Pharma Focus Asia

Pierre Fabre Selects AGC Biologics as CDMO to manufacture the orphan drug ER-004

Tuesday, December 22, 2020

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004 – an intra-amniotic drug that will pioneer the treatment of a rare and debilitating genetic disorder. AGC Biologics will manufacture GMP material for the next stage of clinical trial.

"We are very pleased that Pierre Fabre has entrusted us with the manufacture of this product," says AGC Biologics Chief Business Officer, Mark Womack. "We are really looking forward to seeing this treatment go to the market."

Pierre Fabre has entered into a development and license agreement with the Switzerland-based EspeRare Foundation on ER-004, a fusion protein involved in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disorder affecting ectodermal structures including sweat glands, respiratory glands, skin, hair, and teeth. Clinical manifestations of XLHED are severe and can include severe episodes of hyperthermia, heat intolerance, and an increased risk of serious respiratory tract infections. Delivered through intra-amniotic injections during the late stage of pregnancy, ER-004 shows significant potential in inducing the growth of affected ectodermal structures, resulting in normalized sweat gland function.

Jean-Jacques VOISARD, General Manager of Pierre Fabre Dermatologie said, "We are delighted to entrust the production of the ER-004 product's drug substance to AGC Biologics, a company with a particularly strong and robust experience in the manufacturing of biologics. Their contribution will be instrumental in the success of a therapeutic project aiming at changing the lives of children affected by this rare and debilitating disease."

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