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A novel approach of organ preservation using anti-necrosis agent before transplantation.

Periodic Reporting for period 1 - ELAPHARMA (A novel approach of organ preservation using anti-necrosis agent before transplantation.)

Okres sprawozdawczy: 2019-09-01 do 2019-12-31

Organ shortage is the greatest challenge in the field of organ transplantation. In Europe, 18 persons die every day waiting for transplants and a new patient is added to the waiting list every 10 minutes. Yet each year, a great many organs are wasted because of logistical constraints that could be overcome by organ preservation advances. After removal, organs can only be kept alive for a short period of time (<24h) and insufficient preservation places important logistical limitations. Organs cannot travel long distances severely limiting global transplantation access. Medical staff have only little room to adapt procedures to circumstances or deal with complications with poor outcome to patients. And there is an important cost due to fast delivery and on-the-call surgery reaching as high as €115 000 per patient. To address this challenge ElaPharma has come with a new solution: A small additive molecules inhibiting an intracellular enzyme involved in organ necrosis during preservation. Intended for flushing organs at the time of removal from the donor for storage and transportation, ElaPharma successfully maintain some implants organs (lung and skin) for more than 24h, suppressing all supply constraints to organ replacement. After confirming its technical and commercial feasibility, ElaPharma will reach market thanks to EIC Accelerator by: 1) Optimizing molecule for organ preservation; 2) Elaborating molecule formulation; 3) Processing to pre-clinical and; 4) clinical validation; 5) commercializing the product by a comprehensive dissemination-communication. We will use a B2B strategy with a joint venture with an important company to scale up it expansion. Market launch is expected for 2023, with €83.1M revenue accumulated by 2027 while contributing to increasing organs availability, saving lives to people in need of transplantation.
During the last four months (September-December 2019) ElaPharma staff have worked hard to perform a comprehensive feasibility study supporting:
a. The technical feasibility of ElaPharma - we have defined a complete Roadmap, Execution Plan and Risk Analysis, which comprises all the necessary activities to scale-up ElaPharma from lab to industrial production. This includes 1) all technical aspect to reach ElaPharma TRL8; 2) the regulatory strategy plan for obtaining marketing clearance/approval and 3) possible measures for scale-up production were identified.
b. The economic feasibility of ElaPharma with foreseen sales of 184,750 Units of solution (1 Litres bags) and a 21% of global transplantation (conservative scenario). Overall this would translate into €13.4 million net profit accumulated by our company in the 5 years post-market launch (2023-2027) and a payback period of 2 year post-commercialisation (by 2025).
c. The commercial feasibility of ElaPharma, providing a clear roadmap to follow for a successful commercialization, communication and dissemination during the project and beyond. Phase 1 has allowed identifying key mitigation contingency procedure to ElaPharma regulation and has allow to draw a preliminary strategy for communication and dissemination. Furthermore we have identified key partners that would foster our commercial development (e.g. Biological Industries, PharmaHungary). Phase 1 has also allowed to: a) confirm by a FTO assessment that no patents block ElaPharma commercial development; b) plan the intellectual property strategy and; c) identify the dissemination and distribution channel instruments for a successful commercialization.
a. Tackling the organ shortage and saving lives by increasing the global access to transplantation. This could potentially save millions of lives in the coming years. Today, there is a high amount of donated organs wasted due to the lack of time during transportation. 80% of hearts from organ donors currently goes un-transplanted. Successfully transplanting just 10% of them would provide organs for all of the current heart waitlist patients who do not receive a new organ in time.
b. Reducing the cost for transplantation. Organ procurement and transport averages around €90 000 per patient due to round-the-clock fast delivery (fast jet or helicopter flights) and on-call surgery. Post-transplant outcomes and complications due to extra time limit for additional laboratory test (serology, HLA matching…) before transplantation reach €115 000 per patient. ElaPharma i) eliminate the need for costly jet and helicopter flights to immediately transport; ii) reduce the need for on-call surgical staff and operating and; iii) Reduce readmission for complications by increasing transplant efficacy.
c. A new way to treat necrosis-related disease. Ela Pharma is a company engaged in the development of innovative drugs that address clinical conditions caused by necrosis. The drug development process is based on a new and ground-breaking platform for Anti-Necrosis Technology. Not only anti-necrosis agent can increase the duration of organ but also be applied in numerous other sectors. We expect ElaPharma to also open new markets in the prevention and treatment of necrosis as it is significant to the therapy of numerous pathological conditions and diseases such as Myocardial Infarction, Ischemic diseases, Brain stroke, Traumatic Brain Injury and Neurodegenerative Diseases, Liver failure, Chronic Hepatitis, Pancreatitis and Acute Macular Degeneration which may represent a global market opportunity of €240 billion.
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