ProMetic Life Sci Initiates Rolling Submission Of Its Biologics License Application ("BLA") For Plasminogen With U.S. FDA
LAVAL, QC, Dec. 19, 2016 /PRNewswire/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that it has initiated the rolling submission of its Biologics License Application ("BLA") for plasminogen with the U.S. FDA for treatment of patients with plasminogen congenital deficiency. ProMetic's plasminogen was granted Orphan Drug and Fast Track Designations by the FDA. The Fast Track designation allows rolling submissions of portions of the regulatory application to be submitted and reviewed by the FDA on an ongoing basis.
"Our plasminogen replacement therapy holds promise for patients with congenital deficiency who now have limited treatment options. We look forward to effectively reaching out to all of the patients and to their healthcare professionals attending to their well-being with this first ever available therapeutic solution" stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "The BLA submission for plasminogen has commenced on schedule, and we are on target for an expected commercial launch of plasminogen in the USA in 2017."
The BLA will include data from ProMetic's Phase 2/3 clinical trial of plasminogen which met both its primary and secondary endpoints, with both endpoints achieving a 100% success rate. The primary endpoint successfully achieved a targeted increase in the blood plasma concentration level of plasminogen as a surrogate endpoint. Moreover, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment, which achieved a 100% response rate for this secondary endpoint.
Mr. Bruce Pritchard, ProMetic's Chief Operating Officer, stated: "We are already prepared to accommodate the existing plasminogen product needs of the congenitally deficient patients with our current manufacturing capacity" who added, "We are also prepared for the expected product requirements arising from additional clinical indications treated with plasminogen that will follow the initial commercial launch".
About Plasminogen
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
About Plasminogen Deficiency
The most common condition associated with plasminogen deficiency is ligneous conjunctivitis, which is characterized by thick, woody (ligneous) growths on the conjunctiva of the eye, and if left untreated, can lead to blindness. The growths tend to recur after surgical excision, thereby requiring multiple surgeries.
While ligneous conjunctivitis is the best characterized lesion of plasminogen deficiency, hypoplasminogenemia is a multi-organ disease that can also affect the ears, sinuses, tracheobronchial tree, genitourinary tract, and gingiva. Tracheobronchial lesions including hyper viscous secretions can result in respiratory failure. Hydrocephalus has also been reported in children with severe hypoplasminogenemia, apparently related to the deposition of fibrin in the cerebral ventricular system.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2015, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.
SOURCE ProMetic Life Sciences Inc.
