In August 2014, within days of being stricken by the Ebola virus, two American medical workers received an experimental drug that had never been tested on humans. ZMapp saved their lives.
The recovery of physician Kent Brantly and aid worker Nancy Writebol is testament to the critical work done at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), where research scientists developed one of the three monoclonal antibodies that comprise ZMapp. The antibody was licensed to Mapp Biopharmaceutical of San Diego in October 2009, five years before the unprecedented Ebola outbreak in 2014. Since then, MappBio received a $25.9 million contract from the U.S. Department of Health and Human Services (HHS) to support accelerated development of ZMapp; and Phase I, Class II clinical trials are now underway in West Africa.
The license agreement between the Army and MappBio was the first in the Department of Defense, and perhaps the country, to leverage the U.S. Food and Drug Administration's (FDA) Tropical Disease Priority Review Voucher (PRV) program. As a technology transfer tool, the potential shared proceeds from a PRV represent one of the largest upsides in licensing ever negotiated. Under the program, the first company that receives FDA approval for a treatment or vaccine targeting certain tropical diseases can request a PRV, which can be used by the company to speed FDA review of one of its own drugs or be sold to another pharmaceutical company. This can be a highly valuable asset as gaining another few months on the market with a patented drug can generate enormous revenue for a company. A recent PRV from a pediatric treatment, for example, sold for $350 million.
The recovery of physician Kent Brantly and aid worker Nancy Writebol is testament to the critical work done at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), where research scientists developed one of the three monoclonal antibodies that comprise ZMapp.
Terms developed for the MappBio agreement regarding a potential PRV are now standard in all tropical disease licenses negotiated by the Army Medical Research and Materiel Command's (MRMC) Technology Transfer Office. Considerations include determining the value of the potential voucher and the relative contributions of the licensee and licensor, which are unique to each negotiation. There is also precise language for timely distribution. Should the licensee receive a PRV, it must put it up for auction within a year. The company can purchase the voucher itself, but must outbid the highest bidder by one dollar to ensure that the lab receives a fair market price.
This technology transfer has exceeded all of the partners' expectations. MappBio has transitioned from a company of nine employees to a world leader in biotechnology, while at USAMRIID and the MRMC Technology Transfer Office, interest in Army Ebola-related technology has soared, resulting in many licensing agreements and establishing the lab as a national and international resource.
At the end of the day, it is about saving lives. Ebola patients and healthcare providers now have hope that there is an end to the 60% to 90% fatality rate of the most deadly virus on the planet.