21 June 2011 - 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”.