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<TABLE class=gTable cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=tbMainContent vAlign=top width="100%">2006 post event report
World Vaccine Congress 2006 - A Terrapinn Conference
9-11 October, Lyon, France
Reported by Ben Searle, Thomson Scientific Ltd, London, UK
Email: ben.searle@thomson.com
Introduction
The Eighth Annual World Vaccine Congress covered many aspects of the industry, with speakers representing organizations based in both developed and developing countries, serving both emerging and mature markets. Subjects covered included recent advances in the development of novel vaccines and the growing impact of vaccines in the global pharmaceutical market. Challenges facing the industry were also considered; these included developing the capacity of vaccines companies in emerging markets and supplying affordable vaccines to those in the developing world whose medical need is greatest. The possibility of an influenza pandemic also looms large, and efforts to develop effective vaccines and to develop the necessary infrastructure to manufacture these vaccines in sufficient quantities were discussed by speakers.
Development of novel cancer vaccines at Transgene
Jean-Yves Bonnefoy (VP R&D, Transgene SA, France) chaired a pre-conference briefing on cancer immunology and the technological challenges to the development of cancer vaccines. Many investigational vaccines, including therapeutic cancer vaccines, have been shown to be safe and well tolerated in multiple early-stage clinical trials - an important point for patient quality of life since existing small-molecule therapeutics often have serious side-effects; however, demonstrations of efficacy in humans have proven more elusive.
Challenges for cancer vaccines include the need to induce the optimum immune response, generally characterized by a T helper 2 response. Modulation of the immune response can be achieved by the selection of appropriate adjuvants, and by the mechanism and route of delivery used to administer the vaccine. Another problem is the potential immune tolerance to cancer antigens. This tolerance must be broken, although effective mechanisms for achieving this in human cancers are not well established. One promising area described by Dr Bonnefoy was the use of vaccines in combination with existing small-molecule therapeutics. If effective vaccines could be developed, the doses of toxic drugs required could be reduced. Combinations might also demonstrate synergy due to the immunomodulatory characteristics of small-molecule drugs.
Another problem dogging the field is the lack of biomarkers. In comments echoed by other speakers, Dr Bonnefoy said that surrogate markers of therapeutic efficacy were badly needed in order to conduct trials more efficiently and to better interpret clinical data. On the positive side, development of therapeutic vaccines was simpler and less costly than in the past due to the experience of the pharma industry in developing/ manufacturing biological molecules.
Two therapies were described in detail, first Transgene's MVA-HPV-IL2 (TG-4001), a vaccine for the treatment of human papilloma virus (HPV) infection, a common cause of cervical cancer. The therapy consists of a modified vaccinia Ankara (MVA) encoding the HPV16 antigens E6 and E7, and IL-2 as an adjuvant. A phase II study demonstrated proof of concept and laid the foundations for long-term efficacy studies that would examine cross reactivity and cellular responses in women under 25 years old. The second vaccine described was TG-4010, comprising an MVA vector encoding the MUC-1 antigen and IL-2, for the potential treatment of MUC-1-expressing solid epithelial tumors. Phase II studies in patients with non small cell lung cancer (NSCLC) showed that subjects treated with the vaccine who developed a CD8 T-cell response had slower disease progression and a longer survival time, suggesting that a CD8 response could be a potentially useful biomarker. A phase IIb/III trial, which began in November 2005 and aiming to enroll 140 NSCLC patients, was expected to be complete by the third quarter of 2007.
Overcoming technical challenges at Onyvax The technical challenges involved in the R&D of cancer vaccines were considered by Angus Dalgleish (Founding Director, Onyvax Ltd/St George's Hospital Medical School, UK). One of the key aims of such a therapy would be the expansion of effector and memory cells. Professor Dalgleish also noted that therapies were being discontinued following late-stage clinical trials due to poor overall efficacy. Many late-stage trials in this area were being conducted in melanoma patients. While there is a clear medical need for effective melanoma treatments, and trials can be conducted quickly due to the rapid progression of disease, it was suggested that this is not an appropriate indication to develop new therapeutics against precisely because of its aggressive progression. Cancers such as prostate tumor, with a slow time to progression, would be easier to treat and thus make better targets for first-in-class therapies. The disadvantage of this strategy would be the increased length and cost of phase III trials.
Steven Ward (Head of Process Development, Onyvax Ltd, UK) detailed the development of Onyvax-P, a therapeutic prostate cancer vaccine - Onyvax's leading development candidate. The vaccine, a combination of non-patient specific cancer cells plus BCG as an adjuvant, is for the treatment of hormone refractory prostate cancer (HRPC). Dr Ward explained that the use of allogeneic cell lines has been perceived as a disadvantage since there is a likelihood of an human leukocyte antigen (HLA) mismatch between the cell line and the patient; however, the inflammatory response resulting from any host versus graft disease may result in an enhanced immune response. Using cell lines presents several practical difficulties. Several regulatory issues need to be addressed such as the disease free status of the product, establishing the precise phenotype and ensuring genetic stability of the cells. Also, scaling production from that needed to support phase I and II trials up to phase III levels is complex due to the use of adherent cells, but had been facilitated by the company's use of robotic cell culture and single-use consumables.
The vaccine is designed to create a manageable chronic disease state in patients, with low toxicity. Phase IIa trials were completed in 2004; in one cohort, 26 patients were treated with monthly intradermal injections. The primary endpoint was progression free survival (PFS) and the secondary endpoint was the serum level of prostate specific antigen (PSA). Of the 26 patients, 11 (42%) showed a decrease in the rate of PSA rise, sustained over a period of time, although this is not yet an FDA validated biomarker. An improvement in PFS compared to baseline was observed. The trial generated 20,000 data points, and conventional statistical methods were not able to identify any correlation with Th1 or Th2 type responses and efficacy. The company employed artificial neural networks to find patterns in the data and distinguish useful variables. Results suggested that a Th1-like signature was predictive of response to therapy. Clinical development was continuing with a planned phase IIb double-blind, randomized, placebo controlled trial which would enroll 75 patients. The primary endpoint was to be PFS, with PSA and overall survival as secondary endpoints. The identification of predictive immunological biomarkers was also planned through the ENACT network, using MS of samples and serum immunology.
Oxxon's Hi-8 prime boost strategy
A different approach was outlined by Joerg Schneider (VP Research, Oxxon Therapeutics, UK) who detailed his company's Hi-8 prime boost strategy which has been tailored for the treatment of melanoma as Hi-8 MEL. The vaccine consists of an intramuscular DNA prime followed by an intradermal boost with an MVA vector. The DNA and viral constructs encode a string of HLA-A2 cytotoxic T-lymphocyte (CTL) epitopes from melanoma cells. Using this heterologous boost, a much greater expansion of the immune response resulting from primary vaccination occurred than is observed with homologous prime-boost strategies. The vaccine is designed to induce a strong CD8-positive T-cell response.
A phase IIa trial was completed in 41 patients in the UK and Germany with HLA-A2 positive stage III/IV metastatic melanoma. Efficacy was assessed by RECIST criteria, time to progression and overall survival compared to patients receiving standard treatment. The trial explored several different dosing regimens whereby patients received up to two doses of 2 to 4 mg of DNA.Mel3, followed by a boost of 5x10(7) to 1x10(9) plaque-forming units (pfu) of MVA.Mel3 at 3-weekly intervals, followed by further boosts at week 16 and 24 if no evidence of progression was observed. The vaccine was well tolerated. There was some reactogenicity to MVA.Mel3; however, this decreased in severity with subsequent doses and did not lead to any discontinuations. The most common adverse reactions were local skin reactions, pyrexia and headache. Over 111 weeks, the proportion of PBMCs that were CD8-positive cells specific for melan A increased according to tetramer and ELISPOT assays. Sustained responses were observed in 91% of patients given high doses of the vaccine; one patient displayed a partial response for over 24 months, and seven showed stable disease for at least 6 months. Antitumor responses were only seen in patients receiving therapy. While the DNA alone showed some efficacy, MVA alone resulted in no antitumor response. In 87% of the antitumor responses there was an association with immune response. In responders, a median overall survival of 86 weeks was seen, with 63% surviving to one year or more; these values were 37 weeks and 11%, respectively, for non-responders.
AVANT's vaccine pipeline
Ron Ellis (Senior VP R&D, Avant Immunotherapeutics, US) provided an update on his company's vaccine pipeline. Avant's lead developmental vaccine, Peru-15 (CholeraGarde), had completed phase II trials in the US, and was in an ongoing phase II study in South Asia, with phase III trials being planned. A high level of efficacy in prevention of diarrhea after challenge with live cholera bacteria was demonstrated in the phase II US studies. The typhoid fever vaccine TY-800 was in ongoing phase I/II trials with a phase II study planned. The ETEC vaccine was being manufactured for upcoming phase I trials. The company was exploring different drying processes for its vaccine formulations, including lyophilization and vacuum drying, and bulk drying equivalents for delivery to markets in developing countries. Dr Ellis described a funding mechanism to assist in the provision of vaccines for developing countries. Under the US BioShield initiative, in which diarrheal diseases are considered a class B threat, vaccines could be developed and stockpiled, and could be used as part of aid packages in emergency situations where sanitation breaks down and disease outbreaks are likely.
The current state of play of the industry On the second day of the conference, chairpersons Jacques-Francois Martin (President, Parteurop) and Michel Greco, an independent vaccine expert and former president of Aventis Pasteur (France), discussed the current state of the industry. It was noted that there had been a steady growth in sales since 1990, consistently greater than the growth of the pharma market as a whole. In 2006, vaccine sales accounted for approximately 2% of the total market, or about $10 billion, this was projected to be $15 billion by 2010. Five companies represented 85% of the total market: GlaxoSmithKline and Sanofi Pasteur at 22% each, Merck with 19%, Wyeth with 15% and Novartis at 7%. Growth was expected to continue due to drivers including an aging population in developed countries, emerging diseases and growing antibiotic resistance to existing diseases, and funding from international/non-governmental initiatives. Funding for protection from bioterrorism remained an important factor. Several fields of R&D were experiencing serious challenges; little progress had been made in the development of effective HIV and tuberculosis vaccines, although, in the fields of cancer and malaria, breakthroughs were anticipated to be on the horizon.
There remained many areas where innovation could drive market growth, including expanding existing vaccines into new populations, new delivery systems and combinations, new formulations and the development of vaccines for non-infectious diseases. Innovation was also being driven by investment in research by organizations such as the Bill & Melinda Gates Foundation, and efforts to extend vaccine coverage by the Global Alliance for Vaccines and Immunization (GAVI). The alliance, for example, has driven a huge increase in the doses of vaccines delivered in the last five years. In 2001, the organization shipped 20 million doses of vaccines, including ones against diphtheria, HBV, Haemophilus Influenzae type b (Hib) and yellow fever. By 2004, this had risen to approximately 160 million doses, equating to the prevention of an estimated 1.7 million premature deaths. It was interesting to note that, of the $1.7 billion donated to GAVI between 1999 and 2005, more was given by the Gates Foundation ($909 million) than by all the national governments combined (~ $790 million). Given the high costs of developing novel vaccines, such mechanisms - and guarantees of future investment - were thought to be necessary to convince pharmaceutical companies to continue to research and develop novel vaccines where recipients or their health providers would not be able to pay high prices. A new initiative - the International Financing Facility (IFF) - has been proposed by the UK government, to facilitate aid whereby donor governments pledge long term funding to the IFF which are translated to immediately available aid through the issuing of bonds. To date, donations of $4 billion have been committed.
While it has proven difficult to secure funding for vaccine development and manufacture, it was noted that healthcare provision - particularly the supply of lifesaving vaccines - were important factors in the economic development of poor countries and, thus, of effective long-term investment. Additionally, developing countries without effective healthcare infrastructures frequently act as reservoirs for, and sources of, outbreaks of infectious disease which can easily spread to developed countries - healthier populations also insure against this eventuality.
Denis Cavert (VP Marketing and Sales Europe, Baxter Vaccines, Austria) discussed sources of funding for vaccine R&D. Members of the European Vaccine Manufacturers group were currently working on 123 vaccines, with funding from a range of sources, including internal industrial funding, venture capitalist or biotech investment, government investment (with the US government as a much more significant investor than the EU) and NGOs. The R&D spend in 2004 was around EURO 1.4 billion, or around 20% of sales. External funding has come from the Bill & Melinda Gates Foundation ($1.36 billion in grants in 2005). The US government has pledged $3.4 billion for biodefense through the BioShield program, from 2004 to 2008, mostly targeted at the development and production of vaccines to smallpox, anthrax and botulinum. Likewise, a large proposed budget exists for pandemic influenza: $7.1 billion, of which product development and stockpiling comprise a major fraction. Financing from EU states was more complex, in that individual member states take responsibility for their own health and R&D budgets; however, the overall funds available were much lower than from the US government. Viable means of funding vaccine development in developing countries were also discussed. Tiered pricing mechanisms based on market economies are one proposed solution to enable poor countries to purchase vaccines; however, this is a controversial measure which can lead to pressure to reduce prices in other markets. Also, secondary trading of products between regions with markedly different prices can occur, undercutting manufacturer's profits.
Further trends within the industry were presented by David Lawrence (CFO, Acambis, UK) who noted that the growth in the industry and the attractiveness of vaccines were being recognized by analysts and the media. Approximately 50% of market growth in the last decade has come from new product introductions, with the remainder from increased pricing and market penetration. It was predicted that the current rate of growth would be maintained until 2010, with potential for further growth beyond that point from improvements to existing vaccines and vaccines for diseases not yet protected against. The market in developing countries was also increasing; a market worth $2.5 billion in 2005 was expected to be worth $4 billion by 2015. Vaccine sales were expected to contribute to a larger proportion of overall sales for many pharma companies. For example, vaccines sales at GlaxoSmithKline, Sanofi Pasteur, Wyeth and MedImmune are all currently single digit percentages but were all expected to increase to double-digit percentages within three to six years.
http://www.lifescienceworld.com/2007/wvcl/Custom_12905.stm
Next conference: 9 - 11 October 2007, Palais des Congr?s de Lyon, Lyon, France
http://www.lifescienceworld.com/2007/wvcl/
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</TD></TR></TBODY></TABLE>
World Vaccine Congress 2006 - A Terrapinn Conference
9-11 October, Lyon, France
Reported by Ben Searle, Thomson Scientific Ltd, London, UK
Email: ben.searle@thomson.com
Introduction
The Eighth Annual World Vaccine Congress covered many aspects of the industry, with speakers representing organizations based in both developed and developing countries, serving both emerging and mature markets. Subjects covered included recent advances in the development of novel vaccines and the growing impact of vaccines in the global pharmaceutical market. Challenges facing the industry were also considered; these included developing the capacity of vaccines companies in emerging markets and supplying affordable vaccines to those in the developing world whose medical need is greatest. The possibility of an influenza pandemic also looms large, and efforts to develop effective vaccines and to develop the necessary infrastructure to manufacture these vaccines in sufficient quantities were discussed by speakers.
Development of novel cancer vaccines at Transgene
Jean-Yves Bonnefoy (VP R&D, Transgene SA, France) chaired a pre-conference briefing on cancer immunology and the technological challenges to the development of cancer vaccines. Many investigational vaccines, including therapeutic cancer vaccines, have been shown to be safe and well tolerated in multiple early-stage clinical trials - an important point for patient quality of life since existing small-molecule therapeutics often have serious side-effects; however, demonstrations of efficacy in humans have proven more elusive.
Challenges for cancer vaccines include the need to induce the optimum immune response, generally characterized by a T helper 2 response. Modulation of the immune response can be achieved by the selection of appropriate adjuvants, and by the mechanism and route of delivery used to administer the vaccine. Another problem is the potential immune tolerance to cancer antigens. This tolerance must be broken, although effective mechanisms for achieving this in human cancers are not well established. One promising area described by Dr Bonnefoy was the use of vaccines in combination with existing small-molecule therapeutics. If effective vaccines could be developed, the doses of toxic drugs required could be reduced. Combinations might also demonstrate synergy due to the immunomodulatory characteristics of small-molecule drugs.
Another problem dogging the field is the lack of biomarkers. In comments echoed by other speakers, Dr Bonnefoy said that surrogate markers of therapeutic efficacy were badly needed in order to conduct trials more efficiently and to better interpret clinical data. On the positive side, development of therapeutic vaccines was simpler and less costly than in the past due to the experience of the pharma industry in developing/ manufacturing biological molecules.
Two therapies were described in detail, first Transgene's MVA-HPV-IL2 (TG-4001), a vaccine for the treatment of human papilloma virus (HPV) infection, a common cause of cervical cancer. The therapy consists of a modified vaccinia Ankara (MVA) encoding the HPV16 antigens E6 and E7, and IL-2 as an adjuvant. A phase II study demonstrated proof of concept and laid the foundations for long-term efficacy studies that would examine cross reactivity and cellular responses in women under 25 years old. The second vaccine described was TG-4010, comprising an MVA vector encoding the MUC-1 antigen and IL-2, for the potential treatment of MUC-1-expressing solid epithelial tumors. Phase II studies in patients with non small cell lung cancer (NSCLC) showed that subjects treated with the vaccine who developed a CD8 T-cell response had slower disease progression and a longer survival time, suggesting that a CD8 response could be a potentially useful biomarker. A phase IIb/III trial, which began in November 2005 and aiming to enroll 140 NSCLC patients, was expected to be complete by the third quarter of 2007.
Overcoming technical challenges at Onyvax The technical challenges involved in the R&D of cancer vaccines were considered by Angus Dalgleish (Founding Director, Onyvax Ltd/St George's Hospital Medical School, UK). One of the key aims of such a therapy would be the expansion of effector and memory cells. Professor Dalgleish also noted that therapies were being discontinued following late-stage clinical trials due to poor overall efficacy. Many late-stage trials in this area were being conducted in melanoma patients. While there is a clear medical need for effective melanoma treatments, and trials can be conducted quickly due to the rapid progression of disease, it was suggested that this is not an appropriate indication to develop new therapeutics against precisely because of its aggressive progression. Cancers such as prostate tumor, with a slow time to progression, would be easier to treat and thus make better targets for first-in-class therapies. The disadvantage of this strategy would be the increased length and cost of phase III trials.
Steven Ward (Head of Process Development, Onyvax Ltd, UK) detailed the development of Onyvax-P, a therapeutic prostate cancer vaccine - Onyvax's leading development candidate. The vaccine, a combination of non-patient specific cancer cells plus BCG as an adjuvant, is for the treatment of hormone refractory prostate cancer (HRPC). Dr Ward explained that the use of allogeneic cell lines has been perceived as a disadvantage since there is a likelihood of an human leukocyte antigen (HLA) mismatch between the cell line and the patient; however, the inflammatory response resulting from any host versus graft disease may result in an enhanced immune response. Using cell lines presents several practical difficulties. Several regulatory issues need to be addressed such as the disease free status of the product, establishing the precise phenotype and ensuring genetic stability of the cells. Also, scaling production from that needed to support phase I and II trials up to phase III levels is complex due to the use of adherent cells, but had been facilitated by the company's use of robotic cell culture and single-use consumables.
The vaccine is designed to create a manageable chronic disease state in patients, with low toxicity. Phase IIa trials were completed in 2004; in one cohort, 26 patients were treated with monthly intradermal injections. The primary endpoint was progression free survival (PFS) and the secondary endpoint was the serum level of prostate specific antigen (PSA). Of the 26 patients, 11 (42%) showed a decrease in the rate of PSA rise, sustained over a period of time, although this is not yet an FDA validated biomarker. An improvement in PFS compared to baseline was observed. The trial generated 20,000 data points, and conventional statistical methods were not able to identify any correlation with Th1 or Th2 type responses and efficacy. The company employed artificial neural networks to find patterns in the data and distinguish useful variables. Results suggested that a Th1-like signature was predictive of response to therapy. Clinical development was continuing with a planned phase IIb double-blind, randomized, placebo controlled trial which would enroll 75 patients. The primary endpoint was to be PFS, with PSA and overall survival as secondary endpoints. The identification of predictive immunological biomarkers was also planned through the ENACT network, using MS of samples and serum immunology.
Oxxon's Hi-8 prime boost strategy
A different approach was outlined by Joerg Schneider (VP Research, Oxxon Therapeutics, UK) who detailed his company's Hi-8 prime boost strategy which has been tailored for the treatment of melanoma as Hi-8 MEL. The vaccine consists of an intramuscular DNA prime followed by an intradermal boost with an MVA vector. The DNA and viral constructs encode a string of HLA-A2 cytotoxic T-lymphocyte (CTL) epitopes from melanoma cells. Using this heterologous boost, a much greater expansion of the immune response resulting from primary vaccination occurred than is observed with homologous prime-boost strategies. The vaccine is designed to induce a strong CD8-positive T-cell response.
A phase IIa trial was completed in 41 patients in the UK and Germany with HLA-A2 positive stage III/IV metastatic melanoma. Efficacy was assessed by RECIST criteria, time to progression and overall survival compared to patients receiving standard treatment. The trial explored several different dosing regimens whereby patients received up to two doses of 2 to 4 mg of DNA.Mel3, followed by a boost of 5x10(7) to 1x10(9) plaque-forming units (pfu) of MVA.Mel3 at 3-weekly intervals, followed by further boosts at week 16 and 24 if no evidence of progression was observed. The vaccine was well tolerated. There was some reactogenicity to MVA.Mel3; however, this decreased in severity with subsequent doses and did not lead to any discontinuations. The most common adverse reactions were local skin reactions, pyrexia and headache. Over 111 weeks, the proportion of PBMCs that were CD8-positive cells specific for melan A increased according to tetramer and ELISPOT assays. Sustained responses were observed in 91% of patients given high doses of the vaccine; one patient displayed a partial response for over 24 months, and seven showed stable disease for at least 6 months. Antitumor responses were only seen in patients receiving therapy. While the DNA alone showed some efficacy, MVA alone resulted in no antitumor response. In 87% of the antitumor responses there was an association with immune response. In responders, a median overall survival of 86 weeks was seen, with 63% surviving to one year or more; these values were 37 weeks and 11%, respectively, for non-responders.
AVANT's vaccine pipeline
Ron Ellis (Senior VP R&D, Avant Immunotherapeutics, US) provided an update on his company's vaccine pipeline. Avant's lead developmental vaccine, Peru-15 (CholeraGarde), had completed phase II trials in the US, and was in an ongoing phase II study in South Asia, with phase III trials being planned. A high level of efficacy in prevention of diarrhea after challenge with live cholera bacteria was demonstrated in the phase II US studies. The typhoid fever vaccine TY-800 was in ongoing phase I/II trials with a phase II study planned. The ETEC vaccine was being manufactured for upcoming phase I trials. The company was exploring different drying processes for its vaccine formulations, including lyophilization and vacuum drying, and bulk drying equivalents for delivery to markets in developing countries. Dr Ellis described a funding mechanism to assist in the provision of vaccines for developing countries. Under the US BioShield initiative, in which diarrheal diseases are considered a class B threat, vaccines could be developed and stockpiled, and could be used as part of aid packages in emergency situations where sanitation breaks down and disease outbreaks are likely.
The current state of play of the industry On the second day of the conference, chairpersons Jacques-Francois Martin (President, Parteurop) and Michel Greco, an independent vaccine expert and former president of Aventis Pasteur (France), discussed the current state of the industry. It was noted that there had been a steady growth in sales since 1990, consistently greater than the growth of the pharma market as a whole. In 2006, vaccine sales accounted for approximately 2% of the total market, or about $10 billion, this was projected to be $15 billion by 2010. Five companies represented 85% of the total market: GlaxoSmithKline and Sanofi Pasteur at 22% each, Merck with 19%, Wyeth with 15% and Novartis at 7%. Growth was expected to continue due to drivers including an aging population in developed countries, emerging diseases and growing antibiotic resistance to existing diseases, and funding from international/non-governmental initiatives. Funding for protection from bioterrorism remained an important factor. Several fields of R&D were experiencing serious challenges; little progress had been made in the development of effective HIV and tuberculosis vaccines, although, in the fields of cancer and malaria, breakthroughs were anticipated to be on the horizon.
There remained many areas where innovation could drive market growth, including expanding existing vaccines into new populations, new delivery systems and combinations, new formulations and the development of vaccines for non-infectious diseases. Innovation was also being driven by investment in research by organizations such as the Bill & Melinda Gates Foundation, and efforts to extend vaccine coverage by the Global Alliance for Vaccines and Immunization (GAVI). The alliance, for example, has driven a huge increase in the doses of vaccines delivered in the last five years. In 2001, the organization shipped 20 million doses of vaccines, including ones against diphtheria, HBV, Haemophilus Influenzae type b (Hib) and yellow fever. By 2004, this had risen to approximately 160 million doses, equating to the prevention of an estimated 1.7 million premature deaths. It was interesting to note that, of the $1.7 billion donated to GAVI between 1999 and 2005, more was given by the Gates Foundation ($909 million) than by all the national governments combined (~ $790 million). Given the high costs of developing novel vaccines, such mechanisms - and guarantees of future investment - were thought to be necessary to convince pharmaceutical companies to continue to research and develop novel vaccines where recipients or their health providers would not be able to pay high prices. A new initiative - the International Financing Facility (IFF) - has been proposed by the UK government, to facilitate aid whereby donor governments pledge long term funding to the IFF which are translated to immediately available aid through the issuing of bonds. To date, donations of $4 billion have been committed.
While it has proven difficult to secure funding for vaccine development and manufacture, it was noted that healthcare provision - particularly the supply of lifesaving vaccines - were important factors in the economic development of poor countries and, thus, of effective long-term investment. Additionally, developing countries without effective healthcare infrastructures frequently act as reservoirs for, and sources of, outbreaks of infectious disease which can easily spread to developed countries - healthier populations also insure against this eventuality.
Denis Cavert (VP Marketing and Sales Europe, Baxter Vaccines, Austria) discussed sources of funding for vaccine R&D. Members of the European Vaccine Manufacturers group were currently working on 123 vaccines, with funding from a range of sources, including internal industrial funding, venture capitalist or biotech investment, government investment (with the US government as a much more significant investor than the EU) and NGOs. The R&D spend in 2004 was around EURO 1.4 billion, or around 20% of sales. External funding has come from the Bill & Melinda Gates Foundation ($1.36 billion in grants in 2005). The US government has pledged $3.4 billion for biodefense through the BioShield program, from 2004 to 2008, mostly targeted at the development and production of vaccines to smallpox, anthrax and botulinum. Likewise, a large proposed budget exists for pandemic influenza: $7.1 billion, of which product development and stockpiling comprise a major fraction. Financing from EU states was more complex, in that individual member states take responsibility for their own health and R&D budgets; however, the overall funds available were much lower than from the US government. Viable means of funding vaccine development in developing countries were also discussed. Tiered pricing mechanisms based on market economies are one proposed solution to enable poor countries to purchase vaccines; however, this is a controversial measure which can lead to pressure to reduce prices in other markets. Also, secondary trading of products between regions with markedly different prices can occur, undercutting manufacturer's profits.
Further trends within the industry were presented by David Lawrence (CFO, Acambis, UK) who noted that the growth in the industry and the attractiveness of vaccines were being recognized by analysts and the media. Approximately 50% of market growth in the last decade has come from new product introductions, with the remainder from increased pricing and market penetration. It was predicted that the current rate of growth would be maintained until 2010, with potential for further growth beyond that point from improvements to existing vaccines and vaccines for diseases not yet protected against. The market in developing countries was also increasing; a market worth $2.5 billion in 2005 was expected to be worth $4 billion by 2015. Vaccine sales were expected to contribute to a larger proportion of overall sales for many pharma companies. For example, vaccines sales at GlaxoSmithKline, Sanofi Pasteur, Wyeth and MedImmune are all currently single digit percentages but were all expected to increase to double-digit percentages within three to six years.
http://www.lifescienceworld.com/2007/wvcl/Custom_12905.stm
Next conference: 9 - 11 October 2007, Palais des Congr?s de Lyon, Lyon, France
http://www.lifescienceworld.com/2007/wvcl/
</TD><TD vAlign=top width=150>
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