• Crucell is developing an Ebola vaccine in collaboration with the Vaccine Research Center (VRC) of the NIH National Institute of Allergy and Infectious Diseases (NIAID). It has been shown to completely protect monkeys against the virus with a single dose of the vaccine.
• Under the terms of the agreement with VRC, Crucell has an option for exclusive worldwide commercialization rights to the Ebola vaccine. 
• Crucell’s Ebola vaccine entered Phase I clinical trials in Q3 2006. Results are expected to be reported in the first quarter of 2008.
• For the Phase I study two groups of 16 volunteers have been enrolled and vaccinated. The clinical data is still blinded, however initial indications suggest that the vaccine is safe at the tested doses and appears to be immunogenic in a subset of subjects.

To date, numerous attempts to protect against Ebola infection using a variety of strategies have failed. However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a single dose of a recombinant vaccine provided sold protection against an otherwise deadly infection in animal models. Based on these results, we decided to develop an Ebola vaccine using the same approach. Furthermore, Ebola virus is on the US governments Category “A” list of bioterror agents. In 2003 the US government announced that once available, an Ebola vaccine may be stockpiled as part of its preparedness for bio-terror attacks under Project Bioshield. The Bioshield Act was enacted in July 2004, with a total appropriation of US$ 5.6 billion across all programs.

In 2002, we entered into a Collaborative Research and Development Agreement (CRADA) with the VRC of the NIH to develop jointly, test and manufacture an adenovirus-based Ebola vaccine. Under the terms of the agreement, we have an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration. In August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections.

In experiments conducted in 2004 by the VRC together with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), our vaccine candidate confirmed single-dose protection of monkeys against Ebola. Our results are distinct from the earlier trials in that our vaccine is based on PER.C6^® cells, making it highly scaleable and producible.

In 2005 we extended the CRADA with the VRC of the NIH to develop and produce vaccines against Ebola, Marburg and Lassa infections. Crucell was also granted an exclusive license to patents owned by the NIH to develop and commercialize vaccines against Ebola. Furthermore, Crucell signed a contract of up to €21.4 million with the NIH to produce Ebola vaccines.

Crucell’s Ebola vaccine entered Phase I studies in Q3 2006. For this randomized, double-blind, placebo-controlled study, two groups of 16 healty volunteers have been enrolled and vaccinated. The clinical data is still blinded, however initial indications suggest that the vaccine is safe at the tested doses and appears to be immunogenic in a subset of subjects.

The “Two Animal” Rule: In 2002 the FDA issued the so-called ‘‘two animal’’ or animal efficacy rule, which states that efficacy studies in man may not be required to obtain a product license for special categories of products as long as efficacy is established in two independent animal models and safety in man. We believe our Ebola vaccine may be a candidate for regulatory approval under this rule, and the use of the two animal rule could potentially speed up the approval process for our Ebola vaccine.

Ebola fever is one of the most lethal viral diseases, with a mortality ranging from 50% to 90% according to the World Health Organization. Ebola outbreaks occur regularly in tropical Africa, affecting both human and great ape populations. To date, approximately 2,000 cases have been reported since the virus was first discovered in 1976. The Ebola virus belongs to the group of ‘hemorrhagic fever viruses’, which also includes the highly pathogenic Marburg and Lassa viruses. Ebola virus causes a disease characterized by high fever and massive internal bleeding.

For Press Releases and Scientific Papers that relate specifically to our Ebola program, please refer to the Ebola Media Kit.