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Glaxo's Vaccine-Booster May Be Mixed With Sanofi Bird-Flu Shots
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWFG3CjYDX1o&refer=healthcare
By John Lauerman
March 13 (Bloomberg) -- The U.S. may add GlaxoSmithKline Plc's vaccine booster to shots made by Sanofi-Aventis SA, enabling more people to be protected against a possible pandemic sparked by bird flu, a Glaxo executive said.
A so-called adjuvant developed by London-based Glaxo has been shown to increase the potency of vaccines in human tests, and would allow the U.S. government to immunize more people with existing supplies, David Stout, the company's chief operating officer, said in an interview yesterday.
Adjuvants are substances used to enhance the ability of an antigen, the key ingredient in vaccine, to stimulate the immune system. Glaxo's adjuvant-enhanced vaccine is about 25 times more effective in protecting against the H5N1 avian influenza strain than shots made by Paris-based Sanofi. Glaxo has held talks with U.S. officials about buying its product, Stout said.
``We think the value is in the adjuvant, not in the antigen,'' he said.
Antigens are foreign substances in the body that trigger the immune system to form infection-fighting antibodies.
About 30 companies worldwide, including Novartis AG and MedImmune Inc., are working on pandemic vaccines and other treatments as world health officials track the spread of H5N1.
Worldwide, there is enough capacity to produce about 300 million doses of seasonal flu vaccine within six months, David Fedson, a former director of medical affairs in Europe for Sanofi, said in an interview in July. The amount of pandemic flu vaccine that could be produced will depend on the amount of antigen required per shot, he said.
More Power?
Glaxo's proprietary adjuvant, also used in its experimental Cervarix vaccine against cervical cancer, might help the U.S. restore some power to its vaccine stockpile.
The Department of Health and Human Services said in November that one of five shots in its storehouse had begun to lose their effectiveness as they sit on the shelf. The reduction in potency means that the stockpile now contains enough vaccine to fully immunize 3 million people against H5N1, down from 3.75 million, HHS said then.
The Sanofi shots in the U.S. stockpile contain 90 micrograms of H5N1 antigen. Two shots are needed for full protection.
When used with the company's own adjuvant, the Glaxo vaccine provides protection with two doses each as small as 3.75 micrograms. The smaller the dose, the more shots can be made from a given supply of viral antigen, Stout said.
Glaxo charges from about $6 to $11 worldwide for its seasonal flu vaccine, and prices for its H5N1 vaccine will be close to that range, Stout said. He wouldn't say how much the company would charge the U.S. for adjuvant alone.
Antiviral Drugs
Governments are stockpiling vaccine to prepare for the possibility that H5N1, a virus that has spread in birds to at least 56 countries in Asia, Africa, the Middle East and Europe, will start spreading quickly in humans. Of the 278 people known to have been infected since late 2003, 168 have died, according to the World Health Organization.
In addition to vaccine, the U.S. and other governments are stockpiling antiviral drugs such as Roche Holding AG's Tamiflu pills and Glaxo's inhaled Relenza.
Glaxo has stopped development of injectable forms of Relenza, which health officials had said might help treat severely ill avian-flu patients, Stout said.
``We asked people if they were going to buy any and they said `No, we want it to be there just in case,'' he said. The company faced ``huge, expensive clinical programs without any buyer.''
``It's just on hold,'' he said. Orders for the available, inhaled drug have slowed, he said.
Anthrax Scare
The U.S. has stretched its vaccine supplies before to prepare for possible disease outbreaks, Stout said. After five people were killed by attacks with anthrax through the mail in 2001, health officials called on Glaxo and other drugmakers to discuss their ability to make supplies of smallpox vaccine, he said.
Experiments later showed that existing government supplies of stored vaccine could be diluted to make enough for a possible attack, he said. Governments may be seeking to stretch stockpiles of pre-pandemic flu vaccines in a similar way.
``Now they're buying antigen at this 90 microgram dose, figuring `They can't charge me much for a single dose and if I get 90 micrograms then I can buy GSK's adjuvant and use that down at 3.75 micrograms,''' he said.
Glaxo, Novartis AG, and U.S.-based Iomai Corp. received contracts in January to design and develop treatments for pandemic flu including those using adjuvants.
Novartis, based in Basel, Switzerland, got a $55 million contract. Glaxo's is worth at least $63.3 million and Iomai won a $128-million contract to develop a dose-sparing patch to be used with flu vaccine.
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net .
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWFG3CjYDX1o&refer=healthcare
By John Lauerman
March 13 (Bloomberg) -- The U.S. may add GlaxoSmithKline Plc's vaccine booster to shots made by Sanofi-Aventis SA, enabling more people to be protected against a possible pandemic sparked by bird flu, a Glaxo executive said.
A so-called adjuvant developed by London-based Glaxo has been shown to increase the potency of vaccines in human tests, and would allow the U.S. government to immunize more people with existing supplies, David Stout, the company's chief operating officer, said in an interview yesterday.
Adjuvants are substances used to enhance the ability of an antigen, the key ingredient in vaccine, to stimulate the immune system. Glaxo's adjuvant-enhanced vaccine is about 25 times more effective in protecting against the H5N1 avian influenza strain than shots made by Paris-based Sanofi. Glaxo has held talks with U.S. officials about buying its product, Stout said.
``We think the value is in the adjuvant, not in the antigen,'' he said.
Antigens are foreign substances in the body that trigger the immune system to form infection-fighting antibodies.
About 30 companies worldwide, including Novartis AG and MedImmune Inc., are working on pandemic vaccines and other treatments as world health officials track the spread of H5N1.
Worldwide, there is enough capacity to produce about 300 million doses of seasonal flu vaccine within six months, David Fedson, a former director of medical affairs in Europe for Sanofi, said in an interview in July. The amount of pandemic flu vaccine that could be produced will depend on the amount of antigen required per shot, he said.
More Power?
Glaxo's proprietary adjuvant, also used in its experimental Cervarix vaccine against cervical cancer, might help the U.S. restore some power to its vaccine stockpile.
The Department of Health and Human Services said in November that one of five shots in its storehouse had begun to lose their effectiveness as they sit on the shelf. The reduction in potency means that the stockpile now contains enough vaccine to fully immunize 3 million people against H5N1, down from 3.75 million, HHS said then.
The Sanofi shots in the U.S. stockpile contain 90 micrograms of H5N1 antigen. Two shots are needed for full protection.
When used with the company's own adjuvant, the Glaxo vaccine provides protection with two doses each as small as 3.75 micrograms. The smaller the dose, the more shots can be made from a given supply of viral antigen, Stout said.
Glaxo charges from about $6 to $11 worldwide for its seasonal flu vaccine, and prices for its H5N1 vaccine will be close to that range, Stout said. He wouldn't say how much the company would charge the U.S. for adjuvant alone.
Antiviral Drugs
Governments are stockpiling vaccine to prepare for the possibility that H5N1, a virus that has spread in birds to at least 56 countries in Asia, Africa, the Middle East and Europe, will start spreading quickly in humans. Of the 278 people known to have been infected since late 2003, 168 have died, according to the World Health Organization.
In addition to vaccine, the U.S. and other governments are stockpiling antiviral drugs such as Roche Holding AG's Tamiflu pills and Glaxo's inhaled Relenza.
Glaxo has stopped development of injectable forms of Relenza, which health officials had said might help treat severely ill avian-flu patients, Stout said.
``We asked people if they were going to buy any and they said `No, we want it to be there just in case,'' he said. The company faced ``huge, expensive clinical programs without any buyer.''
``It's just on hold,'' he said. Orders for the available, inhaled drug have slowed, he said.
Anthrax Scare
The U.S. has stretched its vaccine supplies before to prepare for possible disease outbreaks, Stout said. After five people were killed by attacks with anthrax through the mail in 2001, health officials called on Glaxo and other drugmakers to discuss their ability to make supplies of smallpox vaccine, he said.
Experiments later showed that existing government supplies of stored vaccine could be diluted to make enough for a possible attack, he said. Governments may be seeking to stretch stockpiles of pre-pandemic flu vaccines in a similar way.
``Now they're buying antigen at this 90 microgram dose, figuring `They can't charge me much for a single dose and if I get 90 micrograms then I can buy GSK's adjuvant and use that down at 3.75 micrograms,''' he said.
Glaxo, Novartis AG, and U.S.-based Iomai Corp. received contracts in January to design and develop treatments for pandemic flu including those using adjuvants.
Novartis, based in Basel, Switzerland, got a $55 million contract. Glaxo's is worth at least $63.3 million and Iomai won a $128-million contract to develop a dose-sparing patch to be used with flu vaccine.
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net .
