December 19, 2016
ProMetic Life Sciences Inc.
PLI Initiates BLA Filing Process for Plasminogen Impact: Positive
First impression
BLA filing for plasminogen initiated. This morning, PLI announced it has initiated the rolling submission of its Biologics License Application (BLA) for plasminogen with the FDA for treatment of patients with plasminogen congenital deficiency. Plasminogen has previously been granted Orphan Drug and Fast Track designation by the FDA, with the Fast Track designation permitting rolling submission of portions of the application. We note that management had previously guided to a Q4/16 BLA filing and we anticipate approval could occur in Q3/17. ProMetic is preparing for a commercial launch of Plasminogen in the U.S. in 2017.
BLA to include data from PLI's Ph. II/III trials of plasminogen.
Management also noted that the BLA will include data from the company's Ph. II/III trial of plasminogen which met both its primary and secondary endpoints. The primary endpoint, a targeted increase in blood plasma concentration level of plasminogen,saw a 100% success rate, and the secondary endpoint, complete healing of active visible lesions, also saw a 100% response rate.
Our View: While we believe the street expected a BLA filing before year-end, per management guidance, we believe that continued progress towards potential approval of PLI's first commercial product should be viewed as an important event. We also believe it helps speak to concerns regarding meeting milestone timelines, as this timing is completely consistent with management's outlook.