Lilly and EVA Pharma announce regulatory approval and release of locally manufactured insulin in Egypt

Rhea-AI Summary

Eli Lilly (NYSE: LLY) and EVA Pharma announced the Egyptian Drug Authority's approval of locally manufactured insulin glargine injection. This achievement stems from their 2022 collaboration aimed at providing affordable insulin to one million people with diabetes in low- to middle-income countries annually by 2030.

EVA Pharma has completed a new biologics facility and obtained regulatory approval in less than two years. Lilly supplies the active pharmaceutical ingredient at reduced prices and provides technology transfer support. EVA Pharma has also submitted human insulin injection for local regulatory approval and is working with WHO for pre-qualification.

The companies recently expanded their partnership to include baricitinib manufacturing for immunological diseases across 56 low- to middle-income countries in Africa.

Positive

• Regulatory approval obtained for insulin glargine injection in Egypt
• Successful completion of new biologics manufacturing facility in under two years
• Partnership expansion to include baricitinib manufacturing for 56 countries

Negative

• None.

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 countries 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 Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. I-LLY

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.

EVA Pharma is one of the fastest-growing healthcare companies in the Middle East and Africa, with an extensive pan-African presence, while operating in more than 70 countries worldwide. For more information, please visit: www.evapharma.com & https://www.evapharma.com/newsroom or follow us on Facebook, LinkedIn & Instagram. 

 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.

Refer to:	Karine Mendelek; mendelek_karine@lilly.com; +971553408407 (Lilly Media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Lilly Investors)
	Ahmed Ellewa: ahmed.ellewa@evapharma.com; +20-1000-053-643 (EVA Pharma Media)

 

 

 

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SOURCE Eli Lilly and Company

FAQ

What is the significance of LLY's insulin manufacturing approval in Egypt?

The approval enables local manufacturing of insulin glargine through EVA Pharma, ensuring sustainable and affordable insulin supply for diabetes patients in low- to middle-income countries.

How many people will benefit from LLY and EVA Pharma's insulin collaboration?

The collaboration aims to provide affordable insulin to one million people with diabetes in low- to middle-income countries annually by 2030.

What is the scope of LLY's expanded partnership with EVA Pharma in 2024?

The expanded partnership includes licensing baricitinib manufacturing know-how for immunological disease treatments across 56 low- to middle-income countries in Africa.

How does LLY support EVA Pharma's insulin manufacturing process?

Lilly supplies active pharmaceutical ingredient at reduced prices and provides pro-bono technology transfer for formulation, filling, and finishing of insulin vials and cartridges.

What regulatory approvals is EVA Pharma seeking for insulin products under LLY partnership?

EVA Pharma has received approval for insulin glargine injection, submitted human insulin injection for local approval, and is seeking WHO pre-qualification for human insulin injection.