- Rare Pediatric Disease Designation granted for the treatment
of patients with necrotizing enterocolitis (NEC)
- NEC accounts for approximately 19% of the US's annual
neonatal medical expenditures as well as an estimated $5 Billion in annual hospitalization costs in the
US
LAVAL, QC, March 5, 2018 /PRNewswire/ - 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 its Inter-Alpha-Inhibitor-Proteins ("IaIp") for the
treatment of Necrotizing Enterocolitis ("NEC"). In addition to the
Rare Pediatric Disease Designation, IAIP has also been granted an
Orphan Drug Designation by the FDA.
"This is the second pediatric designation which our
plasma-derived therapeutics have received from the FDA,
demonstrating the capacity of our plasma purification platform to
generate a variety of drug candidates targeting unmet medical needs
for children with rare diseases," said Mr. Pierre Laurin, President and Chief Executive
Officer of Prometic. "The combination of pediatric and orphan drug
designations provides us with valuable commercial incentives to
continue expanding our pipeline of orphan drugs. We look forward to
working closely with the FDA to bring this innovative therapy to
pediatric patients. The costs associated with this clinical program
will not impact our FY2018."
IaIp are endogenous proteins that control excessive inflammatory
responses to toxins, infectious organisms, tissue and organ damage.
An inverse correlation between IaIp levels in blood plasma and
disease severity / mortality has been demonstrated in humans with
sepsis. In a gold-standard animal model proven to emulate NEC in
humans, the supplementation of IaIp significantly increased the
study subjects' survival rates.
The FDA grants Rare Pediatric Disease Designations for serious
or life-threatening diseases wherein 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 and when approved,
Prometic's IaIp replacement therapy could be eligible to receive a
rare pediatric disease priority review voucher.
NEC is the most commonly acquired gastrointestinal disease
diagnosed in premature neonates and is one of the leading causes of
death in neonatal intensive care units. The economic cost of NEC is
high, accounting for approximately 19% of neonatal expenditures and
an estimated $5 billion per year for
hospitalizations in the United
States alone. Even when surgery can be avoided, the average
cost of hospitalization has been estimated at around $73,000, with a length of stay exceeding 22 days
longer than that for other premature infants. However, if surgical
care is required, there is an average additional cost of
approximately $186,000, and infants
require a length of stay 60 days longer than other premature
infants.
About Inter-Alpha-Inhibitor-Proteins (IaIp)
Inter-alpha inhibitor proteins (IaIp) are serine proteases
inhibitors that modulate endogenous protease activity. Severe
sepsis results in reduced IαIp with the loss of protease inhibitory
activity. Treatment with IαIp is protective in numerous preclinical
sepsis models
About Necrotizing Enterocolitis
Necrotizing enterocolitis (NEC) is a devastating inflammatory
bowel condition that affects predominantly premature infants. NEC
can ultimately destroy the wall of the bowel (intestine) and lead
to perforation of the intestine and spillage of stool into the
infant's abdomen, which can result in an overwhelming infection and
death. The cause of NEC is not well understood but appears to
involve bacteria, injury to the bowel lining, inadequate oxygen
supply to the bowel, and an abnormal immune response. Overall, NEC
affects an estimated 8,000-12,000 live births each year in the
USA. The disease has been reported
to affect about 11 percent of very low birthweight infants born
before 29 weeks of age. Mortality rates are high, and range from
about 15% to 30%.
About Prometic Life Sciences Inc.
Prometic Life Sciences Inc. (www.prometic.com) is a
biopharmaceutical corporation with two drug discovery platforms
focusing on unmet medical needs in the field of fibrosis and orphan
diseases. The first platform, small molecule therapeutics, stems
from the discovery of two receptors GPR40/GPR84 acting as dual
master-switches which are at the core of the healing process as
opposed to fibrosis. The second platform, plasma-derived
therapeutics, leverages Prometic's vast experience in bioseparation
technologies to address unmet medical needs with therapeutic
proteins not currently commercially available, such as Ryplazim™
(plasminogen human). Prometic is also leveraging the second
platform higher recovery yield advantage to develop some more
established plasma-derived therapeutics with significant growth in
demand such as Intravenous Immunoglobulin (IVIG) and provides
access to its proprietary bioseparation technologies to enable
pharmaceutical companies in their production of non-competing
biopharmaceuticals. Globally recognized as a bioseparations expert,
the Corporation derives revenue from this activity through sales of
affinity chromatography media which contributes to offset the costs
of its own R&D investments. 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.