Unique International Collaboration Brings Breakthrough Oral Cholera Vaccine to Market

Singapore-based Hilleman Laboratories,along with Bharat Biotech,confirm launch of new cholera vaccine,HILLCHOL®

Success provides "template for the internationalization of future vaccine and biologics development from Singapore" – Dr. Raman Rao,CEO,Hilleman Laboratories

Hilleman Laboratories Singapore hub advancing global health equity by developing portfolio of vaccines that could benefit up to 500 million people in low- and middle-income countries

Announcement marks significant public health milestone towards pre-qualification from the WHO for wider distribution globally

SINGAPORE,Aug. 27,2024 -- Hilleman Laboratories has today announced that its partner Bharat Biotech,has successfully launched HILLCHOL®,a breakthrough oral cholera vaccine (OCV),achieving a significant global public health milestone.

Hilleman Labs Photo - Dr. Raman Rao

Singapore-based Hilleman Laboratories - a joint venture between MSD and Wellcome - is a first-of-its-kind vaccine development hub,focused on accelerated end-to-end research and the development of affordable vaccines for distribution in low- and middle-income countries (LMICs).

The launch of HILLCHOL® is a result of an innovative model of international partnership between Hilleman Laboratories and Bharat Biotech,an Indian multinational biotechnology company.

Today's announcement follows the successful completion of HILLCHOL® Phase III clinical trials and approval for licensure by Bharat Biotech in India. This is after Hilleman Laboratories developed the vaccine through Phase II clinical research before transferring the vaccine to Bharat Biotech,who now intends to pursue pre-qualification for the licensure of HILLCHOL® from the World Health Organization (WHO) for wider distribution globally.

From its vaccine and biologics development and manufacturing hub in Singapore,Hilleman Laboratories is currently developing a portfolio of vaccines that could benefit up to 500 million people in low- and middle-income countries over the next five years.

Speaking at the launch Dr. Raman Rao,CEO of Hilleman Laboratories said,"From day one our mission has been to develop affordable vaccines and biologics against infectious diseases for countries with the most severe unmet medical needs. This new vaccine delivers on that pledge and provides an innovative template for the internationalization of future vaccine and biologics development from Singapore,that can positively impact global health.

"The launch of the HILLCHOL® vaccine is the result of extensive international collaboration involving Hilleman Laboratories,Bharat Biotech,the University of Gothenburg and Gotovax AB. Ever since it was founded by Wellcome and MSD,Hilleman Laboratories is proud of its role in this joint effort and its dedication to advancing global health equity through affordable,high-impact and sustainable solutions for those who are most susceptible to this disease."

Unlike existing cholera vaccines which contain more than one strain,HILLCHOL® utilizes a single,genetically engineered inactivated 'Hikojima' strain delivered orally,which significantly reduces production costs,and will expand access at a time when cholera epidemics and outbreaks are increasing and becoming more frequent.

This best-in-class OCV is able to prevent infection against two of the main cholera serotypes (Ogawa and Inaba) and is suitable for children over 1 year old and adolescents up to 18 years old and over,with two doses given 14 days apart.

The collaborative and strategic pathway established for this new vaccine began in Sweden at The University of Gothenburg and its spin-off biopharma company,Gotovax AB,which developed the strain of inactivated cholera that forms the core of HILLCHOL®,before Hilleman Laboratories provided the next-stage development solutions,piloted affordable manufacturing techniques and conducted Phase II clinical studies.

The focus by Hilleman Laboratories on identifying an affordable vaccine to tackle cholera has been part of a wider strategy to address unmet medical needs in relation to the main diarrheal diseases including,Rotavirus,Shigella and Escherichia coli (ETEC). Since moving to Singapore in 2021,the organization has expanded its capacity and capabilities,along with adopting a biotechnology platform-based approach which now enables it to develop solutions for a wider spectrum of diseases and an agile response to various outbreaks.

About Hilleman Laboratories

Hilleman Laboratories was established in 2009 as a joint venture between Merck Sharp & Dohme LLC (MSD),a global research-driven pharmaceutical company,and Wellcome,a global charitable foundation dedicated to human and animal health. Hilleman Laboratories' mission is to develop affordable vaccines and biologics against infectious diseases that affect low- and middle-income countries.

The company's expertise in end-to-end product development is targeted at creating novel vaccines and biologics in areas of high unmet need as well as adapting existing vaccines and biologics with more effective delivery tools to meet challenging environments in developing countries. Hilleman Laboratories also seeks to collaborate with local,regional,and global partners and stakeholders,including policymakers and governments,to facilitate wider,affordable access to life-saving vaccines and biologics.

www.hilleman-labs.org

About HILLCHOL®

HILLCHOL® utilizes a single,genetically engineered 'Hikojima' strain which significantly reduces production costs and,as an oral vaccine,helps to enhance access. This best-in-class oral cholera vaccine (OCV) counteracts two of the main cholera strains (Ogawa and Inaba) and has the potential to play a key role in tackling cholera,providing an affordable,efficient and effective solution for low- and middle-income countries (LMICs).

Hilleman Labs Photo - Suite