Syntiron’s vaccines hold remarkable growth potential as vaccines are becoming recognized as the only practical alternative to the use of increasingly ineffective, toxic and expensive antibiotic therapies. The annual market revenue for human vaccine exceeds $12 billion, an increase of 100% since 2002.
Since its incorporation in 2004, Syntiron has been awarded four Phase I NIH grants for the research and development of vaccines against Salmonella spp., Staphylococcus aureus, and Yersinia pestis. The Company has also received a Defense Threat Reduction Agency (DTRA) contract of $4.1 million to explore the application of the technology in the development of a multi-valent vaccine against three major bioterror agents; Anthracis, Burkholderia and Yersinia. (The company is working in cooperation the Naval Medical Research Center, NMRC). Syntiron is in the process of applying for further Department of Defense and NIH funding and is optimistic about its success in receiving significant future funding from these sources. Syntiron is actively pursuing other national and international support for the commercialization of its vaccine technology.
In December of 2009, Syntiron granted sanofi pasteur (the world’s largest vaccine manufacturer ) an exclusive world-wide license for its Staphylococcus sp. human vaccine. Under the terms of the agreement, sanofi pasteur will support the joint, pre-clinical development of the product, working cooperatively with Syntiron, and be responsible for all future developments, regulatory approval, and commercialization of the vaccine. Neither company |
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spelled out the terms, but Syntiron gets an upfront payment, research funding and is eligible for development, regulatory and commercial milestone payments that could reach $149 million in total. Syntiron also stands to earn royalties on sales of products commercialized under the license and collaboration. This partnership validates the potential of the Syntiron vaccine technology platform, which will be adapted to develop vaccines and therapeutics against a significant number of other human bacterial infections.
The relationship with sanofi pasteur is a validation of Syntiron’s strategy of partnering and commercial alignment. This is driven by regulatory costs. Whereas, the cost of manufacturing its vaccines is relatively low, the expenditures required for regulatory and developmental processes, like any human vaccine, can exceed $700 million. Therefore, Syntiron is in discussions with multiple potential strategic partners and various funding agencies to facilitate and/or finance the developmental and approval process. The objective of the Company is to fund a Phase I clinical study for two other vaccines not included in sanofi pasteur license. Those selected represent the two primary families of bacteria: E. coli (a gram-negative bacterium) and Clostridia (an anaerobic gram positive bacterium). The additional funding needed to accomplish this is $15 million and the anticipated time to complete this development is 24-36 months.
Figure 1: Grant and Contract: Status |
