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.

Bioventure, Minapharm Pharmaceuticals and MiGenTra Sign an Exclusive Agreement for the Commercialization of Multiple Biosimilar Candidates of Alvotech in the Middle East and Africa

Bioventure, a Dubai-based pharmaceutical company, Minapharm Pharmaceuticals, a Cairo-based pharmaceutical company, and MiGenTra GmbH, a Berlin-based pharmaceutical company, announced today the signing of an exclusive license agreement for the commercialization of multiple biosimilar candidates developed and manufactured by Alvotech, in Egypt and eighteen additional countries in Africa and the Middle East (the "Territory").

Minapharm Pharmaceuticals Announces the Successful Completion of its Phase 1 Clinical Trial in Europe for its Recombinant Teriparatide, Bonosome.

Minapharm Pharmaceuticals announces the successful completion of the phase 1 clinical trial in Germany evaluating its Teriparatide Biosimilar, Bonosome, a recombinant formulation of endogenous parathyroid hormone (PTH) injection indicated for mild to severe osteoporosis. This achievement marks the first African biosimilar to succeed in a European clinical trial, with an aim to enhance African self-sustainability and provide innovative, quality and affordable medicines to the region.

ProBioGen and Minapharm Pharmaceuticals incorporate MiGenTra GmbH – A Healthcare Transforming Medicines Company

ProBioGen and Minapharm Pharmaceuticals announce the incorporation of ProBioGen's subsidiary "MiGenTra" with headquarters in Berlin and access to a site in Cairo, which will house its principal manufacturing plant. The formation of MiGenTra accelerates ProBioGen's 2030 growth roadmap and showcases that further growth is not limited to the ongoing capacity increase but reveals one of several significant steps in the diversification of ProBioGen's business.

BioGaia Signs Exclusive Agreement in Egypt

BioGaia has signed an agreement with Minapharm Pharmaceuticals for the exclusive rights to sell BioGaia Protectis drops in Egypt. The probiotic will be sold under the BioGaia brand. Launch is planned to Q4 2021.

RDIF and Minapharm Agree to Produce over 40 Million Doses of the Sputnik V Vaccine in Egypt

Moscow/Cairo/Berlin, April 22, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), Egypt’s Minapharm, the regional leader in recombinant DNA technology, and its Berlin-based subsidiary ProBioGen AG announce the agreement to produce over 40 million doses per year of the world’s first registered vaccine against COVID-19, Sputnik V.

Minapharm Announces the First of its Kind Approval from the German Regulatory Authority BfArM to Conduct a Phase 1 Clinical Trial of a Biosimilar Developed in Egypt and the Region

Minapharm Pharmaceuticals S.A.E has announced today that the German regulatory authority BfArM (Federal Institute for Drugs and Medical Devices) approved a phase 1 clinical trial for its biosimilar teriparatide in Germany. The product has been submitted...