- Triple designation of orphan drug, fast track status, combined with rare pediatric designation, underscores significant
unmet need for therapy
LAVAL, QC, Aug. 29, 2017 /CNW Telbec/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that the U.S Food and Drug Administration (FDA) has
granted a Rare Pediatric Disease Designation to Prometic's Ryplazimä, a plasminogen replacement therapy for the treatment of
patients with congenital plasminogen deficiency. In addition to the Rare Pediatric Disease Designation, Ryplazimä has already
been granted Orphan Drug and Fast Track Designation by the FDA.
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 to receive
a rare pediatric disease priority review voucher.
"We are pleased that RyplazimTM has received this pediatric designation from the FDA. In addition to
Ryplazim'sTM orphan drug status, this designation represents another validation of the approach we have taken
regarding our plasminogen's clinical program," said Mr. Pierre Laurin, President and Chief
Executive Officer of Prometic. "The pediatric designation also provides an important incentive for Prometic to continue
developing therapies addressing unmet medical needs for children with rare diseases. We look forward to continue to work closely
with the FDA to bringing this innovative therapy to patients suffering from plasminogen deficiency."
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 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 is active in developing its own novel small-molecule therapeutic products
targeting unmet medical needs in the field of fibrosis, cancer and autoimmune diseases/inflammation. A number of plasma-derived
and small molecule products are under development for orphan drug indications. Prometic also 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.
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 and
Asia.
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, 2016, 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.
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