Lilly and EVA Pharma announce regulatory approval and release of locally manufactured insulin in Egypt
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.
Eli Lilly (NYSE: LLY) e EVA Pharma hanno annunciato l'approvazione da parte dell'Autorità del Farmaco egiziana per l'iniezione di insulina glargine prodotta localmente. Questo traguardo deriva dalla loro collaborazione del 2022, mirata a fornire insulina a prezzi accessibili a un milione di persone con diabete nei paesi a basso e medio reddito ogni anno entro il 2030.
EVA Pharma ha completato una nuova struttura per biologici e ha ottenuto l'approvazione normativa in meno di due anni. Lilly fornisce l'ingrediente farmaceutico attivo a prezzi ridotti e offre supporto per il trasferimento di tecnologia. EVA Pharma ha inoltre presentato un'iniezione di insulina umana per l'approvazione normativa locale e sta collaborando con l'OMS per la prequalifica.
Le aziende hanno recentemente ampliato la loro partnership per includere la produzione di baricitinib per malattie immunologiche in 56 paesi a basso e medio reddito in Africa.
Eli Lilly (NYSE: LLY) y EVA Pharma anunciaron la aprobación por parte de la Autoridad Egipcia de Medicamentos para la inyección de insulina glargina fabricada localmente. Este logro proviene de su colaboración en 2022, con el objetivo de proporcionar insulina a precios asequibles a un millón de personas con diabetes en países de ingresos bajos y medianos cada año para 2030.
EVA Pharma ha completado una nueva instalación de biológicos y ha obtenido la aprobación regulatoria en menos de dos años. Lilly suministra el principio activo farmacéutico a precios reducidos y proporciona soporte para la transferencia de tecnología. EVA Pharma también ha presentado una inyección de insulina humana para la aprobación regulatoria local y está trabajando con la OMS para la pre-calificación.
Las empresas recientemente ampliaron su asociación para incluir la fabricación de baricitinib para enfermedades inmunológicas en 56 países de ingresos bajos y medianos en África.
엘리 릴리 (NYSE: LLY)와 EVA 제약은 이집트 의약품 관리국의 현지 제조 인슐린 글라진 주사 승인 소식을 발표했습니다. 이 성과는 2022년 협력의 결과로, 2030년까지 저소득 및 중산층 국가에서 100만 명의 당뇨병 환자에게 저렴한 인슐린을 제공하는 것을 목표로 하고 있습니다.
EVA 제약은 새로운 생물 의약품 시설을 완공하고 2년도 채 되지 않아 규제 승인을 받았습니다. 릴리는 활성 제약 성분을 할인된 가격에 공급하고 기술 이전 지원을 제공합니다. EVA 제약은 또한 인슐린 인젝션에 대한 현지 규제 승인을 제출했으며 WHO와 협력하여 사전 자격을 등록하기 위해 노력하고 있습니다.
두 회사는 최근 아프리카의 56개 저소득 및 중산층 국가에서 면역 질환을 위한 바리시티닙 제조를 포함하도록 파트너십을 확장했습니다.
Eli Lilly (NYSE: LLY) et EVA Pharma ont annoncé l'approbation par l'Autorité égyptienne des médicaments pour l'injection d'insuline glargine fabriquée localement. Ce succès est le fruit de leur collaboration de 2022, visant à fournir de l'insuline à des prix abordables à un million de personnes diabétiques dans les pays à revenu faible ou moyen chaque année d'ici 2030.
EVA Pharma a terminé une nouvelle installation de biotechnologie et a obtenu une approbation réglementaire en moins de deux ans. Lilly fournit l'ingrédient pharmaceutique actif à des prix réduits et apporte un soutien au transfert de technologie. EVA Pharma a également soumis une demande d'approbation réglementaire locale pour une injection d'insuline humaine et travaille avec l'OMS pour la préqualification.
Les entreprises ont récemment élargi leur partenariat pour inclure la fabrication de baricitinib pour les maladies immunologiques dans 56 pays à revenu faible ou moyen en Afrique.
Eli Lilly (NYSE: LLY) und EVA Pharma haben die Genehmigung der ägyptischen Arzneimittelbehörde für die lokal hergestellte Insulin-Glargin-Injektion bekannt gegeben. Dieser Erfolg ist das Ergebnis ihrer Zusammenarbeit im Jahr 2022, die darauf abzielt, bis 2030 jährlich eine Million Menschen mit Diabetes in einkommensschwachen und mittleren Ländern mit erschwinglichem Insulin zu versorgen.
EVA Pharma hat eine neue Biologika-Anlage erbaut und innerhalb von weniger als zwei Jahren die Genehmigung der Aufsichtsbehörden erhalten. Lilly liefert den aktiven pharmazeutischen Inhaltsstoff zu reduzierten Preisen und bietet Unterstützung beim Technologietransfer an. EVA Pharma hat außerdem eine menschliche Insulininjektion zur lokalen Genehmigung eingereicht und arbeitet mit der WHO an der Vorqualifizierung.
Die Unternehmen haben kürzlich ihre Partnerschaft auf die Herstellung von Baricitinib für immunologische Erkrankungen in 56 einkommensschwachen und mittleren Ländern in Afrika ausgeweitet.
- 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
- None.
Insights
This strategic partnership marks a significant expansion into emerging markets, particularly Africa, where diabetes care accessibility remains a critical challenge. The local manufacturing approval in Egypt creates a powerful distribution hub for reaching 56 LMICs, potentially capturing a substantial market share in underserved regions. EVA Pharma's rapid execution in completing the biologics facility and obtaining regulatory approval demonstrates strong operational efficiency.
The reduced-price API supply arrangement and technology transfer from Lilly creates a sustainable business model while maintaining quality standards. This approach could serve as a template for future market expansion in other regions. The WHO pre-qualification pursuit adds credibility and could facilitate faster market entry in other countries. The expansion to include baricitinib manufacturing rights further strengthens the partnership's long-term value proposition.
The localization of insulin manufacturing in Egypt represents a significant advancement in addressing the critical need for diabetes care in Africa. The technology transfer ensures maintenance of Lilly's quality standards while improving regional accessibility. The inclusion of both human insulin and insulin glargine provides essential treatment options for type 1 and type 2 diabetes patients.
The rapid timeline from agreement to production demonstrates efficient technology transfer and regulatory compliance. The pursuit of WHO pre-qualification indicates a commitment to maintaining international quality standards. The addition of baricitinib manufacturing rights expands the potential impact beyond diabetes care to immunological diseases, creating a comprehensive healthcare solution for the region.
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
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
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
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
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