankyo
Status: Phase III trial.
In March 2009, BTAHY.PK reported the completion of the enrollment process of the Phase III trial of CS-8958.
Mode of Administration: Inhaled
Mechanism of Action:
The flu virus attacks the human cells, multiplies and ultimately releases itself from the infected cells and infects new ones.
A protein, called viral neuraminidase, present on the surface of the virus enables the virus to get released from the infected cells.
CS-8958is a drug that inhibits the functioning of viral neuraminidase, thereby inhibiting the release of the virus from the infected cells.
Advantages of CS-8958:
In contrast to existing drugs like Tamiflu, which needs twice-daily oral administration for 5 days, and Relenza, which require twice-daily inhalation for 5 days, CS-8958 needs to be inhaled only once.
Peramivir Intravenous by BioCryst Pharmaceuticals, Inc. (BCRX)
Status: Phase II trial
In October 2008, the company reported positive data from the Phase II trial of Peramivir Intravenous.
Mode of Administration: Intravenous (injected in the vein) injection.
Mechanism of Action:
Peramivir Intravenous inhibits the functioning of viral neuraminidase, thereby inhibiting the release of the virus from the infected cells.
Advantages of Peramivir Intravenous:
Existing drugs like Tamiflu (which requires oral administration) and Relenza (which is inhaled) are difficult to be administered in unconscious flu patients. In contrast, Peramivir Intravenous is injected, hence, can be easily administered in unconscious patients.
Companies with Drugs that Potentially Target the Swine Flu Outbreak
The pharmaceutical and biotechnology companies that play an active role in the flu treatment and prevention market are expected to experience a substantial increase in the sales of their drugs if the outbreak of swine flu continues and the demand for the antiviral drugs, vaccines and other preventive measures increases drastically.
Roche Holding Ltd. (RHHBY.PK): It is a large-cap pharmaceutical company that focuses on the development and marketing of a wide range of pharmaceutical and diagnostic products. The company develops and markets Tamiflu, which is a drug approved for the treatment and the prevention of flu in individuals who are over 1 year old. Gilead Sciences, Inc. (GILD) co-develops Tamiflu and receives a 20% royalty on the net sales of the drug. RHHBY reported sales of approximately $349 million for the three months ended on March 31, 2009, for Tamiflu. RHHBY has increased the production of Tamiflu as the FDA has authorized the off-label use of Tamiflu for the treatment of swine flu.
GlaxoSmithKline Plc. (GSK): A large-cap pharmaceutical company, which is focused on the discovery, development and marketing of a variety of pharmaceutical and consumer health-related products. GSK in collaboration with Biota Holdings Ltd. (BTAHY.PK) develops and markets Relenza, which is approved as the treatment of flu for individuals who are over 7 years of age and as the prevention of flu in people, who are over 5 years old. GSK reported sales of approximately $462 million for the three months ended on March 31, 2009 for the drug. The FDA has authorized the emergency off-label use of Relenza for the treatment of swine flu, resulting in an escalated production of Relenza.
Biota Holdings Ltd. (BTAHY.PK): A pharmaceutical company that focuses on the development of drugs and vaccines for the treatment and the prevention of infections. In collaboration with Daiichi Sankyo of Japan, the company is developing a dry powder inhaled drug CS-8958 for the treatment of flu. The drug has been found to possess long-acting properties against the influenza virus and is also expected to work against swine flu virus.
BioCryst Pharmaceuticals Inc. (BCRX): A biotechnology company focused on the development of drugs for cancer, viral infections and immune system diseases. The company is developing Peramivir Intravenous, an antiviral drug for the treatment of flu.
Novavax Inc. (NVAX): The company focuses on developing vaccines for infectious diseases, using its proprietary technology platform known as virus-like particle (VLP) technology. This vaccine technology is one of the fastest methods for creating a vaccine, which is expected to successfully target the unmet market need for swine flu vaccine.
Virus-like particle (VLP) technology: By using this technology, a virus like particle (VLP) is made, which is structurally similar to the targeted virus (the live, disease-causing virus, against which a vaccine is being made) but does not contain the particular genetic information of the virus that is necessary for the viral replication process. When the VLP is injected into the body, it enters the human cells, just like a natural live virus. Since the VLPs look like the live virus, the immune system recognizes them as foreign, becomes activated and starts acting against them. Once the immune system gets exposed to and activated against a dummy virus (the VLP) it is able to recognize the virus if there’s ever any future contact and mounts a strong attack against it at that time. Since, the VLPs resemble the live disease-causing virus, the immune system (which has been already exposed to the VLP) easily recognizes them as foreign and launches a powerful attack, when the actual live virus attacks the body.
Since, the VLP does not contain any genetic information necessary for the viral replication process, the dummy virus cannot replicate itself in the body so it does not pose any threat of infection to the person being vaccinated.
MedImmune, a unit of AstraZeneca PLC (AZN): MedImmune, wholly owned by AZN is focused on infection, cancer, respiratory diseases, inflammation, cardiovascular and gastrointestinal disease. The company is developing a needle-free, nasal spray swine flu vaccine by using its Live Attenuated Influenza Vaccine (LAIV) technology.
Live Attenuated Influenza Vaccine (LAIV) technology: By using this technology, a needle-free, nasal spray flu vaccine is made. This vaccine delivers live flu virus strains that are weakened so as not being able to cause the disease but prompt the recipient’s body to produce an immune response against the virus.
Novartis AG (NVS): A multinational pharmaceutical company is developing swine flu vaccine. On June 12, 2009, NVS announced that it has produced the first batch of its swine flu vaccine, which will now be forwarded for pre-clinical testing and is also being considered for use in human clinical trials.
Sanofi-Aventis (SNY): A pharmaceutical company that focuses on enhancing the life of humans by providing medicines, vaccines and integrated health care solutions for cardiovascular, metabolic diseases, oncology, central nervous system disorders (the brain and the spinal cord disorders) and vaccines. Its vaccine unit has begun the development of swine flu vaccine.
Baxter International Inc. (BAX): This is a pharmaceutical company focused on the development and marketing of products for immune disorders, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. The company makes both seasonal and pandemic vaccines and has shown considerable interest in the development of a vaccine for swine flu.
3M Company (MMM): A diversified technology company with a wide portfolio of products and services (including health care products) to serve customers. The health care segment focuses on providing medical and surgical supplies, skin health and infection preventive products and dental products. The company makes protective face masks (marketed as N95 respirators), which are currently being used by people to prevent swine flu. This mask can effectively filter the virus from the air and prevent people from contracting the disease.
Financial Data
(Data as on May 4, 2009, the initial report date)
Roche Holding Ltd. (RHHBY.PK)
Stock Price as on May 4, 2009: $31.86
Market Cap as on May 4, 2009: $109,917.00
52 weeks Range: $26.01 - $93.41
Revenue FY08 ($MM): $39,772.40
EPS FY08: +$2.23
Cash Per Share: $5.26
R&D FY08 ($MM): $7,711.80
Gilead Sciences, Inc. (GILD)
Stock Price as on May 4, 2009: $44.90
Market Cap as on May 4, 2009: $40,865.29
52 weeks Range: $35.60 - $57.63
Revenue FY08 ($MM): $5,335.75
EPS FY08: +$2.10
Cash Per Share: $3.83
R&D FY08 ($MM): $721.76
GlaxoSmithKline Plc. (GSK)
Stock Price as on May 4, 2009: $30.95
Market Cap as on May 4, 2009: $80,160.50
52 weeks Range: $27.15 - $49.48
Revenue FY08 ($MM): $36,450.20
EPS FY08: +$2.64
Cash Per Share: $4.02
R&D FY08 ($MM): $5,247.80
Biota Holdings Ltd. (BTAHY.PK)
Stock Price as on May 4, 2009: $2.50
Market Cap as on May 4, 2009: N/A
52 weeks Range: $0.60 - $4.95
Revenue FY08 ($MM): N/A
EPS FY08: N/A
Cash Per Share: N/A
R&D FY08 ($MM): N/A
BioCryst Pharmaceuticals Inc. (BCRX)
Stock Price as on May 4, 2009: $3.08
Market Cap as on May 4, 2009: $118.06
52 weeks Range: $0.85 - $4.89
Revenue FY08 ($MM): $56.56
EPS FY08: -$0.65
Cash Per Share: $1.62
R&D FY08 ($MM): $73.32
Novavax Inc. (NVAX)
Stock Price as on May 4, 2009: $1.68
Market Cap as on May 4, 2009: $115.68
52 weeks Range: $0.52 - $3.88
Revenue FY08 ($MM): $1.06
EPS FY08: -$0.53
Cash Per Share: $0.50
R&D FY08 ($MM): $24.33
Sanofi-Aventis (SNY)
Stock Price as on May 4, 2009: $29.27
Market Cap as on May 4, 2009: $79,907.10
52 weeks Range: $23.95 - $39.68
Revenue FY08 ($MM): $38,233.00
EPS FY08: +$1.95
Cash Per Share: N/A
R&D FY08 ($MM): $6,069.90
Baxter International Inc. (BAX)
Stock Price as on May 4, 2009: $50.08
Market Cap as on May 4, 2009: $30,299.40
52 weeks Range: $46.63 - $71.53
Revenue FY08 ($MM): $12,348.00
EPS FY08: +$3.16
Cash Per Share: $2.74
R&D FY08 ($MM): $868.00
3M Company (MMM)
Stock Price as on May 4, 2009: $58.48
Market Cap as on May 4, 2009: $40,607.34
52 weeks Range: $40.87 - $79.89
Revenue FY08 ($MM): $25,269.00
EPS FY08: $4.89
Cash Per Share: $2.70
R&D FY08 ($MM): $1,404.00
AstraZeneca Plc. (AZN)
Stock Price as on May 4, 2009: $35.99
Market Cap as on May 4, 2009: $52,185.50
52 weeks Range: $29.96 - $49.85
Revenue FY08 ($MM): $31,601.00
EPS FY08: +$4.20
Cash Per Share: $3.10
R&D FY08 ($MM): $5,013.00
Novartis AG (NVS)
Stock Price as on May 4, 2009: $38.58
Market Cap as on May 4, 2009: $87,190.80
52 weeks Range: $33.34 - $61.30
Revenue FY08 ($MM): $42,584.00
EPS FY08: +$3.59
Cash Per Share: $3.43
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Swine Flu vs. Seasonal Flu
Seasonal Flu
Description in Short: Outbreak of flu that follows a predictable seasonal pattern and occurs almost every year, usually from November to March.
Symptoms: Fever, headache, tiredness, dry cough, sore throat, runny nose and muscle pain.
Market Size: U.S.: Approximately $2 billion annually
Patient Population: U.S.: Approximately 226,000 cases annually
Individuals at Risk: Old, very young and those individuals with chronic illnesses
Number of Deaths:
- Worldwide: 250,000 – 500,000 people annually
- U.S.: Approximately 36,000 people annually
Availability of Preventive Vaccines:
Six approved flu vaccines - Afluria (made by CSL Limited), Fluarix (made by GlaxoSmithKline Biologicals, a subsidiary of GSK), FluLaval (made by ID Biomedical Corporation, a subsidiary of GSK), FluMist (made by MedImmune Vaccines Inc., a subsidiary of AZN), Fluvirin (made by Novartis Vaccines and Diagnostics Limited, a subsidiary of NVS) and Fluzone (made by Sanofi Pasteur Inc., a subsidiary of SNY)
Available Treatments:
- Tamiflu by GILD/RHHBY and Relenza by GSK/BTAHY.PK
Swine Flu
Description in Short: Sudden outbreak of a new type of flu, which has never occurred before
Symptoms: High fever (103-105°F), cough, sore throat, runny nose, nasal congestion, body aches, headache, chills, lack of appetite and fatigue, nausea, vomiting, diarrhea and dehydration
Market Size:
Estimated** U.S.: Approximately $120 billion
Patient Population:
Current:
- Worldwide: 28,774 confirmed cases
- U.S.: 13,000 confirmed cases
Estimated**
- Worldwide: Approximately 1.5 billion cases
- U.S.: Approximately 90 million
Individuals at Risk: Everyone, including young and healthy individuals who are not suffering from any kind of chronic illnesses
Number of Deaths:
Current*
- Worldwide: 144 deaths
- U.S.: 27 deaths
Estimated**
- Worldwide: Approximately 70 million
- U.S.: Approximately 2 million
Availability of Preventive Vaccines: None
Available Treatments: Tamiflu by GILD/RHHBY and Relenza by GSK/BTAHY.PK are being used off-label but no treatment that is specifically intended or indicated for the disease.
*Data as of June 11, 2009
** An estimate by the World Health Organization (WHO).
Effects on the Economy Due to Swine Flu
The swine flu outbreak poses a potential threat to the global economy. The world economy is currently suffering from the worst financial crisis in decades. If there is a widespread outbreak of swine flu pandemic, it is expected to cost approximately $3 trillion (an estimate by the World Bank), triggering a new threat to the already crippled economy.
The travel and tourism and airlines industries may undergo a major hit due to the outbreak of swine flu. All U.S. citizens have been asked to avoid nonessential travel to Mexico. The European Union has urged its citizens to avoid visiting affected parts of the U.S. and Mexico. Thailand, Australia, Japan and Singapore are certain countries that are screening travelers from North America for the disease. Hong Kong, Russia and Taiwan will quarantine visitors with flu-like symptoms.
The food industry has also been affected by the outbreak of the disease. The U.S. is a major exporter of pork. Many countries such as China and Russia, which are major importers of pork and pork products, have banned imports from the U.S.
Swine Flu vs. Bird Flu
Among the recent outbreaks of flu across the world, avian (bird) flu is a notable one and has been caused by the Type A influenza virus. Birds have been reported to be attacked by various subtypes of the Type A influenza virus including H1N1, H1N8, H2N9, H3N2, H3N8, H4N3, H4N6, H5N1, H5N9, H6N1, H6N2, H6N5, H6N8, H7N1, H7N3, H7N7, H8N4, H9N2, H9N6, H10N7, H10N8, H11N6, H11N9, H12N5, H13N6, H14N4, H15N4 and H15N9. However, all these subtypes are not responsible for causing severe infection in birds. Out of all these viruses, the H5N1 subtype of the Type A influenza virus is the most infective type, which caused serious avian flu and killed millions of poultry globally. An outbreak of avian flu was first reported in Asia in mid-2003.
There have been reports (predominantly in Asia), of the H5N1 virus spreading from birds to humans, primarily in people working closely with birds. Since 2003, there have been approximately 421 human cases of avian flu worldwide, which have resulted in 257 deaths. In the U.S, while the H5N1 virus caused outbreaks amongst poultry in 2003 and 2004, there was only one human infection reported in 2003. The symptoms of avian flu include fever, cough, sore throat, muscle aches, eye infections, pneumonia and respiratory problems.
The current swine flu outbreak is anticipated to be much more severe than avian flu because in the case of avian flu, the human-to-human transmission was very rare, whereas in case of swine flu, the virus has the ability to spread from one person to another, posing a high risk of a pandemic.
Swine Flu vs. Mad Cow Disease
Mad cow disease is an infectious, fatal disease in cattle that affects the brain of the animals. The causative agent of this disease is an abnormal protein called prion that destroys the brain tissues of the animals, making sponge like holes in parts of the brain, ultimately causing their death. The disease was first reported in the United Kingdom (UK) in 1986, which was followed by many European countries. Canada reported its first incident of mad cow disease in May 2003, followed by another incident in Washington in the U.S. in December 2003.
Humans get infected if they eat the diseased tissues of the infected cattle and develop the human form of the disease called Creutzfeldt-Jakob disease (CJD). The first case of CJD was identified in the UK in 1996. This disease is rare in human beings and approximately 200 people are known to die from CJD annually in the U.S. The symptoms include depression, anxiety, memory lapses, social withdrawal, lack of sleep, visual disturbances, fatigue and bizarre behavior.
CJD is not caused by any virus or bacteria. It is caused by an infectious protein and does not appear to get transmitted from person to person. Additionally, CJD is not contagious.
What Are the Steps to Prevent Swine Flu?
Frequent hand washing – Frequent washing of hands with soap and water is a highly recommended measure to combat swine flu because the swine flu virus can be contracted by touching objects contaminated by the virus. Since, it’s unknown about how long the swine flu virus can survive on surrounding objects, it’s highly recommended to have frequent hand washes.
Masks – Wearing a mask that is capable of protecting against infections can help prevent swine flu because it prevents the virus from entering the body via the respiratory tract.
Cover the mouth and nose during coughs and sneezes – Cover the mouth and nose by a tissue while coughing and sneezing and avoid touching the mouth and nose with one’s hands because the swine flu virus is transmittable through the respiratory droplets of an infected person. This is important because an individual carrying the swine flu virus can be contagious for several days before showing any symptoms of the infection. The tissue, once used should be thrown away in the garbage immediately.
Stay at home – In case a person feels sick with flu-like symptoms, he/she should stay at home and not go to work, school and any social gathering. If the condition worsens, then he/she should contact a healthcare provider or a hospital emergency room. In this way, the infection can be prevented from spreading to others.
Avoid close contact as much as possible with people who are sick – Healthy individuals should avoid coming close to infected ones, which is a method of preventing the spread of the infection.
Conclusion
The current outbreak of the swine flu virus has reached a serious pandemic threat because it is a mutated form of a virus for which there are no specific preventive or curative treatments till date.
To make matters worse, the disease is highly contagious and can be spread from person to person via the airborne method. Current treatments for the disease include off-label use of some existing seasonal flu drugs but there are companies that are in the process of developing a treatment that is specifically indicated and targeted towards swine flu.
Until a definitive treatment is developed for this disease, the only solution is prevention and control.
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This article has 11 comments:
FDA pending masks and respirators that destroy the virus
finance.yahoo.com/news...
" SIGA's proposal, submitted in 2008, sought funding for preclinical development and IND filing of its identified lead compound, ST-669, a broad spectrum antiviral that has demonstrated in vitro antiviral activity against several different viral families."
source: investor.shareholder.c...
BioCryst also announced preliminary results from its Phase 2 study of intramuscular (i.m.) peramivir for the treatment of seasonal influenza. While the study demonstrated a numerical trend in its primary endpoint of improvement in the median time to alleviation of symptoms (TTAS) in subjects with confirmed, acute, uncomplicated influenza infection versus placebo, the difference between the two study groups was not statistically significant.
oudaily.com/news/2009/.../
"The efficacy of intravenous peramivir demonstrated in a prior study conducted by Shionogi & Company Ltd. indicates its potential as a treatment for acute uncomplicated influenza," commented Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "Based on the clinical evidence of activity, safety and tolerability of peramivir, we are currently in discussions with HHS-BARDA and the U.S. Food and Drug Administration (FDA) regarding further development of i.v. peramivir as a treatment for influenza."
www.bio-medicine.org/m.../
Here's a good place to start: investorshub.advfn.com...
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Bio Defense Solutions,Inc.