Currently, Relenza, marketed by GlaxoSmithKline, is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years old and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years old and older. Tamiflu, marketed by Roche, is approved for the treatment and prevention of influenza in patients 1 year old and older.

The Emergency Use Authorizations allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year old, and to provide alternative dosing recommendations for children older than 1 year old. In addition, under the Emergency Use Authorizations, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of healthcare workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.

These temporary extensions of the indication will terminate when the emergency no longer exists.

GlaxoSmithKline has received orders from several governments aiming to stockpile a new candidate A (H1N1) adjuvanted influenza vaccine as a precautionary measure. The company will manufacture the new vaccine once virus seed is made available by the World Health Organization. The first doses of the vaccine are expected to be available four to six months later, subject to regulatory approval. Since the outbreak, the company has been in continuous discussions with governments and public health authorities to help develop appropriate options to respond to the emergence of the new A (H1N1) influenza strain.

In May, the World Health Organization requested deployment of the “Rapid Response Stockpile,” which includes the 2 million treatment courses held by the WHO and the 3 million treatment course rapid response stockpile held by Roche. The stockpile is being deployed to countries in need at the discretion of WHO.

In addition, Roche is continuing to maximize manufacturing output of Tamiflu to meet the growing demand. Roche ramped up Tamiflu output at multiple points in the supply chain, and production ramp up will continue over time resulting in a continuous and increasing flow of Tamiflu.

According to analysts with research company Datamonitor, during the last five years governments around the world have invested significant amounts of money in establishing emergency stockpiles. The United States alone has built up a supply of 50 million courses of antiviral medicine on a federal level and a further 22 million courses on a state level. Datamonitor analysts believe that while even these amounts are not sufficient to protect the entire population, they should have a significant impact on protecting people working on the front line of a pandemic, such as healthcare workers, thereby limiting the spread.

In response to a National Institutes of Health request for assistance in combating the outbreak of swine flu, Blue Heron Biotechnology Inc. managed to deliver a synthetic DNA gene sequence in just three days.

“We were able to draw on our 10 years of gene synthesis expertise to come up with an approach to deliver this critical research tool to the NIH in far less time than usual” says John Mulligan, Blue Heron’s chief scientific officer. The synthesized gene was part of the H1N1 virus and was delivered using Blue Heron’s proprietary GeneMaker gene synthesis platform.

BioSante Pharmaceuticals Inc. plans to conduct additional pre-clinical studies to confirm its vaccine adjuvant, BioVant, can increase the efficacy of flu vaccines, including a potential new H1N1 swine flu vaccine. Previously presented BioSante data from three BioVant-adjuvanted flu vaccine pre-clinical studies using the M1 protein, H1N1 (similar to today’s swine flu), H3N1, and H5N1 antigens showed that BioVant effectively delivered flu vaccines while also enhancing the body’s natural immune responses to flu virus antigens, including the potentially pandemic swine flu.

Juvaris BioTherapeutics Inc. announced results demonstrating that its universal influenza vaccine produces robust antibody responses and complete protection in H1N1 and H3N2 pre-clinical challenge models. A universal vaccine would protect against both epidemic virus strains mismatched with the annual seasonal vaccine and new pandemic threats like the H1N1 swine flu and could be stockpiled. Juvaris’ universal flu vaccine is composed of conserved antigenic epitopes for both influenza A and B strains combined with its proprietary adjuvant, JVRS-100.

Vical Inc. has entered into a Cooperative Research and Development Agreement with the U.S. Naval Medical Research Center, a biomedical research organization within the U.S. Navy, for the expedited development of a vaccine against the H1N1 strain of influenza virus. The goal of the collaborative development program is to rapidly advance a Vaxfectin-formulated H1N1 DNA vaccine into clinical testing as quickly as possible. Vical would be responsible for securing regulatory approval of the vaccine for use in the United States and other countries.

Sinovac Biotech Ltd., a developer and provider of vaccines in China, has initiated preparatory activities for the development of a vaccine for swine flu. Sinovac has contacted various Chinese government authorities and other global health organizations in order to closely monitor the disease and evaluate strategies to control and prevent its transmission.

In 2008, following the receipt of a Chinese government grant, Sinovac expanded its annual manufacturing capacity for its pandemic influenza vaccine, Panflu, to 20 million doses. These facilities can also be used in the development of a swine flu vaccine. In April 2008, Sinovac received SFDA approval to produce Panflu. The approval of Panflu in China followed a fast track regulatory approval process.

Scientists at Baylor Institute for Immunology Research received a renewal of a multi-million dollar grant from the National Institutes of Health to design new vaccines to prevent influenza, including swine flu. The grant will also help BRI develop advanced technologies that could be used for early detection of many other diseases, such as cancer, autoimmune diseases, and infectious diseases.

Canopus BioPharma Inc. has commissioned a team of experts led by Dr. Akihiro Shimosaka, to assist with its plans for major collaborations to license, manufacture, and distribute its H1N1 swine flu statin antiviral. This team is in negotiations with the Office of Disease Control and Emergency Response, the CDC ,and the SFDA in China with a view to initiating large scale clinical trials and gaining marketing approval on behalf of Canopus BioPharma.

Canopus has patented and developed novel aerosol formulations of the widely used cholesterol lowering drugs statins, which Canopus has proved effective against all previous pandemic strains of influenza. The objective of Canopus’ newly appointed scientific and commercial panel is to launch aerosol statin formulations as viable antiviral medications to target all strains of influenza.

“We believe that statins hold the key to mass treatment of influenza pandemics in humans,” says Patrick Prendergast, chairman and CEO of Canopus BioPharma. “It is also expected that this aerosol formulation will demonstrate a high degree of efficacy against H1N1 Swine flu, as it is a broad spectrum influenza antiviral, having shown efficacy against not only H1N1, H3N2, and H5N1, but also against equine influenza, H3N8 in separate animal studies.”

Cannabis Science Inc. has extended its offer to provide its whole cannabis-extract lozenge to health and homeland security officials in Canada and Mexico. The company’s offer followed the World Heath Organization raising its pandemic flu alert level to 5, the last step before declaration of a multi-continent pandemic. Following April’s declaration of a public health emergency by U.S. Secretary of Homeland Security Janet Napolitano, the company offered to provide emergency cannabis formulations to the Department of Homeland Security for distribution.

Diagnostics company Osmetech has submitted a request to FDA for Emergency Use Authorization for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus. Osmetech’s Respiratory Pathogen Test Panel test, which is expected to be launched as a research use only product next quarter, detects and differentiates between 18 common bacterial and viral infections, including the influenza A virus and its H1N1 subtype. Osmetech is developing an extension to the Respiratory Pathogen Test that will differentiate this H1N1 subtype between the human and swine forms of the virus.

DeltaTRAK Inc., a manufacturer of cold chain management solutions and life science products, has increased production of all products that help ensure product efficacy for vaccines and pharmaceuticals. All these products are designed to monitor and record temperature and can be used during transport and/or storage of vaccines and pharmaceuticals.

Many vaccines and pharmaceuticals have temperature sensitivity where they must be kept between two and eight degrees centigrade. If temperature limits are exceeded, these chemicals change to where they lose potency. For the transportation and temporary storage of vaccines, DeltaTRAK offers the FlashLink CT BioLogger, an electronic data logger with preset temperature alarm limits at two and eight degrees centigrade. These data loggers include ShadowLog, a feature that guarantees temperature data is collected even if an operator fails to start the device.

Rx Response, a partnership created to help ensure the continued flow of medicines to patients in a severe public health emergency, has been put on Alert Status as concerns grow over the health threat posed by outbreaks of swine flu in the United States. Rx Response is a single point of contact for the entire pharmaceutical supply system and relies on a network that allows federal and state emergency management officials to communicate with Rx Response regarding pharmaceutical needs and other issues that may affect the supply system. The communications are actively monitored by all segments of the pharmaceutical supply system to ensure the fastest possible resolution.

“Americans need to know that the medicines they rely on will be available even in an emergency,” says Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, a member of Rx Response. “Rx Response provides federal and state crisis managers with the critical information they need about the pharmaceutical supply chain to help communities affected by an emergency return to normal as quickly as possible.”

Alert Status means that Rx Response members are now closely monitoring developing information regarding influenza cases detected in the United States and are working with local, state, and federal health authorities to help ensure the continued efficient functioning of the nation’s pharmaceutical supply chain.

Rx Response was developed more than two years ago in response to Hurricane Katrina and the threat of pandemic influenza.

The outbreak of influenza A (H1N1) is testing pandemic preparedness strategies around the world. According to analysts with Datamonitor, while widely implemented strategies seem to have prepared the world better than ever before for such an outbreak, important gaps regarding the logistics of drug and vaccine distribution remain.

Responding to growing fear of a flu pandemic over recent years, many governments around the world, encouraged by the WHO, have developed pandemic preparedness plans. Because influenza A (H1N1) has proved to be relatively mild with Mexico the only country to report significant mortality, however, the current outbreak has not yet tested the limits of global public health systems. The real test for pandemic flu preparedness will come if the virus spreads more widely or returns in a more severe form in the coming winter. While it is very hard to predict the future development and size of threat caused by H1N1, Datamonitor analysts believe that several key challenges remain in order to successfully tackle the possible pandemic if H1N1 regains momentum and severity.

“A timely re-assessment and implementation of anti-pandemic measures is our best hope to significantly reduce the impact of a pandemic, and avoid the millions of deaths observed in previous global influenza outbreaks,” says Datamonitor infectious diseases senior analyst Hedwig Kresse.

Fears do appear to be on the decline. According to SDI’s Vector One: National, for the week ending May 8, the number of new antiviral prescriptions dispensed at retail pharmacies was 118,578, a 59% drop compared with about 277,000 new prescriptions the week before. Tamiflu accounted for 90% of the market’s new prescriptions last week.

Unfortunately, some unscrupulous parties are taking advantage of the emergency. FDA and the Federal Trade Commission are warning the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat, or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending Web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared, or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” says Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

Products that are offered for sale to the public with claims to diagnose, prevent, mitigate, treat, or cure infections caused by the H1N1 influenza virus that have not been proven to be safe and effective for these uses must be carefully evaluated. Many of these deceptive products are being sold over the Internet via illegitimate Websites. These fraudulent products come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices, or vaccines.

“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” says FTC Chairman Jon Leibowitz. “The FTC will act swiftly against companies that resort to deceptive advertising.”

Meanwhile, researchers are learning more from the previous flu scare. An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided insights into how to combat the virus. The findings by FDA scientists and collaborators better explain what part of the “bird flu” virus is seen by the immune system once a person becomes infected. As one result of this research, a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus.

“Analysis of blood from patients recovering from the H5N1 avian influenza virus can lead to new tools for testing the potential protective activity of vaccines under development,” says Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “The findings could also lead to new tests to detect infections, and improved therapies.”

Since 2003, more than 400 people worldwide have been infected with the bird flu virus. About 60% of them have died. No cases of avian flu have been reported in the United States. Most of the avian flu infections in humans involve people who have had direct contact with infected poultry. However, there is a potential risk for a global influenza pandemic should the virus acquire the ability to spread directly from person to person.

The researchers adapted an existing technique using genetically modified viruses (phages) to create a library of fragments representing all of the proteins found in the H5N1 virus. Scientists mixed these fragments with antibodies from five Vietnamese patients recovering from the H5N1 infection and observed which fragments attracted the patient’s antibodies.

Several targets that are likely to trigger strong antibody responses to the H5N1 virus were identified, including PB1-F2, a protein that researchers believe contributes significantly to the virus’s ability to cause disease.

“We believe this is the first evidence of the human immune system reacting this strongly against PB1-F2,” says Hana Golding, Ph.D., chief of CBER’s Laboratory of Retrovirus Research. “This is an indication that it may be a good target for a drug or vaccine.”