- Approval confirmed for the UK, Belgium, Finland, Ireland, Luxemburg, Netherlands and Sweden
- Octapharma to also target American and Canadian markets
LAVAL, QUEBEC, CANADA and CAMBRIDGE, UK – November 23, 2011 – ProMetic Life Sciences Inc. (TSX: PLI) (“ProMetic”or the “Company”) announced today that it has received as expected, confirmation from Octapharma of the regulatory approval of Octaplas®LG for additional European Union countries.
ProMetic’s proprietary prion capture resin PrioClear®, is incorporated into Octapharma’s manufacturing process for its solvent/detergent treated, prion-reduced, plasma product, Octaplas®LG. Octaplas®LG which was previously approved for marketing in 4 countries (Germany, Switzerland, Portugal and Australia) has now received regulatory approval for marketing in several more European Union countries, namely the United Kingdom, Ireland, Belgium, Netherlands, Luxemburg, Sweden and Finland. ProMetic recently received a purchase order and binding forecast from Octapharma for approximately $3 million of PrioClear® resin to be manufactured between December 2011 and June 2012 with further binding forecasts anticipated for the second half 2012.
“We are very happy that Octapharma received official confirmation of the regulatory approval of Octaplas®LG in several more E.U. countries. These countries represent key markets in which we look forward to demonstrate with our valued partner Octapharma, the numerous economical and technological benefits of using ProMetic’s industry tailored solutions.” said Pierre Laurin, Chief Executive Officer of ProMetic Life Sciences Inc. “We expect other key markets to adopt and follow the industry’s migration towards safer plasma derived products and we are pleased with Octpharma’s plan to advance OctaplassLG® in North America.” added Mr. Laurin.
Earlier today, Octapharma reported the following:
This particular amendment to the octaplas® production process was approved by the German drug authorities (Paul-Ehrlich Institut) in 2009 and later by the regulatory bodies in Australia, Switzerland and Portugal. Since the introduction of this new generation solvent/detergent (S/D) virus inactivated plasma in Germany, more than 130,000 bags of the novel product have been sold and used under the trade name octaplasLG® (LG; ligand gel) to treat almost 45,000 patients. The very positive post-marketing feedback regarding the efficacy, safety and tolerability of octaplasLG® mirrors the impeccable record demonstrated by octaplas® over the past 20 years, with 7.2 million bags used to treat approximately 2.4 million patients worldwide.
On November the 16th, we were informed that the introduction of this specific prion removal column into the manufacturing process of octaplas® was approved by seven additional countries in Europe through a Mutual Recognition Procedure (MRP). In addition to the United Kingdom (UK) as the Reference Member State for this MRP, the approval was endorsed and is valid for Belgium, Finland, Ireland, Luxemburg, Netherlands and Sweden as well. Today octaplas® is sold in all these countries with an average market share of almost 25% (170,000 bags per year). Based on the approval of the process variation to octaplas®, Octapharma assumes to reach at least a 50% market share in these countries by 2013, with approximately 350,000 bags sold annually.
Together with the upcoming launch of octaplas® in Canada and a growing positive interest in this product in other European countries outside the MRP, there is a need for a significant increase in the production capacity of octaplas(LG)® as well. Therefore Octapharma is equally happy to announce that the new octaplas(LG)® manufacturing line in Stockholm (Sweden) was simultaneously approved by the same MRP countries. This means that the long-term planning by the Octapharma Board of Directors and € 15 million investments finally materialised into both an add-on and back-up facility to the Vienna (Austria) plant, which has served as the sole production facility for octaplas(LG)® for almost 20 years.
“The approval of the prion safeguarding variation for octaplas® is a major milestone achievement for our company.” says the Chairman Wolfgang Marguerre. “This success results from a planned life-cycle management in line with our company’s long-term commitment to provide plasma-derived products with an utmost safety profile to patients worldwide.”
“Due to an increasing demand for octaplas(LG)® worldwide, we needed to strengthen our manufacturing capacity, both in terms of add-on production and back-up to our facility in Vienna,” says the General Manager of Octapharma AB (Stockholm) Tobias Marguerre. “Our substantial investments and efforts into getting the Stockholm octaplas(LG)® plant approved will ensure a steady product supply for our large number of customers – both current and future users of our unique therapeutic plasma.”
Octapharma plans to submit a Biological License Application (BLA) for octaplasLG® to the Food and Drug Administration (FDA) before the end of this year, as well as an update of the Canadian license in line with the now approved variation in Europe.
“The Canadian and US market accounts for almost 4.4 million bags of fresh-frozen plasma, of which Octapharma will start to supply just above 10% of the 300,000 bags annual market in Canada in February 2012,” says the President of Octapharma’s US Organisation in Hoboken (NJ) Flemming Nielsen. He further emphasises that “The approval of our Stockholm facility by the European drug authorities is both promising and necessary for the North-American activities around octaplasLG®, as long-term routine manufacturing experience is needed before the upcoming FDA inspection and a broad product launch based on the Vienna facility would not be possible in competition with the increasing number of European customers.”
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (http://prometic.com/) is a biopharmaceutical company specializing in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic “drug-like” protein mimetics. 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, Asia and in the Middle-East.
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 23 of ProMetic’s Annual Information Form for the year ended December 31, 2010, 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.