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GSK, Sanofi and Novartis share US flu contracts; GSK Pandemic Flu H5N1 Vaccine Filing with FDA
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21/11/2006
www.pharmatimes.com
The US Department of Health and Human Services has assigned contracts with a total of just under $200 million to three European drugmakers that will provide 5.3 million doses of vaccine against the pandemic influenza strain H5N1.
GlaxoSmithKline, Sanofi-Aventis and Novartis are all tasked with supplying 'pre-pandemic' H5N1 vaccines, in other words vaccines designed on current predictions of the strains of the virus most likely to cause a human pandemic. Although a specific vaccine against a pandemic strain can only be produced after the infection has started to spread, it is hoped that these 'best guess' vaccines will offer at least partial protection and provide a first line of defence.
The new orders are intended to replace an earlier stockpile of H5N1 vaccine, based on an older form of the flu strain that has started to lose its potency and needs to be replaced.
Sanofi-Aventis is the biggest beneficiary of the contracts, with its Sanofi Pasteur subsidiary standing to receive up to $120 million for 3.7 million doses, while GSK and Novartis are in the frame for around $40 million and 800,000 doses apiece.
The contract with Sanofi is for supply of so-called 'clade 2' H5N1 vaccine, a strain that has been circulating in Indonesia and China. Previous deliveries of pre-pandemic H5N1 vaccine to the US government by Sanofi have been for clade 1 strains that have been encountered in Thailand, Vietnam and Cambodia.
Novartis' contract is for egg-based production of its H5N1 vaccine, possibly alongside its proprietary MF59 adjuvant, at its vaccines production facility in Speke, Liverpool, UK. This facility was acquired along with Chiron earlier this year.
GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. Terms of the contract also state that the company may be directed to formulate this bulk antigen at some point in the future, with or without one of its proprietary adjuvants, said GSK in a statement.
GSK vaccine likely to be preferred candidate?
Analyst Navid Malik at Collins Stewart said he believed GSK has the best vaccine candidate of the three companies, because its access to potent adjuvants means that limited supplies of the vaccine antigen can go further.
He believes GSK could eventually win the lion's share of H5N1 flu vaccine contracts, perhaps producing as much as 100 million doses next bringing in windfall revenues of $800 million.
"The trigger for further substantial orders is a decision by the World Health Organisation (WHO) on which strain of H5N1 to nominate for stockpiling and GSK's demonstration that its vaccine can provide cross-protection against a number of viral types," said Malik.
GSK gearing up to file pandemic flu vaccine
26/07/2006
GlaxoSmithKline says it is only months away from filing for approval of a vaccine against the H5N1 strain of avian influenza, currently thought to be the most likely to cause a flu pandemic in humans, after promising results in clinical trials.
An interim analysis of a 400-patient trial conducted in Belgium suggests that GSK's formulation - which includes just 3.8mcg of H5N1 antigen and includes a novel, proprietary adjuvant to boost its activity - stimulated a protective immune response in over 80% of subjects.
Trial participants were vaccinated twice during the course of the trial and four different levels of antigen dose were tested, with 3.8mcg being the lowest dose assessed.
The use of the adjuvant means that scarce supplies of the H5N1 antigen can be stretched further, and GSK's chief executive Jean-Pierre Garnier told the Today programme on the BBC's Radio 4 this morning that it could be in a position to produce 'hundreds of millions' of doses by the end of the year, and could also cost as little as $4 a dose, roughly equivalent to the price of seasonal flu vaccines.
Sanofi takes another pandemic flu vaccine into the clinic
20/09/2006
Sanofi Pasteur has completed production of the first clinical trial materials for its new generation of H7N1 pandemic influenza vaccine and says it will be able to move ahead with patient recruitment.
Like the notorious H5N1 strain of the virus, H7N1 is a bird flu that may be able jump the species barrier between poultry and humans. H7N1 caused lethal outbreaks in Italian poultry in 1999 and was subsequently shown to be related to the 2003 H7N7 poultry virus in the Netherlands, which was responsible for over 80 human infections and one death.
This trial broadens the company's pandemic flu development programme, which has already achieved notable successes such as securing a $150 million contract to supply a candidate H5N1 vaccine to the US government. This vaccine has already started clinical testing at the US National Institute of Allergy and Infectious Diseases.
This Phase I clinical trial of the H7N1 strain is getting underway today in Bergen, Norway, and is the first to assess the safety of a split, inactivated prototype pandemic H7N1 vaccine produced in cells rather than eggs, as well as its ability to generate an immune response. The vaccine is made in Crucell's PER.C6 cell line, which is increasingly
A total of 60 healthy adults will be vaccinated with one of four formulations: two dosages - 12 micrograms and 24 micrograms - of the H7N1 antigen with or without an aluminum hydroxide as an adjuvant.
The vaccine has been developed as part of the European FLUPAN initiative, a consortium of European academic, industry and regulatory groups. FLUPAN selected H7N1 as a target because it was thought to be the most likely pandemic flu candidate when the project got underway in 2001.
Encouraging data with Sanofi's H5N1 vaccine
12/05/2006
A candidate vaccine against the H5N1 strain of avian influenza, developed by French drugmaker Sanofi-Aventis, has been found to be safe and effective in a Phase I trial published yesterday in The Lancet.
The vaccine, developed by Sanofi Pasteur, is based on a modified strain of the virus. Two doses of the candidate produced protective antibodies in the trial, which involved 300 healthy volunteers.
The authors of the study said the regimen of two 30mcg doses was safe - with only a few cases of adverse reactions - and achieved an antibody response "consistent with European regulatory requirements for licensure of seasonal influenza vaccine."
However, they cautioned that the actual level of antibodies that would provide protection against H5N1 is currently unknown.
The study involved several formulations of the vaccine, half of which were adjuvanted with alum, with the 30mcg version using an adjuvant performing the best with a 67% seroconversion rate. But there were encouraging responses with lower doses of the vaccine, which could mean that currently limited stocks of the antigen could be stretched further in the event of an H5N1 flu pandemic.
A study of a similar, unadjuvanted candidate H5N1 vaccine produced by Sanofi Pasteur in the USA that was published in the New England Journal of Medicine in March required two 90mcg doses to generate a significant immune response in about 50% of trial participants, leading to fears that antigen stocks laid in by the US government would only provide a quarter of the number of doses initially envisaged.
Lancet editor Richard Horton said the results were particularly encouraging and mean that it should be possible of developing an effective vaccine over the next 12 to 18 months.
A number of other companies are working on the development of pandemic flu vaccines, in most cases based on the H5N1 strain, including GlaxoSmithKline, Chiron, Akzo Nobel, MedImmune and Baxter International.
All told, 31 vaccines against bird flu are currently being tested in clinical trials, with 22 targetting the H5N1 strain which has infected 186 people in eight countries and killed 105, according to the latest World Health Organisation figures. Eight vaccines will have undergone Phase II trials by the end of 2006.
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