ANNAPOLIS, Md., Sept. 26 PharmAthene, Inc.(Amex: PIP), a biodefense company developing medical countermeasures againstbiological and chemical threats, announced today that the National Instituteof Allergy and Infectious Diseases (NIAID), part of the National Institutes ofHealth (NIH), has awarded the Company a multi-year contract for up to $83.9million for advanced development of a third generation recombinant protectiveantigen (rPA) anthrax vaccine.
The objective of the government's third generation program is to developan rPA anthrax vaccine which can be stored, transported and used without theneed for a conventional cold chain - an important advantage for civilianbiodefense deployment within the Strategic National Stockpile. In particular,the vaccine must maintain stability for three years at 35º C and induceprotective immunity in just one or two doses.
Under the contract, PharmAthene will receive initial funding ofapproximately $13.2 million during a "base period" of performance. Duringthis time the Company will be responsible for preclinical activities,including, development and qualification of assays, stability testing,toxicology studies and development of non-clinical animal models. During thebase period NIAID retains the option of extending the contract under twoseparate options with a combined value of up to $9.7 million. Additionaloptions covering advanced manufacturing and clinical development could bringthe total potential value of the contract up to approximately $83.9 million,provided that certain milestones are achieved and that all contract optionsand extensions are exercised by the government.
"We are pleased that NIAID has awarded such a significant contract to fundthe continued development of our third generation rPA anthrax vaccine program.This latest contract is in addition to an earlier NIH contract for up to $6.9million, which was awarded in 2005," commented David P. Wright, President andChief Executive Officer. "PharmAthene has built a diversified, best-in-classportfolio of novel biodefense product candidates and we view this latest awardas a direct validation of our technology as well as a reaffirmation of the U.S.government's commitment to the development and procurement of next generationmedical countermeasure solutions."
Mr. Wright added, "Based on development efforts to date, PharmAthene'sthird generation vaccine could offer significant improvements in bothstability and storage compared to the current FDA approved vaccine, therebymeeting the government's requirements for civilian deployment in the StrategicNational Stockpile. By comparison, the currently available anthrax vaccine,BioThrax(R) Anthrax Vaccine Adsorbed, which was initially licensed by the Foodand Drug Administration in 1970, requires six doses over a period of eighteenmonths to achieve protective immunity and is required to be stored at between2 degrees Celsius and 8 degrees Celsius."
PharmAthene believes that the third generation rPA anthrax vaccinecontract is part of a broader strategy by the Department of Health and HumanServices to ensure that the Strategic National Stockpile (SNS) contains themost efficacious anthrax medical countermeasures currently available.Near-term, the Company believes second generation rPA anthrax vaccine willgradually replace the currently licensed vaccine. Longer-term, thirdgeneration rPA vaccine -- with substantial improvements in stability andstorage requirements -- will be the procurement option of choice.
Mr. Wright continued, "PharmAthene is strategically building a leadingfranchise in anthrax countermeasures - a potential billion dollar market. Thisincludes not only our third generation rPA vaccine candidate, but also ournovel second generation rPA anthrax vaccine, SparVax(TM) which is positionedfor near-term procurement consideration. As previously disclosed on July 31,2008, we submi