BNNFrom: Zivitz, Noah [mailto:Noah.Zivitz@bellmedia.ca] Sent: October-13-17 10:01 AM To: rg Subject: RE: ATTN: Noah Zivitz...important morning announcement definitely worth an update on BNN... Hi Thanks for the email. Prometic will likely be covered in some market updates today. Noah Zivitz Managing Editor Business News Network Desk: (416) 384-2590 Cell: (416) 550-8813 From: rg Sent: Friday, October 13, 2017 9:10 AM To: Zivitz, Noah Subject: ATTN: Noah Zivitz...important morning announcement definitely worth an update on BNN... Good Morning Noah, Any chance BNN could get a quick update from Pierre Laurin, CEO, Prometic Life Sciences (PLI) on this morning's announcement below. This is very positive news for a Canadian biotech. A rare breed here in Canada (unfortunately). Catherine Murray recently had an excellent interview with Pierre Laurin so she would be well versed on the company. Please consider. Thank you, rg BNN viewer and PLI investor ProMetic receives FDA acceptance for plasminogen BLA 2017-10-13 07:09 ET - News Release Mr. Pierre Laurin reports PROMETIC ANNOUNCES FDA ACCEPTANCE OF ITS BIOLOGICS LICENSE APPLICATION FOR PLASMINOGEN (RYPLAZIM) The U.S Food and Drug Administration (FDA) has accepted ProMetic Life Sciences Inc.'s biologics licence application (BLA) for its plasminogen replacement therapy (Ryplazim), having granted a priority review status and set a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018. Ryplazim had previously been granted fast-track, orphan drug and rare pediatric disease designations by the U.S. FDA. "The acceptance of our BLA filing and setting of the PDUFA date by the FDA is a significant milestone for ProMetic," said Pierre Laurin, president and chief executive officer of ProMetic. "The FDA has recognized the seriousness and unmet need of available therapeutic solutions for plasminogen deficiency, granting orphan, fast-track and rare pediatric disease designations. We will continue to work closely with the FDA in the coming months with the goal of making our plasminogen replacement therapy Ryplazim available to patients as soon as possible." The FDA grants rare pediatric disease designation for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children and adolescents. If approved, ProMetic's plasminogen replacement therapy will be eligible for a rare pediatric disease priority review voucher (PRV). The grant of the priority review was another important prerequisite for ProMetic's eligibility for a PRV. ProMetic has previously reported data from this pivotal phase 2/3 trial, which showed that Ryplazim treatment consistently replaced and maintained the plasminogen concentration at an appropriate level and that it resolved all lesions in all patients treated. 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 remodelling, 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 multisystemic disease that can also affect the ears, sinuses, tracheobronchial tree, genitourinary tract and gingiva. Tracheobronchial lesions including hyperviscous 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 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 number of industry leaders. The company uses its own affinity technology, which provides for highly efficient extraction and purification of therapeutic proteins from human plasma, to develop best-in-class therapeutics and orphan drugs. We seek Safe Harbor. 2017 Canjex Publishing Ltd. All rights reserved.