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news.Vascular Solutions has entered into a cooperative research and development agreement with the US Army Medical Materiel Development Activity (USAMMDA) to develop a freeze-dried plasma product for use in battlefield treatment of severe hemorrhage.
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The early administration of plasma has an important role in reducing battlefield mortality rates, and therefore the USAMMDA has prioritized the development of a freeze-dried plasma product. Currently, the only plasma available in the US is in the form of fresh frozen plasma (FFP), which must be stored frozen until use and then requires a lengthy thawing process.
Due to the difficulty of using FFP in remote locations such as military hospitals and battlefield situations, the USAMMDA has requested the development of a stable, durably-packaged, freeze-dried plasma product that can be easily stored, transported and used in remote locations.
Under the terms of the agreement, the USAMMDA has selected Vascular Solutions as its development partner for the commercialization of a freeze-dried plasma product. Vascular Solutions will be responsible for completing development of the product and establishing manufacturing operations, including chemistry, manufacturing, and controls (CMC) information to support the Investigational New Drug (IND) application to the FDA.
The Army will be responsible to sponsor, manage and fund all pre-clinical and clinical studies required by the FDA for regulatory approval, as well as to sponsor and fund a post-approval clinical study to broaden the approved indication if required by the FDA.
Following regulatory approval, Vascular Solutions will be responsible for all post-licensure production, regulatory and commercial marketing and distribution of the freeze-dried plasma product, and the United States Army will purchase quantities of the freeze-dried plasma product from Vascular Solutions for military use.
Vascular Solutions also will be entitled to market the product to other government agencies and for civilian use, subject to regulatory authorization. In the United States, more than four million units of FFP are administered annually, and the growth in consumption is accelerating in response to recent transfusion studies that demonstrated significant decreases in mortality with a higher concentration of plasma.
Vascular Solutions CEO Howard Root noted that the company believes that a freeze-dried plasma product will offer important benefits for both the U.S. military and the general public.
"Freeze-dried plasma will have wide applicability in emergency situations where plasma is not currently available or when time constraints limit the use of fresh frozen plasma. In addition to the military and other government agencies, freeze-dried plasma would be a natural option for rural treatment facilities and private first-responder organizations with advanced life support capabilities," Root added.
For more than a decade, Vascular Solutions has developed extensive expertise in the lyophilization of biologic products, which has led to the commercialization of several successful and market-leading products, including the D-Stat(R) Dry topical hemostat. During the development of the lyophilized plasma product, Vascular Solutions has invented a process and materials for freeze-drying and packaging human plasma for use in field settings. Vascular Solutions has filed a U.S. patent application related to its system and method that protects the human plasma from contamination through the steps of filling, freeze-drying, packaging, storing, and delivery.
Vascular Solutions expects its freeze-dried plasma product to be regulated by the FDA as a blood product and to require a Biologics License Application (BLA). Vascular Solutions is currently targeting submission of the BLA in 2018-2019, following completion of the required clinical studies. Vascular Solutions expects the BLA to target an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., due to liver disease) or rapid reversal of the effect of warfarin therapy.
The company also plans to seek, as part of a Phase IV development commitment sponsored and funded by USAMMDA, an indication for patients with massive transfusion who have clinically significant coagulation deficiencies. The company does not expect the development costs associated with this program to have a material impact on its financial performance during the development period.