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Multiple Achievements
in Recent Years

Dialysis is a lifesaving treatment, but also exerts adverse effects on different organs, such as the cardiovascular system.

Peritoneal Dialysis has better survival outcome during the first 3 to 5 years, but this therapy is limited in time, due to peritoneal fibrosis. Therefore, the WHO and Western health authorities recommend starting dialysis treatment with PD and switching to HD as peritoneal ultrafiltration efficacy attenuates.

PD shows better survival rates for ESRD patients
hd_pd_diagram
Source: Annual Data Report, USRDS 2020, End Stage Renal Disease: Chapter 5
PD reduces body fluid and uremic toxins through an osmotic driver. In current PD solutions, the glucose is present at relatively high osmotic pressure. Furthermore, glucose itself represents a metabolic challenge.

Opterion applies different strategies to reduce different side effects of PD:

  • Reducing osmotic pressure during PD dwells without compromising ultrafiltration efficacy.
  • Eliminating glucose from PD solutions to avoid metabolic syndrome.
  • Decrease cytotoxicity of PD solutions to the peritoneum, reducing fibrosis, with the goal to prolong PD treatment time.
  • Clinical studies will show whether the Opterion PD solution may also reduce systemic inflammation.

Osmotic Driver (ODR):

  • Opterion develops a new osmotic driver for PD (Opt100), composed of short glucose polymers (~5kDa) and maltose. Opt100 can be applied for short and long dwells1. Different Opt100 concentrations allow to adapt Ultrafiltration efficacy, comparable to glucose-based PD solutions. But Opt100 contains less than 0.1% glucose1, thereby representing less or no metabolic challenge as compared to current PD treatments.
  • Opt100 is the first osmotic driver allowing all dwells of a PD patient to be run by a glucose free PD solution (reduced metabolic challenge).
  • All ODR components have previously been applied in humans at very comparable concentrations with no tolerability issues.
  • Opt100 manufacturing and toxicology studies to be established in 2020/21.
  • Manufacturing partners for preclinical and clinical trials supply engaged.

    1 Grentzmann & Steinhauer 2018, WO2018146345 (A1)

 

Biocompatibility-enhancing Agent (BCA):

  • Cell-culture of primary human peritoneal mesothelial cells show decreased cytotoxicity of PD-solutions in presence of different stilbenoids, including Resveratrol2.
  • Resveratrol reduces vascular endothelial growth factor (VEGF) in a rat PD model2.
  • Stilbenoids are solubilized and stabilized by saccharide containing solutions such as Opt1003.
  • Resveratrol is an established food additive and has GRAS* status in the USA.

 

  • 2 Grentzmann 2017, WO2017013120 (A1)
    3 Grentzmann 2017, WO2017013121 (A1)
    * GRAS: generally recognized as safe

Formulation for ODR1 & BCA2

1New Osmotic Driver; 2Biocompatibility Enhancing Agent

Animal studies on increased Ultrafiltration efficacy of ODR

Cell & Animal studies on decreased cytotoxicity and inflammation on BCA

API3 specifications for ODR & BCA

3Active Pharmaceutical Ingredient

Trial designs and budgeting completed

Manufacturing partners for preclinical and clinical trials supply

Internal genomic analysis identified new PD4 markers (supports patent strategy)

4Peritoneal Dialysis

Positive EPO5 feedback on ODR & BCA patent applications:
- 2 patents granted in Japan
- 1 patent granted in Australia

Opterion obtained SME Status at EMA6

6European Medicines Agency

Marc Willuhn

Head of CMC
Marc Willuhn joined Opterion in January 2023 as Head of CMC. Marc has more than 20 years of experience in drug development for global markets. He has an outstanding track record in pharmaceutical product development, resulting in several approved products. Marc held senior leadership roles at Fresenius Kabi and Baxter Healthcare before founding his own company in 2018, providing technical and strategic consulting services to life sciences companies. Marc holds a master’s degree in chemistry (Gerhard-Mercator-University Duisburg, Germany) and a PhD in organic chemistry from the Max-Planck-Institute for Coal Research in Mülheim/Ruhr, Germany. He completed postdoctoral studies at the Faculté de Pharmacie in Paris, France, and also holds an MBA.

Ulrike Grimm

Head of Project Management

Opterion Health engaged Ulrike Grimm in June 2020 to establish project excellence for its development program.

Ulrike started her career as a sales representative for Sanol Pharma and joined Merck KGaA in 1997, where she held roles of increasing responsibility starting as team leader for R&D projects and continuing as product leader for Merck’s second commercial oncology drug.

From 2007 to 2010 she was the Vice President of Project and Portfolio Management at Fresenius Biotech. Ulrike joined Vifor Pharma in 2010 and served as the Vice President for Project and Alliance Management as well as Clinical Operations during the next eight years. In 2019 Ulrike started her own consulting company Pro2S AG.

Peter Reinemer

Chief Executive Officer

Peter Reinemer, PhD, MBA, has been appointed as Chief Executive Officer (CEO) of the company as of February 2023. He joined Opterion in July 2021 as Chief Technology Officer (CTO) and will assume this position in addition to his new role for the time being.

Peter has more than 30 years of experience in the pharmaceutical and biotechnology industries, and began his career at Bayer Pharma, where he spent over 10 years in discovery research in Germany and Japan. He subsequently served as Chief Scientific Officer, Head of Business Development, Chief Operating Officer and Senior Vice President, Corporate Development, of Proteros, a discovery services company based in Munich and Boston. He co-founded IMD Natural Solutions, developer of the all-natural preservative agent Nagardo®, which was acquired by Lanxess AG in 2017. Peter holds a Master in Chemistry, a PhD from the Max Planck Institute for Biochemistry/TU Munich (Structural Biology, Prof. Dr. Robert Huber), and an MBA.

Mylène Fleurant

Head of Quality

Mylène Fleurant joined Opterion Health in July 2021 as Head of Quality having spent more than 20 years in leading quality (QA) functions in the life sciences industry. She worked for 10 years as Region Head Quality Europe at Novartis and implemented global quality systems at Merck Serono. Prior to founding her own consulting company in 2019, Mylène was Global Head of QA at Novimmune and VP Quality Affairs at Alvotech.

Mylène is a chemical engineer and holds a master’s degree from the University of Sherbrooke, Canada, as well as a degree in Quality Assurance Management from L’Ecole de Technologie Supérieure (ETS) at the University of Quebec.

Daniel Lustenberger

Chief Financial Officer

Daniel Lustenberger is an experienced international finance, accounting and management consulting professional and joined Opterion Health in September 2021 as Chief Financial Officer (CFO). He is a Swiss Certified Public Accountant, holds an Executive MBA from IMD in Lausanne and has 20 years of life sciences and technology experience.

Daniel supports several start-ups and growth companies, particularly in the life sciences and high tech sectors, as a part-time CFO, business advisor and board member.

Prior to Opterion, he held senior finance positions with Vifor Pharma, Gategroup and DKSH. In his early career, he spent several years with PwC, providing advisory services in M&A, IPOs, process and system improvements, corporate governance and risk management.

Jan Anders Karlsson

Board Member
Dr Jan-Anders Karlsson, PhD, has 40 years of experience as a CEO and board member in pharma and biotech companies in Europe, Asia and the US. Jan-Anders was a founder and CEO of Reset Pharmaceuticals Inc, and prior to this served as CEO of Verona Pharma, a NASDAQ-listed biopharmaceutical company developing respiratory drugs. As CEO of S*BIO Pte Ltd, he focused on the discovery and development of drugs for the treatment of cancer – its product Vonjo (pacritinib) is approved in the US. Prior to S*BIO, he was Head of Pharma Global Research at Bayer Healthcare AG and held positions in Rhone-Poulenc Rorer and Astra AB. Jan-Anders received a doctorate in Medical Science (PhD) in Clinical Experimental Pharmacology from the University of Lund, Sweden.

Andreas Schmidt

Board Member

Andreas Schmid has more than 25 years of experience in Finance in the Life Sciences. He worked as a Pharma Analyst at Merrill Lynch and also has experience in fund raising as well as business development.

During the span of his career Andreas was one of the highest-ranked dialysis and generic pharma analysts, with special expertise in European and CEE/emerging markets. His coverage universe included companies such as Fresenius/FMC (Germany), Gambro (Sweden), Stada (Germany) and Aspen (South Africa). Furthermore, he played a major part in the IPOs of Zentiva (Czech Republic) and Hikma (Jordan). Andreas has also been active as a speaker at various industry conferences, for example in New York, Frankfurt, but also in Warsaw and other Eastern European countries.

In addition, Andreas works as finance lecturer at the Hochschule Pforzheim and is a board member of the German shareholder association SdK.

Ricardo Cordero

Vice Chairman
Dr Ricardo Cordero, PhD, serves as Vice Chairman of Opterion Health since 2016. Ricardo has over 30 years of experience in the Financial Services Industry where he held various senior positions, for example as CEO of BZ Bank, Managing Partner at Reichmuth & Co Investmentfonds AG, Co-founder and Co-CEO at BWO Bank, etc. Further, he is a passionate and experienced private Swiss investor and holds various investments in the Life Science, Technology and high-end Consumer Goods industry.

David Ebsworth

Chairman
Dr David Ebsworth, PhD, has been Chairman of Opterion Health since December 2016. David has over 40 years of experience in the Pharma, Healthcare and Biotech industry. David is a past CEO of Galenica, Vifor Pharma as well as Oxford GlycoSciences and past global head of the Pharmaceutical Division of Bayer. He has chaired several private and public companies and has served on numerous boards as either chairman of the audit, remuneration or nominations and governance committees. David is currently Chairman of Verona Pharma and Actimed Therapeutics.

Guido Grentzmann

Founder / CSO
Dr Guido Grenzmann, PhD, is the founder of Opterion Health and has more than 25 years of experience in Pharma R&D and Project Management. After academic work on bacterial and viral mechanisms of translational regulation, he became Group Leader Molecular Biology/Genomics at Pfizer and Director Biochemistry/GeneProfiling at Altana Pharma where he worked in Discovery of inflammation in respiratory diseases. In 2007 he founded PBS PharmaBioServices providing contract research and consulting mainly in inflammatory diseases, in multiple therapeutic domains. 2012, Guido founded Opterion, with the aim to develop a new PD solution, to decrease side-effects of this promising therapy.