RhuDex (AV 1142742) / Active Biotech, Dr Falk, Medigene - LARVOL DELTA

Results from a phase 2a trial with the CD80 antagonist RhuDex as a second line treatment for primary biliary cholangitis (EASL-ILC 2024) - "Background and Aims: About one third of patients with primary biliary cholangitis (PBC) present with a suboptimal response to ursodeoxycholic acid (UDCA) and require additional second line therapy. This trial did not show statistically significant or clinically relevant differences between RhuDex and placebo treatment. Higher AE frequencies were observed in the RhuDex groups. In this trial RhuDex did not contribute to potential second line therapies in PBC."

Clinical • P2a data • Dermatology • Fatigue • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus • CD80 • TNFA

Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis Klinikai vizsgálat a RhuDex granulátum hatékonyságának és biztonságosságának placebóval való összehasonlítására a primer biliaris cholangitis májbetegség kezelésében (clinicaltrialsregister.eu) - P2; N=136; Ongoing; Sponsor: Dr. Falk Pharma GmbH

Clinical • New P2 trial • Hepatology • Immunology • Primary Biliary Cholangitis

MediGene receives authorization for the clinical formulation study of RhuDex (MediGene) - MediGene announced that United Kingdom Medicines & Healthcare Products Regulatory Agency (MHRA) granted authorization of the planned clinical formulation study of RhuDex, a drug candidate being developed for treatment of RA

Pipeline update • Regulatory • Immunology • Rheumatoid Arthritis

Corporate Presentation (MediGene) - Anticipated initiation of P2 POC study for several autoimmune diseases in 2012/2013

Anticipated new P2 trial • Immunology

Inhibition of B7-1 (CD80) by RhuDex reduces lipopolysaccharide-mediated inflammation in human atherosclerotic lesions. (PubMed) - "The present data support B7-1 alone as an important costimulatory molecule in the context of LPS-mediated inflammation in atherosclerotic lesions. Due to its marked inhibitory effects, RhuDex may be a useful therapy to modulate the inflammatory milieu in atherosclerosis."

Journal • Acute Coronary Syndrome • Atherosclerosis • Biosimilar • Dyslipidemia • Immunology • Inflammation

Medigene: Corporate Presentation (MediGene) - Anticipated initiation of P2 trial for primary biliary cirrhosis in H1 2014

Anticipated new P2 trial • Immunology

Active Biotech AB Interim Report January - September 2010 (Active Biotech) -

RhuDex - preparations for continued clinical development in progress

Pipeline update

Medigene: Corporate Presentation (MediGene Press Release) - Anticipated data from P2 trial for primary biliary cirrhosis by end of 2015

Anticipated P2 data • Immunology

Active Biotech AB Year-end Report January - December 2010 (Active Biotech) -

Preclinical studies of Rhudex aimed at optimizing clinical development program were completed during 2010; Clinical development of RhuDex for RA is in progress & fully financed by Medigene;

Immunology

RhuDex: Anticipated approval in US, Europe and Japan in 2024 (MediGene) - Annual Report 2016

European regulatory • Japanese regulatory • NDA • Immunology

Medigene: Annual Report 2013 (MediGene) - Anticipated patent expiry of choline salt in EU in 2027; Anticipated patent term extension in EU until 2032 

Anticipated patent expiry • Immunology

Medigene: Corporate Presentation (MediGene) - Anticipated patent protection on compound family until 2024; Anticipated patent protection on salt until 2027; Anticipated extension of patent protection until 2032

Anticipated patent expiry • Immunology