PharmAthene, Inc. (NYSE Amex: PIP) announced today that it has achieved significant progress in the development of its second generation anthrax vaccine, SparVax™. In addition to completing initial technology transfer at the 100 liter scale and demonstrating 36 month stability, the Company announced today that it has now completed a 1,500 liter engineering production run for SparVax™. As a result, PharmAthene has shown it is able to produce bulk drug substance for SparVax™ at the final commercial scale for the product.
Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer, remarked, "PharmAthene has developed a robust manufacturing process for SparVax™ with the capability to produce more than 200 million rPA vaccine equivalent doses of bulk drug substance at the 50 mcg dose range on an annual basis. The use of recombinant vaccine technology employing modern, industrial biotechnology manufacturing processes provides the flexibility to rapidly scale-up production in the event of a national emergency, which should enable a much more refined and cost-effective vaccine for the U.S. government and its citizens."
"As we remember and honor those who tragically lost their lives on September 11, 2001, we must not forget that it was also 10 years ago that our nation was introduced to the specter of biological terrorism in the form of the anthrax letter attacks. Since those tragic events, our government has dedicated unprecedented resources to ensuring our nation's preparedness against future bioterrorism events," remarked Eric I. Richman, President and Chief Executive Officer for PharmAthene.
"Recently, the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS) released The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Review, which outlined a bold strategic initiative to ensure our nation's safety from bioterrorism and emerging infectious disease threats. We at PharmAthene are extremely proud to be working in collaboration with HHS and its various agencies to achieve this objective by advancing important new, next generation technologies based on modern biotechnology processes, that address these critical biosecurity threats," continued Mr. Richman. "The benefits of next generation anthrax vaccines are well established and could yield potential improvements in cost, convenience, safety and effectiveness for the U.S. government and its citizens. We believe that our anthrax vaccine candidate, SparVax™, is at the forefront of efforts in this field and remain committed to working closely with our respected colleagues at the Biomedical Advanced Research and Development Authority (BARDA) to bring a second generation anthrax vaccine to market."
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