Specialty pharma firm Advicenne has signed a supply agreement with the pharmaceutical contract development and manufacturing organization (CDMO) Elaiapharm Lundbeck for the manufacturing of its lead product, with a view to its worldwide commercialization as a treatment for distal Renal Tubular Acidosis (dRTA).
 
Based in Sophia Antipolis, France, Elaiapharm is a wholly owned subsidiary of H. Lundbeck A/S. Under the agreement, Elaiapharm will secure manufacturing for the global commercialization of ADV7103, in accordance with cGMP requirements. This agreement is the result of an eight-year collaboration for the pharmaceutical process development of Advicenne’s lead drug candidate, ensuring an extensive knowledge of the product by Elaiapharm.
 
Alongside the manufacturing of batches for clinical trials conducted by Advicenne, Elaiapharm has scaled up the production process for commercial use and has produced multiple GMP batches.
 
ADV7103 is an innovative product with a prolonged-release formulation, designed to maintain sustained release over a twelve-hour period. The product was developed as a multi-particulate formulation in 2mm granules that contains two active pharmaceutical ingredients, to ease its administration in patients of all ages. This patented formulation combines state-of-the-art technology and the development of a substantial know-how for its manufacture. The experience of Elaiapharm is essential to ensuring that the 2020 commercial production of ADV7103 begins on schedule, and the agreement marks Advicenne’s planned evolution into an industrial and commercial pharmaceutical company.
 
“For years, our close working collaboration with Elaiapharm has pushed us past many challenges to make the innovative manufacturing process of ADV7103 a success,” said Caroline Roussel, co-founder and director of operations, Advicenne. “We are very pleased to continue working as a team with Elaiapharm. Their knowledge and high-quality industrial standards are a key advantage for the commercial production of our lead candidate.”
 
Bo Hilligsøe, senior vice president, pharmaceutical production, H. Lundbeck A/S, said, “The supply agreement is the result of a great collaboration between Advicenne and Elaiapharm. Both companies have invested significant resources and expertise in developing the manufacturing process for ADV 7103, and we are committed to support Advicenne in their efforts to successfully bring this new and innovative treatment to patients in an area of significant unmet need.”