- Prescription Drug User Fee Act (PDUFA) action date is set
for April 14, 2018
- Ryplazim™ previously granted Fast Track, Rare Pediatric
Disease and Orphan Drug Designations by U.S. FDA
LAVAL, QC, Oct. 13, 2017 /CNW Telbec/ - Prometic
Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today
announced that the U.S Food and Drug Administration (FDA) has
accepted its Biologics License Application (BLA) for its
plasminogen replacement therapy (RyplazimTM) 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 Mr.
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 pre-requisite for Prometic's
eligibility for a PRV.
Prometic has previously reported data from this pivotal Phase
2/3 trial, which showed that RyplazimTM 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 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.