Merck & Co., Inc. (NYSE:MRK) has just announced that its Ebola vaccine candidate, VSV-ZEBOV has been granted FDA’s BreakthroughTherapy Designation alongside European Medicine Agency (EMA) Priority Medicines (PRIME) status. What this means for the drug is additional regulatory support as it seeks to marketing approval. The drug has already displayed promising clinical data and potentially the best current Ebola option.
The Ebola vaccine candidate is a product of collaboration between Merck and NewLink Genetics. NewLink has in the past received donations to aid in their research and development for this vaccine. In April this year, it received $26.1 million in additional funding from Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services. Overall BARDA has invested $74.6 million in the project since 2014. Merck plans to submit the vaccine candidate for approval by the end of 2017. A partnership with Gavi will see it pay $5 million to build a stockpile.
Merck’s drug candidate success comes at a time when Zika virus has been a major cause for concern. Some experts have even warned that complacency could lead experts away from unfinished projects as the vaccine research community turns to Zika. A portion of U.S. federal funding for Ebola was even redirected to Zika.
In April, Paula Annuziato, Vice President of clinical research at Merck Research Laboratories noted that the milestones achieved by the vaccine candidate allow the company to continue to accelerate its development, potentially meeting the public health need.
Apart from Merck, other big pharmas are also pushing on with their Ebola drug candidates. GlaxoSmithKline plc (NYSE:GSK) and Johnson & Johnson (NYSE:JNJ) have advanced Ebola candidates into Phase III. Inovio Pharmaceuticals Inc (NASDAQ:INO) and Profectus Bioscience have candidates as well.