Fears about swine flu have spurred more than 3,000 people so far to volunteer to take part in upcoming clinical trials of a new vaccine. That’s already more than the number scientists will need at eight different sites around the U.S. “We don’t generally ever get a response like this,” Dr. Lisa Jackson, the principal researcher in charge of the clinical trials being readied at Seattle-based Group Health Cooperative, which fielded more than a thousand calls from people in two days.
Analysts note that the pandemic couldn’t have come at a better time for Glaxo, one of the world’s largest vaccine makers. Generics have been steadily eating into the company’s margins, leaving Glaxo looking for new products to make up the shortfall.
Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine.
The World Health Organization last week raised the pandemic level to phase 6, calling for the implementation of “individual, societal, and pharmaceutical measures” as well as implementation of contingency plans for health systems. WHO continues to recommend no restrictions on travel and no border closures, however. Some 100,000 doses of Protein Sciences’ PanBlok vaccine, being produced from this week forward, will be targeted for clinical trials and for vaccinations in countries that have granted regulatory clearance. Meanwhile, following the WHO announcement, GlaxoSmithKline says it is going to increase production of its anti-viral Relenza, and continue developing a swine flu vaccine. Separately, Chinese vaccine maker Sinovac Biotech says it hopes to put its H1N1 vaccine through its first clinical trial by the end of July.
GlaxoSmithKline has aggressively pursued a vaccine-production capability in Asia with a Chinese flu shot joint venture and a new plant in Singapore to make pneumonia vaccines. The company inked an alliance with Shenzhen Neptunus to make flu vaccines for markets in China, Hong Kong and Macau; Glaxo gets a 40 percent initial stake in the JV in exchange for a contribution of cash and assets worth $34 million. Within two years, GSK plans to take a majority interest in the partnership.
International Coalition of Advocates for the People’s first educational advocacy effort has been a success. Seven women who became international advocates wrote a paper about HPV vaccines to educate all necessary parties in Europe. This paper has been distributed throughout Europe and to select individuals in the United States. Presently, thirteen German scientists from the Robert Koch Institute are questioning the effectiveness of these vaccines. They are also asking for evidence now from the Standing Committee based on the scientists’ views.
“Startups could co-locate with us and create a new type of foundation for discovery,” Witty told the International Association of Science Parks conference in Raleigh, home to one of the country’s largest research centers. And he reiterated GSK’s interest in small acquisitions and partnerships to provide a fresh jolt of new ideas for a company in bad need of good drug development programs. Witty also underscored that the presence of large academic institutions staffed with top researchers won’t be enough to woo companies like GSK in the future. Even more important, he says, is a pro-business attitude “to make the interface between industry and academia porous.”
“What concerns us is that the two manufacturers of the vaccine aren’t always using facts. They claim that a lot of high-risk strains of cancer-causing virus are protected against but equally there are others that are not. If protection is not more than 20 per cent then that is an awful lot of money to be spending, particularly as the vaccines have quite serious side-effects.” — Professor Martina Doren, of the Charitie Hospital in Berlin:
JPMorgan pharma analyst Chris Schott wrote in a research note to clients Friday, “The larger issue for cervical cancer vaccines in the US is the relative stagnation of the US market. We forecast a decline in US vaccinations (and thus US market sales) in 2009 relative to 2008, with 2010 sales returning to roughly 2008 levels.”
Touting competing studies, Merck and Glaxo use 25th International Papillomavirus Conference as venue to fight for increased sales for their HPV-vaccines, Gardasil and Cervarix. Glaxo released a new Cervarix vs. Gardasil head-to-head study, saying Cervarix prompted a stronger immune response. Merck has been promoting its own ‘new’ study data, which claims Gardasil offers protection from certain HPV strains for up to 9.5 years. Can trial data make a big difference in revenues for either company? Merck is facing declining sales and Glaxo has yet to gain FDA approval and is dealing with efficacy issues in the U.K.
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