1. Overview of pandemic influenza A/H5N1 and influenza A/H1N1

a. H5N1 influenza  pandemic:

- A H5N1 flu is a kind of infections disease caused by avian influenza virus (including poultry). It is enzootic in all kinds of birds although some kinds have much better immunity than other kinds’. Bird flu was firstly identified in Italy more than 100 years ago, and then it spread all over the world.

- Avian influenza virus rarely affects mammal animals such as: pigs, tigers, panther and cats. It also seldom causes illness in humans. However, humans who catch an influenza virus, without natural immunity capacity against this virus, could be heavily affected or even caused death by this avian influenza virus. (7)

b. H1N1 influenza  pandemic::

- A H1N1 flu is a flu pandemic having high virulence at mortality rate of more than 0.1%. H1N1 flu rapidly spread in the society due to human-to-human transmission of the virus. “The current speed of spread is very fast. H1N1 flu virus now takes just within 6 weeks to develop instead of taking 6 months to develop like other pandemics in the past.” WHO warned on the Website.

- Since the first A H1N1 case was reported in Mexico in April 2009, there were more than 503536 humans who have caught H1N1, including 6260 people died from it in 206 countries and areas throughout the world until November 8^th 2009 (1).

- In our country, according to Pasteur/ epidemic prevention centers’ reports, Vietnam confirmed 10,800 human cases caught A H1N1, 41 human cases died from it at 5 pm on November 11^th 2009 (2). On October 22^nd, The Ministry of Finance spent 790 billion on H1N1 flu prevention (3)

2. The process of designing and developing product:

- Vien Dong Pharmaceutical Leader Board decided to research and develop pharmaceutical product against H5N1 in March 2008;

- On May 2^nd 2008, Flu treatment product research Group was established, including:

• Pharmacist, MBA Le Van Dung – General Director of  Vien Dong pharmaceutical company;

• Pharmacist Hoang Xuan Quang – Pharmaceutical Producing Expert;

• Pharmacist, MBA Dang Viet Hung – Deputy General Director of  Vien Dong pharmaceutical company;

• PhD Nguyen Hai Nam – Dean of Pharmaceutical Chemistry, Hanoi University of Pharmacy – Consultant – Project consultant in supporting professional knowledge.  

- In June 2008, several active elements anti-viral were selected by the research group, including Interferon; Zanamivir; Oseltamivir; Ramantadine; Amantadine, Arbidol.

- On June 24^th 2008, the research group decided to focus on researching product with Arbidol active element to treat H5N1 avian influenza named Fludon after seeking, analysing and comparing time.

- Arbidol is an active element by inhibiting the fusion of viral lipid membranes with cell membranes and prevent contact and entry of virus into cells. This element has confirmed in clinical trial that it is effective for prevention and treatment for SARS, hepatitis B and C, Herpes, Dengue Fever, RSV and especially several flu virus for both A H1N1 flu and H5N1 flu. Arbidol has been researched by many scientists and it has been issued the pharmaceutical registration number to be used in many countries after the invention of a Russian scientist named Nikolaevich Glushkov in 1973. When A H1N1 flu out-broke in Russia in 2009, Russia’ s Ministry of Health and Social Development selected  Arbidol to officially prevent and treat A H1N1 flu nationwide.
- On June 30^th 2008, the research group has made the program outline phase 1 including studies:

• Standard establishment and test methods;

• Stability research;

• Production process establishment;

• Registration record completion;

• Arbidol synthesis on the laboratory scale;

- At the end of April 2009, seeing the rapid spread of A H1N1 flu in the North America, members of Vien Dong pharmaceutical Leader Board gave preliminary remarks and confirmed that: “This is a new kind of flu, humans have no immunity capacity and it is human-to human transmission that make the spread of this flu more quickly. Epidemic will rapidly spread and be more dangerous to Vietnam simply because it is a country with habits such as: communicating with many people or taking part in community activities. From this point of view, Leader Board decided the program key was A H1N1 flu, and the product was renamed Fludon H1.

- The research group has fully finished processes: Standard establishment, Stability research, Production process establishment on August 12^th 2009

- Associate professor, PhD. Nguyen Hai Nam declared the success in Arbidol synthesis on the laboratory scale on September 21^st 2009,

- The research group completed product registration record on October 15^th 2009