News & events
05-07-2011 Cml selected by summit corp
Cambridge Major Laboratories Europe Selected to Support Summit’s “Superbug Antibiotic” Clostridium Difficle Programme
Weert, The Netherlands (June 27th 2011) – Cambridge Major Laboratories Europe (CMLE), a leading supplier of chemistry services supporting drug substance development, has been selected by Summit Corporation plc (Summit) to provide solid state studies and manufacture cGMP material for use in clinical studies for preclinical development candidate SMT 19969.
Summit recently announced the selection of SMT 19969 as the preclinical development candidate in its programme developing new antibiotics that target infection caused by the hospital ‘superbug’ Clostridium difficile (‘C. difficile’).
“We were impressed with the expertise and responsiveness of Cambridge Major, in particular their understanding of key project drivers and the regulatory environment around the compound,” confirmed Dr. Richard Vickers, Associate Director and Principal Investigator on the programme for Summit.
“We look forward to working with Summit to support an aggressive project development timeline,” commented Roger McDonald, European Business Development Director for CMLE. “This is a Wellcome Trust-funded programme and it is important to have a clear, risk-managed focus on delivery to ensure Summit is able to achieve their milestones as quickly as possible. A key aspect of how we manage such first-time scale-up programmes is the ability to perform crystallization & polymorph screens in parallel with process chemistry. This approach is extremely efficient and manages risk very effectively.”
SMT 19969 is currently in formal preclinical development studies, the successful completion of which will enable it to enter human clinical trials. Summit anticipates submitting an application to regulatory authorities to commence clinical trials in Q3 2012.