PharmAthene Files Protest Against HHS Over Anthrax Vaccine Bidding Process
ANNAPOLIS, Md., Aug. 5, 2016 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against anthrax, today filed a formal protest against the Department of Health and Human Services, challenging its solicitation for a next-generation Anthrax vaccine provider.
According to the protest, filed with the U.S. Government Accountability Office, the government's "Request for Proposals" was written in a way that eliminates competition and assures a sole source award to Emergent BioSolutions Inc., the company that has long been the sole-source provider of the vaccine. The protest requests the GAO suspend the award under the solicitation while it reviews PharmAthene's complaint. Under federal procurement regulations, GAO has 100 days to review the complaint.
"The government wrote its solicitation in a way that protects its long-time, sole-source provider without regard to what is best for the public," said PharmAthene CEO John M. Gill. "The Anthrax biodefense is too important to sole source to one vaccine provider."
The only FDA-approved anthrax vaccine in the U.S. is Anthrax Vaccine Absorbed (AVA), which was developed by government scientists in the 1960s. Emergent BioSolutions, then known as the BioPort Corporation, later purchased it from the government and "continues to be the sole-source supplier of tens of millions of doses of AVA at a 300% markup," according to the complaint.
The government purchases the vaccine under Project BioShield, which was signed into law 2004 as a part of the strategy to defend America against weapons of mass destruction. While Emergent has been the sole source supplier to the government since it purchased the vaccine, PharmAthene has worked with two government agencies, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) to develop a more effective next-gen vaccine with an improved stability and immunogenicity profile. Combined the two agencies have spent nearly $200 million on development of PharmAthen's SparVax® and SparVax-L® formulations.
The U.S. Government has identified the need for a next-generation Anthrax vaccine with improved potency (protective immunity in two doses), post-exposure prophylaxis efficacy (PEP), at least a four-year shelf life (later changed to a three-year shelf life), a temperature-stable formula with no cold storage chain, and a lower cost. Temperature-stability has been a priority for the military. PharmAthene's SparVax-L vaccine candidate is specifically designed to meet the Government's goals for the next-gen anthrax vaccine.
"SparVax-L's reduced procurement costs positions it to provide substantially better value to U.S. taxpayers," Gill said. "The government has invested a lot of money into our innovative, next-gen product that will be wasted if they give everything they have to Emergent without a fair, competitive review. That's not good for public health. And American taxpayers deserve better."
Contact: Terry Neal, 202-879-9384, email@example.com
PharmAthene is a biodefense company engaged in the development of next generation medical countermeasures against biological threats. The Company's development portfolio includes a next generation Anthrax vaccine that is intended to improve protection while having favorable dosage and storage requirements compared to other Anthrax vaccines.
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