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To provide scale-up and manufacture of clinical batches of Macuneos
October 24, 2016
By: Kristin Brooks
Managing Editor, Contract Pharma
BIOPHYTIS, a biopharma company specializing in drugs to treat age-related diseases, has entered into an agreement with Patheon for the industrial scale-up and manufacture of clinical batches for a Phase IIB trial for drug candidate Macuneos in AMD (age-related macular degeneration). Macuneos is a drug candidate against the dry form of AMD, which affects the central part of the retina, called the macula, causing severe visual impairment and irreversible loss of central vision. Macuneos works to protect retinal pigment epithelium by reducing the accumulation of A2E, and eventually slowing the degenerative process of the retina. Patheon will provide industrial scale-up and manufacture of Macuneos clinical batches for use by BIOPHYTIS for the Phase IIB study to be launched in Europe and the U.S., once regulatory approvals have been obtained. Stanislas Veillet, chief executive officer of BIOPHYTIS, said, “We are very pleased to outsource the production of Macuneos to such an internationally recognized actor. This is the first stage of the MACA clinical program dedicated to treat dry AMD, a pathology with no therapeutic solution on the market so far. Our whole team is dedicated to the success of the MACA clinical project, a strategic axis of development for BIOPHYTIS.”
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