Prometic completes the filing of its plasminogen Biologics License Application ("BLA") with the U.S. FDA
Apr 05, 2017, 06:00 ET
LAVAL, QC, April 5, 2017 /CNW Telbec/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or the "Corporation") announced today that it has completed the filing of its plasminogen Biologics License Application ("BLA") with the U.S. FDA for the treatment of patients with plasminogen congenital deficiency.
Prometic's plasminogen replacement therapy has been granted Orphan Drug and Fast Track Designations by the FDA. Prometic has also applied for a pediatric designation as its research demonstrates that the most serious and life-threatening manifestations of the congenital plasminogen deficiency occur most commonly in pediatric patients. Moreover, data gathered over a very large sample size in the USA (more than 900 million medical claims), enabled the Corporation to provide evidence to the FDA that an estimated 2,100 patients have sought medical care and treatment for plasminogen deficiency in the USA over a nine month period (between Q4 2015 and Q3 2016) with such requirements occurring disproportionately more often in patients aged 18 years old and younger.
"The completion of the plasminogen BLA filing is a significant milestone achievement for Prometic and, eventually, for all the patients who suffer from the complications associated with this deficiency", stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "We look forward to launching plasminogen in the USA in Q4 2017 and providing a cost effective therapy for this serious unmet medical need".
The BLA modules filed include non-clinical information, clinical data from the completed phase 2/3 clinical trial in which Prometic's plasminogen achieved a 100% success rate on both primary and secondary endpoints, a draft label of the product to be licensed, and a description of the chemistry, manufacturing and controls as it pertains to the manufacturing facilities and the manufacturing process for the production of human 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 corneal damage and blindness. Ligneous 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-systemic 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.
For further information: Pierre Laurin, President and CEO, ProMetic Life Sciences Inc., [email protected], +1.450.781.0115; Frédéric Dumais, Senior Director, Communications and Investor Relations, ProMetic Life Sciences Inc., [email protected], +1.450.781.0115
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