EuBiologics Acquires Licensure for New Cholera Vaccine

EuBiologics Acquires Licensure for New Cholera Vaccine
- First cholera vaccine made in Korea for use in developing world
- Global health partnership between EuBiologics and International Vaccine Institute to control cholera in poor countries
- Application for WHO approval underway

Seoul, South Korea - EuBiologics Co., Ltd. and the International Vaccine Institute (IVI) announced that the inactivated oral cholera vaccine (OCV) Euvichol obtained licensure for export from the South Korean Ministry of Food and Drug Safety on January 28, 2015, making this the first cholera vaccine produced in Korea and paving the way for vaccine approval by the World Health Organization (WHO). An application has already been submitted for obtaining WHO prequalification of Euvichol.

“After several years of hard work and effort, we are extremely pleased that Euvichol has been licensed since we are one step closer to WHO prequalification and ensuring access of the vaccine for the world’s poor,” said Mr. Yeong-Ok Baik, EuBiologics CEO, “We are thankful to IVI for their support in helping make this happen.”

Since 2010, EuBiologics and IVI have been collaborating on the development and production of a new inactivated oral cholera vaccine following technology transfer from IVI to EuBiologics. Their aim is to ensure a reliable global supply of safe, effective and affordable cholera vaccines to prevent and control endemic and epidemic cholera in the world’s poorest communities. Cholera is a potentially fatal infectious disease that causes acute watery diarrhea. It is a disease of poverty and strikes in areas with poor sanitation and lack of clean water. Approximately 3 million people are infected and up to 100,000 people die from cholera annually, the majority of which are from developing countries in Africa and South Asia.

In collaboration with partners in Vietnam, Sweden, the United States and South Korea, IVI reformulated the oral inactivated cholera vaccine and transferred the technology to Shantha Biotechnics (part of the Sanofi group), an Indian manufacturer. The vaccine Shanchol was licensed in India in 2009 and WHO-prequalified in 2011. In 2010, IVI transferred technology for the cholera vaccine to EuBiologics, which was unprecedented for a Korean company at the time. Euvichol will be the third internationally licensed vaccine against cholera (Shanchol and Dukoral produced by Crucell, part of Johnson & Johnson).

The development of Euvichol started with preclinical studies that included production of consistency lots at the EuBiologics cGMP (current Good Manufacturing Practice) facility in Chuncheon and toxicology studies to establish safety prior to human studies. The clinical studies were conducted beginning with a phase I study in Korea to establish safety in a small number of people and to demonstrate an immune response against cholera. Following the success of the phase I trial, a phase III trial was conducted in about 3,600 people in the Philippines, which established that Euvichol was safe and highly immunogenic.

IVI has been providing support to EuBiologics in production, quality control and clinical vaccine evaluation. In addition, IVI has been providing advice to EuBiologics on the conduct of the clinical trials and application for WHO prequalification. EuBiologics has also received excellent support from the Korean Ministry of Food and Drug Safety through its “consultative groups” for supporting global vaccine commercialization and WHO-PQ accreditation. The Ministry has provided advice on licensure of the vaccine including GMP issues and clinical development.

EuBiologics intends to license Euvichol in cholera-endemic countries or where there is potential for cholera outbreaks such as Dominican Republic, Haiti, Pakistan, the Philippines, Thailand, and Egypt. It is anticipated that sales of Euvichol will begin in the first half of this year. WHO prequalification is expected to be obtained in early 2016, which will in turn open the door to internationalization of the vaccine through sales to international organizations such as UNICEF and Gavi, the Vaccine Alliance. Euvichol will be the first WHO-prequalified cholera vaccine from Korea, highlighting the contribution Korea is making to public health through its vaccine initiatives.

“Euvichol will be an important advance for the control of cholera, a deadly diarrheal disease that sickens and kills countless people in the developing world,” said Dr. Jerome H. Kim, IVI’s Director General Elect, “Thanks to our partnership with EuBiologics and to the support of Korea, we can save more lives and improve the health and wellbeing of the poorest people in the world.”

About PQ(Pre-qualification)
WHO prequalification indicates that the vaccine meets international standards in quality, safety and efficacy, and enables the vaccine to be purchased by UN agencies.

About IVI
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.

About EuBiologics
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.

Media Contact:

IVI
Tae Kyung Byun
Public Awareness/Advocacy Officer, IVI
Phone: +82-2-872-2801 (Ext. 159)
Mobile: +82-11-9773-6071
Email: tkbyun@ivi.int

Burson-Marsteller Korea
Ayoung Jang Nayoung Kim
Phone: +82-2-3782-6465 +82-2-3782-6458
Mobile: +82-10-3596-2440 +82-10-8967-1909
Email: Ayoung.Jang@bm.com Nayoung.Kim@bm.com

EuBiologics
Dr. Sue-nie Park
Vice President
EuBiologics Co., Ltd.
Phone: +82-02-572-6675
Mobile: +82-10-4115-4093
Email: suenie@eubiologics.com