- First publication on utility of PRDT's prion reduction technology to
further reduce risk of variant Creutzfeldt-Jakob Disease ("vCJD") from
- Octapharma sponsoring lunchtime Symposium at meeting to discuss prion
removal capacity, technical performance and product quality.
MONTREAL, Canada and CAMBRIDGE, United Kingdom, June 10 /CNW Telbec/ -
ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") announces that Octapharma
AG ("Octapharma"), one of the World's leading plasma fractionators and
manufacturer of Octaplas(R) (Solvent/Detergent treated plasma), is sponsoring
a Symposium during the 30th International Congress of the International
Society of Blood Transfusion ("ISBT") meeting being held in Macao SAR, China.
The Symposium is entitled "Prion safety and Transfusion Plasma" and will have
some of the world leading authorities in Transmissible Spongiform
Encephalopathy ("TSE") disease research presenting data on the utility of
Pathogen Removal and Diagnostics Technologies Inc.'s ("PRDT") prion removal
resin technology in this application.
The use of PRDT's proprietary ligand technology, which is licensed
exclusively to ProMetic, 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 vCJD agent.
"Over the past several months, we have forged an excellent working
relationship with Octapharma," stated Dr. Steve Burton, Chief Executive
Officer of ProMetic's U.K. division. "We are now concluding the scale-up phase
of the development program and are extremely excited about the future
potential of the product".
"We are pleased with the progress made during the development and
scale-up phase of the program," stated Mr. Tor-Einar Svae, Director
International Market Access, Octapharma PPGmbH. "The affinity resin product
performs well in our manufacturing process and we look forward to a lasting
relationship with our colleagues at ProMetic".
"The implementation of PRDT's prion removal resin into the manufacturing
process of Octaplas(R) to further improve the prion safety margin documented
for this biopharmaceutical is regarded as a natural product lifecycle
evolution, according to both our Company's pathogen safeguarding policy and
regulatory guidelines in force," underlined Kim Bjvrnstrup, Deputy Chairman of
the Octapharma Group.
"Publication of data on the utility of the prion removal resin by
Octapharma is testimony to the efficacy of the product manufactured by
ProMetic," commented Mr. Pierre Laurin, ProMetic's President and Chief
Executive Officer. "We commend Octapharma for taking a proactive stance
against vCJD by investigation of a further safety feature to their process".
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 TSEs such as vCJD in red blood cell
About Variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob disease ("vCJD") is a fatal central nervous
system disorder which incubates without symptoms for ten years or more before
beginning an inexorable clinical progression to death over a 6 to 24 months
period. vCJD first appeared in 1996 following a massive exposure of the UK
population to Bovine Spongiform Encephalopathy ("BSE"; 'Mad Cow Disease')
contaminated meat and other bovine products during the previous decade. So
far, most of the infections have occurred in children and young adults who
accumulate characteristic depositions of misfolded prion proteins in their
brains and other nervous tissues. The death of neurons gives a sponge-like
appearance to the brain. Even though the first wave of vCJD cases has peaked,
scientists remain concerned that other peaks will follow. This is because the
first cases were from a single genetic subgroup of the prion protein that
appears to have a shorter incubation time than other prion genotypes.
Infections in these other genotypes may still be incubating. A survey of
surgically removed tissues analyzed for abnormal prion protein estimated a
minimum of 3,800 asymptomatic vCJD carriers in the UK. The number could be
much larger. vCJD carriers appear normal and donate blood with the same
frequency as the general population. So far there have been four recognized
cases of transmission of vCJD by transfusion of blood donated by persons
incubating the disease. Transfusion transmission appears to be highly
efficient in humans and animals. The 2006 National CJD Surveillance Unit
report concluded that "the incidence of vCJD may increase again, particularly
if different genetic subgroups are found but with longer incubation periods".
Abnormal prion proteins are an essential component of vCJD infectivity and may
be the only component. The adsorption of prion proteins by PRDT ligands
removes vCJD infectivity.
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.
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 according to a strict quality system based on good manufacturing
practice at PBL's ISO 9001:2000 certified 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 Octapharma AG
Octapharma, a Swiss-based company, is an independent, global plasma
fractionation specialist. Its core business is the development, production and
sale of high quality human proteins. The Company has grown to 2,500 employees
in 27 countries since its founding in 1983. Octapharma owns five modern,
state-of-the-art production facilities in Austria, France, Sweden, Mexico and
Germany. Sales turnover in 2007 exceeded Euro 752 million. Octapharma
continues to grow and invest heavily in the future. Profits are mainly
channeled into R&D and further improvements and expansion of Production. In
the highly demanding market of life-saving plasma products, Company success is
only possible through reliable product quality and a proven safety record.
Octaplas(R) is a pharmaceutical quality human coagulation active plasma
for transfusion. Besides being solvent/detergent virus inactivated, the
product is standardized, which promotes a better planning and monitoring of
treatment. Furthermore, the removal of all residual blood cells and
neutralization of both allergens and antibodies against leukocytes render this
medicinal product virtually free from causing allergic reactions and the risk
for transfusion-related acute lung injuries ("TRALI"), being the most common
cause of death in transfusion medicine, has been abolished. Octaplas(R)
increases through these multiple favourable features the level of efficacy and
security in transfusion medicine, both representing the foundation in all
medical care, and reduces costs. The product is used to treat complex and
isolated coagulation disorders - both congenital and acquired - where no
specific coagulation factor concentrate is available, and thrombotic
thrombocytopenic purpura ("TTP") - usually in conjunction with plasma
exchange. Octaplas(R) is fully licensed in 29 countries worldwide, and roughly
6 million bags have been used successfully to treat approximately 2 million
patients around the world since 1991.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (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 Montréal (Canada), ProMetic has R&D facilities in
the UK, the US 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,
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, 2007, 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.
For further information:
For further information: Company Inquiries: Pierre Laurin, President and
CEO, ProMetic Life Sciences Inc., (514) 341-2115, firstname.lastname@example.org; Peter
Edwardson, PRDT Program Director & Vice-President, Medical Technologies,
ProMetic Life Sciences Inc., +44.1223.420.300,
email@example.com; Anne Leduc, Manager, Investor Relations
and Communications, ProMetic Life Sciences Inc., (514) 341-2115,
firstname.lastname@example.org; Dominic Sicotte, Echoes Financial Network Inc., (514)
842-9551, email@example.com; Investor Relations: Bruce Voss,
Lippert/Heilshorn & Associates, (310) 691-7100, BVoss@lhai.com; Kim Golodetz,
Lippert/Heilshorn & Associates, (212) 838-3777, KGolodetz@lhai.com; Media
Relations: Jules Abraham, Lippert/Heilshorn & Associates, (212) 838-3777,