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Major Milestones for Development of Korea’s First Cholera Vaccine for the World’s Poor
Major Milestones for Development of
Korea’s First Cholera Vaccine for the World’s Poor
-Global Access Agreement between EuBiologics Co., Ltd. and International Vaccine Institute
- Investments by Global Health Investment Fund I, LLC (GHIF) and domestic investors to EuBiologics
- Milestones pave the way to make an oral cholera vaccine available for developing countries
SEOUL, KOREA – EuBiologics Co., Ltd. (EuBiologics) and the International Vaccine Institute (IVI) announced today that major milestones have been met in their collaborative efforts to develop an oral cholera vaccine (OCV) for use in developing countries. EuBiologics has entered into a Global Access Agreement with IVI to ensure that the cholera vaccine will be made available and accessible at an affordable price for the public sector. Furthermore, Global Health Investment Fund I, LLC (GHIF), a new $108 million USD fund developed by the Bill & Melinda Gates Foundation, Lion’s Head Global Partners and JPMorgan Chase & Co., has committed 2.5 million USD of equity capital and made a 2.5 million USD loan to support EuBiologics in the development and production of the OCV. In addition, Korea-Seoul Life Science Fund (KSLSF) and Korea Investment Global Frontier Fund (KIGFF) have each invested 1.25 million USD of equity capital alongside the GHIF in this financing.
“We are thankful to receive the OCV technology from IVI and are very much delighted to have an opportunity to work with GHIF,” said Mr. Yeong-Ok Baik, CEO of EuBiologics, “We are confident that our vaccine, Euvichol will achieve WHO prequalification with IVI’s support and assistance. We are pleased to supply Euvichol worldwide as per the Global Access Agreement made with IVI, and we are committed to contribute to global efforts to prevent and control cholera in poor communities around the world.”
The OCV was specifically developed for use in developing countries through a public-private partnership led by IVI with support from the Republic of Korea, Sweden, and the Bill & Melinda Gates Foundation. The partnership initially involved Shantha Biotechnics (part of the Sanofi group) in Hyderabad, India; Vabiotech, a state-owned vaccine manufacturer in Hanoi, Vietnam; and the University of Gothenburg in Sweden. IVI transferred the OCV production technology to Shantha, and the vaccine, licensed as Shanchol™ in India, was prequalified by the World Health Organization (WHO) in September 2011.
“Through a phase III clinical trial in Kolkata, India, IVI has shown that the vaccine provides sustained protection against cholera at an efficacy of 65% for at least five years, the longest duration of protection conferred by an oral cholera vaccine to date,” said Dr. Thomas F. Wierzba, Deputy Director General for IVI’s Development and Delivery, “The vaccine is safe and it clearly works. IVI is gratified to be working with a partner like EuBiologics who share IVI’s mission of discovering, developing and delivering safe, effective and affordable vaccines for developing nations.”
Cholera continues to exert a devastating toll in many countries worldwide, as witnessed by the recent cholera outbreak in Haiti. The United Nations announced a ten-year plan to eliminate cholera in Haiti and the Dominican Republic, which would involve the use of the OCV. Shanchol™ is being used in the global cholera vaccine stockpile administered by WHO and was recently deployed to fight cholera outbreaks in South Sudan and Haiti.
To ensure a sufficient supply of the cholera vaccine for the global public market, IVI has been collaborating with EuBiologics since 2010 on the technology transfer and clinical development of the OCV with the intent to have the vaccine WHO-prequalified by 2016. If successful, Euvichol will become the second OCV that is suitable for use in the developing world to be approved by the WHO, as well as the first WHO-approved cholera vaccine to come from the Republic of Korea.
“After we complete our pivotal clinical trial for Euvichol in the Philippines, we will submit dossiers to the Korean Ministry of Food and Drug Safety for an export license this year,” said Dr. Sue-Nie Park, Vice President of EuBiologics, “After obtaining the export license, we will apply for WHO prequalification by early 2015, which will enable us to provide Euvichol, a low-cost and high-quality product, to the world’s poor.”
With support from the Bill & Melinda Gates Foundation, IVI has been providing technical support to its tech transfer partners in product development that include conducting the requisite studies for WHO prequalification. As part of the partnership between IVI and EuBiologics, EuBiologics has entered into a Global Access Agreement with IVI in which it agrees to sell the OCV at a low cost for the public-sector market.
With IVI’s assistance, EuBiologics has secured an investment from GHIF, an innovative fund that aims to catalyze investment activity for research in medical technologies to address global health challenges, as well as investments from KSLSF and Korean Investment Partners.
“I’m pleased that we have achieved these milestones with EuBiologics, a strategically important partner to IVI in Korea,” said Mr. John Morahan, IVI’s Acting Director General and Chief Financial Officer, “With the Global Access Agreement, and further financial support from GHIF and domestic investors, IVI, EuBiologics and Korea are contributing to global efforts to preventing misery and suffering from cholera, one of the world’s most deadly and neglected infectious diseases.”
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit http://www.ivi.int.
EuBiologics Co., Ltd. is a biopharmaceutical company conducting development and commercialization for safe and effective vaccines to improve the public health in developing countries and supplying a wide range of “Contract Research and Manufacturing Organization” (CRMO) services for the development of biologics. Since EuBiologics was established in March 2010 it has been working on the commercialization of OCV with the assistance of IVI and developing bacterial or viral vaccines for supplying safe and effective vaccines to the public sector. EuBiologics is capable of manufacturing a variety of mammalian cell and microbe-derived, protein-based therapeutics and antibodies. It provides customized services for various stages of product development, including cell line development, GMP production, validation and regulatory support. To learn more about EuBiologics, please visit http://www.eubiologics.com.
Tae Kyung Byun
Public Awareness/Advocacy Officer, IVI
Phone: +82-2-872-2801 (Ext. 159)
Ms. SunAh Kim
EuBiologics Co., Ltd.