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 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 Montréal (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.