INTERVIEW-Intercell expects data, partner for flu adjuvant
Source: Reuters
By Ransdell Pierson NEW YORK, Sept 10 (Reuters) - The chief operating officer of Austrian vaccine maker Intercell AG <ICEL.VI> said on Thursday he expects mid-stage data and a potential marketing partner in coming months for the company's adjuvant patch meant to bolster vaccines against the H5N1 bird flu virus. Thomas Lingelbach also disclosed in a Reuters interview that the company plans late-stage trials next month for another patch, used to vaccinate against traveller's diarrhea. He said it could garner annual sales of $500 million if the trials succeed and it is approved because there currently is no vaccine for "Montezuma's Revenge," the slang term for the disconcerting ailment. The diarrhea vaccine patch uses the same active ingredient as the pandemic flu vaccine adjuvant -- a protein from the toxin produced by E. coli bacteria meant to jolt the immune system into high gear -- but in a different formulation. Intercell, one of the few remaining independent vaccine makers, in May began a Phase II study of its pandemic bird flu product, financed under a $128 million contract with the U.S. Department of Health and Human Services. "Our vaccine-enhancement patch could be used universally, which means for every single strain" of pandemic flu, said Lingelbach, who is also CEO of Intercell's U.S. operations. In the ongoing mid-stage trial, subjects are being given a single injected dose of vaccine against the bird flu virus. Intercell's adjuvant patch is then placed over the injection site, like a Band-Aid, for six hours. Data from the Phase II study are expected by the end of 2009, by which time the company expects to choose a marketing partner, Lingelbach said. It is focusing on vaccine makers because of their related marketing expertise. CHOOSING A PARTNER Intercell has been in partnership talks with the world's 5 biggest vaccine makers, Lingelbach said, including Sanofi- Aventis SA <SASY.PA>, Merck & Co <MRK.N> and Novartis AG <NOVN.VX>, and aims to select a partner "in the next couple of months." "A product like this could have a theoretical market size of $60 million to $100 million" in annual sales, said Lingelbach, who noted no other such patch is on the market. The company is hoping its adjuvant will make a single dose of vaccine adequate to protect against the bird flu. Without an adjuvant, Lingelbach said bird flu vaccines now in development might require at least two doses to be effective. The H5N1 bird flu has affected flocks of birds in Asia, parts of Europe and Africa and experts fear it could mutate into a form that humans can catch and transmit easily. If it does, it could kill millions. Even in its current hard-to-catch form, it has infected and killed hundreds of people since 2003. "It's very clear that there has been less attention on H5N1 recently, but that doesn't mean that it does not continue to be a threat," Lingelbach said. The adjuvant patch could be approved by 2012, but could be made available as soon as next year in the event an emergency is declared by health authorities, Lingelbach said. Lingelbach said new tests of the the adjuvant patch will likely begin next year, among subjects receiving a vaccine against the new swine flu virus sweeping the globe, called H1N1. The World Health Organization forecasts that as many as 2 billion people will eventually become infected with the swine flu virus. So far, the flu has been deemed relatively mild and of shorter duration than the typical seasonal flu, but has caused jitters because of its potential prevalence and tendency to infect children. (Reporting by Ransdell Pierson; editing by Andre Grenon)
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