The FDA Orphan Drug designation program provides incentives to sponsors who are developing therapies for rare diseases that affect fewer than 200,000 people in the United States. ViraCyte is now qualified to receive significant benefits throughout its orphan drug development program, including tax credits for clinical research costs, frequent FDA interactions, and protocol assistance. Also included is a waiver of Biologic Licensing Application (BLA) filing and user fees, and a seven-year term of market exclusivity upon FDA approval of the orphan drug.
"I am confident that ViraCyte will achieve additional important clinical and regulatory milestones in 2017, all of which enhance our ability to provide ViraCyte's unique T cell therapies to critically-ill patients," stated Dr. Brett Giroir, ViraCyte's Chief Executive Officer. "Our success continues to reflect our collaborative research and clinical relationships with many of the world's leading health care institutions in the Texas Medical Center."
About ViraCyte, LLC
ViraCyte's current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte's lead T cell products are in Phase 1 and Phase 2 clinical trials, with effectiveness rates of greater than 90% in patients who have failed conventional therapy. More information can be found at www.viracyte.com
ViraCyte is a resident company at JLABS @ TMC, Houston, Texas.
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SOURCE ViraCyte, LLC