VaxGen ordered to stop exaggerating anthrax vaccine claims
By PAUL ELIAS
Associated Press
SAN FRANCISCO - Federal regulators have ordered VaxGen Inc. officials to stop exaggerating the benefits of the company's experimental anthrax vaccine, which the government wants for a national stockpile.
On March 24, the Food and Drug Administrations sent the troubled company a warning letter complaining that VaxGen sales material handed out at a government biodefense research meeting in October contained "false and misleading statements" about the experimental vaccine and how it compares to competitor Michigan-based BioPort Corp.'s vaccine.
In particular, the sales brochure claimed VaxGen's vaccine is "at nearly 100 percent purity - significantly higher than what can be obtained using older technologies such as BioPort's."
The FDA said that statement and two others were false or misleading because Brisbane-based VaxGen is only in the early stages of development and such claims are premature.
In fact, VaxGen said it will fail to deliver the first 25 million doses of its anthrax vaccine to the Health and Human Services Department by November as promised under a $877.5 million contract the company signed with HHS in November.
The contract was the first awarded under Project BioShield, a law President Bush signed in 2004 that promises $5.6 billion to develop remedies against possible bioweapons.
VaxGen's vaccine will be added to U.S. reserves to protect against a terrorist attack using anthrax spores. The small biotechnology company has been trying to refashion itself as biodefense specialist since a closely watched human experiment testing its experimental AIDS vaccine flopped in 2003.
Company spokesman Paul Laland said the company has asked HHS to amend the contract to allow it to complete delivery of the first 25 million doses sometime next year.
Laland also said the company would respond to the FDA warning letter and that the company is no longer using the sales brochure touting the experimental vaccine, which uses a piece of the anthrax virus genetically engineered to provoke an immune response.
HHS spokesman Bill Hall declined to comment because he said the department doesn't discuss details of active contracts.
The Nasdaq Stock Market dropped VaxGen from its exchange after the company failed to file two quarterly reports in 2004. VaxGen's stock is trading over the counter and it share price fell 75 cents, or 8 percent, to $8.30 as news of the FDA letter was made public.
Associated Press
SAN FRANCISCO - Federal regulators have ordered VaxGen Inc. officials to stop exaggerating the benefits of the company's experimental anthrax vaccine, which the government wants for a national stockpile.
On March 24, the Food and Drug Administrations sent the troubled company a warning letter complaining that VaxGen sales material handed out at a government biodefense research meeting in October contained "false and misleading statements" about the experimental vaccine and how it compares to competitor Michigan-based BioPort Corp.'s vaccine.
In particular, the sales brochure claimed VaxGen's vaccine is "at nearly 100 percent purity - significantly higher than what can be obtained using older technologies such as BioPort's."
The FDA said that statement and two others were false or misleading because Brisbane-based VaxGen is only in the early stages of development and such claims are premature.
In fact, VaxGen said it will fail to deliver the first 25 million doses of its anthrax vaccine to the Health and Human Services Department by November as promised under a $877.5 million contract the company signed with HHS in November.
The contract was the first awarded under Project BioShield, a law President Bush signed in 2004 that promises $5.6 billion to develop remedies against possible bioweapons.
VaxGen's vaccine will be added to U.S. reserves to protect against a terrorist attack using anthrax spores. The small biotechnology company has been trying to refashion itself as biodefense specialist since a closely watched human experiment testing its experimental AIDS vaccine flopped in 2003.
Company spokesman Paul Laland said the company has asked HHS to amend the contract to allow it to complete delivery of the first 25 million doses sometime next year.
Laland also said the company would respond to the FDA warning letter and that the company is no longer using the sales brochure touting the experimental vaccine, which uses a piece of the anthrax virus genetically engineered to provoke an immune response.
HHS spokesman Bill Hall declined to comment because he said the department doesn't discuss details of active contracts.
The Nasdaq Stock Market dropped VaxGen from its exchange after the company failed to file two quarterly reports in 2004. VaxGen's stock is trading over the counter and it share price fell 75 cents, or 8 percent, to $8.30 as news of the FDA letter was made public.
