Kedrion and ProMetic Form Strategic Alliance to Develop Orphan Drugs from Plasma
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- Published on Wednesday, 14 March 2007 02:00
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LUCCA, ITALY and MARYLAND, MD, USA and MONTREAL, Canada | Mar 13, 2007 | Kedrion S.p.A. and ProMetic BioTherapeutics, Inc., a subsidiary of ProMetic Life Sciences Inc. (TSX: PLI) ("ProMetic") have formed a strategic alliance to develop orphan drugs derived from human plasma utilizing ProMetic's proprietary manufacturing process, the Plasma Protein Purification System (PPPS).
The alliance between the two companies was created to select specific proteins which can be manufactured into drugs that either have received orphan drug designation or have the potential to receive it. High value plasma proteins have long served as therapeutics for a wide variety of disorders including many rare diseases. The PPPS technology, which was co-developed with The American Red Cross, can be applied to the recovery of certain proteins that have established therapeutic value but cannot be extracted effectively via current manufacturing practices, or that are not the focus of large plasma fractionators.
Paolo Marcucci, President and Managing Director of Kedrion, stated, "The combination of ProMetic's powerful PPPS technology and Kedrion's infrastructure and manufacturing capabilities are ideally suited to producing plasma-derived therapies in a financially and time-efficient manner. This alliance will also look at jointly implementing technology transfers to developing countries with the objective to increase the availability of plasma derivatives in systems where production is particularly low and to promote and expand treatment level improving standards for doctors and patients".
Although the financial details of the alliance were not disclosed, ProMetic and Kedrion will share in the revenue derived from the sales of commercialized therapeutics and will initially target Europe.
Pierre Laurin, President and Chief Executive Officer of ProMetic, commented, "We are very pleased to have partnered with Kedrion, an established plasma fractionator that brings a strong track record of product development. This approach will not only improve the manufacturing process of existing products, but also enable the manufacturing of a range of new therapies that will be very beneficial for the patient communities and both companies."
PPPS is an application of ProMetic's core technology to extract the most valuable therapeutic proteins from plasma. Each protein is removed from plasma by a specific ProMetic Mimetic Ligand™ adsorbent and subsequently purified in a side stream. The removal sequence has been optimized to give exceptionally high protein recoveries at unprecedented activity levels. One of the latent and most promising aspects of PPPS technology is its ability to recover additional new proteins that could treat uncommon diseases and thus benefit from orphan drug status.
More about Orphan drugs
Orphan drugs treat uncommon diseases. In the USA an uncommon disease is defined as one that afflicts fewer than 200,000 Americans. So-called "fast-track approval" guidelines set out by the FDA are designed to encourage the development of therapeutics for these diseases, and to bring them as quickly as possible to market. Although patient populations are small the revenue from orphan drugs can be immense.
More about Kedrion
Kedrion is a biotechnology company specializing in the development, production and distribution of plasma derivatives. 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 30 countries, and is in 6th place in the world for volume of fractionated plasma and 7th for sales. The company's turnover has increased from 125 million euros in 2003 to over 155 million euros forecasted in 2006. 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. The company 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, producing plasma-derived drugs and virus deactivated plasma and it also distributes flu vaccines. Contract Manufacturing, working with the National Health Service, Kedrion receives the plasma from the regions and transforms it into drugs that are redistributed to the regions in order to respond to the population's therapeutic requirements. Transfer of technological know how by means of international partnerships offering its technological know how concerning two main activities, the construction of plasma-derived product production plants and the transfer of technological production processes). Its Web site is www.kedrion.com.
More on Prometic Life Sciences
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™ enabling 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 US, 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, the Company'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 the Company 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 17 of the Company's Annual Information Form for the year ended December 31, 2005, 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.
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SOURCE: ProMetic Life Sciences Inc. and Kedrion