Cambrex to develop process for Evolutec's rEV131
Evolutec Group, a biopharmaceutical company engaged in developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, has signed an agreement with Cambrex BioScience, of Baltimore, to manufacture rEV131, Evolutec's lead compound, for Phase III clinical trials and planned marketing.
Evolutec Group, a biopharmaceutical company engaged in developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, has signed an agreement with Cambrex BioScience, of Baltimore, to manufacture rEV131, Evolutec's lead compound, for Phase III clinical trials and planned marketing.
rEV131 has been manufactured to date according to Good Laboratory Practice (GLP) standards for the Phase II clinical trials planned for 2005 in allergic rhinitis and post-operative cataract surgery. The current GLP process produces good yields of rEV131.
The agreement with Cambrex covers process development work, during which Cambrex will develop a robust, scaleable, current Good Manufacturing Practice (cGMP) process for purified rEV131, with the goal of optimising the process yield. The agreement then provides for Cambrex to scale-up the cGMP process.
Mark Carnegie Brown, Evolutec's chief executive, said: 'This agreement, with a market leader, represents a significant endorsement of Evolutec's core asset rEV131 and serves to support planned clinical trials and marketing.'
Steven Klosk, chief operating officer, Cambrex Biopharma business, commented: 'We are pleased that Evolutec has selected Cambrex for the manufacture of its lead compound rEV131. Our extensive experience developing scaleable processes and dedication to quality will be key features of the project's success. We look forward to working on this exciting new therapeutic.'