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

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."

About Pierre Fabre:
Pierre Fabre is the 2nd largest private French pharmaceutical group and 2nd largest dermo-cosmetics laboratory in the world. Its portfolio is made of medical franchises (oncology, dermatology, pharmaceutical care) and leading dermo-cosmetic brands (Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, Pierre Fabre Oral Care…). In 2019, Pierre Fabre generated revenues of €2.4 billion, two-thirds of which came from international sales. Headquartered in the South-West of France, the Group employs some 10,400 people worldwide, owns subsidiaries or offices in 45 countries, and distributes its products in over 130 countries. 86% of the Pierre Fabre group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. In 2019, Ecocert Environment assessed the Group's CSR approach in accordance with the ISO 26000 sustainable development standard and awarded it the Ecocert 26000 "Excellence" rating. For more information, please visit www.pierre-fabre.com

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our global network spans the U.S., Europe and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 1,600 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice.