ProMetic Life Sciences Inc. Announces Signature of Definitive License Agreement with Kedrion S.p.A. for Two Hyperimmune Products
Published: Feb 26, 2008
MONTREAL, Feb. 26 /PRNewswire-FirstCall/ - ProMetic Life Sciences Inc. ("ProMetic") (TSX:PLI - News) announced today that it has signed the definitive agreement for development of two hyperimmunes with Kedrion S.p.A. ("Kedrion"). Terms of this agreement call for upfront and milestone payments, as well as service fees to ProMetic amounting to $2 M over the next 12 months. Potential revenues to ProMetic from Hepatitis B Hyperimmune are to exceed $30 M annually, and are derived from royalties on Kedrion sales in Europe and ProMetic sales in North America, which are expected to commence in 2011. The first product to be developed will target the Hepatitis B Hyperimmune market which is currently estimated in Europe and in the U.S. to be at $200 M and is expected to be at $400 M by 2015. Kedrion has in-licensed ProMetic's technologies for the manufacturing of hyperimmune products in Europe. Royalties, licensing and service fees for the sales of products in Europe will be paid by Kedrion to ProMetic with ProMetic retaining the commercial rights for the fully developed hyperimmune products for the North American market. ProMetic will in turn pay Kedrion royalties on its sales of the hyperimmune products in North America. The product development program, including the clinical trial designed to meet U.S. and European regulatory requirements will be funded by Kedrion. Full scale commercial manufacturing will then take place in Kedrion's facility in Italy. "This agreement with Kedrion will leverage ProMetic's ability to penetrate into the North American hyperimmune product market and expand on our existing revenue base," commented Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. More about Hepatitis B HB, hepatitis B IVIG is primarily used in preventing reinfection with hepatitis B in HBV positive liver transplant patients. It is also used in the treatment of acute exposure to hepatitis B following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg positive persons, and household exposure of infants to persons with acute hepatitis B virus infection. The groups usually considered at risk are hepatitis B researchers and workers, and many health care professionals. This group is estimated to lead to a demand for 45,000 doses per year of hepatitis B immune globulin. Pricing varies, but a reasonable rule of thumb is $900 per treatment. The market hepatitis B immune globulin in the U.S. is estimated $42 M in 2005. This should grow at a 10% AAGR to $67.6 M by 2010. (The Blood Industry, Copyright © Business Communications Co., Inc., Norwalk, CT USA, Web: www.bccresearch.com) More about Kedrion S.p.A. Kedrion is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. In Italy, Kedrion is the main reference point for the National Health Service as regards the production of plasma-derived drugs. Moreover, its skills are also put to use in strategic partnerships with overseas health services. Kedrion is present in over 40 countries, and is in 6th place in the world for volume of fractionated plasma and 7th for sales. The quality of its products, its continuous commitment to research and development, its consistent industrial capacity and its consolidated presence on the national and international market are the company's main areas of competitiveness. Kedrion is located in Castelvecchio Pascoli, in the province of Lucca, Tuscany, and has two production plants, Kedrion Bolognana, in the vicinity of Lucca, and Hardis S. Antimo, in the vicinity of Naples. Kedrion's operations cover three different areas of business: production and distribution of plasma-derived products, Contract Manufacturing and transfer of technological know how. The three principal types of plasmaderivates produced by Kedrion are: standard and hyperimmune immunoglobulin, albumin and coagulation factors (procoagulants and anticoagulants). Its Website is www.kedrion.com. About ProMetic Life Sciences Inc. ProMetic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) 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 Montreal (Canada), ProMetic has R&D facilities in the UK, the USA and Canada, manufacturing facilities in the UK and business development activities in the USA, 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 21 of ProMetic's Annual Information Form for the year ended December 31, 2006, under the heading "Risk Factors". 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. Source: PROMETIC LIFE SCIENCES INC.