PharmAthene Progresses Second Generation rPA Anthrax Vaccine
- Category: Vaccines
- Published on Monday, 31 October 2011 17:41
- Hits: 1113
Completes SparVax GMP Manufacturing Production Run
ANNAPOLIS, MD, USA I October 31, 2011 I PharmAthene, Inc. (NYSE Amex: PIP) announced today further development progress of its second generation rPA anthrax vaccine, SparVax™. The new vaccine is being developed to provide rapid manufacturing scale-up to respond to a national security emergency. The Company completed its first cGMP manufacturing run at 1,500 liter commercial scale. Final analytical testing is ongoing and expected to be completed in December.
"There is widespread acknowledgement of the need for a modern, next-generation anthrax vaccine that can meet the government's needs in the event of an emergency. A recombinant anthrax vaccine offers the potential for an improved vaccine that is safe, convenient, cost-effective and provides for a significant increase in production yields," remarked Eric I. Richman, President and Chief Executive Officer. "SparVax™ is the first medical countermeasure to successfully transition from early research funded by the National Institutes of Health (NIH) to advanced development in partnership with the Biomedical Advanced Research and Development Authority (BARDA). SparVax™ represents how our medical countermeasure development program can create products with desired characteristics to meet the needs of our country. We look forward to continuing a very productive collaboration with our partners in government to address this need and advance this important product."
"This achievement marks the latest in a series of accomplishments for our rPA anthrax vaccine program in 2011," commented Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer. "Earlier this year, we successfully completed the technology transfer of our manufacturing process from the United Kingdom to a United States-based contract manufacturing organization. Most importantly, PharmAthene has data supporting 36 months of stability for SparVax™ – an important accomplishment given the historical issues associated with rPA anthrax vaccine stability. The use of recombinant vaccine technology employing modern, industrial biotechnology manufacturing processes provides the flexibility to produce a well-characterized product that can be rapidly scaled-up for production in the event of a national emergency.
A key differentiator for PharmAthene's rPA technology platform is the utilization of E. coli. This technology enables a more robust manufacturing process and the capability of annually producing more than 150 million rPA vaccine equivalent doses of bulk drug substance (at a 50 mcg dose) – a substantial improvement in rPA production yield without the production of destructive proteases. In addition, PharmAthene's manufacturing platform has the ability to produce stable production intermediates in the event surge capacity is required. All these factors contribute to key advantages of SparVax™ over other rPA-based anthrax vaccine programs."
PharmAthene's rPA anthrax vaccine program has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority.
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
Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
rBChE - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
In addition, pursuant to an opinion issued September 22, 2011 from the Delaware Court of Chancery, PharmAthene is entitled to 50% of the 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 (once SIGA earns $40 million in net profits from sales of ST-246.)