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PharmAthene, Nanotherapeutics to advance biodefense programs

PharmAthene and Nanotherapeutics, a privately-held biopharmaceutical company, have formed a Strategic Alliance to advance the development of certain medical countermeasures for the U.S. biodefense market.

Under the Alliance Agreement, each company will contribute its specific expertise and resources with the objective of advancing biodefense products to be agreed to under individual product plans.

"There is a real concern that the nation is not as prepared for manmade and naturally occurring biothreats as it can be and should be. We believe our alliance with Nanotherapeutics will accelerate the development and availability of promising medical countermeasures," commented Eric I. Richman, President and Chief Executive Officer of PharmAthene.

"In addition, we believe this Alliance is an excellent strategic fit for our business model and our Government customers. By combining our complementary resources and expertise on select programs, we hope to accelerate the development of urgently needed medical countermeasures."

PharmAthene’s pipeline of products to prevent and treat emerging infectious diseases and biodefense threats fits well with Nanotherapeutics manufacturing and development capabilities and within the objectives of the Department of Defense (DoD) mandate for Advance Development and Manufacturing program.

The agreement provides for the selection of various products from either Company’s portfolios and the ability to move forward with respect to funding proposals, research and development.

The first Alliance Product on which the Companies will focus is PharmAthene’s rBChE bioscavenger (recombinant human Butyrylcholinesterase), a medical countermeasure for nerve agent poisoning by organophosphorous (OP) compounds, including nerve gases and pesticides.

Specifically, the Companies will capitalize on Nanotherapeutics’ extensive manufacturing and formulation capabilities in order to progress PharmAthene’s second generation approach to the rBChE bioscavenger, which utilizes a cell-based expression system (the PER.C6 human cell line) that is expected to yield distinct manufacturing and cost advantages over traditional and developmental approaches, including higher production yields, lower production costs and a more streamlined path to FDA licensure for the product.

DoD has highlighted the need for chemical bioscavenger products to enhance readiness and protect the warfighter potentially enabling near-term partnering opportunities for the Alliance.

In 2013, the DoD selected Nanotherapeutics as its exclusive prime contractor through a competitive process. The 10-year, $359 million contract provides for the establishment of a Medical Countermeasures Advanced Development and Manufacturing Center (NANO-ADM) to provide more rapid development and manufacture of bulk vaccines and biologics for the DoD and potentially other government and commercial partners.

Construction of the NANO-ADM Center commenced in October 2013 and is expected to be completed in 2015. At present, Nanotherapeutics has manufacturing capabilities in their own facility along with the full complement of development and clinical expertise.

"We look forward to utilizing Nanotherapeutics’ manufacturing capabilities for this program. Nanotherapeutics is vertically-integrated to support clinical development to commercial supply for products such as PharmAthenes’. Nanotherapeutics will provide a highly experienced team with expertise from preclinical through FDA licensure in this alliance," said Dr. James Talton, President and Chief Executive Officer of Nanotherapeutics.

Financial terms of the strategic alliance were not disclosed, however, they do not involve a substantial funding commitment by either party