By Julie Steenhuysen - Analysis
CHICAGO (Reuters) - Tiny companies with big ideas for making flu vaccines have captured the attention of investors and governments looking for a quicker way to make a vaccine against the pandemic of swine flu.
But while the vaccine rush has given companies new opportunities for grants and some the chance to test their technologies on people, few will actually have an H1N1 vaccine any time soon, analysts and vaccine experts said on Tuesday.
The World Health Organization forecasts that as much as a third of the world’s population, or 2 billion people, will eventually become infected with the new H1N1 virus, a tempting market for many companies.
“There’s a lot of companies that put out these press releases because they’re looking for investor money,” said Dr. Greg Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, who tests new vaccines.
“What I have learned over several decades is ‘Show me the data.’ They put out these wild things hoping to attract angel funding, but you look at the data and they’ve got a study in 20 mice.”
Vaccine experts say the threat of swine flu has made it clear to governments that the current 60-year-old method of growing flu vaccines in chicken eggs -- a process that can take up to six months -- must be replaced.
“Flu can move faster than we can,” said Dr. John Treanor of the University of Rochester Medical Center, who tests flu vaccines.
“I think that it’s possible that this episode would be a real stimulus to propel some of these approaches onward a bit faster than they would have been able to move.”
The smaller biotech companies poised to benefit are those that have already tested their products in people, but a lot will also depend on the virus itself, said Rodman & Renshaw analyst Elemer Piros.
He said a severe pandemic may mean some countries will take a gamble on newer technologies.
“I don’t see them playing here or next season on U.S. soil, but that doesn’t exclude countries like India, where they could have a much lower regulatory bar,” he said.
Many countries have signed deals or are in talks with companies such as Novavax Inc, Vical Inc, Medicago Inc and privately held Protein Sciences Inc.
“Novavax seems to be in a lead position there with an alternative platform because they already have about 600 patients worth of clinical data -- safety and efficacy -- of their platform,” Piros said.
The company is developing a vaccine using virus-like particle, or VLP, technology, the same method used by Merck & Co Inc to make its Gardasil HPV vaccine for cervical cancer.
Novavax has been using the technology to develop a vaccine against H5N1 avian influenza and said last month its seasonal flu vaccine was effective in a mid-stage trial.
Its H1N1 vaccine induced a strong immune response in animals and the company plans to ask the FDA for permission to start a trial in people this quarter.
Other companies, including Medicago Inc in Quebec, have virus-like particle technology. The company uses tobacco plants to make their proteins.
Medicago signed a letter of intent last week with Tabuk Pharmaceuticals, the second biggest drugmaker in Saudi Arabia, for a deal to develop, produce and sell Medicago’s vaccines in Saudi Arabia and other places in the Middle East and North Africa. The company has said it is also in talks with China’s Hunan Province.
Protein Sciences Corp, a closely held biotech, is another company that has fairly extensive human experience with its new vaccine made in genetically modified insect cells.
In late June, it won a $35 million federal contract to make vaccines for pandemic influenza. If testing goes well, the contract could be expanded over five years for a total of nearly $150 million.
And last spring, it struck a deal with Mexican authorities to operate a vaccine factory there.
Poland said DNA vaccines hold promise because they can be made without growing the virus or the need for biocontainment facilities.
Vical has already done human tests on an avian flu vaccine and has several other vaccines in advanced testing, including a late-stage melanoma vaccine.
Vical has landed a contract to test its vaccine with the U.S. Navy and said it will begin clinical trials of its swine flu vaccine as soon as the grant is funded.
Inovio Biomedical Corp is using DNA-based vaccine technology to jointly develop with the U.S. National Institutes of Health a universal vaccine that targets several strains of the virus.
Vaccine experts said it is hard to say which new vaccine approaches will ultimately prove to be the best and there may be more than one winner.
Additional reporting by Scott Anderson in Toronto; editing by Maggie Fox and Andre Grenon