ProMetic's Plasminogen Gets FDA's Orphan-Drug Status for Hypoplasminogenemia By Melodie Warner (WSJ)
March 14, 2013, 7:06 a.m. ET - ProMetic's Plasminogen Gets FDA's Orphan-Drug Status for Hypoplasminogenemia By Melodie Warner
ProMetic Life Sciences Inc.'s (PFSCF, PLI.T) plasma-purified human plasminogen drug obtained orphan-drug status from the U.S. Food and Drug Administration as a potential treatment for hypoplasminogenemia.
Hypoplasminogenemia, or type I plasminogen deficiency, is a rare genetic condition associated with chronic lesions on mucous membranes throughout the body.
ProMetic, a biopharmaceutical company focused on small molecules that mimic specific interactions between proteins, is developing a systemic formulation to treat T1PD in partnership with Hematech Biotherapeutics Inc.
Plasminogen is a naturally occurring protein that is involved in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis. ProMetic said it has already scaled up the manufacturing process.
"Given the multitude of organs and tissues that are affected by such type of disorders, it is critical to be able to provide a safe and reliable source of plasminogen for these patients in need," said ProMetic Chief Executive Pierre Laurin. "The scale-up of our proven manufacturing platform at our Laval, Quebec, facility will enable the global supply of plasminogen as well as several other therapeutics targeting serious unmet medical conditions."
The FDA's orphan drug designation is granted to potential treatment for rare disease or conditions affecting fewer than 200,000 patients in the U.S.
The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon marketing approval, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and the waiver of prescription drug user fees.