Insulin Glargine(Boehringer Ingelheim)

EVA Pharma, DNA Script and Quantoom Biosciences signed the MoU. Credit: © 2022 Eva Pharma All Rights Reserved. EVA Pharma of Africa, DNA Script and Quantoom Biosciences have signed a memorandum of understanding (MoU) to establish the first digital-to-biologics, end-to-end mRNA production platform in Egypt. It will focus on the production of nucleic acid-based vaccines and therapeutics. The platform integrates technologies from all partners. French company DNA Script will contribute its enzymatic DNA synthesis technologies, while Quantoom of Belgium will bring its Ntensify mRNA synthesis and Ncapsulate formulation technologies to the table. EVA Pharma will leverage its expertise in vaccine development, GMP [good manufacturing practice] sterile manufacturing and commercialisation. The partnership aims to provide a quick response to outbreaks of infectious disease and routine immunisations. Aiming to produce 100 million doses of RNA-based vaccines every year, this partnership aligns with Africa Centres for Disease Control and Prevention’s (Africa CDC) goal of 60% local vaccine production by 2040. It also supports Egypt’s target of producing 385 million vaccine doses every year by 2030. The initiative will focus on self-amplifying RNA (saRNA)-based vaccines for both human and animal health, employing a One Health approach to bolster defences against zoonotic diseases. The initiative was announced on the sidelines of the second Vaccine and Other Health Products Manufacturing Forum for African Union member states. Africa CDC organised the forum and the Egyptian United Procurement Authority hosted it. By leveraging their combined expertise, the partners aim to deliver scaleable and impactful healthcare solutions in the country and beyond, enhancing regional pandemic preparedness. EVA Pharma CEO Dr Riad Armanious stated: “Our cross-continental collaboration will empower patients with next-generation, scaleable and versatile solutions that transform what once took years into a process achievable in weeks.” The development follows an announcement in December 2024 when EVA Pharma and Eli Lilly received approval from the Egyptian Drug Authority for the human insulin glargine injection, designed to treat patients with type 1 and type 2 diabetes.

The collaboration of Lilly and EVA Pharma began in 2022 to provide affordable insulin. Credit: © 2022 Eva Pharma All Rights Reserved. Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection to treat type 1 and type 2 diabetic patients. EVA Pharma manufactures the injection in partnership with Lilly. The collaboration, which began in 2022, aims to provide quality, affordable insulin to a minimum of one million type 1 and type 2 diabetic individuals in low to middle-income countries (LMICs) annually, predominantly in Africa. In under two years, EVA Pharma then established a new biologics manufacturing facility, completed stability testing and finalised insulin formulations, along with gaining the regulatory approval secured for the insulin injection locally. Lilly has been instrumental in supplying its active pharmaceutical ingredient (API) for insulin at a low cost and offering technology transfer to EVA. This has enabled the local formulation, filling and finishing of insulin vials and cartridges. In parallel, EVA has submitted its insulin injection for local regulatory approval. The collaboration also includes efforts to achieve World Health Organization (WHO) pre-qualification for insulin injection, which would affirm the high-quality standards of EVA’s medicines as set by WHO. The initiative aligns with the Lilly 30×30 goal, which aspires to enhance access to quality healthcare for 30 million people in resource-limited settings every year by 2030. Lilly International president and executive vice-president Ilya Yuffa stated: “For more than a century, Lilly has been at the forefront of diabetes care, offering innovative solutions that make life better for people around the world. “Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. “ In September 2024, Lilly also agreed to license baricitinib manufacturing know-how to EVA, enabling the supply of treatments for immunological diseases in 56 LMICs across Africa. In a separate development, the China National Medical Products Administration (NMPA) approved Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion) for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment and mild dementia stage who have confirmed amyloid pathology. The NMPA application was supported by data from the Phase III TRAILBLAZER-ALZ 2 trial.