High Tech Cold Chain Sanaria, a Maryland-based company that has been plugging away at a malaria vaccine for more than ten years, recently brought attention to its collaboration to develop a “robust” cold-chain distribution system for Africa. In a press release, the company noted a collaboration with Cryoport, a CA company that makes liquid nitrogen dry vapor shipping containers which maintain a constant below -150°C temperature. Sanaria’s vaccine, called PfSPZ, is soon to enter field trials in Mali and will require refrigerated storage and distribution. The cost and feasibility of such a distribution system was not mentioned.
Dx Automat Thyrocare Technologies, Inc., is an Indian company that may be a model for drastically reducing the cost of diagnostics testing. According to its website, the company offers a menu of almost 200 tests and runs more than 30,000 samples overnight in an automated facility in Navi Mumbai. It services 200 clients in 2000 cities and towns, uses an IT-enabled air cargo system for sample delivery, and plans to go public this year (story in FierceMedicalDevices).
Made in China In a first for a drug being developed by a Taiwanese company, the FDA granted a “breakthrough therapy designation” for a novel HIV-entry inhibitor called TMB-355 (ibalizumab) to TaiMed Biologics. As described in a FiercePharmaAsia story, the drug has been under development for about a decade and is being manufactured for clinical studies by WuXi PharmaTech, an international and NYSE-listed CRO based in Shanghai. The designation is intended to accelerate the regulatory approval of needed and novel meds.
IP Theft versus Deals A recent academic study published in Health Affairs, Beall et al. 2015, compared the prices of antiretroviral drugs resulting from compulsory licensing (in which a country’s government allows an in-country manufacturer to make a drug it would otherwise be required to obtain a license for from the drug originator company) to prices available through an international procurement program. Compulsory licensing has been promoted by global health “advocates” as a method for decreasing the cost of needed drugs in developing countries. The authors looked at 30 compulsory license cases and 673 procurements made by the WHO and Global Fund and found the compulsory license prices exceeded the procurement price median in 19, often with a difference of more than 25 percent. Application of these findings by governments, international agencies, and pharma companies may result in improving access to medicines in low-income countries.
BMGF Ventures Again The Bill and Melinda Gates Foundation recently placed a substantial bet when it invested $52 million in the German company, CureVac (press release in FierceBiotech). The Foundation evidently liked the company’s unique mRNA-based technology and its potential low-cost and thermostable vaccines since this equity buy and additional undisclosed project-specific funding is many times any of the Foundation’s few previously-made investments. According to CurVac’s website, the company has more than six RNA vaccines in development, several of which (rotavirus, HIV, and tuberculosis) have large developing-world demand. CureVac has two major pharma partners and long-time backing by Dievini, a leading European venture capital firm founded by IT billionaire, Dietmar Hopp, which also made an additional $24 million investment (story in FierceBiotech).