Quotient Clinical, a business unit of Quotient Bioresearch (Quotient), today announced an agreement with MediGene AG (MediGene), the German biotechnology company, to undertake a RapidFACT™ formulation development and clinical testing program on RhuDex®, subject to ethical and Medicines and Healthcare products Regulatory Agency (MHRA) approval. Rhudex® is a new potential first-in-class treatment for rheumatoid arthritis and other inflammatory disorders.
Quotient Clinical’s RapidFACT service exploits its tightly integrated GMP manufacturing and clinical testing processes and facilities to enable the rapid clinical evaluation of new drug formulations. Compared to conventional development processes, RapidFACT enables shortening of project timelines, and a reduction of ~90 per cent in API consumption, which combine to deliver significant cost savings. MediGene will use the drug formulation selected in this program as the basis for the further clinical development of RhuDex®.
Mark Egerton, MD Quotient Clinical, commented: “We are delighted to be working with MediGene to advance RhuDex® to the next stage of clinical development. RhuDex® targets a novel mechanism and has the potential to become a new first-in-class therapy for rheumatoid arthritis. RapidFACT has now been employed across a wide selection of development projects, and we have secured strong data to validate the time and cost savings benefits that can be delivered to development project teams”.
For more information on Quotient Clinical, please call UK +44 (0)115 974 9000, USA – 1-800-769-3518, email
or visit www.quotientbioresearch.com/clinical.
About Quotient Clinical
Quotient Clinical is a leading provider of early development services. Its Translational Pharmaceutics™ platform offers a unique and streamlined process to reduce the time from First-in-Human studies to Proof-of-Concept by integrating flexible drug product manufacture into clinical trials.
Drug product formulations can be efficiently optimised for downstream development using the RapidFACT™ service (Rapid Formulation development And Clinical Testing) in a process that significantly shortens timelines and saves significant money.
14C clinical studies can be provided as a fully integrated service using the flexible Synthesis-to-Clinic™ platform. Synthesis-to-Clinic enables all the processes involving 14C drug products, from synthesis of the 14C labelled drug molecule through to conduct of human clinical trials, to be undertaken with a single vendor and a single project manager throughout, delivering significant time and cost savings.
With a strong customer base across the United States, Europe and Japan, the goal of Quotient Clinical is to provide a unique and comprehensive range of early development services to pharmaceutical and biotechnology customers.
Quotient Clinical is a business unit of Quotient Bioresearch.
About Quotient Bioresearch
Quotient Bioresearch is a leading provider of early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients worldwide. The company offers a unique range of drug development service through its three business units – Chemistry and Metabolism, Bioanalytical Sciences and Clinical. Quotient has grown rapidly in the past three years through a combination of both acquisition-led and organic growth.
For further information: www.quotientbioresearch.com
MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. MediGene is the first German biotech company to have revenues from marketed drugs. It has various drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases.