Aug. 10, 2012
/PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today it has received notification from the U.S. Food and Drug Administration (FDA) that its SparVax™ rPA anthrax vaccine program has been placed on clinical hold. The Agency indicated that the Company will receive a letter providing details of the basis for the clinical hold within 30 days. During this period, PharmAthene will continue to provide the agency with analytical data from its recently produced GMP lot of material. The clinical study, which was expected to begin by the end of this year, has not enrolled any subjects to date and accordingly, there have been no adverse events reported.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of
the United States
and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
- SparVax™ - a second generation recombinant protective antigen (rPA) anthrax vaccine
- Recombinant BChE- a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
- Valortim ® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, pursuant to a final judgment issued
May 31, 2012
Court of Chancery, PharmAthene is entitled to 50% of the net profits over 10 years from all sales of SIGA Technologies' ST-246
, a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox, and related products, once SIGA receives the first
in net profits from sales of ST-246
. For more information about PharmAthene, please visit