Tetra Bio-Pharma Announces FDA Orphan Drug Designation for PPP001 in Treatment of Complex Regional Pain Syndrome

OTTAWA, ONTARIO--(Marketwired - March 14, 2018) - Tetra Bio-Pharma Inc. ("Tetra" or the "Corporation") (TSX VENTURE:TBP)(OTCQB:TBPMF), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the active ingredients of its PPP001 drug (delta-9-tetrahydrocannabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome (CRPS). The Orphan Drug Designation was granted for the active moiety of the drug PPP001 and not the formulation.

The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect less than 200,000 people in the USA. This designation gives Tetra a seven-year marketing exclusivity, after drug approval by the FDA, and provides Tetra potential incentives such as access to federal grants and tax credits as well as a waiver of Prescription Drug User Fee Act filing fees.

Tetra successfully completed a placebo-controlled Phase 1a and 1b study of PPP001 in healthy volunteers and demonstrated that PPP001 can be safely consumed. "We are pleased to receive FDA Orphan Drug Designation for PPP001 and we look forward to discussing the clinical program with the US FDA that will be used to demonstrate the safety and efficacy in patients suffering from CRPS," said Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer of Tetra.

According to the USA National Institute of Health, "complex regional pain syndrome (CRPS) is a chronic pain condition that most often affects one limb (arm, leg, hand, or foot) usually after an injury. CRPS is believed to be caused by damage to, or malfunction of, the peripheral and central nervous systems. CRPS is characterized by prolonged or excessive pain and changes in skin color, temperature, and/or swelling in the affected area."

Appointment of a New Director - Tetra also announced the appointment of a new Director, Mr. Benoit Chotard, effective immediately. Mr. Chotard was previously a member of the Board of Directors from September 2016 to July 2017, he left for personal reasons, no longer applicable, and is pleased to come back. "We are glad to welcome back Mr. Chotard to the board and we look forward to working closely with him in building Tetra as a leading biopharmaceutical organization," said Andre Rancourt, Chairman of Tetra Bio-Pharma. "Mr. Chotard's tremendous experience as an advisor of publicly listed companies will be a huge addition to our team. His local and international network will be a key factor in the Company's growth."