Hilleman Laboratories, in partnership with Bharat Biotech,announced the successful launch of HILLCHOL®, a groundbreaking oral cholera vaccine (OCV) that marks a significant global public health achievement. This vaccine represents a pivotal step forward in the global fight against cholera, a disease that continues to pose a severe threat in low- and middle-income countries (LMICs).

Hilleman Laboratories, a Singapore-based joint venture between MSD and Wellcome, is at the forefront of vaccine development, focusing on accelerating research and delivering affordable vaccines to LMICs. The launch of HILLCHOL® is the culmination of an innovative international collaboration between Hilleman Laboratories and Bharat Biotech, an Indian multinational biotechnology company renowned for its contributions to public health.

The announcement follows the successful completion of Phase III clinical trials for HILLCHOL® and subsequent licensure approval by Bharat Biotech in India. Hilleman Laboratories initially developed the vaccine through Phase II clinical research before transferring the vaccine to Bharat Biotech, who now aims to seek pre-qualification for WHO licensure, enabling wider global distribution.

Dr. Raman Rao, CEO of Hilleman Laboratories, expressed his enthusiasm for this milestone, stating, "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. The launch of HILLCHOL® not only fulfills this commitment but also sets a precedent for the internationalization of vaccine and biologics development from Singapore, with the potential to positively impact global health."

HILLCHOL® is distinct from existing cholera vaccines, as it utilizes a single, genetically engineered inactivated ‘Hikojima’ strain, which significantly reduces production costs. This innovation expands access to cholera vaccination at a time when cholera epidemics are becoming increasingly frequent. The vaccine effectively prevents infection against two main cholera serotypes, Ogawa and Inaba, and is suitable for children over one year old and adolescents up to 18 years old, administered in two doses 14 days apart.

The development of HILLCHOL® represents a strategic and collaborative effort, beginning in Sweden at The University of Gothenburg and its spin-off biopharma company, Gotovax AB. The strain of inactivated cholera at the core of HILLCHOL® was developed by Gotovax AB before Hilleman Laboratories advanced the vaccine through next-stage development, piloted cost-effective manufacturing techniques, and conducted Phase II clinical studies.

Prof. Jan Holmgren, lead cholera researcher at the University of Gothenburg, remarked, "Cholera is a serious infection that can have devastating consequences for many communities, particularly in the global south. Today’s announcement is a proud moment, highlighting the essential role of collaboration between industry and academia. Hilleman Laboratories has been pivotal in this joint effort, advancing both vaccine discovery and delivery, and addressing health equity in LMICs."

Alex Pym, Director of Infectious Disease at Wellcome, added, "Cholera is a growing global health threat, exacerbated by poverty, conflict, and climate change. With the world’s supply of oral cholera vaccines unable to meet rising demand, HILLCHOL® is a promising step toward increasing global vaccine availability and providing much-needed protection to vulnerable populations."

Sanat Chattopadhyay, Executive Vice-President at MSD and Chair of Hilleman Laboratories, commented, "The launch of HILLCHOL® is an inspiring public health milestone, demonstrating the power of strategic collaboration to overcome complex challenges. This endeavor exemplifies our commitment to advancing scientific innovation and health equity through transformative partnerships."

Hilleman Laboratories' focus on developing affordable vaccines to combat cholera is part of a broader strategy to address unmet medical needs related to major diarrheal diseases, including Rotavirus, Shigella, and Escherichia coli (ETEC). Since relocating to Singapore in 2021, Hilleman Laboratories has expanded its capabilities, adopting a biotechnology platform-based approach to develop solutions for a broader range of diseases and enabling a more agile response to various outbreaks.