Mystery, Iraqi Sheikh Cloud Hungary's Bird-Flu Vaccine Claims
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May 31 (Bloomberg) -- Hungary says it has invented an effective human vaccine against bird flu. The trouble is, the country can't seem to prove it.
Seven months after proclaiming the product effective against a potential pandemic virus, the Hungarian government and Omninvest Kft., the private company that developed the vaccine, haven't sold a vial. They haven't released any scientific evidence backing their claim. Nor have they sought regulatory approval from the European Union that would encourage its use by potential buyers.
Omninvest, based outside Budapest, increased skepticism about the vaccine in April when it turned to an Iraqi investor based in Budapest to help market the product. The man, who identifies himself as the leader of Iraq's Sunni Muslims, says he has no pharmaceuticals sales experience, and was once investigated by Hungarian police over the disappearance of a shipment of medical aid to Iraq.
``I am really very suspicious until I see a big pharmaceutical company with clear marketing potential get behind this,'' Gabor Blasko, a member of the Hungarian Academy of Sciences in Budapest, said in a telephone interview. Scientists at Hungary's National Epidemiology Center, which developed the vaccine, may have been too hasty when they pronounced the vaccine ready for the international market late last year, he said.
The H5N1 avian influenza virus has killed 127 of the 224 people who have gotten the illness since 2003, with most cases resulting from exposure to infected animals, the World Health Organization says.
Winner of Vaccine Race
Several drugmakers, including Paris-based Sanofi-Aventis SA and London-based GlaxoSmithKline Plc, are racing to develop a vaccine in case the virus begins spreading from human to human.
Omninvest and Hungary said in October they had beaten the bigger rivals. Neither will release research data for scientific peer review. Their claim also is clouded by questions over the Iraqi sheikh's business credentials and Sumpter Pharmaceuticals Ltd., Omninvest's Cyprus-based parent company, whose owners decline to identify themselves.
Hungary's Prime Minister, Ferenc Gyurcsany, told Parliament Oct. 17 that Hungary would profit from sales of the vaccine, which showed promise against the deadly H5N1 strain of bird flu in human testing. The country's National Epidemiology Center said it began testing the vaccine on 146 volunteers in Budapest in September.
Potential customers such as Romania say they won't order the vaccine or the technology to produce it without EU approval.
A Siberian Buyer
Glaxo, Europe's biggest drugmaker, inspected Omninvest's production facility in the town of Pilisborosjeno, then decided to continue developing its own bird-flu vaccine, Gyorgy Leitner, head of the company's Hungarian unit, said in an interview.
Russia's Chelyabinsk region in Siberia, which had a bird-flu outbreak in poultry last August, is considering buying Hungary's technology to produce the vaccine itself, said Victor Shepelev, the regional minister for health care in a May 30 interview in Budapest. First, the vaccine will have to be approved by Russian authorities, a process that could take up to a year, Shepelev said.
``As a business case, this has been a failure rather than a success,'' Peter Pazitny, a partner at the Bratislava, Slovakia- based Health Policy Institute, which advises eastern European governments on health policy, said in a telephone interview.
Hungarian Surgeon General Laszlo Bujdoso said he disagrees with suggestions that the vaccine hasn't sold because it doesn't work.
Protected Data
``We'll be eagerly awaiting experts in Hungary, so they can come to the scene and we can acquaint them with the production and the technological details,'' he said in a March 27 e-mail.
Asked to produce a copy of the certificate the government said it issued to Omninvest March 14 authorizing the vaccine's sale, Bujdoso said, ``The document is not public, because it contains protected data.''
Sanofi announced May 11 that its bird-flu vaccine was able to stimulate an immune response in 42 days after inoculation in a test group of 300 volunteers, according to a company-sponsored study in the Lancet medical journal. World governments are expected to spend millions of dollars stockpiling an effective vaccine to protect people should a pandemic be declared.
Former State Secretary for Health Erzsebet Pusztai of the opposition Hungarian Democratic Forum said she'll push for an inquiry into how and why Hungary's Socialist-led government subsidized Omninvest's vaccine with 2 billion forint ($9.8 million) of taxpayer money.
Owners in Cyprus
``If it were just a private company, there'd be nothing to say,'' Pusztai said in a telephone interview. ``But Omninvest is getting state money. Why is this?''
She also questioned who will profit from sales of the treatment. Omninvest is 98-percent owned by Cyprus-registered Sumpter Pharmaceuticals, an investment company managed by AJK Bureau of Consultants Ltd., based in Larnaca, Cyprus.
AJK specializes in helping investors create businesses in countries such as Cyprus, the Bahamas, and the Isle of Man, according to the company's Web site. It also manages at least a dozen companies based in Moscow, according to Russian online business directory Polpred.com.
Andreas Karapatakis, AJK's chairman and Sumpter's director, refused to identify Sumpter's owners.
``We don't have to disclose this information to anyone unless they are investigating a crime,'' Karapatakis said in a telephone interview May 25.
Iraqi Sheikh
Sheikh Semir Sabih Khelil al-Dulaimi, a 43-year-old Iraqi- Hungarian investor, announced April 27 he had purchased the rights to sell the vaccine to governments and companies in 29 countries. Hungary accepted Dulaimi's offer to join the vaccine business because it needs help selling the vaccine to foreign governments, Economy Minister Janos Koka said in a brief interview May 9.
``We never expected to go abroad on our own,'' he said ``We had to get a multinational company.''
Hungarian-born Dulaimi said he paid ``tens of millions'' of dollars in February to Omninvest for the rights to the technology to produce its bird-flu vaccine. He declined to give exact financial details.
His Web site lists businesses in Iraq ranging from drilling to civil engineering and the Al-Dulaimi Airlines.
Dulaimi said he didn't announce the contracts until after the April 23 elections in order to keep Hungary's opposition party from finding out about the deal. Hungary's ruling Socialist government will get 14 percent of the revenue from the vaccine.
Payment Disputed
Andras Batiz, Hungary's government spokesman in Budapest, said in an e-mailed statement the government hadn't received any money from Dulaimi. The Iraqi has non-exclusive permission to help sell the technology, he said.
``It's not my business to decide if he's trustworthy or not,'' Batiz said. He referred further questions to Omninvest, whose spokesman, Zsolt Nemeth, said he wasn't able to comment.
Dulaimi says he has the right to sell the vaccine in Australia, Japan, the U.K., Germany, Iraq and two dozen other countries, from which he will get 50 percent of the proceeds, he said.
Dulaimi was investigated by Hungarian police in 2003 in connection with the disappearance of a 60 million-forint consignment of drugs bound for war-torn Iraq, he said. No charges were brought against him.
``A lot of people don't like us,'' Dulaimi said. ``But that's the way it is.''
Lajos Molnar, a physician who will become the nation's health minister June 12, said in an interview May 30 that he will ``look into'' the vaccine claim and Dulaimi's involvement after he takes office.