Tuesday, October 17, 2017 8:11:33 AM
CEO Chairman Blog Quotes - LymPro CLIA Certification, Launch & Commercialization
http://www.thechairmansblog.com/amarantus-bioscience/blogs/
Blog #2.) Onwards and Upwards: Building Value From a Solid Foundation
January 14th, 2013
• As The last few weeks have been very exciting for Amarantus. Since our initial Chairman’s Blog post on December 11th, 2012 we have achieved several important corporate milestones to set the stage for growth in 2013, including: Licensing a Phase 2-ready Alzheimer’s disease diagnostic blood test called LymPro to detect mild to moderate Alzheimer’s disease; a diagnostic category highly sought by Big Pharma
Blog #3.) Q1: Setting the Stage for Growth in 2013
February 20th, 2013
• Spinning off Amarantus Diagnostics: Last week we disclosed the creation of Amarantus Diagnostics, a subsidiary company to further develop the Company’s LymPro and NuroPro diagnostic assets. The internal estimates of the market opportunity for these assets exceeds $800 million and the time to market is likely significantly less than our MANF asset, due to different regulatory requirements for marketing of these types of diagnostics. Moreover, with recent guidance from the FDA regarding the need to focus drug development programs on early-stage patients, Amarantus Diagnostics will be positioned among the most innovative companies developing products in the Alzheimer’s space with LymPro. From the corporate perspective, we believe we can unlock the true value of these assets without further diluting the value of the MANF opportunity for our shareholders with this strategy.
• We are currently working on updating the clinical trial design for the LymPro and NuroPro assets in light of recent developments in the field and will update the marketplace in the near future regarding timelines to key milestones on their path to commercialization.
Blog #4.) The Stage is Now Set for Growth: Focus on Parkinson’s and Alzheimer’s
March 25th, 2013
• A key area of internal focus over the last quarter has been on our recently licensed LymPro Alzheimer’s Diagnostic Blood Test, which has taken on increasing importance as the role of early stage diagnostics has been further validated by the FDA’s clear guidance to pharmaceutical companies regarding the need to focus therapeutic development on early stage patients. There are a number of disease-modifying drug candidates with blockbuster potential currently in late-stage development by leading biopharmaceutical companies; LymPro would enhance those programs by providing drug developers with a better way to efficiently conduct the NDA-enabling Phase 3 clinical trials required to gain FDA approval. We are finalizing product development plans in this area over the next several weeks, and will announce further details on those plans thereafter. We believe this program is among the most promising currently in development at Amarantus.
• …internal priorities are shifting with the emergence of new information regarding the market demand for LymPro; and we are planning for significant growth in the second quarter. Management believes we are on the right path to achieve success for all stakeholders involved in Amarantus.
Blog #5.) Continued Progress with our Business Plan in Central Nervous System Disorders
May 16th, 2013
• Moving MANF imminently closer to a first-in-man study for one or more indications where there is relatively little competition, and where MANF has the potential to have significant disease-modifying effects in these multi-billion dollar market opportunities; getting LymPro commercialized and generating revenue, while also working with various pharmaceutical companies to identify an appropriate match as a companion diagnostic.
Blog #6.) C4CT Concussion Awareness Summit – The Emergence of TBI in the Concussion Debate
July 11th, 2013
• I look forward to sharing significant corporate developments with our shareholders in the coming weeks. Heading into the third quarter, this is an exciting time at Amarantus with results expected over the next several weeks in our MANF Orphan Drug program and our LymPro Test® Alzheimer’s diagnostic program.
Blog #8.) LymPro Heading into 2014: Shifting the Diagnostic Paradigm in Alzheimer’s
November 4th, 2013
• One thing that is 100% guaranteed as we transition into the execution phase of the Affordable Care Act’s implementation is that we have little certainty what US healthcare will look like in the second half of 2014, when we expect LymPro to be commercialized.
• The LymPro Test license agreement we executed in the fourth quarter of 2012 that was the centerpiece of our business development strategy of the last 12 months is turning out to be a tremendously beneficial transaction for Amarantus. With the analytical performance of the assay now established, and as we prepare the analytical and clinical performance packages necessary to support the commercial launch of LymPro Test® in the second half of 2014 as a Laboratory Developed Test (LDT) under the Clinical Laboratory Improvement Amendments (CLIA), we are continuing to execute on our strategy of recruiting highly skilled and experienced personnel to lead the charge to put LymPro front and center in the effort to help shift the diagnostic paradigm of AD.
• Our Advisors Adam Simon, PhD and Colin Bier, MD have a wealth of practical experience in AD diagnostic development, and both believe in LymPro’s diagnostic and prognostic potential. We are in the process of adding additional regulatory and reimbursement expertise to the team to further cement the LymPro development plan through to FDA approval and unrestricted nationwide Centers for Medicare & Medicaid Services (CMS) reimbursement.
• Beyond the product development aspects of the assay, our team is beginning to work on defining the appropriate pricing strategy for LymPro once it is launched, as well as establishing realistic cost of goods sold (COGS) at time of launch, and what type of economies of scale would be gained over time as we work to ramp up distribution of LymPro from initial launch to mass distribution.
• We have been working on numerous case scenarios where we establish sales forecasts, and all of them have us reaching the $500M per year in peak sales if LymPro becomes the gold standard in the industry.
• While there are certainly a number of clinical utility (value to payer vs. price) arguments to be made for widespread adoption of a blood test for AD as a standalone product that could see LymPro become an attractive profit center able to support other activities within the Company…
• This could ultimately lead to LymPro’s use as a companion diagnostic to screen for patients that would be put onto drug therapy once those therapies are approved, further driving LymPro sales and demonstrating its value to CMS and therapeutic companies from a clinical utility perspective.
• We expect the initial target market for LymPro to be pharmaceutical companies investigating therapeutics in AD, key opinion leading physicians seeking to establish new diagnostic paradigms in AD, and individuals seeking to better understand whether Alzheimer’s could be the a cause of their cognitive impairment.
• Once we establish sufficient data through tracking commercial sales cases and in well-controlled clinical studies, we expect to evaluate the reimbursement strategy at the state and national levels
Blog #10.) Unlocking Shareholder Value as Milestones Approach: Uplisting in 2014
January 6th, 2014
• The LymPro commercial development strategy is becoming clearer as we finalize the business plan for our Diagnostics division and interact with key stakeholders involved in LymPro’s development.
In late December our team reviewed the Company’s development, regulatory, reimbursement and marketing plans with experts in the field, and we are now preparing to implement the strategy for LymPro’s most lucrative path forward for Amarantus shareholders.
• It has also become clear while interacting with the Alzheimer’s community that there is a tremendous amount of interest in LymPro’s potential to become the first blood-based test for Alzheimer’s disease.
• A significant opportunity exists for LymPro development in national and international jurisdictions following these key sets of data. We remain on track to commercialize LymPro in the second half of 2014.
Blog #11.) 2014: Initiation of Eltoprazine Phase 2b and LymPro Commercialization
January 17th, 2014
• With commercialization expected later this year, the investment community has become interested in the manner in which we intend to make this dramatic shift to a revenue generating company.
• The Company is focused on improving its value while mitigating the potential risks associated with the development of LymPro by ensuring long-term reliability, defining the ultimate FDA and multinational strategy with our key Alzheimer’s advisors and ensuring that upon commercial use of the assay, the ultimate selling entity will have an established method of reimbursement.
• We believe that we are making significant progress on all of these fronts and intend to formally update the marketplace as these key events are solidified. Each one of these de-risking steps, especially reimbursement, dramatically improves the net present value of LymPro which in turn would increase its attractiveness to physicians, investors and potential partners. We believe that we are in a great position to bolster the value of the LymPro asset in a very short period of time by employing this strategy, thereby increasing potential competition for the assay while giving the Company as many options as possible for ultimate value creation.
Blog #13.) Q1-2014: The Maturation of Amarantus
February 24th, 2014
• The Company expects to commercialize LymPro in the second half of 2014 under CLIA in Alzheimer’s disease, one of the largest and most underserved markets in the world ($200B+ in the US alone, $500B+ worldwide) where we will seek to fulfill the key unmet medical need of early diagnosis.
Blog #15.) Commercialization On-Track for 2014: Updating LymPro Test Progress
March 31st, 2014
• The Company remains on track to commercialize the LymPro Test® in the second half of 2014. Since the fourth quarter, when we last updated our shareholders on the progress of LymPro, we have achieved a number of key milestones that we believe will add significant value to our product as well as mitigate risk in certain critical areas in order to increase the net present value of our assay. As a result of these steps, we are in a position to initiate partnering process for the CLIA commercial launch of LymPro in the 2nd half of 2014.
• As we prepare for LymPro’s commercialization in the second half of 2014, we believe it is critical to properly position LymPro within the scientific community, the investment community and the general population as THE commercially-validated blood test as we prepare for product launch. We want to ensure LymPro will not be overlooked by the scientific community when our next sets of results are released.
• Among the primary differences between LymPro Test® and our academic competition is that LymPro is well ahead in terms of commercial development. It is essential going forward that the Company release results produced solely from the validated assay in order to maintain commercial credibility for our claim set. The Company remains on track to complete CLIA-grade validation and preparation of the Analytical Performance Package (APP) for LymPro in the first half of 2014. We have begun the implementation of our commercial scientific marketing strategy and that foundation begins with an analytically validated assay. We believe this rigor going forward will lead to the most successful commercial launch in the second half of this year and allow us to achieve our corporate objective of establishing LymPro as the standard Alzheimer’s Blood Test in the industry by nurturing the market through its infancy as we prepare LymPro for FDA submissions.
• We are currently seeking counsel with our regulatory consultants regarding the appropriate FDA strategy, and expect to initiate a dialogue with the agency upon completion of the APP for LymPro. We are hopeful this dialogue will ultimately facilitate FDA approval for LymPro and catalyze market penetration.
• We have retained Boston Healthcare to assist us with our reimbursement strategy and believe we have developed a strong framework that will form the basis of a successful and sustainable reimbursement profile for LymPro.
• In summary, we have continued to make progress in recent months with our LymPro product development program and have put ourselves in a position to develop a meaningful commercialization and marketing partnership for our CLIA assay as we head into the second quarter of 2014. We will continue to update our shareholders of critical milestones as they are achieved, with the next milestones expected in the second quarter as we prepare the marketing process for LymPro’s commercialization in the US.
Blog #16.) 2H-2014: Milestones ahead to Position Amarantus for the Up-list
June 18th, 2014
• Our primary focus will be the data of the LP001 retrospective patient record study currently underway with our collaborator’s facility at Banner Sun Health Research Institute in Phoenix, AZ. We believe this data will be the most compelling for Key Opinion Leaders (KOLs) and pharmaceutical companies, our target market for the initial launch of LymPro, as this will provide longitudinal data regarding LymPro’s performance and diagnostic integrity.
• With regards to a partnership agreement to allow for the CLIA launch of LymPro in 2014, we are currently working through the intricacies of what such an agreement would entail. We have identified the laboratory that we believe has the technical know-how and marketing capabilities required for the launch of the LymPro Test both within the clinical trials setting to support pharmaceutical development, as well as a commercial launch under CLIA. We expect to be in a position to deliver definitive information to the marketplace over the summer. We believe the data to be released at AAIC and potentially the #C4CT Summit will increase the value of LymPro and give us additional leverage in negotiations. Following the release of this data, we intend to outline a forecast for LymPro revenues and market uptake in our second quarter earnings conference call that will provide the basis for financial projections.
Blog #19.) AAIC 2014 - Understanding the Data Being Presented - LymPro Test Ver. 2
July 9th, 2014
• The Company believes this Version 2 may improve upon certain critical principles established in Version 1, and make the diagnostic value of LymPro even higher than originally described.
• Combined, these four data sets could provide a strong rationale for moving solely to Version 2 of the assay which the Company believes would add tremendous value to LymPro’s diagnostic value.
• We believe AAIC represents a golden opportunity to let the scientific community know about LymPro’s advancements and that it will be on the market later this year (we are finding in our business development outreach that many research groups liked the concept in the Provista days, however lost track post-2008).
• We believe our approach of assessing an underlying aspect of disease biology and preparing for commercial-launch ahead of a major media push is the correct path so we can maximally capitalize on potential media attention, not only by an increase in the number of interviews I conduct, but most importantly by product sales.
• We will be first to market by years. This will allow us to appropriately establish a market for LymPro ahead of others and make LymPro the standard within the space.
• What is ultimately missing for cell cycle to takeoff as a significant ‘drugable’ target is a diagnostic that can identify cell cycle early-on in the disease process, and LymPro can fill that need as it is the most advanced cell cycle diagnostic test.
• We have noted recent interest in Alzheimer’s blood diagnostics from competing labs, and continue to believe that we have the most advanced diagnostic blood test in terms of commercial readiness due to the rigor we endeavored upon with Becton Dickinson, and scientific fundamentals.
• Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval.
Blog #20.) Understanding Data Presented at AAIC & Why Amarantus is Well Positioned Heading into #C4CT
July 17th, 2014
• Some may ask, “How will you get another clinical study completed by the end of the year in the CLIA lab, as is required to support submission?” The answer is that we are proving right now that we can execute under such timelines with the current study. . This is where the relationships and expertise and experiences of Dr. Kirby’s over 400 clinical trials are a huge advantage for Amarantus. We are establishing a well-oiled clinical organization capable of translating protocols to practice, and ultimately to data at a very rapid pace.
• We remain on track to complete the partnering process with our CLIA lab by the end of the summer, transfer the analytical process from BD to the target partner (a process that these organizations have completed extremely successfully several times), and achieve CLIA submission within our targeted timeframes. We believe the raw data for LymPro overwhelming demonstrates its validity even in suboptimal conditions, and now we are poised to move it to the main stage. We believe that by the time AAIC comes around in 2015, the data that we will be presenting will be the subject of significant oral presentations. We are excited with the progress made at this year and the credibility we have injected back into LymPro after rescuing it from PLS, and believe that we are very well positioned for the second half of 2014. LymPro has a bright future and we are happy to have brought it back to life for the benefit of patients and shareholders.
Blog #21.) #C4CT Wrap-up & the Decision to Present Interim LP-002 Data
August 4th, 2014
• We will now focus on completing the enrollment for LP-002 protocol and continuing preparations for commercial launch under CLIA.
• Our strategy was successful and we expect significant collaborations to emerge as a result.
• We are well positioned to continue forward with our LymPro program and remain on track to achieve our corporate objectives by the end of 2014.
Blog #23.) Initiating Studies for CLIA Launch at ICON Central Lab’s
Sept. 2th, 2014
• This morning we announced the initiation of CLIA-enabling studies at Icon Central Laboratories, a CLIA-certified laboratory that will serve as the facility that carries out the LymPro assay for CLIA launch.
• With this agreement, we also gain access to a global distribution network for LymPro, including central laboratories in Europe, Singapore, India and China that will allow LymPro to enter these new markets seamlessly through an already established distribution framework.
Blog #24.) Fundamental Milestones Ahead – Uplisting from Strength
Sept. 18th, 2014
• We entered into an agreement with Icon Central Laboratories that gives the Company access to a global distribution network for LymPro and positions us to begin marketing LymPro to the Research Use Only (RUO) in the fourth quarter – we began ‘soft marketing’ to pharma companies at the Alzheimer’s Association International Conference in July and can now definitively describe our path forward with Icon
• By the end of 2014 the Company anticipates: Completing the validation work at Icon to support LymPro’s launch
Blog #25.) Eltoprazine, LymPro and MANF: The Path Forward to Value Creation
Oct. 27th, 2014
• LymPro is our most advanced program, given that it is set to be commercialized in the very near future. We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use.
• LymPro is our most advanced program, given that it is set to be commercialized in the very near future. We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use.
• As we expect to soon derive value from our diagnostics division, we believe it will be important to replenish our pipeline with strategically positioned programs that have the potential to deliver significant return on investment for the company, as LymPro has.
Blog #26.) Amarantus Diagnostics Launching our First Product in the Neuro-diagnostics Market
December 22nd, 2014
• We believe the timing of this article is ideal, as our emerging diagnostics division, Amarantus Diagnostics, is ready to have a major impact in the field of biomarkers to diagnose Alzheimer’s disease, and potentially monitor drug response. The Bloomberg article focuses on tests with recently published data in peer-reviewed journals on their approach, and LymPro will be joining those ranks in 2015 following the announcement of the full LP-002 data set that will occur before the end of this year. LymPro is the only Alzheimer’s blood diagnostic with two independent peer-reviewed publications, and we intend to publish several additional articles on LymPro in 2015 predicated upon our clinically-derived data.
• As of today, we have completed the necessary analytical performance protocols required to confidently and reproducibly offer LymPro to the pharmaceutical industry, and we will now be able to offer this test to the pharmaceutical industry for use in their clinical development programs. This represents a major achievement for Amarantus, as we have achieved the critical milestone of commercializing LymPro in 2014, targeting our preset market: the pharmaceutical industry.
Note:
Commencing in January, 2015, Amarantus’s “Business Plan” changed once again to now include the newly acquired Georgetown University Blood Based Biomarker Assays into a newly formed Amarantus Diagnostics Division holdings. LymPro’s much touted ability to commercialize, attain CLIA certification, commence marketing, or earn revenue as provided by Amarantus between $100-Mil. to $150-Mil. via the IUO (Investigational Use Only) market place will now become masked by Amarantus’s ‘spinning off’ of the Diagnostics Div. The Diagnostic spinoff was supposed to have provided shareholder value and share price appreciation – but never really does.
Blog #27.) Amarantus Diagnostics
January 28th, 2015
• Under the terms of the agreement, we have been granted immediate access to the underlying data the lipid and exosome work, and will have the opportunity to analytically validate the assays at Icon Central Labs so that we can prepare for Investigational Use Only (IUO) and, thereafter, Clinical Laboratory Improvement Amendments (CLIA) launch while building the necessary corporate infrastructure for a standalone neuro-diagnostics franchise. The work we intend to perform during the option period will bring these technologies closer to commercial launch for the IUO market, so that when we exercise the option and complete the licenses, we will have a solid handle on analytical assay performance. Importantly, this agreement allows us to position Amarantus Diagnostics, our newly-formed, wholly-owned subsidiary, to the pharmaceutical industry and the institutional investor community as having cornered a huge part of the enormously attractive Alzheimer’s blood diagnostics market.
• We believe the size of the (diagnostic) market opportunity will eventually grow from the $150 million IUO market, to a potential $3 billion worldwide commercial market opportunity as we move from the IUO market (marketing these diagnostics to pharmaceutical companies for research only) to the CLIA market. Being first-to-market is the most important fight to win in this space. We believe in all AD blood diagnostic technologies described in this article for different reasons, and are convinced that by having the ability to answer a myriad of different questions in AD diagnosis with these technologies in parallel, pharma companies will give us a leg up vs. potential ‘one-trick pony’ competitors as we carve-out a leading position for ourselves in this emerging vertical. However, given that therapies for Alzheimer’s disease are still potentially several years away from reaching true game-changing potential that will justify a strong reimbursement profile, we recognize the near term limitations of the $150 million IUO market.
Blog #28.) Amarantus Shareholder Update: Fundamental Progress on the Pipeline Strategy Continues
March 26th, 2015
• The LymPro® Test for Alzheimer’s disease (AD), MSPrecise® for the diagnosis of multiple sclerosis (MS) and the NuroPro® diagnostic for PD make up our Diagnostics division. In addition, we have entered into an option agreement with Georgetown University for a license for two more diagnostic assays for AD, because we believe the combination of these two assays with LymPro will cement our position as a leader in the emerging field of Alzheimer’s blood diagnostics. Taken together with our diagnostics for MS and PD, we have positioned our Diagnostics division as one of the premier neuro-diagnostic companies in the world.
Some recent diagnostics development highlights include:
LymPro
• Announcing the availability of LymPro Test biomarker services for use by the pharmaceutical industry for IUO.
Blog #31.) Amarantus Shareholder Update: Fundamental Progress on the Pipeline Strategy Continues
March 26th, 2015
• The data presented by Amarantus today at the 2015 Alzheimer’s Association International Conference in Washington, DC is encouraging because it is consistent with the reference standard used in the diagnostic paradigm, Beach et al (2012). In the world of diagnostic development this is highly encouraging because a diagnostic test cannot be better than the standard against which it is judged. This is especially promising because Amarantus now has the opportunity to conduct additional work to by comparing the LymPro results against an FDA approved biomarker reference standard, amyloid PET imaging and that data. Stay tuned for more information about this promising blood test. Add on studies are being planned to compare it to the diagnosis of AD using amyloid PET, which will provide some concordance data that will drive the design of a confirmatory clinical validation study. The assay is available now for investigational use only.
Blog #32.) Improving Healthcare for Patients & Families: Believing in our Vision through Ups & Downs
November 6th, 2015
• Last week, the Company’s diagnostics team made good progress on the commercial launch plan for MSPrecise at a meeting we held in Dallas, TX. We are also continuing to evaluate the next set of studies to further enhance LymPro’s value by combining datasets with other markers, such as PET imaging. We have come to the decision that we will be focusing on the assets currently in the company, and will forego the option agreement with Georgetown University. With data coming up on the use of LymPro in Chronic Traumatic Encephalopathy that we recently completely enrollment for in Boston University’s DETECT study, we believe we have sufficient critical mass to make a very successful business from our current diagnostics portfolio and are now focused on the CLIA launch plans for these products. We remain on track to transact on the diagnostics division in the fourth quarter and will provide updates on this as progress is made. The Company is looking forward to the JP Morgan Healthcare Conference the week of January 11, 2016 as a key time to potentially make public announcements of definitive agreements.
• In closing, while the Company has gone through a difficult period, we believe the sheer strength of our portfolio will allow the Company to overcome the challenges we face. We believe we have a strong execution plan, with achievable milestones that will allow for growth. We believe the support of our shareholders at this time in our corporate history is paramount, and I look forward to working with our team to bring the tremendous portfolio of product candidates we have to market to help patients.
Gerald Commissiong - the pathological liar !!!
http://www.thechairmansblog.com/amarantus-bioscience/blogs/
Blog #2.) Onwards and Upwards: Building Value From a Solid Foundation
January 14th, 2013
• As The last few weeks have been very exciting for Amarantus. Since our initial Chairman’s Blog post on December 11th, 2012 we have achieved several important corporate milestones to set the stage for growth in 2013, including: Licensing a Phase 2-ready Alzheimer’s disease diagnostic blood test called LymPro to detect mild to moderate Alzheimer’s disease; a diagnostic category highly sought by Big Pharma
Blog #3.) Q1: Setting the Stage for Growth in 2013
February 20th, 2013
• Spinning off Amarantus Diagnostics: Last week we disclosed the creation of Amarantus Diagnostics, a subsidiary company to further develop the Company’s LymPro and NuroPro diagnostic assets. The internal estimates of the market opportunity for these assets exceeds $800 million and the time to market is likely significantly less than our MANF asset, due to different regulatory requirements for marketing of these types of diagnostics. Moreover, with recent guidance from the FDA regarding the need to focus drug development programs on early-stage patients, Amarantus Diagnostics will be positioned among the most innovative companies developing products in the Alzheimer’s space with LymPro. From the corporate perspective, we believe we can unlock the true value of these assets without further diluting the value of the MANF opportunity for our shareholders with this strategy.
• We are currently working on updating the clinical trial design for the LymPro and NuroPro assets in light of recent developments in the field and will update the marketplace in the near future regarding timelines to key milestones on their path to commercialization.
Blog #4.) The Stage is Now Set for Growth: Focus on Parkinson’s and Alzheimer’s
March 25th, 2013
• A key area of internal focus over the last quarter has been on our recently licensed LymPro Alzheimer’s Diagnostic Blood Test, which has taken on increasing importance as the role of early stage diagnostics has been further validated by the FDA’s clear guidance to pharmaceutical companies regarding the need to focus therapeutic development on early stage patients. There are a number of disease-modifying drug candidates with blockbuster potential currently in late-stage development by leading biopharmaceutical companies; LymPro would enhance those programs by providing drug developers with a better way to efficiently conduct the NDA-enabling Phase 3 clinical trials required to gain FDA approval. We are finalizing product development plans in this area over the next several weeks, and will announce further details on those plans thereafter. We believe this program is among the most promising currently in development at Amarantus.
• …internal priorities are shifting with the emergence of new information regarding the market demand for LymPro; and we are planning for significant growth in the second quarter. Management believes we are on the right path to achieve success for all stakeholders involved in Amarantus.
Blog #5.) Continued Progress with our Business Plan in Central Nervous System Disorders
May 16th, 2013
• Moving MANF imminently closer to a first-in-man study for one or more indications where there is relatively little competition, and where MANF has the potential to have significant disease-modifying effects in these multi-billion dollar market opportunities; getting LymPro commercialized and generating revenue, while also working with various pharmaceutical companies to identify an appropriate match as a companion diagnostic.
Blog #6.) C4CT Concussion Awareness Summit – The Emergence of TBI in the Concussion Debate
July 11th, 2013
• I look forward to sharing significant corporate developments with our shareholders in the coming weeks. Heading into the third quarter, this is an exciting time at Amarantus with results expected over the next several weeks in our MANF Orphan Drug program and our LymPro Test® Alzheimer’s diagnostic program.
Blog #8.) LymPro Heading into 2014: Shifting the Diagnostic Paradigm in Alzheimer’s
November 4th, 2013
• One thing that is 100% guaranteed as we transition into the execution phase of the Affordable Care Act’s implementation is that we have little certainty what US healthcare will look like in the second half of 2014, when we expect LymPro to be commercialized.
• The LymPro Test license agreement we executed in the fourth quarter of 2012 that was the centerpiece of our business development strategy of the last 12 months is turning out to be a tremendously beneficial transaction for Amarantus. With the analytical performance of the assay now established, and as we prepare the analytical and clinical performance packages necessary to support the commercial launch of LymPro Test® in the second half of 2014 as a Laboratory Developed Test (LDT) under the Clinical Laboratory Improvement Amendments (CLIA), we are continuing to execute on our strategy of recruiting highly skilled and experienced personnel to lead the charge to put LymPro front and center in the effort to help shift the diagnostic paradigm of AD.
• Our Advisors Adam Simon, PhD and Colin Bier, MD have a wealth of practical experience in AD diagnostic development, and both believe in LymPro’s diagnostic and prognostic potential. We are in the process of adding additional regulatory and reimbursement expertise to the team to further cement the LymPro development plan through to FDA approval and unrestricted nationwide Centers for Medicare & Medicaid Services (CMS) reimbursement.
• Beyond the product development aspects of the assay, our team is beginning to work on defining the appropriate pricing strategy for LymPro once it is launched, as well as establishing realistic cost of goods sold (COGS) at time of launch, and what type of economies of scale would be gained over time as we work to ramp up distribution of LymPro from initial launch to mass distribution.
• We have been working on numerous case scenarios where we establish sales forecasts, and all of them have us reaching the $500M per year in peak sales if LymPro becomes the gold standard in the industry.
• While there are certainly a number of clinical utility (value to payer vs. price) arguments to be made for widespread adoption of a blood test for AD as a standalone product that could see LymPro become an attractive profit center able to support other activities within the Company…
• This could ultimately lead to LymPro’s use as a companion diagnostic to screen for patients that would be put onto drug therapy once those therapies are approved, further driving LymPro sales and demonstrating its value to CMS and therapeutic companies from a clinical utility perspective.
• We expect the initial target market for LymPro to be pharmaceutical companies investigating therapeutics in AD, key opinion leading physicians seeking to establish new diagnostic paradigms in AD, and individuals seeking to better understand whether Alzheimer’s could be the a cause of their cognitive impairment.
• Once we establish sufficient data through tracking commercial sales cases and in well-controlled clinical studies, we expect to evaluate the reimbursement strategy at the state and national levels
Blog #10.) Unlocking Shareholder Value as Milestones Approach: Uplisting in 2014
January 6th, 2014
• The LymPro commercial development strategy is becoming clearer as we finalize the business plan for our Diagnostics division and interact with key stakeholders involved in LymPro’s development.
In late December our team reviewed the Company’s development, regulatory, reimbursement and marketing plans with experts in the field, and we are now preparing to implement the strategy for LymPro’s most lucrative path forward for Amarantus shareholders.
• It has also become clear while interacting with the Alzheimer’s community that there is a tremendous amount of interest in LymPro’s potential to become the first blood-based test for Alzheimer’s disease.
• A significant opportunity exists for LymPro development in national and international jurisdictions following these key sets of data. We remain on track to commercialize LymPro in the second half of 2014.
Blog #11.) 2014: Initiation of Eltoprazine Phase 2b and LymPro Commercialization
January 17th, 2014
• With commercialization expected later this year, the investment community has become interested in the manner in which we intend to make this dramatic shift to a revenue generating company.
• The Company is focused on improving its value while mitigating the potential risks associated with the development of LymPro by ensuring long-term reliability, defining the ultimate FDA and multinational strategy with our key Alzheimer’s advisors and ensuring that upon commercial use of the assay, the ultimate selling entity will have an established method of reimbursement.
• We believe that we are making significant progress on all of these fronts and intend to formally update the marketplace as these key events are solidified. Each one of these de-risking steps, especially reimbursement, dramatically improves the net present value of LymPro which in turn would increase its attractiveness to physicians, investors and potential partners. We believe that we are in a great position to bolster the value of the LymPro asset in a very short period of time by employing this strategy, thereby increasing potential competition for the assay while giving the Company as many options as possible for ultimate value creation.
Blog #13.) Q1-2014: The Maturation of Amarantus
February 24th, 2014
• The Company expects to commercialize LymPro in the second half of 2014 under CLIA in Alzheimer’s disease, one of the largest and most underserved markets in the world ($200B+ in the US alone, $500B+ worldwide) where we will seek to fulfill the key unmet medical need of early diagnosis.
Blog #15.) Commercialization On-Track for 2014: Updating LymPro Test Progress
March 31st, 2014
• The Company remains on track to commercialize the LymPro Test® in the second half of 2014. Since the fourth quarter, when we last updated our shareholders on the progress of LymPro, we have achieved a number of key milestones that we believe will add significant value to our product as well as mitigate risk in certain critical areas in order to increase the net present value of our assay. As a result of these steps, we are in a position to initiate partnering process for the CLIA commercial launch of LymPro in the 2nd half of 2014.
• As we prepare for LymPro’s commercialization in the second half of 2014, we believe it is critical to properly position LymPro within the scientific community, the investment community and the general population as THE commercially-validated blood test as we prepare for product launch. We want to ensure LymPro will not be overlooked by the scientific community when our next sets of results are released.
• Among the primary differences between LymPro Test® and our academic competition is that LymPro is well ahead in terms of commercial development. It is essential going forward that the Company release results produced solely from the validated assay in order to maintain commercial credibility for our claim set. The Company remains on track to complete CLIA-grade validation and preparation of the Analytical Performance Package (APP) for LymPro in the first half of 2014. We have begun the implementation of our commercial scientific marketing strategy and that foundation begins with an analytically validated assay. We believe this rigor going forward will lead to the most successful commercial launch in the second half of this year and allow us to achieve our corporate objective of establishing LymPro as the standard Alzheimer’s Blood Test in the industry by nurturing the market through its infancy as we prepare LymPro for FDA submissions.
• We are currently seeking counsel with our regulatory consultants regarding the appropriate FDA strategy, and expect to initiate a dialogue with the agency upon completion of the APP for LymPro. We are hopeful this dialogue will ultimately facilitate FDA approval for LymPro and catalyze market penetration.
• We have retained Boston Healthcare to assist us with our reimbursement strategy and believe we have developed a strong framework that will form the basis of a successful and sustainable reimbursement profile for LymPro.
• In summary, we have continued to make progress in recent months with our LymPro product development program and have put ourselves in a position to develop a meaningful commercialization and marketing partnership for our CLIA assay as we head into the second quarter of 2014. We will continue to update our shareholders of critical milestones as they are achieved, with the next milestones expected in the second quarter as we prepare the marketing process for LymPro’s commercialization in the US.
Blog #16.) 2H-2014: Milestones ahead to Position Amarantus for the Up-list
June 18th, 2014
• Our primary focus will be the data of the LP001 retrospective patient record study currently underway with our collaborator’s facility at Banner Sun Health Research Institute in Phoenix, AZ. We believe this data will be the most compelling for Key Opinion Leaders (KOLs) and pharmaceutical companies, our target market for the initial launch of LymPro, as this will provide longitudinal data regarding LymPro’s performance and diagnostic integrity.
• With regards to a partnership agreement to allow for the CLIA launch of LymPro in 2014, we are currently working through the intricacies of what such an agreement would entail. We have identified the laboratory that we believe has the technical know-how and marketing capabilities required for the launch of the LymPro Test both within the clinical trials setting to support pharmaceutical development, as well as a commercial launch under CLIA. We expect to be in a position to deliver definitive information to the marketplace over the summer. We believe the data to be released at AAIC and potentially the #C4CT Summit will increase the value of LymPro and give us additional leverage in negotiations. Following the release of this data, we intend to outline a forecast for LymPro revenues and market uptake in our second quarter earnings conference call that will provide the basis for financial projections.
Blog #19.) AAIC 2014 - Understanding the Data Being Presented - LymPro Test Ver. 2
July 9th, 2014
• The Company believes this Version 2 may improve upon certain critical principles established in Version 1, and make the diagnostic value of LymPro even higher than originally described.
• Combined, these four data sets could provide a strong rationale for moving solely to Version 2 of the assay which the Company believes would add tremendous value to LymPro’s diagnostic value.
• We believe AAIC represents a golden opportunity to let the scientific community know about LymPro’s advancements and that it will be on the market later this year (we are finding in our business development outreach that many research groups liked the concept in the Provista days, however lost track post-2008).
• We believe our approach of assessing an underlying aspect of disease biology and preparing for commercial-launch ahead of a major media push is the correct path so we can maximally capitalize on potential media attention, not only by an increase in the number of interviews I conduct, but most importantly by product sales.
• We will be first to market by years. This will allow us to appropriately establish a market for LymPro ahead of others and make LymPro the standard within the space.
• What is ultimately missing for cell cycle to takeoff as a significant ‘drugable’ target is a diagnostic that can identify cell cycle early-on in the disease process, and LymPro can fill that need as it is the most advanced cell cycle diagnostic test.
• We have noted recent interest in Alzheimer’s blood diagnostics from competing labs, and continue to believe that we have the most advanced diagnostic blood test in terms of commercial readiness due to the rigor we endeavored upon with Becton Dickinson, and scientific fundamentals.
• Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval.
Blog #20.) Understanding Data Presented at AAIC & Why Amarantus is Well Positioned Heading into #C4CT
July 17th, 2014
• Some may ask, “How will you get another clinical study completed by the end of the year in the CLIA lab, as is required to support submission?” The answer is that we are proving right now that we can execute under such timelines with the current study. . This is where the relationships and expertise and experiences of Dr. Kirby’s over 400 clinical trials are a huge advantage for Amarantus. We are establishing a well-oiled clinical organization capable of translating protocols to practice, and ultimately to data at a very rapid pace.
• We remain on track to complete the partnering process with our CLIA lab by the end of the summer, transfer the analytical process from BD to the target partner (a process that these organizations have completed extremely successfully several times), and achieve CLIA submission within our targeted timeframes. We believe the raw data for LymPro overwhelming demonstrates its validity even in suboptimal conditions, and now we are poised to move it to the main stage. We believe that by the time AAIC comes around in 2015, the data that we will be presenting will be the subject of significant oral presentations. We are excited with the progress made at this year and the credibility we have injected back into LymPro after rescuing it from PLS, and believe that we are very well positioned for the second half of 2014. LymPro has a bright future and we are happy to have brought it back to life for the benefit of patients and shareholders.
Blog #21.) #C4CT Wrap-up & the Decision to Present Interim LP-002 Data
August 4th, 2014
• We will now focus on completing the enrollment for LP-002 protocol and continuing preparations for commercial launch under CLIA.
• Our strategy was successful and we expect significant collaborations to emerge as a result.
• We are well positioned to continue forward with our LymPro program and remain on track to achieve our corporate objectives by the end of 2014.
Blog #23.) Initiating Studies for CLIA Launch at ICON Central Lab’s
Sept. 2th, 2014
• This morning we announced the initiation of CLIA-enabling studies at Icon Central Laboratories, a CLIA-certified laboratory that will serve as the facility that carries out the LymPro assay for CLIA launch.
• With this agreement, we also gain access to a global distribution network for LymPro, including central laboratories in Europe, Singapore, India and China that will allow LymPro to enter these new markets seamlessly through an already established distribution framework.
Blog #24.) Fundamental Milestones Ahead – Uplisting from Strength
Sept. 18th, 2014
• We entered into an agreement with Icon Central Laboratories that gives the Company access to a global distribution network for LymPro and positions us to begin marketing LymPro to the Research Use Only (RUO) in the fourth quarter – we began ‘soft marketing’ to pharma companies at the Alzheimer’s Association International Conference in July and can now definitively describe our path forward with Icon
• By the end of 2014 the Company anticipates: Completing the validation work at Icon to support LymPro’s launch
Blog #25.) Eltoprazine, LymPro and MANF: The Path Forward to Value Creation
Oct. 27th, 2014
• LymPro is our most advanced program, given that it is set to be commercialized in the very near future. We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use.
• LymPro is our most advanced program, given that it is set to be commercialized in the very near future. We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use.
• As we expect to soon derive value from our diagnostics division, we believe it will be important to replenish our pipeline with strategically positioned programs that have the potential to deliver significant return on investment for the company, as LymPro has.
Blog #26.) Amarantus Diagnostics Launching our First Product in the Neuro-diagnostics Market
December 22nd, 2014
• We believe the timing of this article is ideal, as our emerging diagnostics division, Amarantus Diagnostics, is ready to have a major impact in the field of biomarkers to diagnose Alzheimer’s disease, and potentially monitor drug response. The Bloomberg article focuses on tests with recently published data in peer-reviewed journals on their approach, and LymPro will be joining those ranks in 2015 following the announcement of the full LP-002 data set that will occur before the end of this year. LymPro is the only Alzheimer’s blood diagnostic with two independent peer-reviewed publications, and we intend to publish several additional articles on LymPro in 2015 predicated upon our clinically-derived data.
• As of today, we have completed the necessary analytical performance protocols required to confidently and reproducibly offer LymPro to the pharmaceutical industry, and we will now be able to offer this test to the pharmaceutical industry for use in their clinical development programs. This represents a major achievement for Amarantus, as we have achieved the critical milestone of commercializing LymPro in 2014, targeting our preset market: the pharmaceutical industry.
Note:
Commencing in January, 2015, Amarantus’s “Business Plan” changed once again to now include the newly acquired Georgetown University Blood Based Biomarker Assays into a newly formed Amarantus Diagnostics Division holdings. LymPro’s much touted ability to commercialize, attain CLIA certification, commence marketing, or earn revenue as provided by Amarantus between $100-Mil. to $150-Mil. via the IUO (Investigational Use Only) market place will now become masked by Amarantus’s ‘spinning off’ of the Diagnostics Div. The Diagnostic spinoff was supposed to have provided shareholder value and share price appreciation – but never really does.
Blog #27.) Amarantus Diagnostics
January 28th, 2015
• Under the terms of the agreement, we have been granted immediate access to the underlying data the lipid and exosome work, and will have the opportunity to analytically validate the assays at Icon Central Labs so that we can prepare for Investigational Use Only (IUO) and, thereafter, Clinical Laboratory Improvement Amendments (CLIA) launch while building the necessary corporate infrastructure for a standalone neuro-diagnostics franchise. The work we intend to perform during the option period will bring these technologies closer to commercial launch for the IUO market, so that when we exercise the option and complete the licenses, we will have a solid handle on analytical assay performance. Importantly, this agreement allows us to position Amarantus Diagnostics, our newly-formed, wholly-owned subsidiary, to the pharmaceutical industry and the institutional investor community as having cornered a huge part of the enormously attractive Alzheimer’s blood diagnostics market.
• We believe the size of the (diagnostic) market opportunity will eventually grow from the $150 million IUO market, to a potential $3 billion worldwide commercial market opportunity as we move from the IUO market (marketing these diagnostics to pharmaceutical companies for research only) to the CLIA market. Being first-to-market is the most important fight to win in this space. We believe in all AD blood diagnostic technologies described in this article for different reasons, and are convinced that by having the ability to answer a myriad of different questions in AD diagnosis with these technologies in parallel, pharma companies will give us a leg up vs. potential ‘one-trick pony’ competitors as we carve-out a leading position for ourselves in this emerging vertical. However, given that therapies for Alzheimer’s disease are still potentially several years away from reaching true game-changing potential that will justify a strong reimbursement profile, we recognize the near term limitations of the $150 million IUO market.
Blog #28.) Amarantus Shareholder Update: Fundamental Progress on the Pipeline Strategy Continues
March 26th, 2015
• The LymPro® Test for Alzheimer’s disease (AD), MSPrecise® for the diagnosis of multiple sclerosis (MS) and the NuroPro® diagnostic for PD make up our Diagnostics division. In addition, we have entered into an option agreement with Georgetown University for a license for two more diagnostic assays for AD, because we believe the combination of these two assays with LymPro will cement our position as a leader in the emerging field of Alzheimer’s blood diagnostics. Taken together with our diagnostics for MS and PD, we have positioned our Diagnostics division as one of the premier neuro-diagnostic companies in the world.
Some recent diagnostics development highlights include:
LymPro
• Announcing the availability of LymPro Test biomarker services for use by the pharmaceutical industry for IUO.
Blog #31.) Amarantus Shareholder Update: Fundamental Progress on the Pipeline Strategy Continues
March 26th, 2015
• The data presented by Amarantus today at the 2015 Alzheimer’s Association International Conference in Washington, DC is encouraging because it is consistent with the reference standard used in the diagnostic paradigm, Beach et al (2012). In the world of diagnostic development this is highly encouraging because a diagnostic test cannot be better than the standard against which it is judged. This is especially promising because Amarantus now has the opportunity to conduct additional work to by comparing the LymPro results against an FDA approved biomarker reference standard, amyloid PET imaging and that data. Stay tuned for more information about this promising blood test. Add on studies are being planned to compare it to the diagnosis of AD using amyloid PET, which will provide some concordance data that will drive the design of a confirmatory clinical validation study. The assay is available now for investigational use only.
Blog #32.) Improving Healthcare for Patients & Families: Believing in our Vision through Ups & Downs
November 6th, 2015
• Last week, the Company’s diagnostics team made good progress on the commercial launch plan for MSPrecise at a meeting we held in Dallas, TX. We are also continuing to evaluate the next set of studies to further enhance LymPro’s value by combining datasets with other markers, such as PET imaging. We have come to the decision that we will be focusing on the assets currently in the company, and will forego the option agreement with Georgetown University. With data coming up on the use of LymPro in Chronic Traumatic Encephalopathy that we recently completely enrollment for in Boston University’s DETECT study, we believe we have sufficient critical mass to make a very successful business from our current diagnostics portfolio and are now focused on the CLIA launch plans for these products. We remain on track to transact on the diagnostics division in the fourth quarter and will provide updates on this as progress is made. The Company is looking forward to the JP Morgan Healthcare Conference the week of January 11, 2016 as a key time to potentially make public announcements of definitive agreements.
• In closing, while the Company has gone through a difficult period, we believe the sheer strength of our portfolio will allow the Company to overcome the challenges we face. We believe we have a strong execution plan, with achievable milestones that will allow for growth. We believe the support of our shareholders at this time in our corporate history is paramount, and I look forward to working with our team to bring the tremendous portfolio of product candidates we have to market to help patients.
Gerald Commissiong - the pathological liar !!!
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