What you should know about the #Vaccines Industry – Update Number 1.

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Vaccines industry, vaccines update, vaccines industry news

Introduction

The world of vaccines changes daily with new diseases, new vaccines and new scientific data. In this review we have reviewed some of the news in the early part of 2012.

Commercial Data

The European Commission has proposed that central purchase of pandemic vaccine may be introduced. This follows the experience with swine flu in 2009 where some countries had an excess of vaccine which was subsequently destroyed while others had no vaccine for their population.

Takeda in Japan have announced that they are setting up a new global vaccine business under the leadership of Rajeev Venkayya who formerly worked for the Gates Foundation and was a White House adviser. They have a vero influenza and an HPV in research to supplement their Japanese product range. Later they announced the loss of 2800 jobs over the next four years, this is as a result of integrating the Nycomed purchase. The RandD site at Konstanz in Germany will be particularly affected with 1200 loses.

Financial Results

Medicago has raised an additional $11M from Philip Morris Investments. They use tobacco leaves to produce their VLP vaccines. Inovio has raised $4m in a public offering. Formula Pharmaceuticals is raising $13m for developing its leukemia (AML) vaccine. IBio is looking to raise $10m for development of its plant based vaccine production platform. Microbix in Toronto have announced a 4% annual reduction in net revenues to $6.2m, this is due to pipeline development.

Seasonal Influenza

Seasonal influenza started the year at low throughout Europe, the only countries reporting above baseline levels are Spain, Turkey and Malta. Similarly in the US all cities report below baseline activity. Costa Rico is the only country of the Americas to show an increase.

Romania has suspended its vaccination campaign due to issues with the vaccines. 350K doses have been withdrawn out of 1m bought from the Romanian Cantacuzino Institute.

Pandemic Influenza

In the last 4 months CDC have received 12 reports of an H3N2 virus that has a matrix gene from a 2009 pandemic strain in the viral shell. This has been given the nomenclature A(H3N2)v. It appears to be able to spread from pig to man and man to man. The CDC has prepared a vaccine seed strain in case the strain spreads and HHS in the US is preparing a clinical trial with vaccine from Sanofi Pasteur and Novartis. No vaccine has been ordered but the manufacturers have been given the working seeds. Some cross protection to H3N2 viruses circulating in the 1990s is expected. Cases of an H1N1v have also been identified.

H5N1 has been identified in gulls in Hong Kong and there is local concern following the death of a bus driver on mainland China. There is no evidence of human to human transmission at present. Poultry movements have been restricted and 17K chickens have been slaughtered.

A report in the journal Virology from Japan has described an H4N8 which was found in shorebirds that is lethal to mice. An H3N8 virus has caused the deaths of several hundred harbour seals off the New England coast. It is of low infectivity to man but the public are being warned not to approach the dead seals. The H5N2 outbreak in South African ostrich farms has devastated the industry following the cull of 38K birds and an H5N1 has killed 15 peacocks in Lahore Zoo.

Policy, Pricing, WHO, EU and Governmental Affairs

The UK has outlined plans for "Public Health England" which will bring together all elements of public health including the HPA, public campaigns and communications under a single central administration.

Opt out rates for childhood vaccination are increasing in the US reaching 9% in Alaska and 7% in Colorado.

WHO have announced the 18 members of the Pandemic Influenza Preparedness Advisory Group.

Manufacturing

According to an IFPMA study influenza manufacturing capacity has grown by 300% in recent years as capacity increases globally. They estimate that within one year of an epidemic being declared 2.5 billion doses of a pandemic vaccine would be available with 5-12 billion doses over the next five years.

The new Novartis cell culture plant at Holly Spring NC has been approved for the production of influenza vaccine in an epidemic. At full capacity it could produce 25% of the US requirement.

Novavax have leased a new HQ/production facility in Gaithersburg. It is 70,000 feet and is being sublet from Intercell.

The Haffkine Institute in India has opened a level 3 bio safety facility.

Scientific Papers

There has been much concern that scientists in the Netherlands have been able to create a mutation of an H5N1 in the laboratory, clearly the risk is the technology falling into the hands of terrorists. The US Government has asked that details of the technique are suppressed but there is considerable debate in the scientific literature on the subject.

A study by Hambidge published in Pediatrics has confirmed that influenza vaccine is safe for children with sickle cell anemia.

Cancer Vaccines

Antigen Express (wholly owned by Generex Corp) have updated investors on their progress, confirming the positive interim results from the phase 2b study with their cancer vaccine AE37 in breast cancer. 89% of vaccine recipients remained disease free compared to 72% in the untreated group

A breast cancer vaccine called E-75 under development by the US military has been shown to reduce the recurrence rate from 20% to 10% over ten years. It is now to enter a larger study for a five year follow up to be undertaken by Galena Pharma.

Medicare has agreed to cover the costs of infusion for Dendreon’s Provenge, a prostate cancer vaccine, as well as the cost of the drug.

Other Vaccines

The FDA has approved the use of Prevnar 13 in older adults. An 85,000 person study is ongoing in The Netherlands. Pfizer describe this as a potential blockbuster.

GAVI has confirmed that both GSK and Pfizer will be discounting their pneumococcal vaccines by more than 50%.

In an early phase 1 study a group at Oxford has reported a promising response against Hepatitis C with an Italian vaccine from the Merck spin out Okairos. The vaccine acts against the more stable internal proteins rather than the very mobile outer coat proteins.

A large follow up of infants receiving rotavirus vaccine in the US published in Archives of Pediatrics has confirmed no increase in intussusceptions.

India has decided to add haemophilus influenzae to its vaccine schedule, it will become part of a recommended DTPHiBHepB pentavalent. They have also started a campaign to vaccinate 134m children with measles vaccine.

The UK JCVI is reviewing Meningococcal B vaccine but is not expected to report until 2013 (which should link to the vaccines European registration).

A study in NEJM has shown that a VLP intranasal vaccine against Norwalk disease (a severe gastroenteritis) was safe and immunogenic in 90 volunteers at phase 1. The vaccine was made by LigoCyte Pharmaceuticals. They are also working on a norovirus (cruise ship diarrhea) vaccine which has been shown to decrease gastroenteritis from 69% to 36% in a volunteer study.

An Ebola vaccine grown in tobacco plants has been shown to be effective in challenge tests on mice. Unlike other Ebola vaccines this appears to be stable which opens the potential for stockpiling.

Crucell have announced that in primates they have developed a vaccine that protects them from the primate equivalent of HIV (SIV Simian Immunodeficiency Virus).

The Iranian Institute Pasteur have started to develop a new HPV vaccine. They also plan to produce rabies, flu and HIB within two years.

Let us know what you think!

Dr Kevin A Bryett

 

This report is complied from information that is already in the public domain. Whilst every effort is made to ensure its accuracy the author, Dr Kevin A Bryett, cannot be held liable for any omissions or errors. Any company or individual taking action as a result of information in this report must verify the facts for themselves.

 

Dr Kevin A Bryett is our expert trainer for the 3 day MBA in Vaccines. The 3 day MBA in Vaccines will get you up-to-date on the latest developments and will teach you the fundamentals in just 3 days. Download the brochure and let us know what you think.

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