- First phase of development of product to reduce risk of variant
Creutzfeldt-Jakob Disease from plasma product completed on schedule
- Scale-up phase worth $ 1 M to ProMetic - Multi-million dollar long-term agreement to supply prion removal affinity
resin following regulatory approval anticipated by mid-2008
MONTREAL and CAMBRIDGE, United Kingdom, Jan. 23 /PRNewswire-FirstCall/ - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") announces that its UK-based subsidiary, ProMetic BioSciences Ltd ("PBL"), has successfully completed the first phases of development utilizing Pathogen Removal and Diagnostic Technologies Inc.'s ("PRDT") ligand technology for prion binding and removal from a plasma product for biopharmaceutical use marketed by a major European plasma fractionator. The program, which is progressing on schedule with expected completion of the scale-up phase in June 2008, is worth approximately $ 1 M to ProMetic. This will be followed by a multi-million dollar long-term supply agreement for the prion reduction resin. The supply agreement is in final stage of negotiation and commercial quantities of resin supply could commence as soon as mid-2008, assuming regulatory approval of the product.
The incorporation in this new application of PRDT's proprietary ligand technology, which is licensed exclusively to PBL, ensures the removal of any abnormal prion proteins that may be present in donated plasma. This additional process will add another level of safety to the already established treatment protocols and is particularly relevant since there is no commercially available diagnostic test for detection of the blood-borne form of the variant Creutzfeldt-Jakob disease ("vCJD") agent.
"We have now demonstrated that the use of the prion reduction technology in process applications is practical," stated Dr. Peter Edwardson, Vice-President, Medical Technologies of ProMetic. "We have already commenced scale-up at our plant on Isle of Man and will remain on target for completion of the final phase of the development program in June 2008."
The PRDT prion removal technology is presently being used in the P-Capt (R) prion filter, CE marked in September 2006, and marketed by MacoPharma for the elimination of Transmissible Spongiform Encephalopathies ("TSEs") such as vCJD in red blood cell concentrates.
"ProMetic is extremely excited about the progress of this product. This
new use represents an extension of the PRDT prion capture technology
platform into the plasma and plasma fractionation industry and we trust
this will culminate in introduction of our first prion reduction product
for the biopharmaceutical industry in 2008," commented Pierre Laurin,
President and Chief Executive Officer of ProMetic.
Notes for Editors
About Variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob disease ("vCJD") is characterized by the accumulation of large deposits in the brain and the nervous system of the misfolded prion protein. The resulting damage causes sponge-like holes to appear in the brain causing a fatal degenerative CNS disorder. Such abnormal prion proteins may be sufficient to transmit the disease. It is now thought that all the population is susceptible to vCJD, irrespective of genetic make-up. vCJD was initially transmitted to humans by the consumption of BSE contaminated meat, but a secondary route of transmission by the transfusion of blood units from asymptomatic vCJD individuals threatens to increase the prevalence of the fatal disease. Although the first incidence of vCJD appears to have peaked, scientists still remain concerned over the potential of a second longer incubation and bigger peak and caution vigilance. Recent scientific research estimates that there are 3,800 asymptomatic vCJD carriers in the UK at a minimum and the 2006 National CJD Surveillance Unit report stated that "the incidence of vCJD may increase again, particularly if different genetic subgroups are found but with longer incubation periods".
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (http://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 U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the US, Europe, Asia and in the Middle-East.
About ProMetic BioSciences Ltd
Using its unique and proprietary Mimetic Ligand(TM) technology, ProMetic BioSciences Ltd ("PBL") specializes in the development and manufacture of robust affinity separation materials which provide very high levels of purification. This is achieved by use of small chemical affinity ligands designed to bind a target biomolecule specifically and reversibly. In view of their use for the production of therapeutics, ProMetic's affinity products are manufactured to strict quality standards at PBL's GMP-compliant manufacturing facility on the Isle of Man, which completed a (pnds stlg)1.5 million expansion in 2005. PBL also operates an R&D laboratory located on the Cambridge Science Park, UK.
About Pathogen Removal and Diagnostic Technologies Inc.
Pathogen Removal and Diagnostic Technologies Inc. ("PRDT") is a joint venture established in April 2002 by The American Red Cross and ProMetic Life Sciences Inc., and allows for the exchange of technology and knowledge between the two organizations. PRDT's main goal is to develop products and devices to remove and detect different pathogens from biological sources. This research augments work that ProMetic, the American Red Cross and PRDT's scientific founders have been conducting independently for many years.
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.|
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