Taiwan Develops New Drug for Middle East Respiratory Syndrome Coronavirus

Taiwan Develops New Drug for Middle East Respiratory Syndrome Coronavirus

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MERS-CoV or Middle East Respiratory Syndrome Coronavirus is a viral respiratory illness that was first identified in Saudi Arabia in 2012. The coronavirus includes viruses that infect animals, cause the common cold in humans, and caused the Severe Acute Respiratory Syndrome (SARS) outbreak in South-east Asia in 2003. In May 2015, MERS-CoV was found in South Korea when a man returned from the Middle East. As of June 19, 2015, the disease has spread to about 166 people and caused 24 deaths in South Korea. The current outbreak in South Korea is the largest reported outside Saudi Arabia.

It is not known for certain how MERS-CoV is transmitted. It is possible the virus is spread via droplets when an infected person coughs or sneezes. MERS-CoV can cause a rapid onset of severe respiratory disease in people similar to pneumonia, including fever, cough, and shortness of breath.

The management of MERS-CoV is similar to that of SARS and dependent on the patient’s medical condition. Patients infected with MERS-CoV require oxygen support and in severe cases mechanical ventilation and intensive-care-unit support. To date no medication or vaccine has been proven to be effective for the treatment or prevention of MERS-CoV. Several drugs have been identified. However results are either inconclusive or further research is required.

Ming-Hon Hou a researcher from the National Chung Hsing University (NCHU) of Taiwan and coronavirus expert Stanley Perlman from the University of Iowa have been working together to develop a potential drug to combat MERS-CoV.Using human CoV-OC43 (HCoV-OC43) as a model for the coronavirus, Hou and his team used the 3D structure of HCoV-OC43 N-NTD complexed with ribonucleoside 5′-monophosphates to identify a distinct ribonucleotide-binding pocket. Using virtual screening and by targeting this pocket, they identified and developed a new coronavirus N protein inhibitor. This proposed drug is called AM1. AMI reduces the N protein’s RNA-binding affinity and hinders the replication of the virus. AM1 has been granted patency in Taiwan, and will undergo further development and testing in the United States.




Ostrich antibodies can protect humans from viruses

Ostrich antibodies can protect humans from viruses
The humble ostrich: savior of the human race

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In 2009, the World Health Organization (WHO) reported 15,000 or more deaths due to a pandemic of a new strain of influenza. The emergence of new strains of influenza is a constant danger, and humanity has no choice but to continue the struggle against this unseen enemy. However, a powerful ally in this fight has appeared: the ostrich. Ostrich eggs have enabled the mass production of antibodies effective in fighting influenza.
Antibodies are created when antigens such as viruses and bacteria invade the bodies of vertebrate animals; when the same antigens invade a subsequent time, the antibodies bind to them, thus rendering them harmless. Since we can use these antibodies to treat many diseases if we can create them in animals other than humans, research so far has been conducted using mice, rabbits, chickens, and other animals. However, because production costs are extremely high and mass production is difficult, we need to develop new technologies for this. It was Professor Yasuhiro Tsukamoto of the Graduate School of Life and Environmental Sciences at Kyoto Prefectural University who first set his sights on ostriches. Professor Tsukamoto, who had originally been conducting research on infectious diseases in poultry, realized that byutilizing ostrich eggs, which are 25-30 times as larger than chicken eggs and strongly effective against infectious diseases, mass production of antibodies was possible.
Even only the prototype reagent, the market scale for antibodies is around 120 billion yen in Japan alone. If further applications for these antibodies can be found in more diverse fields, they hold the promise of generating business with incalculable market value.

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Starting from age 2, ostriches continue to lay eggs for around 40 years.

Ostrich eggs are around 30 times larger than chicken eggs. Moreover, ostriches lay close to 100 eggs per year, which enables a previously unthinkable reduction of costs. For example, approximately 4 grams of high-grade antibodies can be refined from the yolk of one ostrich egg. Thus, 100 eggs yield 400 grams of antibodies, which represents successful mass production. To achieve the same amount using rabbits, around 800 rabbits would be required.

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But the ability to mass-produce is not the only amazing thing about ostrich antibodies. Of course, this research was originally undertaken with a view to mass production; but as research has progressed, other concomitant benefits have been observed.
The first point is the strength of ostrich antibodies. When we say that ostrich antibodies are strong, we mean they have an overwhelming ability to neutralize viruses in comparison to conventional antibodies. Ostrich antibodies are about 20 times more potent at combating viruses than antibodies created from chicken eggs. This is thought to have some bearing upon the strong natural immune system of ostriches. The second point is resistance to heat. Previous antibodies have had almost no resistance to heat, which limited their applications in other fields. However, ostrich antibodies are strongly heat resistant, and it is now clear that they can be utilized in a diverse range of manufactured products. The third point is the uniform quality of the antibodies. Depending on the differences of individual animals (the antigens inside the body), antibodies will vary to some slight degree. Thus, with previous manufacturing methods it has been extremely difficult to create antibodies of consistent quality. However, there is extremely little variation in the ostrich antibodies mass produced from a single egg, which makes them useful from the viewpoint of quality control for use in manufactured products.

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Structure of the ostrich antibodies mask

Antibody masks can be purchased via the Internet

With confidence that ostrich antibodies, which hold such powerful promise, would also be a successful business venture, Professor Tsukamoto successfully applied to the JST Innovative Seeds Business Development Project in order to commence the production of ostrich antibodies in earnest. He established a company, Ostrich Pharma, to achieve a system for the mass production of ostrich antibodies, in cooperation with an ostrich farm located in Japan’s Hyogo Prefecture.
This company is undertaking business development of a diverse range of manufactured products using ostrich antibodies. Naturally, the first theme is preventing influenza virus pandemics. The first commercial product released was the antibody mask. Masks are effective in physically preventing viruses from entering the body, but viruses can live from 2 to 8 hours on the surface of conventional masks. Thus, when the mask is removed they can come into contact with the hands, which can be a vector of infection. However, the antibody mask is a groundbreaking product; if the mask is coated with ostrich antibodies, the antibodies will neutralize any virus coming into contact with the mask. This mask sold not only to local authorities and medical institutions, but is also on general public sale and has earned wide popular appeal. With future product development, perhaps ostrich antibodies will come to protect us on a daily basis in all sorts of ways.

Biosimilars: More Treatment Options Are on the Way



The medical marketplace is about to get bigger. The Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve other biosimilars in the future.

What are biosimilars? To understand that, says Leah Christl, Ph.D., Associate Director for Therapeutic Biologics, it helps to first understand what biological products (or biologics), are.

Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms such as yeast and bacteria.

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Variable in Nature

“Biologics are different from conventional medications. Conventional medications—drugs—are generally made from chemicals, or chemically synthesized, and therefore their structure can be relatively easily defined,” explains Christl.

Unlike conventional medications, biologics can’t be made by following a chemical “recipe.” “Biologics come from living organisms which are variable in nature. In addition, they are generally more complex and not as easy to define and characterize, Christl explains. For that reason, manufacturing biologics is a far more complex process than manufacturing drugs.

Just as it does for drugs, FDA rigorously and thoroughly evaluates a biologic’s safety and effectiveness before granting it licensure (approval). Currently, biologics are among the fastest growing segments of the prescription product market.

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What are Biosimilars?

Christl explains that a biosimilar is a type of biologic that is highly similar to another, already FDA-approved biologic (known as the reference product).

“It is important to note that a biosimilar is not just like a generic drug,” she adds. “Because of the differences in complexity of the structure of the biologic and the process used to make a biologic, biosimilars are not as easy to produce as generics, which are copies of brand name drugs. A biosimilar is not an exact duplicate of another biologic; rather, a biosimilar is highly similar to the reference product.

Before approving a biosimilar, FDA experts must also first verify that there are no clinically meaningful differences between the biosimilar and its reference product. In other words, it will work the same way as the reference product for its approved indications.

Also, the biosimilar must have the same strength and dosage form (injectable, for example) and route of administration as the reference product. The biosimilar must be manufactured following Current Good Manufacturing Practices.

“Patients can rest assured that they’ll be able to rely upon the safety and effectiveness of an FDA-approved biosimilar, just as they can rely on the reference product that the biosimilar was compared to,” Christl says. Like other biologics, biosimilars generally must be prescribed by a physician.

Zarxio, which is biosimilar to Neupogen, is a medication that boosts the production of white blood cells and helps to ward off infection in patients receiving strong chemotherapy for some tumors. The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects include spleen rupture; serious allergic reactions and acute respiratory distress.

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Increased Options, Lower Costs?

“Biosimilars are likely to create greater competition in the medical marketplace,” says Christl. This could not only increase treatment options for patients, but also lead to less expensive alternatives to comparable products. With an increasing number of biosimilars on the market, consumers may expect to get equally safe and effective treatment, but at lower costs, she says.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

March 6, 2015

Reference: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm436399.htm

MERS fears in South Korea: Nearly 700 isolated as health officials seek to block spread

MERS fears in South Korea: Nearly 700 isolated as health officials seek to block spread


South Korean health officials isolated nearly 700 people on Monday in an effort to stop the spread of the potentially deadly Middle East Respiratory Syndrome within its borders after 18 people became infected over the past 10 days — a rate of transmission that appears more aggressive than in other countries.

South Korea has been on high alert since May 20 when a 68-year-old man who had been traveling in Bahrain tested positive for the virus. Since then, the virus has been detected in a number of patients and visitors to the hospital where he was treated — triggering global concern about whether the virus had mutated or genetic or environmental factors may have been at play.

MERS, a coronavirus, is related to the one that infected thousands during the 2003 outbreak of Severe Acute Respiratory Syndrome and has no cure or vaccine.

“We must find the reason for the high rate of transmission unlike in the cases of other countries,” President Park Geun-hye told a meeting on Monday,according to Reuters.

The Associated Press reported that 682 family members, medical staff and others who had had close contact with the man who tested positive for the virus had been isolated in their homes or in state-run facilities. The country is considering imposing a travel ban on those individuals as well.

Since being first reported in 2012, MERS has been mostly contained to Saudi Arabia, the United Emirates and Jordan. The World Health Organization says that 1,150 case have been reported and 427 of the patients have died. The WHO detailed the status of the two most recent cases:

  • The case is a 35-year-old male who developed symptoms of cough, sputum and fever on 6 May and was admitted to hospital on 13 May. The patient has been on tuberculosis medication since his son was diagnosed with the bacterial disease in April. Between 15 and 17, he shared the same ward with the first case during his hospitalization from 15 to 17 May. On 20 May, after his discharge, the patient visited two different hospitals due to fever and was put on antibiotics. As symptoms persisted despite antibiotic therapy, he was admitted to a hospital again on 27 May and confirmed positive for MERS-CoV on 29 May.
  • The case is a 35 year-old male whose mother shared the same ward with the first case. From 15 to 21 May, the patient visited his mother every day at the hospital. He developed symptoms and visited an emergency room on 24 May. The patient was admitted to hospital between 25 and 27 May and confirmed positive for MERS-CoV on 30 May.