ROCKVILLE, MARYLAND and LAVAL, QUEBEC--(Marketwired - Apr 2, 2014) - ProMetic Life Sciences Inc. (PLI.TO) (PFSCF) ("ProMetic" or the "Corporation") announced today that it had a successful Pre-Investigational New Drug ("Pre-IND) meeting with the US Food and Drug Administration ("FDA") for a plasma-derived biopharmaceutical currently under development under the NantPro, LLC joint venture.
The Pre-IND meeting focused on ProMetic's proprietary Plasma Protein Purification System ("PPPS™") manufacturing process as well as the clinical and regulatory pathway for this specific plasma-derived therapeutic.
"This meeting confirmed that the FDA concurs with Prometic regarding the manufacturing data to be included in the IND application filing as well as the design of the bioequivalence clinical trial to be performed", stated Tom Chen, Senior Vice-President Product and Asia Market Development, who added "The successful completion of this meeting is an important milestone as we plan for the GMP manufacturing activities in our Laval facility and prepare the clinical trial sites".
The production of GMP bioequivalence clinical trial material is scheduled to occur during the second quarter of 2014 and the Corporation expects to commence enrolling patients in the fourth quarter of 2014. Following this Pre-IND meeting, Prometic is targeting market approval in the US for this biopharmaceutical product in H2, 2017.
"This is the second successful completion of Pre-IND meetings with the FDA this year relating to our PPPS™ manufacturing process and plasma-derived biopharmaceuticals", commented Pierre Laurin, President and Chief Executive Officer of Prometic. "We also successfully completed a pre-IND meeting for our orphan drug product plasminogen, in February 2014 for which we expect to enter clinical trial stages in Q3 2014 and market entry in 2016", added Mr. Laurin.
The Plasma Protein Purification System (PPPS™) allows for the targeting and removal of multiple high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic's Mimetic Ligand™ adsorbent technology. This system also provides for the recovery of new biotherapeutics as they are discovered and identified. The effect of this process is to reduce the significant losses incurred when using the more conventional Cohn precipitation process.
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 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 tto 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.
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, 2013, 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.