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Consumers of over-the-counter homeopathic and “natural” cold remedies should carefully research such treatment options and properly follow dosage instructions, urges a UMDNJ physician who specializes in integrative medicine.

“People cannot assume that homeopathic or natural products are safe,” commented Dr. Adam Perlman, executive director of the Institute for Complementary & Alternative Medicine in the UMDNJ-School of Wellness Related Professions, following a U.S. Food and Drug Administration (FDA) announcement advising consumers not to use certain Zicam Cold Remedies. According to the FDA, the intranasal zinc product was linked to loss of sense of smell.

“There’s a good chance such products might be helpful on some level, but it’s important to do the research to determine what’s effective and identify what the safety issues, if any, are,” stated Perlman, who is a UMDNJ Endowed Professor of Complementary and Option Medicine and chair of the Department of Primary Care in the UMDNJ-School of Wellness Related Professions.

He also suggests that consumers carefully follow dosage instructions. “Overusage tends to occur with homeopathic or natural products simply because, again, people assume they are safe, but excess doses might be harmful,” he stated.

The jury is still out on the effectiveness of herbs, such as Echinacea, and homeopathic or natural remedies, which includes those providing a boost of zinc or vitamin C, on cold symptoms, but some could be viable alternatives to medication, Perlman stated. “A holistic approach to dealing with a cold also consists of getting plenty of rest and a wholesome diet,” he said.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation’s largest free-standing public wellness sciences university with nearly 5,700 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of well being related professions, a school of nursing and a school of public health on five campuses. Annually, there are more than two million patient visits at UMDNJ facilities and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a statewide mental wellness and addiction services network.

Source
University of Medicine and Dentistry of New Jersey

5 (1 votes)

Commenting on the World Wellness Organisation’s decision to raise its global pandemic alert level to Phase 6 due to the global spread of the novel H1N1 influenza strain, Acting Director General Michael D. Boyd of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), of which the Irish Pharmaceutical Healthcare Association (IPHA) is a member, stated:

“Our members are better prepared than ever to face a pandemic influenza threat. Vaccine makers are ready to start producing novel H1N1 vaccines as soon as requested, and are discussing with WHO measures to help ensure broad access to them. In addition, antiviral manufacturers have provided WHO with stockpiles that have already been distributed to countries in need and are now replenishing those stockpiles. Looking at the broader implications of a pandemic, extensive plans have been made to ensure that companies can continue to produce and distribute essential medicines of all kinds during an influenza pandemic.”

When the novel H1N1 outbreak began, vaccine and pharmaceutical manufacturers began their own internal preparations to respond to the situation. Measures undertaken included preparing to produce a targeted novel H1N1 vaccine and increasing the manufacture of anti-virals. In addition, the IFPMA has been in close contact with the WHO to facilitate timely technical preparations for vaccine production.

Pharmaceutical companies have also worked hard to put in place business continuity plans to make sure that they are able to maintain production and distribution of essential medicines through a possible influenza pandemic.

They are committed to playing their part in protecting communities around the world against this pandemic influenza threat and will continue to work closely with the WHO to address different aspects of this serious public well being challenge.

Source
The Irish Pharmaceutical Healthcare Association

4.33 (3 votes)1 (1 votes)

VaxInnate Corporation today reported positive preclinical results for a recombinant swine flu vaccine it developed in less than three weeks, making it one of the first companies in the world to begin testing a vaccine that could aid halt the spread of the swine flu pandemic.

Preclinical studies in mice suggest that VaxInnate’s recombinant swine flu vaccine could provide protection against the pandemic H1N1 influenza A swine flu strain, VaxInnate CEO Alan Shaw , PhD told attendees in the 7th Annual Biodefense Vaccines and Therapeutics meeting taking place here. Further preclinical testing of the vaccine is already underway.

“Using our novel vaccine technology, VaxInnate was able to rapidly develop and begin testing a vaccine that could be a useful weapon against the pandemic flu,” Dr. Shaw stated. “We’re encouraged by our results to date and are moving forward with further preclinical testing.

“In doing so, VaxInnate is hoping to partner with the U.S. government on further development of our swine flu vaccine,” he added. “The federally-funded vaccine technologies in development cannot produce vaccines as rapidly and efficiently as VaxInnate can, and we want the opportunity to demonstrate our capabilities.”

Dr. Shaw stated VaxInnate is also seeking international partners for the development of this as well as other pandemic vaccines to meet global needs. VaxInnate’s announcement comes less than a week after the World Health Organization (WHO) declared the initial flu pandemic in 41 years.

Promising Results and Technology

VaxInnate’s swine flu vaccine elicited hemagglutinin (HA)-inhibiting antibody in mouse studies at levels that are generally considered to be protective. HA is the key protective component used in flu vaccines for many years. Results were similar to those seen with VAX 125, VaxInnate’s HA-flagellin vaccine for seasonal flu that generated positive Phase I clinical results.

The swine flu vaccine was produced using VaxInnate’s proprietary combination of toll-like receptor-mediated (TLR) immune enhancement and recombinant bacterial production of vaccine antigen.

VaxInnate’s swine flu vaccine genetically fuses the protective subunit of the HA molecule to the TLR agonist, flagellin. Flagellin is a bacterial protein that interacts with the immune system’s TLRs to enhance immunological potency. The proprietary recombinant protein vaccine is produced in bacteria and triggers TLR-mediated enhancement of the immune response.

The ability to produce a recombinant vaccine in a bacterial expression system means that VaxInnate’s technology has significant speed and volume advantages, enabling production of many millions of vaccine doses — sufficient to protect all 300 million Americans, for example — in a time frame of weeks instead of months.

The vaccine must undergo review and licensure by the U.S. Food and Drug Administration (FDA) before it could become available within the United States. Similarly, regulatory agencies in other countries or regions must license the vaccine before it might be used in those areas.

Conventional means of making flu vaccines using eggs takes 6-9 months. While the federal government is funding option cell-based production, vaccine production using cell culture takes about six months compared to the weeks it takes using VaxInnate’s technology.

In addition, due to its transferability and efficiency, dedicated new vaccine factories would not be needed with VaxInnate’s technology. Instead, vaccine could be produced in regional international facilities and manufactured using existing biotechnology facilities with microbial production capacity.

In addition to creating its swine flu vaccine, VaxInnate hopes to evaluate the use of its existing M2e universal flu vaccine candidate against the emerging swine flu. This vaccine has completed Phase I human studies and is slated to enter Phase II human studies this year.

Source
VaxInnate

5 (1 votes)

Arrayit Corporation (OTCBB: ARYC), a leading manufacturer of products and services for disease prevention, treatment and cure, announced that its microarray-based diagnostic test, patented under the trade name Variation Identification Platform (VIP), is ready for manufacture and distribution. A breakthrough screening test using VIP will allow clinicians and researchers to test and detect the H1N1 swine flu virus in population wide studies.

The World Health Organization (WHO) announced on June 11, that the threat level of the H1N1 swine flu virus is now a global pandemic. This news is ideally timed with Arrayit Corporation’s release of its patented VIP screening test.

The Arrayit test will allow researchers and clinicians to detect the presence of the new H1N1 virus in mass numbers of flu patients, and to distinguish this threatening mutated strain from less harmful variants. Arrayit’s very first supplies will be sent to the Centers for Disease Control (CDC) in Atlanta to be approved for use within the USA. Shortly thereafter, the H1N1 test kits will be made available for emergency use by licensed clinics, laboratories and other wellness care organizations worldwide.

The VIP screening test is the initial of its kind developed for multiple numbers of test subjects, with diagnosis available to patients within hours of testing. Up to 80,000 patients may be screened at a time, making it possible for entire communities and whole countries to quickly identify those infected with the new H1N1 virus. The ability to test and quickly diagnose mass numbers of subjects allows wellness clinicians the opportunity to gain control of the spread of the virus in a shorter time frame than current individual testing procedures. The VIP test kits will be made available at an affordable cost (estimated at under $50 per individual), making it feasible even for those without health insurance coverage to be screened.

Source
Arrayit Corporation

4 (two votes)3.33 (3 votes)

Health officials said on Thursday that it looks like the novel H1N1 swine flu virus will continue to spread in the US through the summer months, and then resurge in the autumn. This is different to the previous expectation that the swine flu virus would follow a seasonal flu pattern: abate within the northern hemisphere as it approached the summer, spend a few months in southern hemisphere countries that are now approaching winter, and then return to the northern hemisphere inside the fall.

Two senior officials from the US Centers for Disease Control and Prevention in Atlanta held a telebriefing with journalists yesterday and spoke about the pattern of swine flu transmission within the US and also about infections among well being workers and the need for more rigour in H1N1 infection control in well being care settings.

Dr Daniel Jernigan, Deputy Director of the Influenza Division in the CDC stated 89 per cent of flu instances the CDC are seeing now are the novel H1N1 strain, but the pattern varies widely across the US.

The latest figures from the CDC show that the number of lab-confirmed novel H1N1 situations inside the US now exceeds 17,800, such as about 1,600 that have been hospitalized and 44 deaths, but Jernigan said surveys suggest the actual number of novel H1N1 infections is probably much greater, and around 7 per cent of the population is at present reporting flu-like symptoms.

Although the overall proportion of outpatients getting treated for flu-like illness is now below the national baseline (more or less as expected with seasonal flu), 17 states were still reporting flu activity, with patterns of infection vary significantly from region to region: Northeastern states continue to have the highest number of cases, specifically New York and Massachusetts.

“The US will likely continue to see influenza activity through the summer, and at this point we’re anticipating that we will see the novel H1N1 continue with activity probably all the way into our flu season inside the fall and winter,” stated Jernigan.

He said he and his colleagues in the CDC expect the activity through the summer will be low and then “pick up later”.

The virus continues to affect mostly younger people and so far it is not causing the level of illness and deaths among the elderly that would be expected with seasonal flu, although the symptoms are very similar: fever, cough, shortness of breath, chills and fatigue, and occasionally vomiting and diarrhea.

Jernigan stressed the importance of remaining alert to symptoms of flu, and specifically if they arise in people with underlying conditions such as heart disease, asthma or diabetes. You should go to your doctor straight away if you have any underlying conditions and start to feel symptoms of flu, he said.

From the evidence so far, the CDC stated the antivirals still function, the inhibitors particularly. The agency currently recommends them for use with high-risk patients that are already sick, those who are hospitalized, and anyone severely affected by novel H1N1.

As the summer months approach, and with the virus not abating, outbreaks are now occurring in summer camps. Although adults, teenagers and children at camps are catching swine flu, it appears that mostly children are affected in the summer camps and parents are advised not to send their children to summer camp until seven days after the onset of any illness or four days after it stops, said Jernigan, adding that:

“It’s essential also that aspirin is not used in children with influenza-like illness due to the fact of complications that can occur.”

H1N1 Among Wellness Care Workers

In their 18 June issue of MMWR (Morbidity and Mortality Weekly Report), the CDC gives their latest assessment of H1N1 among well being care workers.

The CDC figures, which include circumstances as much as around mid-May, show that at least 48 wellness care workers have been identified with H1N1. From details of 26 of the infected workers, they discovered that half had been exposed to H1N1 outside of their workplace, but the other half caught it at their workplace. At least one well being care worker caught it from another worker, and the other 12 most probably caught it from sick patients, said the CDC.

Those who caught the virus from sick patients did not “consistently use all recommended forms of personal protective equipment while caring for these patients,” said the CDC, adding that they did not fully follow the CDC guidelines for infection control in caring for patients with novel H1N1 in wellness care settings.

The CDC stressed that health care providers need to stick to the recommended infection control procedures, and specially recognize and triage potentially infectious patients and train staff to follow recommended practice and use protective equipment.

Dr Michael Bell, the Associate Director for Infection Control at the CDC said at the telebriefing that:

“Probably the single most critical thing is that infectious patients be identified in the front door.”

He said the “consistent application of precautions is crucial to make sure that there isn’t occupational exposure,” and identifying potentially infected patients “up front” is essential, whether they are “coming in through the emergency department or the ambulatory care clinic”.

Bell said the CDC recommends using a single patient room for individuals that are infected and make sure they cover their cough.

Health workers should use respirators, gloves and eye protection when seeing to a patient suspected of having H1N1, and take extra care with hand hygiene, he stressed.

– CDC: MMWR 18 June 2009.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

5 (1 votes)

The drugmaker Sanofi-Aventis will donate millions of doses of a vaccine that offers protection against the H1N1 (swine flu) virus to the WHO once the vaccine is ready, the company’s chief executive officer announced Tuesday, Reuters reports (Elsner, Reuters, 6/17). The AP/Google.com writes, “Exceptional instances require exceptional responses. We need to act responsibly and we all have to play our part,” Sanofi CEO Christopher Viehbacher stated in a statement released during the Pacific Health Summit in Seattle. “This flexible donation aims to assist the WHO address the needs of these most vulnerable populations,” he stated.

Viehbacher said Sanofi will give a total of 100 million doses of swine flu and bird flu vaccines, according to the AP/Google.com (Johnson, AP/Google.com, 6/17). “In the event that Sanofi Pasteur’s manufacturing facilities become fully committed to the production of pandemic vaccine,” the company will offer the vaccine to creating countries at a reduced rate, according to a company statement (Sanofi-Aventis release, 6/17).

As drug makers continue to work on developing a viable H1N1 vaccine, the WHO has held off on “whether people should get vaccinated against H1N1, which has spread to all regions of the world,” Reuters writes. “WHO has estimated vaccine makers could produce up to 4.9 billion pandemic flu shots a year in a best-case scenario, leaving some of the world’s 6.5 billion population unprotected, particularly if more than one dose was needed” (Reuters, 6/17).

A GlaxoSmithKline spokesman told Bloomberg the company also plans to donate 50 million doses of an H1N1 vaccine to the WHO. Bloomberg writes, “The decisions by Sanofi and Glaxo contrast with that of Novartis AG, which said this week it wouldn’t donate the vaccine,” but “may look at pricing along with other ways to assure access.” The company’s resistance toward donating vaccines to creating countries stems from their belief “[d]onations won’t address the current pandemic or create sustainable access, [Novartis spokesman Eric] Althoff stated.”

“In principle, I agree that you don’t want to rely on donations, they are not a sustainable model,” Sanofi’s Viehbacher stated. “But a pandemic is an exceptional event, it’s not on-going. We have to do what we can to help the WHO fight [influenza]” (Kelley/Torsoli, Bloomberg, 6/17).

“WHO has confirmed nearly 36,000 cases globally with 163 deaths, although flu experts say there are almost certainly hundreds of thousands of cases,” due to the fact, “Doctors do not test every person with symptoms,” Reuters writes (Reuters, 6/17). Country specific info is available here (WHO Influenza A(H1N1) – update 50, 6/17).

Flu Season In Southern Hemisphere

AFP/Google.com examines growing concerns more than the H1N1 virus threat in South America with vaccine manufacturers “still months away from having enough stocks – too late for the Southern Hemisphere’s winter flu season.”

Researchers at Adolfo Lutz Bacteriological Institute in Brazil announced Tuesday that they had identified a new strain of the H1N1 virus in a patient from Sao Paulo. “It was not yet known whether that variant, called A/Sao Paulo/1454/H1N1, was more aggressive than the more frequent type,” the AFP/Google.com writes (AFP/Google.com, 6/17). According to Fox News, scientists located the new strain following analysis of samples taken from a 26-year-old patient hospitalized with the H1N1 flu in April, who “has since made a full recovery” (Fox News, 6/17).

H1N1 Might Be Creating Antiviral Resistance

There are signs the H1N1 virus is creating resistance to the antiviral drug oseltamivir (Tamiflu), prompting “medical experts to exercise caution when prescribing the antiviral drugs in patients with flu symptoms,” the Bangkok Post reports. According to the newspaper, the topic will be addressed during a WHO meeting today also as ways developing countries can best contain the pandemic.

“Thailand resorted heavily to oseltamivir when treating patients with suspected and confirmed bird flu but experienced an increase in instances creating a resistance to the drug,” the newspaper writes (Treerutkuarkul/Intathep, Bangkok Post, 6/18).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Household Foundation. You are able to view the whole Kaiser Every day Global Health Policy Report, search the archives and sign up for e-mail delivery at globalhealth.kff.org.

? Henry J. Kaiser Household Foundation. All rights reserved.

View drug information on Tamiflu capsule.

- 3 confirmed situations in Wales.

- 0 probable circumstances in Wales.

- 136 people have already been under investigation in Wales. Of these, swine flu has been confirmed in three circumstances (see above) and ruled out in 123 cases, leaving 10 still under investigation. All of these are displaying, or have displayed, mild symptoms.

- Of the 10 people under investigation, seven were nicely when very first identified, but reported recent flu-like symptoms following travel to affected areas. Blood tests are getting undertaken on these individuals to see if they had the flu and to aid the NPHS understand the pattern of the disease from the past. Their symptoms may or might not have already been due to swine flu. Testing will be conducted in a number of weeks to check whether these people did have swine flu – scientifically it won’t work before that. Investigations have shown that people they had close contact with did not catch flu from them when they had been ill.

- No further details will be confirmed or denied about instances in order to protect their right to confidentiality.

- There are now 1,472 laboratory confirmed instances inside the UK – three cases in Wales, 508 cases in Scotland, 952 instances in England and nine in Northern Ireland.

- One person with swine flu within the UK – a case in Scotland – has died. The patient had underlying well being conditions.- Swine flu instances have already been confirmed in 76 countries. For the latest international figures for the spread of swine flu, visit the website of the World Well being Organization at www.who.int

Comment from Welsh Assembly Government and National Public Wellness Service for Wales

- Chief Medical Officer for Wales, Dr Tony Jewell, said:

“So far the virus is generally mild in most people, but proving more severe in a small number of instances, and tragically one person has died in Scotland.

“We have warned that we need to expect that, with large numbers of people contracting swine flu, there will be deaths, particularly in patients with underlying wellness conditions. Even with the seasonal flu, we do see excess deaths occuring.

“Although it is natural for people to feel apprehensive, I would like to reassure the public that we have already been operating to prepare for the arrival of the virus for many years and have robust procedures in place.

“We have made it clear all along that there would be situations in Wales and everyone must continue to be vigilant and try to minimize the spread of the virus.

“We continue to stress that there will be more situations in Wales as the infection spreads within the community and everyone must continue to be vigilant and try to reduce the spread of the virus.

“Our advice to the public remains the same, people should follow good respiratory and hand hygiene to aid stop the spread of influenza – always using a tissue to catch sneezes, throwing away used tissues where germs can linger and killing germs by regularly washing your hands, or cleaning them with a sanitising gel. In short, catch it, bin it, kill it.”

- Dr Roland Salmon, Director of the Communicable Disease Surveillance Centre, National Public Health Service for Wales, said:

“Because this particular type of swine flu is new, people have little or no immunity to it. For this reason, we know it will spread across the country eventually.

“The pandemic will reach different countries at different instances. While the outbreak is dying away in Mexico it is still growing here.

“Whereas we are at present investigating and responding to individual circumstances and prescribing antivirals to all close contacts to stop the quick spread of the disease, there will come a time when it is sensible to change this approach so that our focus moves to treating people who are ill and preventing illness in people who are most at risk. There will be a greater emphasis on local risk assessments by public wellness professionals.

“The World Health Organization considers the overall severity of the pandemic to be moderate. This means that most people recover from infection without the need for hospitalisation or medical care. Levels of clinically severe or fatal instances appear similar to levels seen with seasonal influenza.

“Nevertheless, the death of a patient in Scotland shows we must not be complacent about the effects of the virus in those with pre-existing well being conditions.

“Seasonal flu could be severe, particularly for elderly and vulnerable people, so there is still good reason for us all to take action to reduce its effects. Flu is often confused with a bad cold but is in fact far more serious and leads to many deaths each year in Wales.

“We continue to advise that anyone who has flu-like symptoms and has travelled to one of the affected areas should stay at home and phone their GP or NHS Direct Wales on 0845 46 47.

“People should not go to Accident and Emergency Departments or to their GP surgery without ringing first, as this might risk spreading the infection. It also places undue pressure on the emergency services.

“The National Public Wellness Service for Wales will continue to assess any person with flu-like symptoms.”

Public health advice and messages

- If you have returned from an affected area and have flu-like symptoms, stay at home, phone your GP or NHS Direct Wales and you will be assessed and receive treatment if necessary. Do not go into your GP surgery or Accident and Emergency department unless you are advised to do so or are seriously ill, as you may spread the illness to others.

- Further details such as wellness advice can be found at http://www.wales.gov.uk, http://www.nphs.wales.nhs.uk and http://www.hpa.org.uk . You can also call the Swine Flu Data line on 0800 1 513 513 for recorded information, or NHS Direct Wales on 0845 46 47 for well being advice.

– It is always good practice to follow respiratory and hand hygiene such as:

- Covering your nose and mouth when coughing or sneezing, using a tissue when possible.
- Disposing of dirty tissues promptly and carefully.
- Maintaining good basic hygiene, for example washing hands frequently with soap and water to minimize the spread of the virus from your hands to face or to other people.
- Cleaning hard surfaces (e.g. door handles) frequently using a normal cleaning product.
- Helping your children follow this advice.

Facemasks

- Although we’re aware that facemasks had been becoming given out to the public in Mexico, the available scientific evidence does not support the general wearing of facemasks by those who are not ill whilst going about their normal activities. We’re, however, reviewing NHS supplies and stockpiles of facemasks for healthcare workers who are likely to come into regular contact with people who might have symptoms. The UK will receive an additional 227 million surgical facemasks and 34 million respirators. Wales will receive its proportionate share.

Control measures

- Agreements have already been signed between the UK Government and vaccine manufacturers to secure supplies of as much as 90 million doses of H1N1 vaccine by the autumn. This will not affect the usual seasonal flu vaccination and will be made available to frontline healthcare workers and vulnerable people. Advance purchase arrangements are also in place to buy enough vaccine for the whole population.

- The Welsh Assembly Government’s Well being Emergency Preparedness Unit has issued guidance to Local Wellness Boards on anti-viral distribution. The unit is co-ordinating function on identifying appropriate collection points and the necessary arrangements to support this process.

- People who have travelled to affected areas and have flu-like symptoms have been advised to stay at home and call NHS Direct Wales on 0845 4647 or phone their GP for well being advice.

- The national Swine Flu Details line – 0800 1 513 513 – provides recorded information. People requiring wellness advice should contact NHS Direct Wales on 0845 4647.

- The National Public Health Service for Wales has provided advice to port well being authorities on arrangements for returning travellers.

Features of the outbreak

- Based on assessment of all available info and following several expert consultations, the World Well being Organization (WHO) declared the level of influenza pandemic alert at phase six on 11 June 2009.

- Phase six indicates there is human-to-human spread of the virus in at the least two countries in one World Well being Organization region, with community level outbreaks in at least one other country in a different WHO region.

- A change to phase six means that vaccine manufacturers will need to meet the contractual obligations of advance purchase agreements for vaccines that countries, which includes the UK, have already agreed inside the event of phase six becoming declared.

- A crucial step towards large scale production of a vaccine against swine flu has been completed inside the UK by the National Institute for Biological Standards and Control, part of the Health Protection Agency.

- A strain of virus suitable for vaccine manufacture has now been produced and is becoming made available to the pharmaceutical industry and other flu laboratories.

- More investigations and testing are required to determine the severity of the disease and the ease with which it can spread. These investigations are presently underway with the support of the WHO.

- Testing has shown that the human swine influenza H1N1 might be treated with the antiviral oseltamavir (Tamiflu?) and zanamivir (Relenza?).

- Evidence of sustained community spread of swine flu in Mexico, the USA, Canada, the UK, Australia, Chile and Japan has been confirmed. Person to person transmission of swine flu has also been confirmed in other countries across the world.

- Further data on swine flu and Pandemic Flu is available bilingually from http://www.nphs.wales.nhs.uk

- Further details from the Welsh Assembly Government response is available bilingually at http://www.wales.gov.uk

Source
Welsh Assembly Government

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China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) (“China Aoxing”), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, announced that it has completed the registration trial with Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough. Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.

Under the regulation of China State Food and Drug Administration (“SFDA”), this drug is designated as a Class III New Medicine, or the initial drug to be launched in China while already selling in other regulated territories. As a result, the item is expected to receive a minimum of three-year market exclusivity protection after marketing clearance by the China SFDA. Assuming positive clinical results and timely regulatory approval, the company expects to launch this product in China in 2010.

This registration trial is a randomized, multi-center, double-blind, positive-controlled study designed to evaluate the efficacy of a compound oral solution of codeine phosphate in 215 patient subjects with acute moderate to severe cough.

“We are pleased to report the successful completion of this study, which has demonstrated excellent safety and efficacy among a significant number of patients,” stated Liying Yang, Vice President of Research of China Aoxing. “As we continue our analysis of the data collected in this study, we look forward to presenting the top-line results by the end of the third quarter of 2009.”

The prevalence rate of cough condition is approximately at 15% in China. It is estimated that over 50 million Chinese patients are seeking cough treatment, mainly caused by respiratory disorders. The market size of pharmaceutical product to address cough condition is estimated at approximately $2 billion per year with an annual growth rate of over 10% in China.

Source
China Aoxing Pharmaceutical Company, Inc.

4 (2 votes)1 (1 votes)

The Centers for Disease Control and Prevention (CDC), USA, in its latest update, dated Friday evening, 19th June, 2009, reports a total of 21,449 confirmed human situations of swine flu A(H1N1) infection, including 87 deaths. Authorities say the novel A(H1N1) influenza virus has not mutated and is not more virulent (aggressive) than most normal seasonal human flu viruses. However, health services are bracing themselves for a busy flu season this winter as the swine flu virus will have been circulating for several months, but will still be a relatively novel one.U.S. Human Cases of H1N1 Flu Infection (CDC)Alabama – 172 instances – 0 deaths
Alaska – 23cases – 0 deaths
Arkansas – 18cases – 0 deaths
Arizona – 645 circumstances – 7 deaths
California – 1245 situations – 8 deaths
Colorado – 103 cases – 0 deaths
Connecticut – 767 situations – 3 death
Delaware – 223 circumstances – 0 deaths
Florida – 562 instances – 1 death
Georgia – 51 situations – 0 deaths
Hawaii – 279 circumstances – 0 deaths
Idaho – 47 instances – 0 deaths
Illinois – 2526 situations – 8 deaths
Indiana – 223 cases – 0 deaths
Iowa – 92 instances – 0 deaths
Kansas – 97 – 0 deaths
Kentucky – 108 – 0 deaths
Louisiana – 134 situations – 0 deaths
Maine – 42 – 0 deaths
Maryland – 263 – 0 deaths
Massachusetts – 1270 – 1 death
Michigan – 442 instances – 2 deaths
Minnesota – 365 – 1 death
Mississippi – 81 situations – 0 deaths
Missouri – 46 instances – 1 death
Montana – 44 cases – 0 deaths
Nebraska – 81 instances – 0 deaths
Nevada – 198 cases – 0 deaths
New Hampshire – 187 cases – 0 deaths
New Jersey – 603 circumstances – two deaths
New Mexico – 155 cases – 0 deaths
New York – 1300 – 24 deaths
North Carolina – 125 situations – 0 deaths
North Dakota – 41 instances – 0 deaths
Ohio – 63 instances – 0 deaths
Oklahoma – 112 situations – 1 death
Oregon – 219 instances – 1 death
Pennsylvania – 942 situations – three deaths
Rhode Island – 94 instances – 1 death
South Carolina – 83 – 0 deaths
South Dakota – 17 circumstances – 0 deaths
Tennessee – 121 cases – 0 deaths
Texas – 2519 situations – 10deaths
Utah – 755 situations – 8 deaths
Vermont – 43 situations – 0 deaths
Virginia – 135 situations – 1 death
Washington – 588 instances – three deaths
Washington, D.C. – 33 circumstances – 0 deaths
West Virginia – 77 cases – 0 deaths
Wisconsin – 3008 cases – 1 death
Wyoming – 63 situations – 0 deaths
Territories
Puerto Rico – 18 case – 0 deaths
Virgin Islands – 1 case – 0 deaths

TOTAL – 21,449 circumstances – 87 deaths
(Total includes District of Columbia, Puerto Rico, and US Virgin Islands)

The United Kingdom’s HPA (Wellness Protection Agency) reported on Friday evening, 19th June, 2009, a total of 1,984 confirmed cases, such as one death. Health Canada reported, in the same time and date, 5,710 confirmed human instances and 13 deaths. Australia’s Department of Wellness and Ageing reported at the same time and date two,376 confirmed human cases and no deaths.

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Studies performed in three animal models confirmed the safety and intensive immunogenicity of a new type of intranasal H5N1 influenza vaccine, according to the latest preclinical study data announced today by the Vienna based firm, Avir Green Hills Biotechnology. The study data was just published in PloS One, the Public Library of Science.

“The intranasal immunization with our vaccine has proven itself capable of generating a strong immune response against H5N1 viruses. The technology, with which we produce the vaccine, as soon as again has proven itself an particularly successful path for future vaccines,” reports Dr. Thomas Muster, founder, CEO and CSO of Avir Green Hills Biotechnology. In addition to the intensive immune response, the tests inside the animal models also showed long sustainable protection against different varieties of the virus. “Our approach is an attractive option to conventional influenza vaccines. Clinical evaluations of our pandemic and seasonal vaccine candidates are already in progress.”

Innovative technology for production and application

The process developed by Avir Green Hills Biotechnology for the creation of a vaccine against different influenza strains has several unique features compared to conventional flu vaccines:

- The application as nasal spray instead of injection into the muscle has an advantage in that the immunization protection is stimulated directly at the virus’ portal of entry. The simple practicability of such a spray is enormously advantageous, particularly in the case of pandemics in which circumstances might necessitate the inoculation of numerous people simultaneously.

- The novel vaccine can produce an effective immune reaction against the most distinct varieties of influenza viruses – something only conditionally possible with conventional vaccines. This so-called cross-protection also enables the warding-off of distantly related and already mutated strains of influenza viruses.

- Avir Green Hills has developed a completely novel technology: for the human organism the vaccine appears as a pathogenic flu virus. But it does not produce sickness simply because — through a method developed by the Viennese firm — the NS1 gene responsible for the pathogenic properties of the virus is first extracted from the vaccine, resulting inside the deltaFLU vaccine. Thus, after intranasal administration of the vaccine, a strong immune response is stimulated that provides successful protection against the flu. This method provides for the greatest safety and a good tolerance.

- A fast, efficient method inside the production of a vaccine, the method of reverse genetics developed by Avir Green Hills, makes it possible to produce a vaccine strain against myriad potential viruses within the shortest period of time: an crucial precondition for the rapid provision of vaccination in case of a pandemic.

- Avir Green Hills’ innovative vaccine ultimately is produced in cell cultures (vero cells) – a considerable advantage vis-? -vis conventional production using incubated chicken eggs.

“With this wealth of innovation, the vaccines of Avir Green Hills have the potential to secure a substantial share of the vaccine market,” notes Reinhard Zickler, the company’s chief legal officer.

Technology also suitable for swine flu vaccine

The latest study results are also of significance for the current H1N1 (swine flu) pandemic, Dr. Muster emphasized: “Our technology is applicable for every influenza subtype – including the current ‘new influenza’. The corresponding virus strain that we produced on the basis of the reverse genetics method is already finished and suitable for the vaccine production.” Next, the Viennese company plans as early as summer 2009preclinical testing and then the beginning of a clinical study on these vaccine candidates.

As early as the autumn of 2008, Avir Green Hills Biotechnology had been able to total a clinical Phase I study on its seasonal H1N1 influenza vaccine that yielded excellent results on the safety of the vaccine and high immune response. The results of this trial will be published soon.

Excellent clinical data on the avian flu vaccine expected

The Vienna biotech company also reports crucial progress within the studies initiated in 2008 on the intranasal H5N1 vaccine specially applicable inside the case of a pandemic. In Vienna and St. Petersburg, clinical studies (Phase I) involving the pandemic avian flu vaccine in a total of 68 healthy volunteers are at the moment in progress. Excellent results are expected. The final report of the Russian study is expected by the end of July this year. Data from the Vienna study should be available by the end of 2009.

Source
Avir Green Hills Biotechnology