ANNAPOLIS, MD, USA I December 16, 2013 I PharmAthene, Inc. (NYSE MKT: 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 thirty days. The Phase II 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
PharmAthene is a leading biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® – a next generation recombinant protective (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® – a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in May 2013, the Delaware Supreme Court issued its ruling on the appeal in the company’s litigation with SIGA Technologies, affirming the Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Supreme Court’s opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
SOURCE: PharmAthene
Post Views: 901
ANNAPOLIS, MD, USA I December 16, 2013 I PharmAthene, Inc. (NYSE MKT: 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 thirty days. The Phase II 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
PharmAthene is a leading biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® – a next generation recombinant protective (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® – a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in May 2013, the Delaware Supreme Court issued its ruling on the appeal in the company’s litigation with SIGA Technologies, affirming the Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Supreme Court’s opinion. For more information about PharmAthene, please visit www.PharmAthene.com.
SOURCE: PharmAthene
Post Views: 901
