The Business of Global Health No. 11

ChemBio Dengue Deal  NY-based ChemBio Diagnostics Inc. recently announced a deal to apply its proprietary platform to a point-of-care (POC) dengue fever test with an unnamed “leading diagnostics company” (press release in FierceDiagnostics). ChemBio is to known (to me anyway) for its product development programs funded by ROW (rest-of-world) governments seeking products for public health (see “Dx Connex”). Although the deal’s terms and other party were not given, I am guessing the partners anticipate a large government procurement market among the one hundred or so countries in Asia, the Pacific, Central and South America, Africa, and the Caribbean where almost 3 billion people are at risk.

CSL Expands Global Vaccine Business  CSL Ltd. of Australia announced last week it purchased Novartis’s influenza vaccine business for $275 million (press release in FierceVaccines) (Novartis had sold most of its vaccine business to GlaxoSmithKline in April). Although the company’s sales of its many, mostly in-licensed, vaccines account for less than 10% of its $4 billion annual revenue, the company will be a good position to compete in both the US/EU and ROW vaccine markets for the annual ‘flu and emerging variations that may have epidemic potential. According to CSL, the acquisition will create the second largest supplier of ‘flu vaccine with manufacturing capability in the US, UK, Germany, and Australia.

Vaccine Venture  A local start-up came out of stealth mode last week when it announced receipt of $5 million in seed funding from the Bill & Melinda Gates Foundation. Affinivax will use a technology for making conjugate vaccines that “combines protective polysaccharides and proteins in a single vaccine and induces a broad protective immune response” and was developed by Richard Malley of Boston Children’s Hospital. Its first product will be aimed at pneumococcal pneumonia, a disease of poverty and major killer of children worldwide. In the press release in FierceVaccines, Affinivax’s lead advisor, George Siber, a vaccine industry veteran, said “By increasing the effectiveness and streamlining the development and manufacture of conjugate vaccines, we can make them more available to people in need throughout the world.”

Ebola Product Development  Products intended to address the on-going Ebola epidemic in West Africa are moving through development at an accelerated pace. Recently, France’s Atomic Energy Commission and French diagnostics company, Vedalab, announced a prototype of a rapid POC test to be field-validated soon (story in FierceDiagnostics). Last week, it was reported in FierceMedicalDevices that the USFDA granted emergency authorization for a one-hour, PCR-based Ebola test developed by BioFire Defense, a subsidiary by recent acquisition of the French company, bioMerieux. Earlier in October, the FDA approved an emergency Phase II study of Chimerix’s Ebola drug, brincidofovir which is a lipid-conjugated version of Gilead’s antiviral, cidofovir (FierceBiotech story). The study will be completed in about one year. In FierceVaccines, it was announced that Maryland-based Novavax will start a Phase I clinical trial in December to evaluate the safety and immunogenicity of its EBOV GP vaccine (press release and story). In the very early product development stage, Jim Collins, an applications-oriented bioengineer at Boston University, and Harvard University researchers described the demonstration of paper-based Ebola diagnostic in a recent publication. According to a story in Technology Review, the test detected Ebola RNA but with the limitation that the RNA needs to be isolated first.

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