The Research Foundation Alliance BioSecure, recognized as of public utility, aims to promote fundamental and translational research applied to biological safety, announces today, both at EUROBIO forum in Lille and at Prion 2007 congress in Edinburgh, the results of its international call for projects 2007, launched on April 5th, and for which a total sum of 400,000 Euros was available.
Lille (France), Edinburgh (UK), 28 September 2007 – The Research Foundation Alliance BioSecure, recognized as of public utility, aims to promote fundamental and translational research applied to biological safety, announces today, both at EUROBIO forum in Lille and at Prion 2007 congress in Edinburgh, the results of its international call for projects 2007, launched on April 5th, and for which a total sum of 400,000 Euros was available.
Eight collaborative projects have been selected (out of 36 evaluated dossiers). All of them address the research topics defined by the Scientific Council in accordance with the objectives of the Foundation Alliance Biosecure.
1°) Physiopathology of prion-related illnesses or related to other emerging pathogens,
2°) New methods for detection, elimination and inactivation of prions in biological fluids and in biological or biotechnological medicinal products,
3°) New therapeutic approaches of prion-related illnesses.
The eight selected projects are the following ones :
• Physiopathology of prion-related illnesses in bank vole (Myodes glareolus), a new in vivo model, predictable of human encephalopathies: project conducted by MACOPHARMA. AGRIMI (ISS, Roma, Italy),
• Development of a new in vitro model for culture of human cell lines, infectable by prion: project led by F. MOUTHON (CEA, Fontenay-aux-Roses, France), in collaboration with MACOPHARMA. LAUDE (INRA, Jouy-en-Josas, France) and R. HESP (Health Protection Agency, Weybridge, UK).
• Development of a innovative method for detection of protein aggregates; application to the detection of prion: project carried out by M. KAMALI (Uppsala University, Sweden),
• New methods for detection of prion in blood and titration of its infectivity: project headed by the French Blood Establishment (research centres of Montpellier (J. COSTE) and Lille (D. DERNIS)), in collaboration with K. HOLADA (University of Prague, Czech Republic), MACOPHARMA. LAUDE (INRA, Jouy-en-Josas, France), E. COMOY (CEA, Fontenay-aux-Roses, France) and the Biological Safety laboratory of the company LFB (Les Ulis, France),
• New methods for elimination of prion by filtration : project led by O. ANDREOLETTI (INRA, Toulouse, France), in collaboration with J. GRASSI (CEA, Saclay, France), MACOPHARMA. SIMMONS (VLA, Weybridge, UK), and the company Macopharma (Tourcoing, France).
• Immunotherapy of prion-related illnesses : project conducted by C. ZURZOLO (Pasteur Institute, Paris, France),
• New inhibitors of the conversion of physiological (PrP) into pathological prion (PrPres) : project headed by MACOPHARMA. REZAEI (INRA, Jouy-en-Josas, France) in collaboration with A.SCHWOK (Inserm U696, Ecole Polytechnique, Palaiseau, France) and F. FRATERNALI (King’s College, London, UK),
• Cannabinoïd derivatives, a new therapeutic approaches of prion-related illnesses : project carried out by J. CHABRY (IMPC, CNRS, Nice, France).
Each project is to be granted for 1 year (grant may be renewed). Sums allocated vary from 20,000 to 135,000 Euros, according to the size of the project and the number of teams involved.
A report on the projects granted will be the focus of a scientific symposium to be organised by the Foundation Alliance BioSecure and planned in Autumn 2008.
About Alliance BioSecure research foundation
The objectives of Alliance BioSecure research foundation, recognized as of public utility by the French Government (Dec. 6, 2006), is to improve biological safety in the food and health sectors by working to analyse, understand and manage biological risks.
Alliance BioSecure has a Public Health mission, fulfilled either by evaluating the risks associated with current or emerging pathogen agents, in particular prions, or by contributing to a better understanding of the mechanisms of virulence, pathogenicity, and transmissibility of these infectious agents. The Foundation also aims to improve the detection, elimination and inactivation of these infectious agents in biological or biotechnological medicinal products, products destined for human or animal consumption as well as the equipment used in their production.
The Foundation Alliance BioSecure benefits from the new French momentum for the research foundations, presented in June 2004 by the Minister of research; François D’AUBERT. As a tool for mobilisation of private resources in benefit of research, these kind of Foundation enable to finance ambitious projects, rigorously selected in order to do work of general interest, Public health in the case of Alliance BioSecure research Foundation.
Alliance BioSecure Foundation’s objectives are realised through an annual call for projects. The international quality and independence of the Foundation’s Scientific Council and the transparency of the project selection process guarantee the application of research of the very highest level, guided by excellence and general interest.
Founders united together for the one project, Biological Safety
All industrial Founders of Alliance BioSecure are involved in sectors concerned by biological safety imperatives: medicinal products, derived from human plasma or biotechnologies (LFB, BAXTER), filtration, decontamination or quality control (MACOPHARMA, STERIS, ALBHADES PROVENCE).
The French federation of non-for-profit blood donors (FFDSB) and its main association (UNDSB, Union Nationale des Donneurs de Sang Bénévoles, La Poste France Télécom) join the initiative, that benefits as well from the support of two public health bodies, the French Blood Establishment (EFS) and the National Institute for Blood Transfusion (INTS). The Foundation Alliance BioSecure has been also granted by the French Ministry of Research.
The Foundation Alliance BioSecure is directed by a Board of Administrators, headed by Jean-François PROST, MD, Director of Scientific and Medical Operations at LFB (French Laboratory for Blood Fractioning and Biotechnologies), and that gathers representatives of Foundators and Donators, French Ministries representatives (Health, Research, Industry, Interior), and qualified persons.
Alliance BioSecure is helped by an independent Scientific Board, that gathers experts internationally recognized and involved in the evaluation of scientific interest of the activities of the Foundation. The Scientific Board is managed by two co-Presidents, Dr. Jean-Philippe DESLYS (CEA, Fontenay-aux-Roses, France), coordinator of European network Neuroprion and Pr. Paul BROWN, Former Senior Investigator at the National Institutes of Health (NIH, Bethesda, USA), who safeguard the excellence of Research conducted with the support of the Foundation.
FONDATION ALLIANCE BIOSECURE
Christophe VINZIA, Treasurer
Macopharma – +33 320 11 84 30
The successful completion of two human clinical studies performed on volunteers using the P-Capt prion reduction filter for red cell concentrates has been announced by ProMetic Life Sciences Inc. (“ProMetic”) and Macopharma. The clinical studies evaluated the effect of the filter on units of red cell concentrate collected from human volunteers, to ensure that the use of the filter had no negative effect on the red blood cells themselves. Data demonstrated no negative impact.
Cambridge, UK and Lille, France – January 18th, 2008 – The successful completion of two human clinical studies performed on volunteers using the P-Capt prion reduction filter for red cell concentrates has been announced by ProMetic Life Sciences Inc. (“ProMetic”) and Macopharma. The clinical studies evaluated the effect of the filter on units of red cell concentrate collected from human volunteers, to ensure that the use of the filter had no negative effect on the red blood cells themselves. Data demonstrated no negative impact.
“These studies represent the first use of the P-Capt prion filter in humans and the results demonstrate that not only is the product effective in reducing the risk of transmission of variant Creutzfeldt-Jakob disease (“vCJD”) by blood transfusion but also there is no impact of the treatment on the blood itself,” stated Mr. Christophe Vinzia, Macopharma’s Director of Business Development. “This represents a major milestone and we anticipate the positive results will encourage early adoption of the product in the UK and Ireland”.
This latest news comes after reports of a previously unseen ‘vv’ genotype individual contracting vCJD. “Reports of the vv genotype individual now mean that any individual is susceptible to contracting vCJD,” commented Dr. Peter Edwardson, ProMetic’s Vice-President, Medical Technologies. “More worryingly, it adds weight to the argument that a second wave of vCJD may be on the horizon with these individuals exhibiting much longer incubation times for the disease.”
This latest data and continuation of clinical evaluation of the P-Capt filter by the Irish and UK National Blood Services, in combination with this latest news all point to a likely adoption of the P-Capt filter in 2008. “We are greatly encouraged by the completion of the clinical evaluation on volunteers,” stated Ms. Iwona Walicka, Project Manager, Macopharma. “Both Macopharma and ProMetic are now gearing up for what we expect to be a watershed year for the product.”
Notes for Editors
The P-Capt filter removes, to the limit of detection, the infectivity that is naturally present in blood during infections by Transmissible Spongiform Encephalopathies (“TSEs”), such as variant Creutzfeldt-Jakob disease (“vCJD”) and it reduces the risk of transmission of infection by contaminated blood.
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”) (Macopharma.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 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 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.
Macopharma (Macopharma.Macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. The Company has become the largest supplier of in-line leucodepletion filtration sets in Europe and is expanding its efforts into the biotherapy field by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has three manufacturing facilities in Europe and its products are now sold into more than 55 countries worldwide. One of Macopharma’s aims is to provide a comprehensive range for the reduction of infectious agents in plasma, platelets and red cells. This is conducive with the Macopharma product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion and biotherapy.
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.
Macopharma is proud to announce the launching of the MACOPRESS® Smart, last generation of blood separators intended for the preparation of single donation blood components. It is compatible with all currently available blood bags, both Top & Top and Top & Bottom with or without in line filters.
For more information, please contact your local representative.
Hans Gulliksson is a leading international transfusion specialist at the University Hospital of Karolinska (Stockholm).
Through his involvement in the international research group BEST, he has been instrumental in the study and development of new platelet additive solutions. Karolinska will after the summer period this year start to use SSP+ in routine. This decision will have a huge impact on the SSP+ sales in Scandinavia in particular, but having Karolinska and Hans Gulliksson as a reference will be beneficial to all of us!
We are also extremely pleased to announce that Hans Gulliksson has agreed to talk about SSP+ at 4 symposiums in Scandinavia during spring: Copenhagen, Denmark (March 3rd); Oslo, Norway (March 12th ); Linköping, Sweden (March 19th); Helsinki, Finland (June 11th). Needless to say these symposiums will give our SSP+ sales efforts in Scandinavia a tremendous boost! The final symposium in Helsinki, which will be in English, will be recorded in order to allow other customers (and you) to benefit from Dr Gulliksson’s lecture.
Maco received clearance from the U.S. FDA for the filtration of AS-5 Red Blood Cells.
In the USA, three Red Blood Cell Additive Solutions are licensed. The LEUCOLAB LCG2 filter is now FDA cleared to be used on all three Additive Solutions.
Using a dockable filter has the potential to save Blood Centers from discarding a certain percentage of an expensive In-Line collection system, when the collection is discarded for production reasons, such as QNS draws, overdraws, testing discards etc.
The Leucolab LCG2 dockable system is FDA cleared for ALL Additive Solutions, giving Blood Centers the necessary flexibility to use whichever collection bag they desire, without having to go through the process of writing new SOPs, performing validations, and training staff when a different collection bag is used.
FDA has required all the latest cleared dockable filters to specify clearly in the Indications For Use with which Additive Solution that filter can be used. Not all Additive Solutions are the same.
UnitedPharma, the exclusive importer and distributor of Macopharma products in the USA, is proud to be able to now present the LEUCOLAB LCG2 Dockable Filter as the only filter specifically FDA cleared for use with AS-5 Red Blood Cells in the USA.
On October 12th 2011, Macopharma became aware of an official press release by Afssaps (French Drug and Medical Device Regulatory Body) regarding the gradual stop of the use of therapeutic plasma treated with methylene blue.
Currently, three plasma inactivation technologies are used in France: treatment with solvent-detergent (SD plasma, manufactured by EFS, French Blood Service), treatment with amotosalen (IA plasma, Intercept, Cerus) and treatment with methylene blue (MB plasma, THERAFLEX MB-Plasma, Macopharma).
We would like to draw your attention to three main points in the press release:
- “Afssaps has observed an increased number of infrequent allergic reactions following transfusions with MB plasma in comparison to other types of plasma (1 in approximately 16 000 bags of transfused plasma)”
- “The continuous monitoring of the quality of blood products, performed jointly by Afssaps and EFS, has identified a larger variability in the concentration of fibrinogen in MB plasma than in other therapeutic plasma. The withdrawal of MB plasma is therefore a means of providing increased safety in addition to optimising the quality of transfused products.”
- “Afssaps has taken the decision to remove MB plasma from the list of approved blood products. In order to guarantee that plasma requirements are fully met, EFS in close collaboration with Afssaps, will progressively substitute MB plasma by the two other types of plasma until March 2012.”
Upon reading the press release, it appears as if two reasons are the basis for the decision to gradually stop the use of plasma BM: the frequency of allergic reactions after MB plasma transfusion and variability in the concentration of fibrinogen in MB plasma compared to the other types of plasma marketed in France.
Macopharma, being the only company in France with a Market approval for a plasma pathogen reduction technology using methylene blue and visible light, has still not been « directly and officially » informed by Afssaps about their decision.
Macopharma’s response to the press release is the following :
Afssaps has apparently not taken into consideration the recommendations made by its own Allergy Working Group (GT) related to the last 2010 Haemovigilance report: “GT experts recommend that the results (the results of the full analysis of all allergic cases related to plasma reported between 2005 and 2009) should be interpreted with great caution, due to the following unresolved issues; exhaustivity of reporting, incomplete reports in some of the records (reporting before 2008) and because of the weakness of the analysis related to infrequent events …
The lower frequency of reports of serious allergic reactions to Methylene Blue treated plasma outside of France confirms the French nature of the controversy.
Out of 2.5 million units of MB plasma which have been treated worldwide using the THERAFLEX MB-PLASMA process, 510 000 plasma units have been transfused in France between 2008 and 2010. So far, the only “more frequent serious allergic reports” are those observed by the French haemovigilance network.
Fibrinogen is an important coagulation factor. However, there are no clinical studies demonstrating what mean concentration of fibrinogen is required in a therapeutic plasma unit.
Additionally, according to French, European and American guidelines, the only indicator of quality which is considered for therapeutic plasma is factor VIII.
During the last French transfusion congress (SFTS congress, Lyon, May 2011) Doctor Rachel Petermann (Afssaps) presented the quality control data of different therapeutic plasmas approved in France. The mean fibrinogen value for MB plasma was 2.3g/l ± 1 and 2.2g/l ± 0.8 for IA plasma. Based on Afssaps desire to have a mean value greater than 2g/l, it was calculated that 71.8% of MB plasma units were above this mean with only 60.9% for IA plasma. In conclusion the IA plasma fibrinogen rate is lower than for MB plasma.
Following various observations and internal validations by Macopharma, we can state that the variability in the concentration of fibrinogen in MB plasma cited by Afssaps can be explained by the fact that the analysis is based on inadequately prepared quality control plasma samples and not due to the therapeutic unit to be transfused.
Based on these observations, the position of Afssaps is questionable.
The THERAFLEX MB-Plasma procedure has a long record of successful worldwide usage. It is designed to treat single units of plasma which eliminates the risk of cross-contamination.
The broad target range of the THERAFLEX MB-Plasma procedure minimizes the risk of transmission of a wide variety of enveloped and also non-enveloped viruses.
The substantial additional order of THERAFLEX MB-Plasma systems by the EFS underlines the confidence of the French transfusion services in the procedure.
One of the consequences of ceasing to use MB plasma will be the increased use of other therapeutic plasmas that may not be any safer in terms of adverse events.
In conclusion, the Mediator case has seriously cast aspersions on (criticised) the way in which Afssaps operates (see B.Debré/P.Even report), which also acts today as the French Transfusion Regulatory Body. Consequently they are in the process of re-analysing the benefit/risk ratio of many drugs leading to an overreaction with respect to the THERAFLEX MB-Plasma Process.
Macopharma remains at your disposal for any questions you may have at this stage related to the content of this communication.
We are proud to announce the launching of the MACOSEAL twin, the first Macopharma designed sealer comprising a generator and one or two connected hand sealers.
A specially designed EVA platelet bags sealer is also available with one EVA generator and one EVA sealer (another PVC sealer can also be connected). A yellow mark on the generator and on the sealer indicates the EVA option.
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