Vascular Solutions (VASC) Announces Submission of RePlas IND to FDA

October 18, 2016 7:32 AM EDT

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Vascular Solutions, Inc. (Nasdaq: VASC) announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for RePlas, a freeze-dried plasma product being developed in collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA).

Pending FDA approval of the IND application, Vascular Solutions expects patient enrollment to commence in December. Upon successful completion of the clinical study, a Biologics License Application (BLA) is expected to be filed, followed by commercial launch in the U.S. in 2019-2020 and initial production devoted to meeting the battlefield needs of the U.S. Army.

“Vascular Solutions is honored to be working with the U.S. Army on this critical, life-saving product,” said Howard Root, Chief Executive Officer of Vascular Solutions. “The lyophilization of biologic materials is one of our core technical competencies, as we have demonstrated with multiple successful commercial endeavors starting with our D-Stat® Dry hemostatic bandage over ten years ago. Since entering into the development agreement with the U.S. Army in April 2014, we have made consistent and substantial progress – most recently the installation and validation of our commercial-scale manufacturing equipment in our RePlas manufacturing facility. I am very pleased that we are now taking the next step by entering the clinical study phase of this project.”

Because the early administration of plasma has an important role in reducing mortality from trauma, the USAMMDA has made the development of an FDA-approved source of freeze-dried plasma a top priority. In April 2014, Vascular Solutions entered into a Cooperative Research And Development Program with the USAMMDA to develop RePlas, with the USAMMDA funding the regulatory and clinical work and Vascular Solutions having all ownership rights of the product and intellectual property.

“I cannot think of a more important product needed not only in military trauma, but in trauma care throughout the U.S. and world,” said Steven W. Swann, M.D., FACS, retired Colonel with the U.S. Army Medical Corps and former Command Surgeon, U.S. Special Operations Command (USSOCOM), MacDill Air Force Base in Florida. “The ability to stock freeze-dried plasma with our front-line troops will improve the odds of survival of our wounded soldiers.”

Under the terms of the collaboration agreement, Vascular Solutions is responsible for development of RePlas and establishing manufacturing operations, including chemistry, manufacturing, and controls (CMC) information to support the IND submission. The USAMMDA is responsible for sponsoring, managing, and funding all pre-clinical and clinical studies required to support FDA approval. Following FDA approval, Vascular Solutions will be responsible for all post-licensure production, regulatory, and commercial marketing and distribution of RePlas, while the USAMMDA will purchase quantities of RePlas for use by the U.S. Army. Vascular Solutions will be entitled to market RePlas for all other uses, including sale to the other branches of the military and civilian medical providers.

Currently, the only licensed form of plasma available in the United States is Fresh Frozen Plasma (FFP), which must be stored frozen and requires a lengthy thawing process before use. Due to the difficulty of using FFP in remote locations such as military hospitals and battlefield conditions, the USAMMDA has sought the development of a stable, durably-packaged freeze-dried plasma product that can be easily stored, transported and used remotely.

“We believe RePlas will offer important benefits for both the U.S. military and the general public,” said Mr. Root. “Freeze-dried plasma will have wide applicability in emergency situations where plasma is not currently available and when time constraints limit the use of fresh frozen plasma. We estimate the current market opportunity exceeds $100 million annually, with no current competition.”

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