Will invest US$200m to expand production at Janssen Pharmaceutical Companies
Johnson & Johnson has pledged US$200m to accelerate and expand production of an Ebola vaccine programme in development at its Janssen Pharmaceutical Companies. The company is collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), as well as other key stakeholders, governments, and public health authorities on the clinical testing, development, production and distribution of the vaccine regimen.
The vaccine regimen, which was discovered in a collaborative research programme with the US National Institutes of Health (NIH), combines a Janssen preventative vaccine with another from Bavarian Nordic, a Danish biotechnology company. This vaccine has shown promising results in preclinical studies, and is now planned to be tested for safety and immunogenicity in healthy volunteers in Europe, the US and Africa starting next January.
Janssen is targeting production of more than one million doses of the vaccine in 2015, a quarter of which are expected to be released for broad application in clinical trials by May next year.
The regimen consists of two vaccine components that are based on AdVac technology from Crucell Holland, which is part of the Janssen Pharmaceutical Companies, and the MVA-BN technology from Bavarian Nordic. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development programme for a multivalent vaccine against other virus strains that cause disease in humans, including Ebola and Marburg viruses.
A dedicated team of experts has been assigned to focus on bringing this preventative vaccine to people in need.
Our goal to produce more than a million vaccines in the next few months is within reach
The commitment by Johnson & Johnson includes an equity investment in Bavarian Nordic to provide capital for the development, testing and production of Bavarian Nordic's vaccine. Janssen will take the lead in funding and developing both components of the combination vaccine.
‘We are urgently working to provide our vaccine expertise, production capabilities, our people and resources to address the Ebola crisis,’ said Alex Gorsky, Chairman and CEO, Johnson & Johnson. ‘Our innovation model enables us to quickly mobilise our extensive resources to collaborate with health authorities and governments and other experts to help contain this disease, save lives, and protect the health and lives of those at risk. We have an important responsibility as a leading global healthcare company to do all we can to address this urgent unmet medical need.’
‘Our goal to produce more than a million vaccines in the next few months is within reach,’ says Paul Stoffels, Chief Scientific Officer of Johnson & Johnson and Worldwide Chairman, Pharmaceuticals. ‘We are committed to bringing our science, technology, innovation and resources to help prevent and treat this deadly disease.’
In preclinical testing conducted in partnership with the National Institutes of Health, the combination vaccine regimen has shown complete protection against Ebola, said Johan Van Hoof, Global Head, Infectious Diseases and Vaccines, Janssen. Using its PER.C6 high density cell production technology, the company has been able to produce large quantities of the Janssen component of the vaccine regimen in testing batches, and has already started production towards its goal to have these vaccines available for clinical testing in the next few months.
Last month, Johnson & Johnson and Bavarian Nordic announced that they would fast-track the development and clinical testing of the vaccine programme, which features a prime-boost regimen in which one vector is used to prime and the other to boost the immune response.
The programme has received direct funding from, and is also using, preclinical services from the NIAID, part of NIH. Preclinical experiments conducted at the NIH of the combination vaccine regimen demonstrated that when both vaccines were administered two months apart, complete protection was achieved against the Kikwit Zaire strain of Ebola, which is similar to the virus that is the cause of the current outbreak in West Africa.
ohnson & Johnson is also participating in the ongoing efforts by public health authorities, including the Centers for Disease Control and Prevention and the WHO, to mount a coordinated world response to address the immediate needs raised by the Ebola outbreak.
The company is also seeking to secure additional partners and resources to assist in its efforts to increase vaccine production and further speed up the clinical trial programme.