LAVAL, QC, January 24, 2017 /PRNewswire/ --
ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF),
("ProMetic" or the "Corporation") announced today that its
orally active lead drug candidate, PBI-4050, has been issued a
Promising Innovative Medicine ("PIM") designation by the UK
Medicines and Healthcare Products Regulatory Agency ("MHRA") for
the treatment of Alström Syndrome ("AS").
A PIM designation is an early indication that a medicinal
product is a promising candidate for the Early Access to Medicines
Scheme ("EAMS"), intended for the treatment, diagnosis or
prevention of a life-threatening or seriously debilitating
condition with the potential to address an unmet medical need
following an early review of the clinical data by the agency. To
obtain a PIM designation, the following criteria must be
fulfilled:
- The condition should be life-threatening or seriously
debilitating with a high unmet medical need (no method of treatment
or existing methods have serious limitations)
- The medicinal product is likely to offer major advantage over
methods currently used in the UK
- The potential adverse effects of the medicinal product are
likely to be outweighed by the benefits
Such a designation is a prerequisite to enter the EAMS
scientific opinion assessment step.
Dr John Moran, ProMetic's Chief
Medical Officer, commented on the PIM designation: "We are very
proud to have received the PIM designation. We are pleased to see
the MHRA agree that the data generated so far with PBI-4050 in the
Alström Syndrome phase 2 clinical trial demonstrates that it has
the potential to address this very serious and debilitating medical
condition for which there is basically no complete medical solution
available at the moment".
The EAMS provides an opportunity for important drugs to be used
in UK clinical practice in parallel with the later stages of the
regulatory process. It is anticipated that medicines with a
positive EAMS opinion could be commercially made available to
patients 12 - 18 months before receiving marketing
authorisation.
Mr. Pierre Laurin, President and
Chief Executive Officer of ProMetic stated: "We are very
enthusiastic for patients afflicted with this disease with MHRA's
decision. We believe PBI-4050 to have first-in-class anti-fibrotic
properties and look forward to continue working closely with the
MHRA to advance PBI-4050 through its clinical program and provide
Alström Syndrome patients with a new treatment option as soon as
possible".
The PIM designation follows the recent grant of an orphan drug
designation status for the treatment of Alström Syndrome by the
European Commission.
More about Alström Syndrome:
Alström Syndrome is a rare inherited autosomal recessive
syndrome characterized by the onset of obesity in childhood or
adolescence, Type 2 diabetes with severe insulin resistance,
dyslipidemia, hypertension and severe multi-organ fibrosis,
involving the liver, kidney and heart.
Alström Syndrome is also characterized by a progressive loss of
vision and hearing, a form of heart disease that enlarges and
weakens the heart muscle (dilated cardiomyopathy), and short
stature. This disorder can also cause serious or life-threatening
medical problems involving the liver, kidneys, bladder, and lungs.
Some individuals with Alström Syndrome have a skin condition called
acanthosis nigricans, which causes the skin in body folds and
creases to become thick, dark, and velvety. The signs and symptoms
of Alström Syndrome vary in severity, and not all affected
individuals have all of the characteristic features of the
disorder.
More about PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent
safety and efficacy profiles confirmed in several in vivo
experiments targeting fibrosis. Fibrosis is a very complex process
by which continuing inflammation causes vital organs to lose their
function as normal tissue is replaced by fibrotic scar tissue. The
proof of concept data generated to date confirms our lead drug
candidates' anti-fibrotic activity in several key organs including
the kidneys, the heart, the lungs and the liver. Twenty six million
patients in the U.S. alone are believed to suffer from chronic
kidney diseases ("CKD"). Patients with severe CKD stages (3 and 4)
suffer from a progressive loss of their renal function leading to
end-stage renal disease and the need for dialysis or kidney
transplant. Cardiovascular complications are the most common cause
of death in dialysis patients.
About ProMetic Life Sciences
Inc.
ProMetic Life Sciences Inc. (http://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.
Media contact
Pierre Laurin
President and CEO, ProMetic Life Sciences Inc.
p.laurin@prometic.com
+1-450-781-0115
Frédéric Dumais
Senior Director, Communications and Investor
Relations, ProMetic Life Sciences Inc.
f.dumais@prometic.com
+1-450-781-0115