Lilly and EVA Pharma announce regulatory approval and release of locally manufactured insulin in Egypt The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company...

This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income c ountries annually by 2030

INDIANAPOLIS and CAIRO , Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY ). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.

This marks the first regulatory approval of EVA Pharma's insulin drug products, following Lilly and EVA Pharma's collaboration announcement in December 2022 . Under this agreement, Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges.

Less than two years after the initial announcement, EVA Pharma has completed a new biologics manufacturing facility, finalized insulin formulations and stability testing processes, engaged with the local regulatory authorities to obtain approval of the insulin glargine injection, and released the first batch of the locally manufactured insulin drug product.

Additionally, EVA Pharma's human insulin injection was also submitted for local regulatory approval. Lilly and EVA Pharma continue working with the World Health Organization (WHO) to secure WHO pre-qualification for the locally manufactured human insulin injection. The WHO pre-qualification will further ensure that medicines manufactured by EVA Pharma meet the high-quality standards set by WHO.

"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," said Ilya Yuffa , executive vice president and president of Lilly International. "Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. We will continue to work with global health systems and industry stakeholders to address systemic barriers to healthcare and expand equitable, affordable access to our medicines to transform more people's lives."

"Localizing essential medicines is the key to driving equitable access to healthcare," said Riad Armanious , CEO of EVA Pharma. "It takes bold collaboration, cutting-edge innovation, and tech-driven manufacturing to turn this vision into reality. Our collaboration with Lilly shows what's possible when we push boundaries together. This is just the beginning—we're on track to impact over a million lives annually across 56 countries, making a real difference for people living with diabetes."

This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.

Most recently, Lilly and EVA Pharma expanded their collaboration, announcing that Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases across 56 low- to middle-income countries in Africa.

About EVA Pharma EVA Pharma is dedicated to improving access to affordable, high-quality medicines around the world, focusing on three core pillars: innovation, development and sustainable access. The company leverages cutting-edge technology at two research centers bringing first-of-its-kind capabilities to the Middle East and Africa including mRNA research and development from AI prediction to biological products.

With a 5,000-strong team of professionals, EVA Pharma produces more than one million healthcare products a day at four state-of-the-art manufacturing facilities, which are internationally recognized for innovation, and have been approved by multiple regulatory agencies.

Guided by a relentless drive to ensure sustainable access to pressing yet unmet disease areas, the company's product portfolio focuses on twelve therapeutic areas: Anti-infectives, metabolic health, bone, neuroscience, oncology, respiratory, gynecology, urology and andrology, pediatrics, ophthalmology, gastrointestinal tract, family medicine to meet both local and international demand.

Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly ' s collaboration with EVA Pharma and reflects Lilly's current beliefs and expectations. However, there can be no assurance that Lilly's collaboration with EVA Pharma will achieve Lilly's objectives or that Lilly will execute its strategy as planned. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

SOURCE Eli Lilly and Company