Prometic Life Sciences - die bessere Genta?
oki-wan : Prometic Life Sciences - die bessere Genta?
mit diesem Thread möchte ich die Aufmerksamkeit auf eine kanadische Biotech-Schmiede lenken, welche
1. ein hervorragendes Netz an Partnern aufweisen kann
2. relativ unbeschadet aus der Krise hervorgehen konnte (siehe Quartalsberichte),
3. meines Erachtens um Längen stabiler und seriöser ist als z.B. Genta,
4. Produkte wie PBI 1402 in der Pipeline hat, die allesamt sehr vielversprechend sind und einen riesigen Markt ansprechen,
und 5. bereits Incomes aufweisen kann (durch Herstellung und Lizenzierung von z. B. P-Capt®).
Alles nachzulesen auf der Unternehmenswebsite www.prometic.com/
Hinzu kommt der aktuell noch(?) wirklich günstige (Einstiegs-) Kurs, falls wirklich ernsthaft der Ankauf einer Position in Betracht kommt.
Obwohl die Chancen für Prometic eigentlich gut stehen, gibt es aber weder genug handelbare Aktien in D (siehe Volumen=fast nicht existent) und damit verbunden auch nicht genügend Handelsplätze.
Ich bitte aus diesem Grund um eine rege Beteiligung in diesem Forum und hoffe auf viele wertvolle Beiträge, die die Chancen und das Risiko dieses Papiers, den Handelsmöglichkeiten desselben und generell bereits gemachte Erfahrungen mit Prometic näher beleuchten.
P.S. Meine Aussagen sind keine als Kauf- oder Verkaufsempfehlung und folgende Aussagen von mir in diesem Forum dürfen nicht als solche betrachtet werden.
rstudent : Volumen: Durchschnitt x 10... Wieso?
TheOracleX : News!
Hallo liebe Mitstreiter.
Ich war lange Zeit im Ausland und hatte keine Gelegenheit mich hier aktiv zu beteiligen. Doch wie ich sehe, dümpelt unsere PLI immer noch in seichten Gewässern... Sehr schade, denn wir wissen alle, welches Potenzial nach wie vor in PLI steckt. Daran hat sich hier in der Zwischenzeit auch nichts geändert. Ich arbeite überdies an einer neuen Bewertung von Prometic und werde diese sobald sie fertig ist auch hier reinstellen. Doch nun erst einmal einige positive Quartalszahlen und -berichte. Wie immer nachzulesen auf
ProMetic reports its second quarter 2010 financial results
- Year-to-date Protein Technologies business posts a profit of $0.5 million versus losses of $1.8 million for the same period in 2009
- Revenues at $5.1 million for the second quarter of 2010 compared to $2.3 million for the same period last year
- Second quarter 2010 net loss of $0.9 million versus net loss of $5.1 million for the same period 2009
- Year-to-date revenues increase to $8.3 million compared to $6.2 million at June 2009
- Year-to-date loss reduced to $4.1 million compared to $7.1 million at June 2009
MONTREAL, QUEBEC, CANADA - August 10, 2010 - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") today reports its financial results for the second quarter of 2010. All amounts are in Canadian Dollars unless otherwise indicated.
The following information should be read in conjunction with the financial statements for the second quarter ending June 30, 2010, as well as the Management's Discussion and Analysis for the same period.
Mr. Bruce Pritchard, the Company's Chief Financial Officer commented: "During the second quarter of 2010, the Company has continued to focus on performing against its revenue guidance of $8.1 million for the first half of 2010, issued at the Annual General Meeting of the Shareholders in May. In that respect, it met and exceeded those targets". He went on to add: "Management is focused on delivering deals from both the Plasma-Derived Therapeutics business and from its pipeline of other therapeutic products in the second half. Every effort is being made to ensure that earnings targets for full-year 2010 are met".
"Significant advances were also made with our therapeutics both from a scientific and business development standpoint," stated Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. Mr. Laurin further indicated: "Management reiterates its confidence in executing on partnering deals which would enable the continuation of the PBI-1402 clinical development programs in anemia and oncology as well as the development of new drug candidates targeting fibrosis and autoimmune diseases".
- $8.9 million delivery of Mimetic LigandTM product - During the first half of 2010, ProMetic delivered on the largest order for a single Mimetic LigandTM product worth approximately $8.9 million.
- Wuhan Institute for Biological Products program - The WIBP project is progressing according to schedule. After the successful completion of the initial technology transfer stage earlier this year, ProMetic's scientists have initiated the second technology transfer stage and, over the next quarter, are moving ahead with the retrofit of WIBP's GMP pilot facility. ProMetic's proprietary Plasma Protein Purification System ("PPPSTM") will be integrated in WIBP's facility as part of this retrofit.
Initiation of the scale-up activities for the manufacturing of the first GMP products for the Chinese market are expected in second quarter of 2011. WIBP will then pursue regulatory approval from the Chinese State Food and Drug Administration ("SFDA") for these products manufactured under licence using ProMetic's proprietary protein technologies, by demonstrating their bioequivalence to commercialized products.
- Instituto de Tecnologia do Paraná of Brazil - Due to various government-related, fiscal and administrative matters, the project with the Instituto de Tecnologia do Paraná of Brazil had encountered some unforeseen delays. Following various exchanges and attempts to rectify the situation, ProMetic and Tecpar mutually agreed to terminate the license and development agreement late in the second quarter of 2010.
- Advancement on other Protein Technologies Programs - During the first half of 2010, ProMetic has moved forward on the development of several plasma-derived therapeutics. Several milestones were achieved for various programs, enabling these to move to their next respective phases of development.
- ProMetic presented data on its orally-active PBI-1402 compound at the 15th Congress of the European Hematology Association held in Barcelona, Spain, June 9 - 13, 2010. Clinical and preclinical results were presented about the management of side effects induced by chemotherapy and the treatment of certain cancers such as lung and pancreatic cancers, and certain forms of leukemia.
In addition, an oral presentation was made regarding the positive clinical data generated in patients that developed anemia as a result of their chemotherapy. The clinical trial demonstrated a reduction in the need for blood transfusions in chemotherapy-induced anemic patients. Furthermore, the trial data indicated that the level of hemoglobin and red blood cells never exceeded recommended levels even when the drug was used at high dose. This, combined with anti-cancer activity demonstrated in numerous cancer models, supports the potential use of PBI-1402 to address unmet medical needs in oncology.
- The PBI-1402 development program also led to the discovery of new and proprietary chemical compounds (NCEs) that regulate fibrosis via a novel mechanism of action. Fibrosis is part of the inflammatory process that leads to a loss of functionality in vital organs such as kidney, heart, liver and lungs in certain chronic diseases that affects hundreds of millions of patients. These first-in-class NCEs are orally active, and have been confirmed to exhibit strong anti-fibrotic activity in various in vivo models.
- Further advances were also accomplished with the Company's portfolio of autoimmune disease drug candidates.
- These advances improve the Company's ability to finalize partnering deals that will aim at pursuing the PBI-1402 clinical development programs in anemia and oncology as well as the development of new drug candidates targeting fibrosis and autoimmune diseases.
Second Quarter 2010
The second quarter of 2010 was again a busy one for the business with generated revenues amounting to $5.1 million compared to $2.3 million for the same period last year. It is worth reminding readers again that the revenues of the business do not accrue in a straight line during the year, and that anticipated revenues are geared towards the latter quarters in the Company's plan. During the same period, the Protein Technologies Business unit posted a profit of $1.4 million compared to a loss of $2.1 million in 2009. This performance allowed the entire group to reach an EBITDA breakeven in the second quarter of 2010.
Operating costs for the quarter were down to $5.6 million from $6.7 million in the same quarter of the previous year. This decrease was mainly attributable to the Research and Development tax credits and to the reduced impact of foreign exchange costs and reduced amortization costs.
The debt on the balance sheet consists of loans from long-term shareholders and strategic business partners.
Analyzing the business segment performance for the quarter highlights the loss associated with the Therapeutics division, relating to strategic R&D spend to assist with business development discussions. Protein Technologies posted a gain due to increased revenues and the resulting gross profit together with a reduction in R&D costs. Corporate losses reduced due to exchange rate variances.
Profit (Loss) *
* in thousands of dollars
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 LigandTM 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.
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 24 of ProMetic's Annual Information Form for the year ended December 31, 2009, under the heading "Risk and Uncertainties related to ProMetic's business". 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. All amounts are in Canadian dollars unless indicated otherwise.
Mit besten Grüßen
TheOracleX : Breaking News...
Ich bin zwar mit meiner angekündigten neuen Bewertung noch nicht fertig,
jedoch ereilte mich diese E-Mail vielversprechenden Inhalts zur Zukunft Prometics.
Wir dürften alle noch positiv überrascht werden...
01-09-2010 | PROMETIC LIFE SCIENCES INC.
Information regarding activities of interest to ProMetic/ Octapharma has successfully completed their prion depleted Uniplas® clinical development and filed for European approval
ProMetic would like to bring to your attention a new release from Octapharma AG titled "Uniplas® Clinical Development Successfully Completed". This release can also be accessed through our Information of Interest web page: http://www.prometic.com/en/prometic/information.php.
Uniplas®, is a novel, blood group independent, universally applicable, solvent/detergent treated, human pooled plasma for infusion, that was prion-depleted using ProMetic's pathogen reduction technology platform. Uniplas® can be given to all patients irrespective of their blood group, thus abolishing the risks and serious consequences that can result from a transfusion of an incompatible plasma unit. Trials also demonstrated that adding prion depletion did not otherwise change Uniplas®'s profile.
Octapharma has filed for registration of Uniplas® in Europe and will submit later in the USA.
2010-08-27 Uniplas Clinical Development
TheOracleX : Eine Ladung geballter Updates...
DoH urged to adopt P-Capt(R) filter to safeguard transfusion blood as new HPA research indicates up to 40,000 people in the UK may harbour vCJD prion - News comes as Macau begins routine prion filtration of donated blood with P-Capt(R)
MONTREAL, QUEBEC, CANADA AND LILLE, FRANCE - October 13, 2010 - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") and MacoPharma SA ("MacoPharma"). In the light of new research findings published by the Health Protection Agency ("HPA")+ that 1 in 9160 tonsil samples tested showed evidence of variant Creutzfeldt-Jakob disease ("vCJD"), ProMetic and MacoPharma strongly recommend the UK Department of Health ("DoH") implement the CE marked P-Capt® prion reduction filter as a matter of urgency to safeguard the UK blood supply. The HPA results suggest that up to 40,000 people in the UK (which equates to the population of a medium sized town) may be incubating vCJD without knowing it and could pass it on when they donate blood.
?This latest research highlights the ongoing threat of prion diseases and the need to filter transfusion blood to ensure that donors who are carrying latent prions do not infect recipients' commented Ms. Iwona Walicka, Project Manager of MacoPharma SA, which manufactures and distributes the filter. ?P-Capt® has been extensively and independently tested for three years: it works (99.9% or greater of vCJD reduction efficacy), it's safe, effective for a wide range of prion proteins and its implementation has been recommended by an independent UK Safety committee. We urge the DoH to begin using P-Capt® now, before more people are infected with these lethal agents.'
?The HPA research confirms the threat to human health posed by prions remains very real' added Dr. Steve Burton, Chief Executive Officer of ProMetic BioSciences Ltd, who developed the prion binding material used in the P-Capt® filter in collaboration with the American Red Cross and leading U.S. academics. ?There continue to be deaths from vCJD and a few weeks ago researchers from Case Western Reserve University in the U.S. identified a new human prion brain disease, similar to vCJD, which is associated with a fast-advancing form of dementia. It is now nearly a year since the UK's Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO"), recommended the DoH adopt the P-Capt® filter and it is important that this crucial safeguard against transmissible prion diseases is implemented without further delay".
The HPA report comes at a time when the Macau Blood Transfusion Service has started to use P-Capt® to remove vCJD from red blood cell concentrates ("RBCC") donated by Caucasians at risk of carrying the prion. Macau is a region of China which is close to Hong Kong and home to about half a million inhabitants including a small expatriate community.
?So far 4 people worldwide have contracted vCJD from blood transfusions and 1 haemophiliac from clotting factor concentrates derived from plasma and we know that 31 individuals who contracted and died of vCJD were blood donors' said Ms Walicka. ?The incidence of vCJD is greatest in the UK and since prion infectivity can lie dormant for decades before the disease develops, we simply do not know how widespread the disease could become.'
In the UK, four years after P-Capt® was CE mark approved, prion filtration has still not been implemented despite a recommendation from SaBTO to adopt the filter to pre-treat red blood cells destined for children born since 1 January 1996. SaBTO made this recommendation in November 2009 but the DoH has not commented on the implementation of P-Capt® since then. In Ireland, P-Capt® is being used routinely in one pilot hospital and is currently undergoing a health technology assessment (due to be completed by the end of 2010) in relation to national policy and adoption. Meanwhile, in the UK, according to the leaked ?Quangos at Risk' register it appears that SaBTO, the HPA and the Spongiform Encephalopathy Advisory Committee (SEAC), three groups that focus on vCJD and blood safety, could soon be disbanded.
* vCJD is a devastating disease for which there is no cure.
* P-Capt® has been extensively and independently tested for three years by all the UK Blood Services, the Irish National Blood Transfusion Service and the Health Protection Agency. The filter binds all prions tested to date.
* 1.8 million blood units are donated in England each year.
* At present UK donated red blood cell concentrates are leucodepleted which is not sufficient to prevent vCJD prion infectivity.
* Full implementation to filter all donated blood would cost around a pound per person in England (population 51 million).
* Since 1996 there have been 174 cases of vCJD in the UK of whom 170 have died (Source: The National CJD Surveillance Unit Figures October 4, 2010).
* In June 2009 SaBTO recommended that all plasma from UK blood donors be disposed of due to the vCJD risk and today the UK imports its plasma, largely from the U.S.
TheOracleX : Und noch eine hübschere Meldung...
ProMetic signs terms of strategic agreement for PBI-1402 and PBI-4419 with Allist Pharmaceuticals of China
* Allist to fund and accelerate the development programs for PBI-1402 and PBI-4419
* Allist secures exclusive commercial rights for the Chinese market
* ProMetic retains rights to data for other markets, representing savings of over US $10M in future development costs;
* PBI-1402 clinical development will be further advanced for chemotherapy-induced anemia and cancer related anemia indications
* PBI-4419 will be developed for fibrotic disease indications
* Agreement includes US$ 59 M in milestone payments to ProMetic as well as royalties on sales in China
MONTREAL, QUEBEC, CANADA - SHANGHAI, CHINA - October 18, 2010 - ProMetic Life Sciences Inc. (TSX: PLI) ("ProMetic") and Allist Pharmaceuticals, Inc. ("Allist") announced today that they have entered into a strategic agreement to develop and commercialize ProMetic's drug candidates PBI-1402 and PBI-4419 in China. This agreement strengthens ProMetic's development plan for these assets in other markets.
Allist will fund the development costs required for the regulatory approval in China for the two products. As part of the conditions for the rights granted, Allist undertakes to perform development activities according to standards meeting FDA requirements, which will then allow ProMetic to have full access to and use the data generated by Allist for markets outside China. This represents an investment in the programs well in excess of US$10 M. Allist will retain the rights for the Chinese market for PBI-1402 for the chemotherapy-induced anemia ("CIA") and cancer related anemia ("CRA") indications and for PBI-4419 for fibrotic diseases.
"We are very excited about this strategic relationship as it capitalizes on our respective companies' strengths," stated Dr. Jianhui Guo, Chief Executive Officer of Allist. "ProMetic's research & development program has generated very promising First-in-Class drugs to address unmet medical needs and Allist will accelerate the development of these two drug candidates. Our developmental capabilities provide for a natural, complementary and strategic fit with ProMetic."
Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer commented: "This enabling agreement is perfectly aligned with ProMetic's development strategy for its Therapeutics business unit: (1) It leverages the synergies and the investment made by Allist in the development program in that we can use this critical data for other lucrative markets; (2) It enables us to accelerate the development of these valuable drug candidates on a cash neutral basis; and (3) It provides ProMetic with a solid partner for the ever-expanding Chinese market, expected to become the 4th largest domestic pharmaceutical market by 2013."
In addition to the funding commitments and the execution of the development program, Allist has agreed to pay ProMetic performance milestones totaling US$59 M and royalties on future products sales. Upon ProMetic completing a technology transfer for the two drug candidates this quarter, Allist will proceed with the scale-up of the manufacturing processes and will initiate clinical trials as well as other pivotal development activities.
"Allist is one of the few pharmaceutical companies in China focused on developing innovative therapeutics as opposed to generic drugs," stated Dr. Tom Chen, ProMetic's Vice-President Product and Asia Pacific Development. "Allist is very well funded and will soon have capacity to produce over 250 metric tons of pharmaceutical bulk active drugs. Allist is not only a solid partner to develop and commercialize the products in China, but this relationship strengthens ProMetic's position outside China with expanded manufacturing capabilities. For instance, ProMetic will have the option to access large supply manufacturing capacity for PBI-1402 and PBI-4419 for markets outside China," added Dr. Chen.
ProMetic and Allist will finalize and execute definitive documentation and relevant development work plans regarding this strategic agreement within sixty (60) days from the date hereof.
More on PBI-1402 and PBI-4419
PBI-1402 is a first-in-class, orally active, non-EPO receptor erythropoietic regulating agent ("ERA"), which offers significant advantages in the treatment of anemia in cancer patients. With proven anti-cancer activity and no risk to bring red blood cells or hemoglobin to unsafe levels, PBI-1402 offers the potential to become the safest drug to treat anemia in cancer patients. In a phase Ib/IIa clinical trial performed in patients suffering of anemia induced by chemotherapy, 93% of patients did not require blood transfusion. PBI-4419 is a first-in-class, orally active, more potent third generation analogue of PBI-1402. PBI-4419 is ProMetic's lead candidate drug in development for the treatment of various inflammatory and fibrosis conditions.
About Allist Pharmaceuticals, Inc.
Allist Pharmaceuticals, Inc. (http://www.allist.com.cn/allist_en/) is engaged in discovery, development and commercialization of novel pharmaceutical products for human health. The mission of the company is to be a leading innovator of therapeutic drugs devoted to human health and human life worldwide.
Founded in May of 2004, Allist's Research and Development Center is located in Zhangjiang Hi-tech Park, Shanghai and is focused on new chemical entities and drug delivery systems in the fields of cardiovascular diseases, acid-related diseases and cancers.
At present, taking advantage of a rapidly growing Chinese biomedical and pharmaceutical industry, Allist pushes forward with developing technology and improving human health strategies to realize its goals of becoming one of the leaders in the global pharmaceutical industry.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (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 LigandTM 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, cancer, inflammation and fibrosis. 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 U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and in the Middle-East.
TheOracleX : Und noch eine...
ProMetic reports its third quarter 2010 financial results
* Allist Pharmaceuticals injects $10 Million in the immediate development of PBI-1402 and PBI-4419 and fully funds the clinical and regulatory development of both drugs for the Chinese market
* Stage set for transformational strategic agreements to positively impact the Company
* In spite of lower than expected revenue, adjusted net loss demonstrates improvement in business units' performance in 2010 YTD vs. 2009 YTD
MONTREAL, QUEBEC, CANADA - November 15, 2010 - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") today reports its financial results for the third quarter of 2010. All amounts are in Canadian Dollars unless otherwise indicated.
The following information should be read in conjunction with the financial statements for the third quarter ending September 30, 2010, as well as the Management's Discussion and Analysis for the same period.
"During the third quarter, Management was involved in a significant amount of Corporate and business development activities, setting the stage for a pipeline of transformational strategic agreements to impact positively the Company" stated Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. Mr. Laurin continued: "This includes the first deal involving PBI-4419, one of the recently discovered follow-on analogues of PBI-1402. ProMetic's development program has created potent new drugs targeting significant opportunities for unmet medical needs in the fibrosis market."
Specifically, through this agreement Allist is to fund and accelerate the development programs for PBI-1402 and PBI-4419, in return for exclusive commercial rights for the Chinese market. ProMetic retains rights to the data for other markets, representing savings of over US $10M in future development costs. In relation to the clinical programs, PBI-1402 clinical development will be further advanced for chemotherapy-induced anemia and cancer related anemia indications and PBI-4419 will be developed for fibrotic disease indications. The agreement includes US$ 59 M in milestone payments to ProMetic as well as royalties on sales in China.
Mr. Bruce Pritchard, the Company's Chief Financial Officer commented: "The third quarter of 2010 was a busy one for the business, with much effort going into the business development activities on all fronts. The results for the Year-to-date, when compared to the adjusted results for Year-to-date 2009 which remove the extraordinary gains, show a significant improvement in the business' performance. However, regulatory delays for Octapharma, one of our key customers, have meant that they have delayed their originally anticipated orders for the second half of this year into 2011. This will impact ProMetic's revenue forecast for the second half." Mr. Pritchard stated: "In light of this, efforts continue with cost control so that the cash runway can be stretched."
Mr. Laurin went on to add: "All other business units of ProMetic are engaged in a number of discussions regarding potential strategic agreements that we expect will confirm value and provide cash to the group."
Third Quarter 2010
The third quarter of 2010 was characterized by lower than expected revenues associated with the bioseparations business. Revenues from one of ProMetic's key customers, Octapharma AG ("Octapharma"), were delayed as a result of certain issues on their side, with these issues impacting ProMetic's revenue for the third & fourth quarters of 2010 compared to forecast.
Adjusting the 2009 Year-to-date results to remove the impact of the extra-ordinary gains relating to foreign exchange and the acquisition of the majority share in PRDT demonstrates more clearly the improvement in business performance for the Year-to-date 2010, as summarized in the table below.
2010 2009 Improvement
YTD Revenue 10,317 9,300 11%
YTD Net Loss 4,847 7,740 60%
Net Loss % 47% 83%
* in thousands of dollars
Octapharma has informed ProMetic that it is close to finalizing the approval process for its OctaplasLG® product in additional EU countries. OctaplasLG® is Octapharma's prion-depleted, solvent/detergent treated and pharmaceutically licensed plasma. The product is already approved for use in Germany and Switzerland, as well as in Australia. The UK's regulator (Medicines and Healthcare products Regulatory Agency "MHRA"), which is acting as rapporteur under the mutual recognition process for the approval in other EU member states, will resume their approval process in November 2010 after an additional requested study has been successfully completed by the Octapharma researchers and submitted.
This delay has a number of impacts for ProMetic, stemming from Octapharma not yet ordering its originally estimated volumes of prion reduction resin in the latter part of this financial year. In particular, this will impact second half revenues by around GBP 2.6 Million (approximately CAD $4 Million). In addition to the reduction in revenues, the expected offset of the advance from Octapharma, which sits on the balance sheet of ProMetic, will be diminished. This advance is repayable against ongoing resin orders. As a result, the overall balance will remain higher than anticipated, however, due to profile of sales, the majority of the balance will appear as a long-term rather than a short-term creditor.
Octapharma remains positive regarding the ultimate regulatory approval of its OctaplasLG® product by the MHRA and its ultimate approval in additional key EU countries, we therefore expect orders for resin to recommence in 2011. Furthermore, Octapharma also announced recently that it is seeking regulatory approval for a prion-depleted version of its UniplasLG® product, which will also rely on ProMetic's prion reduction technology.
Offsetting this, continued development of plasma-derived therapeutics products for customers, such as Abraxis BioScience, delivered revenues to the top-line. As a result of all this, revenues for the quarter amounted to $2.1 Million compared to $3.1 Million for the same period in 2009.
Operating costs for the quarter were up to $4.5 Million from $3.5 Million in the same quarter of the previous year. This increase was attributable to exchange rate movements. In general, all other operating costs were in line with those incurred in the third quarter of 2009.
The debt on the balance sheet consists of loans from long-term shareholders and strategic business partners. Discussions are already advancing with these lenders to reschedule the repayment of these loans, to assist further with minimizing the cash requirements for 2011.
Revision to Financial Guidance and impact on cash runway
At the Annual General Meeting in May 2010, guidance was provided indicating EBITDA and Net Loss of approximately $(3) Million and $(6) Million respectively, which was used as a benchmark for cash requirement.
In light of the confirmation from Octapharma, regarding the delay to their predicted resin orders for the latter part of 2010, the Company is revising its financial guidance for 2010. As outlined, the impact of the delay to the Octapharma order is approximately $4 Million to the top line. As a result, revenue guidance is being reduced. This will have an impact on both EBITDA and Net loss which are now expected to be approximately $(6) Million and $(8) Million respectively.
This reduction in forecast revenue is outside the control of ProMetic, and has been confirmed by Octapharma as a delay and not a cancellation in the order. With this in mind, the Company is confident that these revenues will occur in 2011.
Throughout the year, Management has emphasized in the MD&A the importance of its actions to modulate costs, enabling it as far as possible to maintain its EBITDA guidance, and as a result has been able to lessen the impact of this revenue reduction on its cash runway.
Nevertheless, the increase in the net loss attributable to 2010 has had an inevitable impact on the cash reserves. At this stage, the Company is still confident that it can manage its cash runway into the first quarter of 2011, and is actively working on business development activities and additional non-dilutive financing projects.
ProMetic's MD&A and 2010 Third Quarter Financial Statements have been filed on Sedar (http://www.sedar.com/) and are available on the Company's web site at http://www.prometic.com/.
TheOracleX : Ein kleiner Happen aus den Information of interest
Posted on October 15, 2010
ProMetic would like to bring to your attention a recently published article titled "FDA Considers Restricting Amgen Anemia Drugs".
This article states that the Food and Drug Administration is considering new restrictions on widely used anemia drugs that appear to double the risk of stroke in patients with kidney disease and in addition the FDA review states that the ?Treatment did not eliminate the risk of requiring (red blood cell) transfusions".
Given that ProMetic?s PBI-1402 compound does not elevate hemoglobin or red blood cells to potentially dangerous levels (no overshoot), it provides unique positioning strategies for this medical condition that the Company is actively pursuing.
TheOracleX : @ alle Prometic - Freunde
- neue Partnerschaft mit Allist
- quartalsbericht ok, wieder einige verbesserungen
- fda zieht restriktionen bezüglich anämie-medikamenten in betracht, die in konkurrenz zu PBI-1402 stehen = bessere bzw. super chancen für PBI-1402, weil andere funtionsweise!
- nur der aktienkurs scheint davon noch nicht so richtig etwas mitbekommen zu haben...
wenn ab nächsten jahr die italiener ihre licensing fees an prometic abstottern, gibt es wahrscheinlich den ersten knall richtung decke (was natürlich auch wunschdenken widerspiegelt). dennoch gibt es sonst keine bad news, die den niedrigen kurs rechtfertigen. prometic stellt sich für die zukunft auf! vor einigen jahren war es sumitomo für japan, jetzt kommt allist für china hinzu; m.e. die kaufchance. und jetzt drücken wir mal hier schön die daumen...
meine subjektive meinung.keine kaufempfehlung.
TheOracleX : @all
Der Kurs in Deutschland sagt übrhaupt nichts aus (außer Berlin vielleicht).
Guckt euch die 12 CAD-Cent an in Toronto!!! Da wird die Musik gemacht.
Und ja, mea culpa, ich habe es immer noch nicht geschafft eine neue Prognose zu PLI zu machen. Aber ich arbeite dran ;-).... Und jetzt steig endlich an, du Sau!
TheOracleX : @oki-wan
TheOracleX : @all
Im nachfolgenden nun ein Link zur letzten Präsentation von PLI:
Dem kann und will ich eigentlich nichts mehr hinzufügen, da alles wichtige bereits gesagt wurde. Ich glaube weiterhin an Prometic und bescheinige ihr nach wie vor großes Potential.
Good luck allen investierten und bis bald,
Wie immer keine Kauf- oder Verkaufsempfehlung.
Vor dem Hintergrund der jüngsten Entwicklungen (siehe Posting oben von Oracle) gehe ich ab spätestens Ende 2011 von schwarzen Zahlen aus. Dass die Anteilseigner auf die Rückzahlung ihrer gesicherten Anleihen bis Juli 2012 verzichten, damit Prometic sich voll auf die Fortentwicklung ihrer Produkte konzentrieren kann, sehe ich wie in der Mitteilung verfasst als Vertrauen in die Firma. Gleichzeitig wird durch die Verschiebung der Einfluss (gemessen an den Anteilen) von Allist Pharmac. begrenzt.
Ausserdem werden dieses Jahr soweit ich weiß erste Lizenzzahlungen von Kedrion für Mimetic-Ligand-Produkte fällig, überdies noch andere Milestone-Payments. Aber der Knüller ist folgende Geschichte:
Dieses Jahr wird von der britischen Regierung endgültig ein Urteil erwartet, ob landesweit Prionenfilter bei Blutentnahmen bzw. Bluttransfusionen verwendet werden müssen. Irland und Macao haben bekanntlich damit angefangen, sollte GB nachziehen wird in Zukunft die Welle auch auf das Festland schwappen. Gerade Erkrankungen wie Creutzfeld-Jakob oder Alzheimer können dadurch ziemlich wirksam eingedämmt werden.
Hoffen wir also das Beste für unsere kleine feine Perle!
Oki-Wan 2.0 : @all "dringend"
Oki-Wan 2.0 : hat sich erledigt...
TheOracleX : Okiwan
Ich hoffe nur dass die Securities holder nicht auf ihr Geld verzichten, weil sonst Prometic pleite ist.
Oki-Wan 2.0 : PLI wird uns glücklich machen...
folgende Nachricht wurde heute von Prometic herausgegeben und sollte manchem als Anregung dienen, sich mehr über Prometic zu informieren. Mir schwant da was...
ProMetic achieves pivotal milestone for its plasma-derived therapeutics business
- Company secures an established state-of-the-art manufacturing facility on very favourable terms
- Facility to scale-up ProMetic's proven manufacturing technology for plasma-derived therapeutics ("PPPSTM") with a targeted capacity of 150,000 liters of plasma annually
- New subsidiary "NewCo" created to undertake product manufacturing with targeted start-up by the end of 2011
- NewCo to be funded by third party investors, stakeholders and government grants
- Initial equity investment of $2.5 M CDN in NewCo has been committed; of which a first tranche of $750,000 CDN has been received
MONTREAL, QUEBEC, CANADA - February 7, 2011 - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") announced today that the Company has achieved a pivotal milestone for the in-house manufacturing of plasma-derived proteins at commercial scale thereby expanding its reach into the lucrative plasma-derived therapeutics industry.
ProMetic, via its new subsidiary, NewCo, has entered into a long-term lease on very favorable conditions with Quebec's Institut national de la recherche scientifique ("INRS") for an existing state-of-the-art facility.
NewCo will undertake the development and manufacturing of high-value plasma-derived therapeutic biosimilars for ProMetic's current and future clients. This facility, located in Laval's biotech cluster, will have a targeted processing capacity of 150,000 liters which would supply products with a market value exceeding $100,000,000 CDN per annum.
NewCo will be funded via third-party investments and is anticipated NewCo will rapidly become self-sustaining through end product services and sales to ProMetic's existing clients. An initial $750,000 CDN investment has been received as part of a $2,500,000 CDN commitment.
This new business venture has also received pledges for additional funding from various institutions and key stakeholders involved in ProMetic's protein technologies activities which could amount to additional financial contributions of $3,500,000 CDN.
"This is a key development for ProMetic as it enables the Company to benefit, at commercial scale, from the competitive advantage provided by our proven Plasma Protein Purification System ("PPPSTM") as well as our prion capture technologies. Our clients will have access to ProMetic's in-house production of plasma-derived products, in addition to technology transfer and skills training services," said Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer.
Mr. Bruce Pritchard, ProMetic's Chief Financial Officer stated: "We are very pleased to have accessed such a high quality facility on such very favorable terms, as well as having attracted capital to catalyze this exciting venture. The manufacturing plant will supply plasma-derived therapeutic products to our existing and future clients which should generate significant revenue". Mr. Pritchard added: "The plant is expected to start up operations by the end of 2011, provide cGMP products to be used by clients in early 2012, and reach full operating capacity by 2014".
ProMetic will further reduce its overhead cost by relocating its headquarters at this new facility, at the end of March, 2011. This also allows ProMetic to concentrate its core activities near its existing Therapeutic division's research and development site.
ProMetic will be holding a conference call / webcast on Tuesday, February 8, 2011, at 14:00 (EDT) to discuss details regarding this announcement.
The numbers to access the conference call are (416) 981-9000 (international) and 1 (800) 925-4216 (North America toll free). A live audio webcast of the conference call will be available through ProMetic's website at http://www.prometic.com/en/news-events/events.php.
An audio replay of the call will be available for a period of seven days as of Tuesday, February 8, 2011, at 17:00 (EDT). The numbers to access the audio replay are (416) 626-4100 and 1 (800) 558-5253 using access code 21510428. The replay of the web cast may be downloaded directly from ProMetic's web site.
About the Plasma Protein Purification System
The Plasma Protein Purification System ("PPPSTM") allows for the targeting and removal of multiple high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic's Mimetic LigandTM adsorbent technology. This system also provides for the recovery of new biotherapeutics as they are discovered and identified. The effect of this process is to reduce the significant losses incurred when using the more conventional Cohn precipitation process
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (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 LigandTM 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 U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., 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 24 of ProMetic's Annual Information Form for the year ended December 31, 2009, 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. All amounts are in Canadian dollars unless stated otherwise.
For further information please contact:
President and CEO
ProMetic Life Sciences Inc.
Manager, Investor Relations
ProMetic Life Sciences Inc.
Oki-Wan 2.0 : Und wieder neue Sachen von PLI bzw. der Tochter...
Also mir scheint immer mehr, dass ein technischer Angriff im Gange ist. Wie sagt man so schön in der Fachsprache: mit einer bestimmten Strategie einen bestimmten Markt penetrieren.
Jedenfalls ähnelt das Erscheinungsbild immer mehr dem eines zukünftigen multinationalen Konzerns. Dazu sei angemerkt, dass Prometic Biosciences eine 100%ige Tochter von PLI ist und deren Produkte in Europa verkauft und demnächst auch in Asien anbieten will (Macao läuft schon).
Allen Investierten ein Toi Toi Toi und Daumen hoch...
Beste Grüße, Oki-Wan 2.0
hier der Link zu Proemtic's letzter Präsentation zu der neuen Fertigungsanlage:
Viel Spaß beim durchschauen.
Oki-Wan 2.0 : @Zohna
Übrigens werde ich gleich einen neuen Thread zu Prometic eröffnen.
Ich finde, der alte Name "... - die bessere Genta" ist nun wirklich irreführend!