- Scaling up of C1-INH production to take place in H2 2015
- Clinical trials to begin in H1 2016
- C1-INH is the fifth protein to be developed using ProMetic’s proprietary plasma protein purification platform
LAVAL, QUEBEC, CANADA – May 7, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMet” or the Corporation”) announced today that it has selected C1-INH as its next plasma-derived drug candidate to be developed. The C1-INH protein is most commonly used for the treatment of hereditary angioedema (“HAE”), a rare genetic disorder in which C1-INH is lacking. The world market for HAE reached US$1.1billion in 2014 and has been growing at an average rate of 44% in the last three years, and analysts expect the market to exceed US$3 billion by 2020.
ProMetic has successfully completed the bioprocess to isolate and purify C1-INH, and has scheduled scale-up and GMP production to occur during the second half of 2015. ProMetic anticipates commencement of C1-INH clinical trial work in H1 2016. C1-INH adds to a pipeline of previously disclosed proteins already scheduled for clinical development, namely: plasminogen, IVIG and alpha-1 antitrypsin.
“As anticipated, our manufacturing platform is demonstrating its ability to produce multiple high-value biopharmaceuticals simultaneously and at yield and purity levels superior to those commercially available”, declared Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “We will be announcing other proteins in the coming months. Some of these will be developed and marketed with commercial partners and are already, as in the case of C1-INH, in partnering discussions”, added Mr. Laurin.
About C1-INH C1 esterase inhibitor (C1-INH) is a blood protein that controls C1, the first component of the complement system, a complex network of proteins which are important in the body’s ability to resist infection. Congenital deficiency of C1-INH causes hereditary angioedema, Deficiency of C1-INH may rarely be acquired later in life, usually associated with white cell malignancies or autoimmune disease.
About Hereditary AngioEdema (HAE)
HAE is a rare genetic disorder. It is characterized by spontaneous and recurrent episodes of swelling (edema attacks) of the skin in various parts of the body, as well as in the airways and internal organs. Edema of the skin usually affects the extremities, the face, and the genitals. Patients suffering from this kind of edema often withdraw from their social lives because of the disfiguration, discomfort and pain these events may cause. Almost all HAE patients also suffer from bouts of severe abdominal pain, nausea, vomiting and diarrhea caused by swelling of the intestinal wall. Edema of the throat or tongue is particularly dangerous and potentially life-threatening because it can lead to obstruction of the airway passages. Although there is currently no known cure for HAE, it is possible to treat the acute attacks and to provide prophylactic replacement therapy. HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide. The world market reached US$1.1bn in 2014 and has been growing at an average rate of 44% in the last three years.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (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. 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 business development activities in the U.S., 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, 2014, 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.