Provence Technologies and Neuroptis Biotech have announced the further strengthening of their collaboration for transferring the chemical development of Neuroptis Biotech’s drug candidate, ML7, and producing the first GMP batches before the end of 2012.
ML7 is a drug candidate for the treatment of dry eye syndromes. It is the first of a new therapeutic class and has the potential to provide a targeted and effective therapeutic remedy for the millions of people suffering from dry eye syndrome, Gougerot-Sjogren syndrome and inflammations, especially ones caused by allergies.
Provence Technologies and Neuroptis Biotech have already collaborated successfully in developing a synthetic pathway for ML7, manufacturing the first non-GMP batches and devising associated analytical methods.
The two companies have embarked on the process optimization phase to facilitate the transfer of the compound and the start of production on an industrial scale, scheduled for September this year.
“Our know-how in the area of organic synthesis, process development and the management of fine chemistry projects enabled us to handle the chemical development of this drug candidate and produce the first batches of ML7, thereby enabling Neuroptis to begin initial formulation tests,” said Provence Technologies’ chief operating officer, Dr. Babak Sayah.
Dr. Sayah continued, “Our involvement and our tough requirements for undertaking our clients’ projects are strictly the same as those we impose on ourselves for taking our own research and development programs to the commercialization stage.”
“The ML7 development program is a priority for Neuroptis,” said Neuroptis Biotech’s chairman, Dr. Eric Belot. “Our collaboration with Provence Technologies has enabled us to have the first batches of ML7 not only on time but also to a level of purity that means we can proceed to the formulation and toxicity study stages with greater confidence. We have found in Provence Technologies a highly professional partner that has succeeded in managing the project efficiently while keeping us regularly informed with a high degree of transparency during the whole development process.”
Provence Technologies will be participating in Chemoutsourcing at Long Branch, NJ, from 10 to 13 September 2012.