Reverse Silk Road US biotech, medtech, and diagnostic companies face major challenges in developing and launching products for the large, and largely medically-underserved, markets of China and north Asia, one of which is the lack of in-country partners to license, get approved, and sell their products. One company, Beijing-based CANbridge Life Sciences Ltd. is addressing this need. Founded in 2012 by James Xue, a former Genzyme executive, and initially backed by angel investors, the company recently increased its leverage with a $10 million Series A from two Chinese venture firms (FierceBiotech story). CANbridge’s strategy is to license clinical stage products or those already approved in the US to commercialize for unmet medical needs in China, Korea, and Taiwan. To date it has deals with Azaya Therapeutics for a liposomal formulation of a cancer drug and Jazz Pharmaceuticals for an approved treatment of oral mucositis, a condition resulting from chemotherapy.
The Promise of Powder The promise of vaccines delivered via inhalation as dry powders has multiple parts- easy and low-cost administration, stability during storage and transport, and cheaper manufacture and packaging. Since receiving $20 million in funding from the Gates Foundation in 2006, CO-based Aktiv-Dry LLC has been developing an inhalable version of the measles vaccine and recently reported, with their commercial collaborator, the Serum Institute of India, the results of a successful Phase I study (FierceVaccines story and press release). While at least two major vaccine companies have dabbled in dry powder vaccines (GlaxoSmithKline and Novartis), the Aktiv-Dry candidate is the most advanced in testing.
More Affordable But The biologic anti-inflammatory drug, Humira, is a blockbuster for AbbVie (formerly Abbott Pharmaceuticals) with $11 billion in annual sales. Coming off patent in 2016, it is the target of more than three companies and its first generic competitor was launched in India this week. As reported in FiercePharma and Reuters Reuters, Cadila Pharmaceuticals Ltd. is now selling its version, Exemptia, in India for $200 per dose, one-fifth of Humira’s price, cheaper but still expensive for the majority of mostly uninsured patients. The company also noted it plans to seek approval in the US and EU where sales should provide a subsidy for Exemptia’s sale at more affordable prices in the 85 countries where Calida currently sells its other products.
PanVax Progresses The CA-based, “socially responsible” vaccine company, PanVax reported it will be submitting an application to the USFDA in 2015 for approval of its cholera vaccine after successfully completing a Phase III trial in the US and Australia (FierceVaccine story). When approved, it will be the only US-approved and the only single-dose cholera vaccine. While the primary US market is for travelers and is considered a niche market, the vaccine has the potential for large-scale use in controlling outbreaks that occur due to inadequate sanitation and result in three to five million cases and 100,000 to 120,000 deaths per year according to the WHO.
Novel Anti-Malaria MOA As reported in a press release and story story in FierceBiotechResearch, a collaboration led by St. Jude Children’s Research Hospital with the Medicines for Malaria Venture and the Eisai Co., a Japanese pharma, reported successful preclinical results for an anti-malaria drug candidate with a unique mechanism of action. The candidate drug inhibits a sodium pump in the parasite and results in changes in the malaria-infected red blood cells and their elimination by the immune system. The study in mice also suggested that a single dose may be effective in humans and that the potential for the development of resistance was low. A Phase I study is being planned.
Another Ebola Diagnostic The Wellcome Trust, UK’s leading foundation for medical research and technology development, announced the field testing of a portable Ebola diagnostic system in Guinea (press release in FierceDiagnostics). The system uses dry reagents, solar power, and a laptop-sized reader to analyze a blood or salvia sample in 15 minutes. The trial will be led by researchers from the Pasteur Institute in Dakar, Senegal, and the project manager, Enhancing Learning & Research for Humanitarian Assistance (ELRHA News). The program is funded by the Trust and the UK’s Department for International Development.