Press Release | February 13, 2023

Minapharm Pharmaceuticals receives regulatory approval from the Paul-Ehrlich Institute for a phase 1 multi-center clinical trial in Germany for its Adalimumab biosimilar

Cairo, February 13, 2023; Minapharm Pharmaceuticals and Chemical Industries S.A.E announced today the unconditional approval of a phase 1 clinical trial for its Adalimumab biosimilar through the Paul-Ehrlich Institute (PEI) and the responsible ethical committee. The product has been submitted for approval by the Egyptian health authorities and is expected to be marketed under the name Adessia.

The approved study is a multi-center, randomized, double-blind, 2-arm, parallel group trial in 154 healthy male and female participants. It compares the pharmacokinetics, safety, immunogenicity and tolerability of the Adalimumab biosimilar, Adessia, and its reference product Humira®. First dosing will occur in February 2023 and results from the study are expected by the end of this year.

Adessia represents the first biosimilar monoclonal antibody product from Minapharm’s impressive immunotherapeutic pipeline subject to international clinical development.

“The approval of Adessia’s clinical trial in Germany by the PEI comes as a continuum to Minapharm’s two decades of research, development and commercialization of genetically engineered medicines, further validating Minapharm’s regional biotech leadership and the group’s position as a global Biotech player.” said Dr. Wafik Bardissi, CEO and Chairman of the Board at Minapharm Pharmaceuticals.

Dr. Jan Rohde, Director R&D Operations and Project Management at Minapharm Pharmaceuticals added, “The achievement of enrollment of first participants into this study marks a significant milestone. The initiation of this clinical trial strengthens Minapharm’s commitment to improve the lives of patients in Africa and beyond suffering from serious chronic or life-threatening diseases through affordable high-quality biosimilars.”

About Minapharm Pharmaceuticals Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the premier biopharmaceutical company in Africa with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex genetically-engineered proteins, with an impressive immunotherapy pipeline. Together with its wholly owned Berlin-based subsidiary, ProBioGen, Minapharm has established an integrated business model making it to-date the only gene-to-market biopharmaceutical company in the region. Minapharm employs a collective workforce of over 1400 and is listed on the Cairo and Alexandria stock exchange (Symbol: MIPH). For more information on Minapharm and its products please visit Minapharm Pharmaceuticals and Migentra Egypt