PROMETIC ANNOUNCES OPERATIONAL LAUNCH OF ITS PLASMA PURIFICATION FACILITY 12/11/2013 | 09:00am US/Eastern
- First production run at commercial scale performed
- Critical step leading to manufacturing of orphan drugs completed
LAVAL, QUEBEC, CANADA, - December 11, 2013 - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), ("ProMetic" or the "Corporation") is proud to announce that it has achieved a major corporate milestone, by successfully completing the first commercial-scale production run at its ProMetic BioProduction Inc. ("PBP") plasma purification facility located in Laval, Quebec. This production run was
completed on schedule and generated better than expected results.
The installation of specialized process equipment is now completed. A seasoned team of experts has been hired and are currently performing a series of trial production batches. During the first quarter of 2014, the PBP team will be focused on performing the necessary manufacturing activities to enable the upcoming filing of previously disclosed INDs.
"The much anticipated operational launch of our plasma purification facility is a pivotal point in the history of ProMetic. This milestone is of crucial importance to the achievement of our ambitious corporate goals", mentioned Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic Life Sciences. "We are now one critical, but major, step closer to providing patients living with serious, unmet medical needs, with the necessary orphan drugs that will finally improve their quality of life", added Mr. Laurin.
"We are delighted that our facility has performed as planned during this first test of its capability. Our
state-of-the art plasma purification facility was designed to meet and exceed the most stringent industry standards right from the beginning", stated Gordon Harris, Director of Manufacturing at ProMetic BioProduction Inc. "We are grateful to all our employees and partners for their hard work and dedication over the planning and preparation phases and look forward to achieving additional production
milestones in the near future", added Mr. Harris.
Tom Chen, Senior Vice-President Product and Asia Pacific Development commented: "Sartorius and
Proxcys delivered key process equipment on time and provided valuable technical support to achieve such milestone. Our facility will not only manufacture plasma-derived biopharmaceuticals but will also become a showroom and training platform for other licensees worldwide. Our achievement bodes well for future
technical support to enable the start-up of other PPPSTM facilities".
Photos:
Photos of the equipment and production run in process are available at:
https://www.prometic.com/en/index.php
About ProMetic's plasma protein purification system ("PPPSTM")
The Plasma Protein Purification System (PPPSTM) allows for the targeting and removal of multiple
high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic's Mimetic LigandTM 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 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, cancer and autoimmune diseases/inflammation. 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 on page 26 of ProMetic's Annual Information Form for the year ended December 31, 2012, 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.