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      Asian drug-makers ready to make generic versions of Tamiflu

      Posted AtTodayOnline.com

      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.
      .
      "We have no deal with Roche on the product, but could explore a tie-up," Cipla joint managing director Amar Lula told AFP in New Delhi.
      .
      In Taiwan, a health department official, Li Jih-heng. said authorities are planning a trial production of Tamiflu in December.
      .
      "We will continue efforts seeking a patent authorisation from the Swiss company Roche to mass manufacture Tamiflu but the trial production will go ahead to meet emergency needs," Li told AFP in Taipei.
      .
      "The drug will be used to contain bird flu in the event of an outbreak, not for commercial purposes."
      .
      Taiwanese legislators, citing threats of a possible outbreak, have urged health authorities to immediately mass-produce the drug even without Roche's authorisation.
      .
      Roche's Shanghai office has said it was also in touch with the mainland Chinese government and had provided it with full and updated information about the drug.
      .
      Roche is willing to allow other companies in China or the government to produce the drug, it said.
      .
      Vietnam, which accounts for two-thirds of the H5N1 strain's human fatalities, is in contact with Roche, according to Cao Minh Quang, director of the Pharmaceuticals Administration Department in Hanoi.
      .
      Quang said Vietnam could even decide to produce the anti-viral drug without a licence in case of a pandemic -- a situation in which governments would be under intense pressure to put public health above respecting copyright laws.
      .
      Koh, the managing director of Roche's Singapore office, said he hoped the situation would not reach such a point.
      .
      "As Roche is willing to discuss and collaborate on technical matters for the manufacturing of Tamiflu, there is no need for these countries to violate patent laws," he said.
      .
      Singapore said it was increasing its stockpiles of Tamiflu but was not in talks with Roche to manufacture the drug.
      .
      Currently, Singapore has Tamiflu supplies to treat 430,000 people and expects more deliveries to enable it to treat 1.05 million people, or a quarter of the population, within a year, the Ministry of Health (MOH) said.
      .
      "However, MOH will continue to watch the developments in the area of generic anti-viral drugs and keep our options open," it said. — AFP
      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.
      .
      "We have no deal with Roche on the product, but could explore a tie-up," Cipla joint managing director Amar Lula told AFP in New Delhi.
      .
      In Taiwan, a health department official, Li Jih-heng. said authorities are planning a trial production of Tamiflu in December.
      .
      "We will continue efforts seeking a patent authorisation from the Swiss company Roche to mass manufacture Tamiflu but the trial production will go ahead to meet emergency needs," Li told AFP in Taipei.
      .
      "The drug will be used to contain bird flu in the event of an outbreak, not for commercial purposes."
      .
      Taiwanese legislators, citing threats of a possible outbreak, have urged health authorities to immediately mass-produce the drug even without Roche's authorisation.
      .
      Roche's Shanghai office has said it was also in touch with the mainland Chinese government and had provided it with full and updated information about the drug.
      .
      Roche is willing to allow other companies in China or the government to produce the drug, it said.
      .
      Vietnam, which accounts for two-thirds of the H5N1 strain's human fatalities, is in contact with Roche, according to Cao Minh Quang, director of the Pharmaceuticals Administration Department in Hanoi.
      .
      Quang said Vietnam could even decide to produce the anti-viral drug without a licence in case of a pandemic -- a situation in which governments would be under intense pressure to put public health above respecting copyright laws.
      .
      Koh, the managing director of Roche's Singapore office, said he hoped the situation would not reach such a point.
      .
      "As Roche is willing to discuss and collaborate on technical matters for the manufacturing of Tamiflu, there is no need for these countries to violate patent laws," he said.
      .
      Singapore said it was increasing its stockpiles of Tamiflu but was not in talks with Roche to manufacture the drug.
      .
      Currently, Singapore has Tamiflu supplies to treat 430,000 people and expects more deliveries to enable it to treat 1.05 million people, or a quarter of the population, within a year, the Ministry of Health (MOH) said.
      .
      "However, MOH will continue to watch the developments in the area of generic anti-viral drugs and keep our options open," it said. — AFP
      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.
      .
      "We have no deal with Roche on the product, but could explore a tie-up," Cipla joint managing director Amar Lula told AFP in New Delhi.
      .
      In Taiwan, a health department official, Li Jih-heng. said authorities are planning a trial production of Tamiflu in December.
      .
      "We will continue efforts seeking a patent authorisation from the Swiss company Roche to mass manufacture Tamiflu but the trial production will go ahead to meet emergency needs," Li told AFP in Taipei.
      .
      "The drug will be used to contain bird flu in the event of an outbreak, not for commercial purposes."
      .
      Taiwanese legislators, citing threats of a possible outbreak, have urged health authorities to immediately mass-produce the drug even without Roche's authorisation.
      .
      Roche's Shanghai office has said it was also in touch with the mainland Chinese government and had provided it with full and updated information about the drug.
      .
      Roche is willing to allow other companies in China or the government to produce the drug, it said.
      .
      Vietnam, which accounts for two-thirds of the H5N1 strain's human fatalities, is in contact with Roche, according to Cao Minh Quang, director of the Pharmaceuticals Administration Department in Hanoi.
      .
      Quang said Vietnam could even decide to produce the anti-viral drug without a licence in case of a pandemic -- a situation in which governments would be under intense pressure to put public health above respecting copyright laws.
      .
      Koh, the managing director of Roche's Singapore office, said he hoped the situation would not reach such a point.
      .
      "As Roche is willing to discuss and collaborate on technical matters for the manufacturing of Tamiflu, there is no need for these countries to violate patent laws," he said.
      .
      Singapore said it was increasing its stockpiles of Tamiflu but was not in talks with Roche to manufacture the drug.
      .
      Currently, Singapore has Tamiflu supplies to treat 430,000 people and expects more deliveries to enable it to treat 1.05 million people, or a quarter of the population, within a year, the Ministry of Health (MOH) said.
      .
      "However, MOH will continue to watch the developments in the area of generic anti-viral drugs and keep our options open," it said. — AFP
      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.
      .
      "We have no deal with Roche on the product, but could explore a tie-up," Cipla joint managing director Amar Lula told AFP in New Delhi.
      .
      In Taiwan, a health department official, Li Jih-heng. said authorities are planning a trial production of Tamiflu in December.
      .
      "We will continue efforts seeking a patent authorisation from the Swiss company Roche to mass manufacture Tamiflu but the trial production will go ahead to meet emergency needs," Li told AFP in Taipei.
      .
      "The drug will be used to contain bird flu in the event of an outbreak, not for commercial purposes."
      .
      Taiwanese legislators, citing threats of a possible outbreak, have urged health authorities to immediately mass-produce the drug even without Roche's authorisation.
      .
      Roche's Shanghai office has said it was also in touch with the mainland Chinese government and had provided it with full and updated information about the drug.
      .
      Roche is willing to allow other companies in China or the government to produce the drug, it said.
      .
      Vietnam, which accounts for two-thirds of the H5N1 strain's human fatalities, is in contact with Roche, according to Cao Minh Quang, director of the Pharmaceuticals Administration Department in Hanoi.
      .
      Quang said Vietnam could even decide to produce the anti-viral drug without a licence in case of a pandemic -- a situation in which governments would be under intense pressure to put public health above respecting copyright laws.
      .
      Koh, the managing director of Roche's Singapore office, said he hoped the situation would not reach such a point.
      .
      "As Roche is willing to discuss and collaborate on technical matters for the manufacturing of Tamiflu, there is no need for these countries to violate patent laws," he said.
      .
      Singapore said it was increasing its stockpiles of Tamiflu but was not in talks with Roche to manufacture the drug.
      .
      Currently, Singapore has Tamiflu supplies to treat 430,000 people and expects more deliveries to enable it to treat 1.05 million people, or a quarter of the population, within a year, the Ministry of Health (MOH) said.
      .
      "However, MOH will continue to watch the developments in the area of generic anti-viral drugs and keep our options open," it said. — AFP

      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing stepssuch as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla,
      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.
      .
      "We have no deal with Roche on the product, but could explore a tie-up," Cipla joint managing director Amar Lula told AFP in New Delhi.
      .
      In Taiwan, a health department official, Li Jih-heng. said authorities are planning a trial production of Tamiflu in December.
      .
      "We will continue efforts seeking a patent authorisation from the Swiss company Roche to mass manufacture Tamiflu but the trial production will go ahead to meet emergency needs," Li told AFP in Taipei.
      .
      "The drug will be used to contain bird flu in the event of an outbreak, not for commercial purposes."
      .
      Taiwanese legislators, citing threats of a possible outbreak, have urged health authorities to immediately mass-produce the drug even without Roche's authorisation.
      .
      Roche's Shanghai office has said it was also in touch with the mainland Chinese government and had provided it with full and updated information about the drug.
      .
      Roche is willing to allow other companies in China or the government to produce the drug, it said.
      .
      Vietnam, which accounts for two-thirds of the H5N1 strain's human fatalities, is in contact with Roche, according to Cao Minh Quang, director of the Pharmaceuticals Administration Department in Hanoi.
      .
      Quang said Vietnam could even decide to produce the anti-viral drug without a licence in case of a pandemic -- a situation in which governments would be under intense pressure to put public health above respecting copyright laws.
      .
      Koh, the managing director of Roche's Singapore office, said he hoped the situation would not reach such a point.
      .
      "As Roche is willing to discuss and collaborate on technical matters for the manufacturing of Tamiflu, there is no need for these countries to violate patent laws," he said.
      .
      Singapore said it was increasing its stockpiles of Tamiflu but was not in talks with Roche to manufacture the drug.
      .
      Currently, Singapore has Tamiflu supplies to treat 430,000 people and expects more deliveries to enable it to treat 1.05 million people, or a quarter of the population, within a year, the Ministry of Health (MOH) said.
      .
      "However, MOH will continue to watch the developments in the area of generic anti-viral drugs and keep our options open," it said. — AFP

      Drug-makers across Asia are jostling to make generic versions of Tamiflu once patent holder Roche relaxes its grip on the anti-viral pill that could save many lives in case of a bird flu pandemic.
      .
      From India to Southeast Asia, talks are underway with the Swiss pharmaceutical giant for sub-licenses and other arrangements to manufacture the highly sought-after drug as governments beef up their stockpiles.
      .
      Roche, which had kept a tight rein on the manufacturing process to ensure quality control, succumbed to global pressure and agreed this month to share the technology amid escalating warnings of a pandemic that could kill millions.
      .
      Tamiflu is not a vaccine against avian flu, but eases its impact and thus boosts patients' chances to survive infection.
      .
      Evidence that bird flu has spread to Europe from Asia, where the lethal H5N1 strain has killed more than 60 people since 2003, has increased demand for the drug amid fears the virus will become easily transferable among humans.
      .
      "Considering the recent spread of H5N1 virus, the Roche decision was the responsible thing to do and should be applauded," said Duane Gubler, director of the Hawaii-based Asia-Pacific Institute for Tropical Medicine and Infectious Diseases.
      .
      "If there is a pandemic, that decision could result in helping to save many lives," he told AFP.
      .
      Koh Choon Hui, managing director of Roche Singapore Pte Ltd, said the Basel-based group has been approached by "around 100 companies including some governments" in Asia for the production of Tamiflu.
      .
      "These requests are currently being assessed. It is too early to comment who these governments and companies are," Koh told AFP.
      .
      Roche is "willing to collaborate with companies which have expertise in certain specialist manufacturing steps such as fermentation and azide chemistry," he said.
      .
      It is also "willing to grant sub-licenses ... to companies who can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory requirements."
      .
      Roche has said that the production of Tamiflu involves a complex, 10-step process which takes about 12 months and must be carried out in specialised factories.
      .
      Among the Asian firms interested in manufacturing the medication are India's biggest generic drug-makers Ranbaxy Laboratories Ltd. and Cipla, the first company to make cheap AIDS drugs.
      .
      "We have initiated the process of dialogue with Roche for a non-exclusive global voluntary license for the manufacture and sale of the generic version of Tamiflu," Ranbaxy spokesman Ramesh L. Adige told AFP.
      .
      He said Ranbaxy could manufacture the active pharmaceutical ingredients for Tamiflu "in a couple of months" after meeting issues relating to intellectual property and other regulatory clearances.
      .
      Cipla said earlier this month said it would follow its strategy with the anti-AIDS drug by developing a low-cost version of Tamiflu.


      October 31, 2005

       

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