- ProMetic's process (PPPSTM) confirmed to produce Alpha1-antitrypsin (AAT) with three-fold yield advantage over existing industry average
- AAT to be manufactured in ProMetic's Laval facility and Hematech's future facility in Taipei
- 100,000 people affected by AAT deficiency in the USA alone with less than 10% treated
- Current global market for Alpha1-Antitrypsin (AAT) estimated at $750 M / year
LAVAL, QUEBEC, CANADA – August 14, 2013 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that the recovery yield for AAT achieved with its proprietary PPPSTM represents a 220% improvement over existing industry average. Combined with a clear regulatory pathway and reimbursement programs in place, the Corporation has selected AAT as its second plasma-derived therapeutic to address a well-defined unmet medical need.
There is an estimated 100,000 people affected by AAT deficiency in the USA alone with less than 10% treated. According to the Alpha-1 Foundation, there may be as many as 3% of the 20 million patients suffering from Chronic Obstructive Pulmonary Disease (COPD) that may also have an undetected AAT deficiency.
One of the key functions of AAT, which is mainly produced in the liver, is to protect the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. AAT Deficiency is a genetic condition that leads to a lack of AAT in the blood which can then result in serious lung disease in adults and/or liver disease at any age.
"The FDA has established a clear regulatory pathway for the approval of plasma-derived AAT as a replacement therapy for AAT deficiency" commented Mr. Pierre Laurin, President and CEO of ProMetic who
added "There is also growing evidence that AAT could be used for a broad spectrum of inflammatory and immune-mediated diseases. The current dire need for AAT and potential growing demand far exceed industry capacity. Our superior production yield provides ProMetic with a significant strategic commercial advantage and partnering opportunities".
Tom Chen, Senior Vice-President, Product and Asia Pacific Development, commented: "The production capacity for AAT initially enabled by our cGMP facility in Laval will be further augmented as Hematech's plant in Taiwan comes on line with combined potential annual revenues exceeding $150 million per year. ProMetic's PPPSTM is now confirmed to enable the same AAT production output with three times less
plasma when compared with existing manufacturing processes".
The Corporation expects filing the IND in 2014 with a market entry in 2016/2017.
More about AAT
More on Alpha1-Antitrypsin can be found on the Alpha 1-Antitrypsin foundation website at http://alpha-1foundation.org/
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 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.
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, 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