- Interim Clinical Data Shows Non Inferiority to Commercially-Approved Products for Primary Immunodeficiencies
- Clinical Data Generated to Date to Constitute Clinical Package for Regulatory Filing purposes with Health
Canada
LAVAL, QC, Nov. 22, 2017 /CNW Telbec/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced positive interim six-month clinical data from its ongoing
pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies (PID) following review of the data by
the Data Safety Monitoring Board (DSMB), which confirmed no significant safety issues and that efficacy appeared to be comparable
to existing commercial IVIG products.
The current data meets Health Canada's requirements for a New Drug Submission (NDS) filing with at least 20 evaluable PID
patients treated with Prometic's IVIG for a minimum six-month period together with comparison data from a similar six-month
period during which patients received comparable approved commercial IVIG products. Forty-nine adult and 10 pediatric patients
have completed at least six months of treatment with Prometic's IVIG in the current trial. Comparisons with the approved products
include safety, Immunoglobulin (IgG) levels, frequency of infections, use of antibiotics, periods of hospitalization due to
severe infections and missed days of school or work.
"These positive interim clinical results from our pivotal IVIG Phase 3 trial will enable us to complete the clinical portion
of our New Drug Submission with Health Canada", said Pierre Laurin, President and Chief Executive
Officer of Prometic. "We look forward to eventually commercializing our plasma-derived IVIG in Canada initially and contributing to Canada's self-sufficiency with regards to plasma-derived
therapeutics".
Commenting on the interim IVIG data, Bill Bees, Vice President of Plasma Technologies at
Prometic Plasma Resources Inc., stated: "In addition to confirming our ability to produce commercial quality IVIG, the positive
clinical results confirm Prometic's hyperimmune product platform. By actively pursuing the manufacture of specialty IgGs
using our proprietary process and leveraging our speciality plasma collection center, we continue to play a leading role in
targeting and addressing unmet medical needs requiring plasma-derived therapeutics".
According to recent market data, Canada is ranked as the second country in the world after the
United States for the average consumption of IVIG (measured in kilograms per million people), with sales exceeding
$600 million in 2016. The global IVIG market CAGR is expected to reach 5-6% between 2016 and 2025 with Canada having one of
the lowest IVIG self-sufficiency ratios (i.e. less than 20%).
About IVIG
Intravenous immunoglobulin is a preparation of antibodies purified from plasma donations from healthy individuals. It is
indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), including common variable
immunodeficiency, X-linked agammaglobulinemia and severe combined immunodeficiency. It is also indicated for the treatment
of immune thrombocytopenic purpura (ITP) and for many other autoimmune diseases, including Guillain-Barré syndrome, Kawasaki disease.
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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