Pharma, biotech industries rise to H1N1 challenge

As fear over a possible influenza A virus subtype H1N1 pandemic subsides, health experts are still showing caution about preventing the virus’ spread, and drug makers and pharmaceutical research suppliers are actively supporting efforts to protect the public.

Amy Swinderman
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As fear over a possible influenza A virus subtype H1N1 pandemic subsides, health experts are still showing caution about preventing the virus' spread, and drug makers and pharmaceutical research suppliers are actively supporting efforts to protect the public.
First detected in the United States last month, the H1N1 virus is a hybrid of pig, avian and human strains. Officials suspect a link between the U.S. cases and an earlier outbreak of late-season flu cases in Mexico, many of which were fatal. Soon thereafter, the United Nations' World Health Organization (WHO), along with the U.S. Centers for Disease Control and Prevention (CDC), expressed concern that H1N1 could become a worldwide flu pandemic.

Now, although virologists have noted that the outbreak has proven relatively mild and less fatal than historic pandemics, researchers and health officials still stress that precautionary measures be taken to mitigate the strain's spread.

According to the WHO, as of May 11, 30 countries have officially reported 4694 cases of H1N1 infection. Mexico has reported 1626 laboratory confirmed human cases of infection, including 48 deaths. The United States has reported 2532 laboratory confirmed human cases, including three deaths. Canada has reported 284 laboratory confirmed human cases, including one death. Costa Rica has reported eight laboratory confirmed human cases, including one death.

As this story went to press, the WHO's level of influenza pandemic alert remained at Phase 5, which means there has been an increase in the number of cases, but there is no evidence of community transmission.

"We have new cases, most of them are imported cases from travelers, returning travellers or close contacts of these people," said Dr. Sylvie Briand, project leader in the WHO's Global Influenza Program, in a press briefing last week. "These figures are important of course, but the major figure of our work—I mean technical and scientific work—has been to try and understand better what is this new disease exactly? Because this is a new virus, and of course we are still learning about this virus and how it behaves in human population."

Some analysts are predicting that the H1N1 virus could boost sales for major players in the pharmaceutical industry. Since the virus' outbreak, Roche Holding AG has stepped up production and deployed stockpiles of its antiviral drug Tamiflu, one of two drugs that have been shown to work against H1N1.

The second one, an inhaled flu drug called Relenza, is made by GlaxoSmithKline plc. GSK said it is ramping up production of Relenza and preparing to start manufacturing a pandemic vaccine.

French pharma Sanofi-aventis said it will continue to manufacture seasonal influenza vaccines but it is also ready to develop a vaccine against the new influenza strain. Sanofi also won Food and Drug Administration (FDA) approval for a bulk manufacturing plant in Swiftwater, Pa., that will produce the egg-based influenza vaccine Fluzone.

However, government officials said that creating H1N1 vaccines could take longer than expected because of uncertainties over the mutation of the virus and the appropriate dose needed for protection. Dr. Jesse Goodman, the FDA's acting chief scientist, said officials are working with manufacturers on a production strategy, but in order to ensure the vaccines are safe, they are following the same procedure used in making seasonal flu shots.

Scientists at MedImmune, a subsidiary of AstraZeneca, are also in negotiations with the CDC to develop an H1N1 vaccine. MedImmune makes an intranasal treatment for other influenza strains under its FluMist brand.

Netherlands holding company Qiagen NV announced that two of its tests can screen for H1N1— the artus Influenza Kit, which uses Polymerase Chain Reaction (PCR) and runs on LightCycler, a widely used detection platform; and the Resplex II v 2.0 assay, a multiplex test which is also PCR-based, which differentiates between Influenza Type A and B and detects whether a sample contains additional respiratory-related viruses.

Life sciences solutions provider Life Technologies Corp. said it is helping to accelerate detection of H1N1 by providing instrument systems and other components to public health laboratories across the United States, enabling testing for the virus to now be conducted in all 50 states, consistent with CDC methods. The company's Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and the research-use-only marketed Applied Biosystems 7500 Fast Real-time PCR System are being used as part of the FDA's Emergency Use Authorization for use with the H1N1 Real-time RT-PCR Detection Panel for the presumptive diagnosis of the virus.

Luminex Corp.
is reporting that its xTAG Respiratory Viral Panel (RVP) assay has been demonstrated to be effective in surveillance of H1N1. Specifically, Luminex has verified through testing on confirmed swine flu-positive samples that the xTAG RVP assay will correctly identify these samples as positive for influenza A and negative for common seasonal flu strains of influenza A H1 and H3. This is the expected outcome for novel influenza A strains which prompts follow-up testing by state or federal public health labs with assays such as the CDC swine flu assay. Luminex is continuing to work with many current customers, including public health laboratories and officials to gather additional data and samples to further confirm their findings.
Biosearch Technologies Inc. of Novato, Calif. is offering to the public the rapid custom synthesis of all research use only (RUO) oligonucleotide probes and primers composing the H1N1 detection panel recently developed and disclosed by the CDC. Biosearch will, upon customer request, prepare custom probes andprimers for the following assays: InfA probe and primers to detect alluniversal strains of influenza A; swInfA probe and primers to detectall strains of swine influenza A; swH1 probe and primers to detect allstrains of swine influenza H1; and RnaseP probe and primers as a formof positive control.

Catalent Pharma Solutions Inc.
, a Somerset, N.J.-based provider of outsourced dose form manufacturing and packaging services to the global pharmaceutical, biotechnology and consumer health industry, says it also expects to play a vital role in supporting the global pharmaceutical and biotechnology industries' response to H1N1 outbreak.  Catalent has existing customer agreements to produce on-demand, additional commercial supplies for anti-viral drugs currently recommended by the
CDC to treat H1N1. Catalent is also one of the leading outsourcing providers of pre-filled syringe filling for seasonal influenza vaccines at its recently opened Brussels, Belgium facility, and is preparing to deploy significant additional capacity for the multiple H1N1 flu vaccines currently being developed by its customers.

HyTest Ltd. of Turku, Findland said it is offering highly sensitive and specific monoclonal antibodies for detection of H1N1 that can be used in routine immunoassays.

A few venture capital-backed biotechs have also joined the battle. Startups Pulmatrix and NanoBio are investigating anti-infective compounds that might combat H1N1 while a vaccine is being developed. Pulmatrix's inhaled drug is showing potential to treat those infected by activating the formation of a protective biophysical barrier against pathogens, while NanoBio is working on an experimental nasal spray that can kill pathogens on contact and adjuvants that boost immune response triggered by a viral or bacterial antigen.

The H1N1 outbreak may also serve as a boon to researchers as well. Last week, scientists at the Public Health Agency of Canada's microbiology lab in Winnipeg announced that it completed the full genetic sequencing of virus. The researchers said the discovery would help health authorities pinpoint the origin of the virus, how its spreads and how it changes over time.

The virus was also the subject of a special health report by Harvard Health Publications (HHP), a division of Harvard Medical School. The multilingual report, Swine Flu: How to understand your risk and protect your health, explains what the illness is, how it is diagnosed and treated and how families and businesses can protect themselves against it.

Amy Swinderman

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