pandemic

GSK bird flu vaccine wins race for European OK

Mon, 19 May 2008 06:59:58 -0400

After investing about $2 billion in development efforts, GlaxoSmithKline has won European approval for the first bird flu vaccine that can be used either in advance of or in the early days of a human pandemic. Glaxo is clearly expecting to see orders for Prepandrix shoot up after regulators for the European Commission firmly placed the vaccine well in the lead in the heated race to develop an antidote designed to protect populations against H5N1. Switzerland has already ordered 8 million doses, enough to inoculate its entire population. And the U.S. has ordered 27.5 million doses.

"It's clear that some governments are more proactive than others," said Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo. "The policy is evolving, and I'm looking for some kind of alignment in terms of what governments are going to do. Governments are concerned by the real medical and economic threat of a pandemic."

Sanofi Aventis and Novartis are also in the race to gain approvals for a new vaccine, anxious to capture a market that may total about $1 billion a year.

- read the story from the International Herald Tribune

ALSO: South Korea, meanwhile, mobilized soldiers for a second time to help cull millions of poultry in the face of an outbreak of H5N1 in the country's bird population. Report

ALSO NOTED: Sirtris, NCI collaborate on cancer models; Kylin expands in Indiana; and much more...

Thu, 21 Feb 2008 06:59:50 -0500

> Sirtris announced a collaboration with the National Cancer Institute to its enzyme activators in cancer models. Report

> Kylin Therapeutics in Indiana has been expanding with the help of funds provided by the state's Economic Development Corp. Report

> The Los Angeles Times reports on the growing profitability of the HIV drug sector, which has been particularly beneficial to Gilead Sciences. Article

> Sirion Therapeutics has licensed rights to develop eye therapies using a anti-inflammatory agent developed by Bridge Pharma. Release

> LA-based ImmunoCellular Therapeutics announced today that Manish Singh, Ph.D., MBA has taken on the full-time position of president and CEO. Release

> Eurand has been granted a priority review by the FDA for Zentase--EUR-1008. Release

> Forest Laboratories and Cypress Biosciences say the FDA has agreed to review their NDA application for milnacipran, a treatment for fibromyalgia. Report

> Medical device makers got some supreme protection yesterday. The highest court raised a partial shield against lawsuits, saying that devices that passed the FDA's most stringent premarketing review are exempt from consumer lawsuits. Report

> A Nobel Prize-winning biologist says that researchers are no closer to developing a vaccine against HIV than they were 20 years ago, when the scientific quest began. Report

> Can a vaccine control high blood pressure? Report

> There's growing evidence around the U.S. that the flu jab offers only marginal protection against the seasonal ailment. Report

> In 2007, drugmakers jacked prescription prices up 7.8 percent. Report

And Finally…The CDC says the U.S. has made enormous efforts to prepare for a health crisis, like a flu pandemic, but cautions that an enormous amount of work remains to be done. Article

SPOTLIGHT: GAO questions antidotes for pandemic

Thu, 24 Jan 2008 06:59:53 -0500

The GAO says that a pandemic vaccine can offer little help during the crucial initial stages of an outbreak. The Department of Health and Human Services has estimated that it would take 20 to 23 weeks to develop and manufacture a vaccine targeted at a specific strain. And increasing access to antivirals--the second key strategy for dealing with a pandemic--would demand construction of new facilities and fresh sources of production material. FierceVaccines

SPOTLIGHT: Flu pandemic "inevitable"

Wed, 15 Aug 2007 06:59:53 -0400

Australia's health minister says that it's only a matter of time before a flu pandemic hits the country. But he's not releasing the country's antiviral stockpile in the face of a deadly outbreak of influenza A. Report

Press Release: Novavax Licenses Wyeth's Virus-Like Particle Technology

Maureen Martino — Mon, 09 Jul 2007 11:01:51 -0400

Novavax Licenses Wyeth's Virus-Like Particle Technology

ROCKVILLE, Md., July 9 -- Novavax announced today that is has signed a non-exclusive, worldwide license agreement with Wyeth, to obtain rights to a patent application covering virus-like particle (VLP) technology for use in human vaccines in certain fields of use. The agreement provides for an upfront payment, annual license fees, milestone payments and royalties on any product sales. Payments under the agreement to Wyeth could aggregate $5 million through the end of 2008.

Novavax is developing pandemic and seasonal influenza vaccines based upon the VLP technology. VLPs mimic the three-dimensional structure of a virus but do not contain genetic material. Therefore, they cannot replicate and are believed to be incapable of causing infection or disease. Because VLPs maintain functional properties of two influenza surface proteins, hemagglutinin and neuraminidase, they have been shown to activate multiple responses in the immune system. The licensed patent application supplements Novavax's extensive patent portfolio in the VLP field.

"We are delighted to have completed this license agreement with Wyeth and see this license as another important step in building a strong intellectual property position for our influenza vaccine programs," stated Rahul Singhvi, President and Chief Executive Officer of Novavax, Inc.

About Novavax

Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome® adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.

Forward-Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding product sales, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward- looking statements.

CDC offers advice in combating a pandemic

Thu, 01 Feb 2007 19:01:35 -0500

With experimental vaccines in short supply, the CDC has outlined a series of public responses to a flu pandemic. Saying the U.S. needs to prepare for a "Category 5" pandemic, the agency suggests that schools should be closed and public events should be canceled to help slow the spread of a dangerous outbreak. In addition, the CDC is suggesting that business shifts should be staggered and entire families should stay home if one of them is sick. But the CDC is warning against closing state borders or disrupting transportation, noting that such a strategy would interrupt the flow of emergency supplies. The U.S. government, like many around the world, has been stockpiling Tamiflu, although resistant strains of H5N1 have already emerged.

- check out the CDC's plans
- here's the article on pandemic preparations

PLUS: HHS has triggered a provision giving vaccine makers immunity from product liability suits. The agency called it a precautionary step in light of new cases of avian flu in Asia and Nigeria. Report (WSJ sub. req.)

Related Articles:
New CDC guidelines target drug-resistant infections. Report
HHS issues contracts for pandemic vaccine research. Report
WHO recommends dual therapy for avian flu. Report

Press Release: GSK Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Maureen Martino — Wed, 17 Jan 2007 12:38:17 -0500

GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Company Begins Government and Retail Shipments of its Antiviral Relenza(R)
PHILADELPHIA, Jan. 17 -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK's ongoing pandemic vaccine research in using the company's innovative adjuvant technology in combination with antigens to induce a strong immune response.
Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the U.S. Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event of a flu pandemic. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
"A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, President of Pharmaceuticals at GlaxoSmithKline. "GSK's research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK's short and long-term vision of helping governments around the world in their pandemic preparedness efforts."
In a separate action related to pandemic preparedness GSK also announced that the company has begun shipping up to 15.5 million treatment courses of its antiviral Relenza® (zanamivir for inhalation). The Relenza shipments are part of GSK's agreement with the Federal Government announced last year to provide the U.S. Government and the states with Relenza for building their flu pandemic stockpiles. GSK also has started to ship Relenza to retail pharmacies to fulfill patient prescriptions for seasonal flu treatment and prevention.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.
GSK's 2005-2007 Milestones in Pandemic Preparedness
January 2007: GSK begins supplying its antiviral Relenza® zanamivir for inhalation), to the U.S. Government and begins working with private-sector businesses and other organizations to provide Relenza as part of their business continuity planning.

December 2006: GSK received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use CHMP) for its candidate alum-adjuvanted pandemic vaccine. GSK plans to submit a file to the European regulatory authorities in the coming weeks for the licensing of both a pandemic and a pre-pandemic vaccine with our proprietary adjuvant system technology.

November 2006: GSK received a $40 million initial order for bulk H5N1 antigen from HHS.

2006: GSK signs contracts with several countries for pre-pandemic vaccines.

September 2006: GSK reached an agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting the right to manufacture and sell the antiviral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.

July 2006: Clinical studies announced by GSK showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

May 2006: GSK received an award of $274 million to develop cell-culture technology to speed the development of new cell-culture-based seasonal and pandemic influenza vaccines scale-up cell-culture manufacturing capability at GSK's Marietta, PA site.

2005: GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

HHS issues contracts for pandemic vaccine research

Tue, 16 Jan 2007 19:01:38 -0500

GlaxoSmithKline has won a $63.3 million contract from Health and Human Services to develop pre-pandemic and pandemic vaccines, supporting its research into adjuvants that boost the effectiveness of vaccines. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines. Iomai, meanwhile, announced it will receive a contract from HHS to fund the development of a dose-sparing patch for use with a pandemic influenza vaccine.

A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, president of pharmaceuticals at GlaxoSmithKline.

- here's the release on GSK's contract
- and here's the release on Iomai

Related Articles:
HHS awards H5N1 contracts. Report
Switzerland to stockpile GSK's bird flu vaccine. Report
Novartis wins $220M flu vaccine contract. Report

Bird flu outbreaks spread across Asia

Mon, 15 Jan 2007 19:01:36 -0500

Indonesia is preparing more hospitals to take victims of a new bird flu outbreak, as one facility reports that its small isolation ward has been filled. At least one family cluster has been affected as officials report the deaths of at least four people in that country in just the past week. Japan, meanwhile, is reporting that it has confirmed the presence of the lethal H5N1 version of bird flu in poultry, its first outbreak in three years. And reports of bird flu in poultry in Vietnam and Thailand have also surfaced. In many ways, the current spate of new cases fits into a well-established winter pattern in the Northern Hemisphere. As cold weather spreads, more victims surface, renewing fears that the virus could mutate into a new form that could trigger a human pandemic. Health officials, though, say that this year, government agencies appear to be responding much more quickly, in order to contain any outbreaks that occur. The fear of a pandemic has also prompted major efforts to develop new vaccines to protect populations. But that effort is still in a very early stage.

- here's the report on avian flu from ENS

Related Articles:
Vietnam steps up efforts to control bird flu. Report
New bird flu death adds to toll. Report
WHO calls for $10B in bird flu vaccine research. Report
The challenges of infectious disease. Report

Press Release: Juvaris BioTherapeutics Announces First Round Closing Of Series A Financing

Maureen Martino — Tue, 09 Jan 2007 10:46:39 -0500

Juvaris BioTherapeutics Announces First Round Closing Of Series A Financing

PLEASANTON, Calif., Jan. 8 -- Juvaris BioTherapeutics, a private company, today announced it has closed the first of two rounds of a Series A financing with a $6 million investment from Kleiner Perkins Caufield & Byers Pandemic & Biodefense Fund. The second closing will occur within 120 days from the date of the first closing, bringing the total Series A Round to $12 million.

The funds will enable the Company to advance its lead vaccine products for influenza and pneumonia indications to clinical trials. The Company will also pursue immunotherapy products for Hepatitis B and Biodefense applications. The funds permitted the Company to close asset purchase agreements negotiated with Valentis. The purchased assets include relevant intellectual property that had been the subject of a worldwide exclusive license and a fully operational 10,800 sq. ft. manufacturing plant in Burlingame, CA. As part of this transaction, Juvaris has hired seven former Valentis employees engaged in production and QA/QC activities.

In commenting on the investment, Juvaris Co-Founder, Chairman, and CEO Martin D. Cleary said, "There could not have been a more favorable outcome for our program, employees and shareholders than to have KPCB take this investment interest in Juvaris. Their long-term view and willingness to help guide our strategic direction has already made a major contribution to our effort. Together we will build a very successful company."

In commenting for the KPCB Pandemic & Biodefense Fund, Partner Thomas P. Monath M.D. recently appointed to Juvaris' Board of Directors said, "The Juvaris team has done a superb job of demonstrating the potential of their proprietary adjuvant and immunotherapeutic platform for multiple disease targets. With the acquisition of manufacturing assets from Valentis, the Company can now rapidly progress to clinical proof of concept."

About Juvaris

Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA complex, which as a single product will have utility in multiple infectious disease and cancer applications. The JuvImmune product has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants.

When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. Moreover, substantial immune responses have been induced following oral and intranasal administration. This platform provides the opportunity to develop many disease-specific immunotherapy products, for which there are significant unmet medical needs.

In January 2006, the Company announced the award of a two-year Small Business Technology Transfer (STTR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH for the development of an influenza A virus vaccine. In March 2006, the Company announced the award of an 18-month Small Business Innovation Research-Advanced Technology (SBIR-AT) grant from NIAID for the development of an HIV vaccine, and in September 2006, the Company announced the award of a two-year biodefense SBIR grant from NIAID for the development of an immunotherapeutic treatment for Tularemia. Recently, the Company announced the award of an SBIR grant from the National Cancer Institute for the development of a vaccine for leukemia.

About Kleiner Perkins Caufield & Byers

Since its founding in 1972, Kleiner Perkins Caufield & Byers has backed entrepreneurs in 475 ventures, including AOL, Align, Amazon.com, Citrix, Compaq Computer, Electronic Arts, Genentech, Genomic Health, Google, Hybritech, IDEC Pharmaceuticals, Intuit, Juniper Networks, Netscape, Lotus, Nuvasive, Sun Microsystems, Symantec, Verisign and Xilinx. KPCB portfolio companies employ more than 250,000 people. More than 150 of the firm's portfolio companies have gone public. Many other ventures have achieved success through mergers and acquisitions. KPCB has broadly invested in both life sciences and information technology since inception in 1972. In the last six years, KPCB has expanded its focus to include Greentech and pandemic preparedness.

Company Contact: Martin D. Cleary Juvaris BioTherapeutics, Inc. 925.399.6200 mdcleary@juvaris.com

Juvaris BioTherapeutics
CONTACT: Martin D. Cleary of Juvaris BioTherapeutics, Inc.,+1-925-399-6200, mdcleary@juvaris.com

Sequoia gains $35M in third round

Mon, 08 Jan 2007 19:01:35 -0500

The Wellcome Trust has led a $35 million third round of venture capital for Sequoia Pharmaceuticals, which has been developing a therapy for drug-resistant HIV. MedImmune Ventures also jumped in as a new investor in the company. Much of the money is earmarked for product development.

- here's the release on the venture round

ALSO: Kleiner Perkins Caufield & Byers Pandemic & Biodefense Fund has added $6 million to Juvaris BioTherapeutics' first venture round. The money goes to pushing its lead vaccine products for influenza and pneumonia indications into clinical trials. Release

Press Release: GlaxoSmithKline Reaches Milestone in Its Flu Pandemic Vaccine Development Programme

Maureen Martino — Thu, 14 Dec 2006 12:20:45 -0500

GlaxoSmithKline Reaches EU Regulatory Milestone in Its Flu Pandemic Vaccine Development Programme

LONDON, RIXENSART, Belgium, Dec. 15, 2006--GlaxoSmithKline Biologicals today announced that Daronrix®, its first generation alum-adjuvanted inactivated whole virus candidate flu vaccine* for use once a pandemic has officially been declared by the WHO/EU, has received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP). This is a first step in the preparation against a possible H5N1 pandemic.

GSK will submit a second file to the European Regulatory Authorities within the next few weeks for its second generation H5N1 candidate vaccine. This vaccine, which is currently in late-stage development, utilises GSK’s novel proprietary adjuvant system technology. Upon licensure, this second vaccine could potentially be used as part of a proactive pre-pandemic vaccination campaign, helping to prepare the human immune system in advance of a pandemic and give broad protection against different H5N1 strains. This new generation vaccine candidate could also be adapted for use as a pandemic vaccine once the flu strain causing the pandemic has been identified. It also has the added benefit of requiring a substantially lower amount of antigen to raise a strong immune response and gives the ability to produce very large quantities of vaccines for mass vaccination.

Jean Stéphenne, President of GSK Biologicals, the vaccine division of GSK, said: “Receiving this positive opinion today from the CHMP is testament to the company’s ongoing commitment to provide health authorities with concrete options against the threat of an influenza pandemic. I believe, with the imminent filing of our second generation vaccine GSK has brought two solid vaccine solutions to prepare for pandemic or proactive pre-pandemic vaccination.”

The submission dossier for the first generation vaccine, which received the positive opinion today, was based on a series of data including a pivotal clinical trial involving 400 healthy adults1. This trial evaluated the safety, reactogenicity and immunogenicity of different doses of the candidate vaccine and compared it to different doses of non-adjuvanted H5N1 influenza vaccine. It was concluded from the study, that two doses containing at least 15mg of H5N1 HA antigen are required to meet the EMEA’s (European Medicines Agency) licensing criteria for seroprotection rate (SP³70%), seroconversion rate (SC³40%) and seroconversion factor (2.5). The vaccine also had a safety and reactogenicity profile similar to non-adjuvanted vaccine1.

GSK’s proprietary-adjuvanted second generation (pre-)pandemic vaccine, which the company expects to file shortly, requires significantly less antigen (3.8mg) to meet the EMEA’s licensing criteria2. This marked reduction in the amount of antigen required to obtain a strong immunogenic response (the so-called ‘antigen-sparing’ phenomenon) should allow more people to be vaccinated in the event of a pandemic.

Avian influenza

H5N1 avian influenza infections lead to severe disease in both birds and humans. To date, the WHO has reported 260 human cases of bird flu from 10 countries resulting in 153 deaths3.

Public health experts fear that this virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic4. Influenza pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu virus strain.

GSK, a leader in flu treatment and preparedness

GSK has an active research and development programmetargeted at both seasonal and pandemic influenza and has recently committed over $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza® (zanamivir for inhalation). In North America, GSK acquired a major influenza vaccine manufacturer, ID Biomedical Corporation in 2005.

GSK is one of the world’s leading research-based pharmaceutical and health care companies. GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

ENDS

Daronrix and Relenza are registered trademarks of the GlaxoSmithKline group of companies

*GSK’s alum-adjuvanted inactivated whole virus candidate pandemic vaccine can only be marketed when the following conditions have been fulfilled:

- There is an official WHO/EU declaration of an influenza pandemic

- The flu strain variation to be introduced into the pandemic vaccine has been approved

References:

1. Hehme N et al. Whole virus alum-adjuvanted pandemic vaccine: safety and immunogenicity data on a vaccine formulated with H5N1. IVW 2006 oral presentation

2. Borkowski A et al. Antigen sparing effect of a novel adjuvant system in a split H5N1 pandemic vaccine. IVW 2006 oral presentation

3. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO, 13 November 2006(www.who.int)

4. Global pandemic influenza action plan to increase vaccine supply, WHO September 2006

Press Release: GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

Maureen Martino — Mon, 20 Nov 2006 15:26:31 -0500

GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

GlaxoSmithKline awarded HHS contract

Philadelphia, PA, November 20, 2006–– GlaxoSmithKline (NYSE:GSK), one of the world’s largest vaccine manufacturers, today announced it has been awarded a contract to supply pre-pandemic vaccines to the US strategic national stockpile. The company has received an initial $40 million order under the contract from the U.S. Department of Health and Human Services (HHS) for bulk H5N1 antigen - the substance in the vaccines that will help produce an immune response.

Under the terms of the contract, GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the HHS Office of Public Health Emergency Preparedness and the Office of Public Health Emergency Medical Countermeasures.

“We applaud the US government’s proactive steps in protecting American citizens against this potential public health threat,” said David Stout, President, Pharmaceutical Operations, GlaxoSmithKline. “We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the US government in its preparedness efforts.”

GSK remains in active discussions with other governments to supply their public health programs and has been steadily increasing its support to flu pandemic preparedness efforts globally, leveraging the company’s vaccine and anti-viral expertise.

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

About GSK Biologicals

GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world’s leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.

Editor’s note

In 2005, GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

GSK was the first company to submit a “mock-up” dossier for an egg-based pandemic vaccine with traditional alum adjuvant to European regulators.

In May 2006, GSK announced, along with HHS, that it had received an award of $274 million to develop cell-culture technology to speed the development of new cell culture-based seasonal and pandemic influenza vaccines, and to scale-up cell culture manufacturing capability at GSK’s Mariettasite.

Clinical studies announced by GSK in July of this year showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

GSK has supplied its anti-viral, Relenza ® (zanamivir for inhalation), to the U.S. government and is now working with private-sector businesses and other organizations to provide Relenza ® as part of their business continuity planning.

A new agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnamand all Least Developed Countries.

The US is one of several countries to sign a contract with GSK for a pre-pandemic vaccine.

Roche's Tamiflu ads spark criticism

Maureen Martino — Wed, 01 Nov 2006 12:55:12 -0500

If Roche has its way, a gaggle of happy penguins will charm consumers into stocking up on flu drug Tamiflu. Using penguin characters from a current children's feature as a theme, Roche Pharmaceuticals has developed a multi-million dollar ad campaign to create demand for the costly medication. Tamiflu, which has attracted international attention as a possible stopgap in the war against bird flu, is designed to slow flu progression and minimize symptoms. The ads, which come just before the start of flu season, don't mention Tamiflu specifically. Critics say the promotion is irresponsible. Dr. Jerry Avorn, a Harvard Medical School professor, argues that the drug's benefits are minimal. Worse, he suggests that if consumers use Tamiflu heavily, Americans will develop a resistance to the drug and won't benefit from it if and when bird flu does become a pandemic. The drug is already proving to be a bonanza for Roche. The pharmaco reported that Tamiflu sales rose to $1.3 billion during the third quarter of this year, an increase of 88 percent over the Q3 '05. Report

SPOTLIGHT: GSK signing new vaccine deals

Sun, 29 Oct 2006 19:01:33 -0500

Fresh from signing a deal to supply Switzerland and Singapore with enough avian flu vaccine to inoculate the country's entire population, GlaxoSmithKline is now in talks to sign similar deals with France and the U.K. The vaccine has not yet been approved, but the EMEA's stamp of approval is expected in a matter of weeks. Some concerns have been raised that the new vaccine may not be effective against any new strain of avian flu that may trigger a human pandemic. Report

Sanofi vaccine effective against new bird flu strains

Wed, 18 Oct 2006 20:01:36 -0400

Sanofi Pasteur says that its experimental bird flu vaccine has proved effective against recent variations of the virus, leading its researchers believe that the therapy could be effective against a viral mutation that could trigger a human pandemic. Sanofi researchers announced last May that the vaccine appeared safe and effective in early human trials. And the new data indicates that the vaccine produces antibodies that work against recently discovered strains of H5N1.

- here's the AFX report on the vaccine

Switzerland to stockpile GSK's bird flu vaccine

Tue, 17 Oct 2006 20:01:37 -0400

GlaxoSmithKline's experimental bird flu vaccine hasn't been submitted for European approval yet, but Switzerland has already signed a deal to buy enough for its entire population. Switzerland will receive 8 million doses of the vaccine for stockpiling and another 7.5 million doses after any potential pandemic strain is identified. GSK and others in this field believe that creating vaccines based on the H5N1 virus will still afford protection to people after the virus mutates. In its current strain, the virus is not easily transmitted to people. GSK plans to submit the vaccine for approval later this year.

- read the AFX report on the stockpiling deal

Related Articles:
GSK bird flu vaccine spurs more questions. Report
The challenges of infectious disease. Report

Alnylam wins $23M biodefense contract

Wed, 27 Sep 2006 20:01:34 -0400

Alnylam Pharmaceuticals is launching a new initiative dubbed Alnylam Biodefense after winning a $23 million government contract to develop new biodefense therapies. Alnylam will use its RNAi technology that works as a switch on genes, turning them on and off. Its researchers will concentrate on hemorrhagic fever viruses like Ebola. Alnylam says that the government support will help it push other therapies now in the pipeline.

- read the Boston Business Journal report on Alnylam

ALSO: The House passed a new biodefense bill today that would create the Biomedical Advanced Research and Development Authority to develop therapies for pandemic viruses and biodefense attacks. The authority would "streamline" the development of new drugs. Report

SPOTLIGHT: Air travel spreads influenza

Mon, 11 Sep 2006 20:01:33 -0400

A new study says that air travel plays a direct role in the spread of influenza. Researchers found that the plunge in air traffic after 9/11 delayed the arrival of seasonal flu by two weeks. But some experts cautioned against reading too much into the study, noting that a shutdown of the global transportation system, for example, would not be an effective method to stop the spread of a pandemic. Article

Novartis to build $600M flu plant in N.C.

Tue, 18 Jul 2006 20:01:39 -0400

With the help of a $220 million federal government grant, Novartis announced it will build a $600 million flu-vaccine manufacturing facility in North Carolina. Construction will begin in 2007 and the plant will be ready for vaccine production for the 2012 flu season. Novartis's decision to construct a new plant is an effort to update older manufacturing facilities that have had production problems in recent years. Rather than making the vaccine from chicken eggs, production at the new facility will obtain the vaccines using cell-culture technologies. It's a method that is quicker and more reliable to the traditional approach, though the FDA has yet to approved the method for flu vaccines. Novartis will pump out an estimated 50 million doses of the vaccine from the new plant.

The North Carolina facility will also be equipped to produce up to 150 million avian flu vaccines in the event of a pandemic. In early May, five pharmaceutical companies--MedImmune, DynPort Vaccine, GlaxoSmithKline, Novartis and Solvay Pharmaceuticals--won a combined $1 billion dollars worth of government contracts in the race to develop new technology to make flu vaccines needed to combat a human pandemic. Interestingly, the project's $600 million price tag is $200 million more than CEO Daniel Vasella had projected May.

- read this San Francisco Chronicle article
- check out this The Washington Post report for background on the government contract