CASE STUDY-AJ Pharma developing the world’s first halal vaccines

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AJ Pharma seeks to address a global need to make vaccines and medicines that are high quality and affordable for all. With Muslims representing close to 25 percent of the global population, the company also seeks to address a robust demand for halal medicines.

1. Addressing a major market gap: The starting point for AJ Pharma was identifying major barriers to the effective delivery of vaccines

2. Securing the help of major stakeholders at the start: AJ Pharma’s efforts were enabled by a substantial capital commitment, or ‘patient money’, which supported an ambitious goal that requires significant time and effort to accomplish

3. Need to promote awareness of marginal, sidelined or 'taboo' issues affecting Muslims: In order to increase collective awareness and knowledge of critical issues affecting Muslims around the world, such as immunization and the need for affordable (halal) medicines, AJ Pharma has reached out and made important connections and partnerships with key Islamic Economy stakeholders

AJ Pharma Holdings is a pharmaceutical product manufacturing company based in Malaysia that is developing vaccines that are affordable, high quality and accessible to all segments of the population, including Muslim consumers. The company is fully funded by Al Jomaih group in Saudi Arabia, and its first commercial batches of vaccines should be available in 2017.

1. Established a global footprint through the acquisition of Danish medical laboratory Statens Serum Institut (SSI)

2. Secured seed investment of $100 million to launch the first-ever vaccine facility in Malaysia and the first-ever halal vaccine globally

3. Initiated development of vaccines against hand, foot and mouth disease and meningococcal meningitis in 2016

Establishing Malaysia’s first-ever vaccine facility

According to company CEO Dr Tabassum Khan AJ Pharma expects to invest between $250 million and $300 million, sourced from Saudi conglomerate Al Jomaih, to establish the first vaccine development facility in Malaysia. This is a milestone that will help boost Malaysia’s bio-economy and reduce its reliance on imported vaccines. In October 2014 the company signed a memorandum of understanding with Malaysia’s Halal Industry Development Corporation (HDC) for the development of the halal vaccine industry.

The investment of up to $300 million is to be received in phases, with the first $100 million already committed.

 “AJ Biologics, AJ Pharma’s Malaysia-based vaccine manufacturing facility, is under construction and is expected to start commercial operations in the first quarter of 2018. The primary target markets would be ASEAN, Middle East and South Asia,” said Dr Khan.

Addressing critical needs in the Islamic world

The product development emphasis for AJ Pharma, through its subsidiary AJ Biologics, has been on addressing critical healthcare needs in Southeast Asia and in the broader Organisation of Islamic Cooperation (OIC) markets. The company has been able to deliver this objective through forming key partnerships and leveraging advisory support from German engineering consultants NNE Pharmaplan, Danish law firm Bech-Bruun and consultants KPMG.

Top of its agenda is addressing polio. “We would like to be an important partner in the noble cause of eradicating polio from the face of the earth in collaboration with, and the support of, international agencies such as the Bill and Melinda Gates Foundation,” said Dr Khan.

Regarding the development progress of AJ Biologics vaccines, he added, “EV71 is in phase III and MCV4 shall begin phase I in the last quarter of 2016. The MCV4 will be the first ever halal-certified meningococcal vaccine for all the pilgrims traveling to Saudi Arabia. Developing an animal source-free polio vaccine would be a major contribution to the Islamic world.”

To encourage awareness of halal vaccines in Muslim-majority countries, AJ Pharma Holdings has also sponsored global events including the World Islamic Economic Forum in 2014. Outside of the halal industry, the organization has also participated in key pharmaceutical industry events, including the Pharmaceutical Regulatory Affairs Asia conference in Singapore in 2016.

Developing upstream manufacturing capabilities

AJ Pharma has taken a critical step through its acquisition of Danish medical laboratory Statens Serum Institut (SSI), developing a footprint in Europe and leveraging knowledge related to vaccinology. SSI’s vaccine production business is internationally recognized and the institute has produced strategic vaccines for polio and the vaccine for tuberculosis, bacille Calmette-Guerin (BCG).

“The biggest motivation for acquisition of SSI was to have access to the global vaccine market and to have upstream manufacturing capabilities for our project in Malaysia. The other motivation was to have access to a polio vaccine and to develop new formulations and expand our reach to contribute to the World Health Organization objective of eradicating polio,” Dr Khan told Salaam Gateway. 

Affordable pharma

Globally, 400 million individuals are without access to healthcare, and have been left behind by the existing pharmaceuticals industry, according to the World Health Organization. There is a significant need and opportunity for new players to make pharmaceutical products more affordable.

Muslims globally spent an estimated $78 billion on pharmaceutical products in 2015, according to DinarStandard estimates. They represent a significant consumer segment, with a notable portion demanding access to halal-certified alternatives for medicines and driving the growth of the halal pharmaceuticals industry.

Breaking resistance barriers

Dr Khan told Salaam Gateway, “As far as the impact of the development of halal vaccines is concerned, there would definitely be a positive step in increasing immunization rates in the Muslim-dominated countries, as psychologically the highest resistance is perpetuated by misinterpreted religious perceptions.”

Discussing how polio is an issue that could be addressed with a halal vaccine, Dr Khan said, “Polio primarily affects children under the age of 5 and one in 200 infections lead to irreversible paralysis. Among those paralyzed, almost 5-10 percent face death. Awareness needs to be created that as long as a single child remains infected, children throughout the world are at risk. Failure to eradicate polio from the countries where it is present, mainly Pakistan and Afghanistan, can result in as many as 200,000 cases every year globally, putting the future generations at the risk of disability and premature deaths.”

Precision medicine

AJ Pharma is also exploring the nascent sector of halal precision medicine. “Precision medicine is an emerging approach that takes into account the individual variability in genes, environment and lifestyle of each person. The whole concept of it, at the moment, is in its initial stage, so bringing halal into it at this point of time can only be explored,” said Dr Khan.

The fragmented halal regulatory and certification industry will present many challenges facing halal pharmaceutical ingredient manufacturers. “The main overall challenges faced by the industry will include the confusion surrounding halal standards, primarily because they are being compiled by many different government-linked organizations, private organizations and independent halal certification bodies,” said Dr Khan.

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