LAVAL, QC, Dec. 11, 2017 /CNW Telbec/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) announced today
that its orally-active drug candidate, PBI-4050, has been issued a
Promising Innovative Medicine (PIM) designation by the United Kingdom (UK) Medicines and Healthcare
Products Regulatory Agency (MHRA) as add-on treatment to nintedanib
in patients with idiopathic pulmonary fibrosis (IPF).
"We are proud to have received a second PIM designation in the
UK for PBI-4050, following the designation previously received for
Alström syndrome," said Pierre
Laurin, President and Chief Executive Officer of Prometic.
"We believe PBI-4050 has the capabilities to address various unmet
medical conditions such as IPF and Alström syndrome, for which
there are severe limitations with the existing standards of care.
We look forward to continuing to collaborate with the MHRA with the
goal of advancing both the PBI-4050 IPF and Alström syndrome
clinical programs as quickly as possible."
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
unmet medical need. The PIM designation is a prerequisite to
proceed to the EAMS scientific opinion assessment phase, the second
and final step in the EAMS process.
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 made available to patients 12 – 18
months before receiving marketing authorization.
More about Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating,
and ultimately fatal disease characterized by a progressive decline
in lung function. It is a specific type of interstitial lung
disease in which the small air sacs of the lung, the "alveoli,"
gradually become replaced by fibrotic (scar) tissue and is the
cause of worsening dyspnea (shortness of breath). IPF is usually
associated with a poor prognosis. The term "idiopathic" is used
because the cause of pulmonary fibrosis is still unknown. IPF
usually occurs in adult individuals of between 50 and 70 years of
age, particularly those with a history of cigarette smoking, and
affects men more often than women. IPF affects about 130,000 people
in the United States, with about
48,000 new cases diagnosed annually. Approximately 40,000 people
with IPF die each year, a similar number of deaths to those due to
breast cancer. The 5-year mortality rate for patients with IPF is
estimated to range from 50% to 70%.
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 confirms the anti-fibrotic activity of
PBI-4050 in several key organs including the kidneys, the heart,
the lungs and the liver. It is also effective in improving glucose
control in preclinical models of diabetes. Open label Phase II
studies in idiopathic pulmonary fibrosis, Alström syndrome and type
2 diabetes have provided preliminary evidence that the results seen
in preclinical models translate into the corresponding human
diseases.
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.