PRESS RELEASE 17 December 2020

Global media contact: AJ Vaccines A/S | Denmark Mr. Christian Malling M: +45 2552 8170 E: cmal@ajvaccines.com

AJ Vaccines intend to widen activities in the Middle East Region

AJ Vaccines’ production site-facility in Copenhagen, Denmark has been approved by the Gulf Health Council (GHC) effective 9 November 2020. The approval indicates the vaccine production is at a high standard which will help to secure timely patient access to vaccines in the Gulf Cooperation Council (GCC) countries and wider Middle Eastern region.

In recent years, the regulatory requirements for vaccine registration have become increasingly sophisticated in the GCC countries, namely the Kingdom of Saudi Arabia, the United Arab Emirates, Bahrain, Kuwait, Qatar and Oman. As vaccines are given to large numbers of healthy individuals there is a strong focus upon quality, safety and efficacy in assessing their benefit-risk to public health.

“This GHC registration accentuates AJ Vaccines’ ambitions to further improve access to high-quality, innovative vaccines to serve the global community and for patients to diagnostics and therapeutic solutions. In addition, it is a testimony to the resilience, dedication and professionalism of the entire AJ Vaccines team securing this achievement for our company amid the continued restrictions due to COVID-19”, says Jesper Helmuth Larsen CEO of AJ Vaccines.

Promising growth trajectory
The new GHC registration is in line with AJ Vaccines’ ambition for global growth. “Our employees are aware of the current global challenges and are committed to finding solutions towards a world free of serious diseases across all generations. The GHC registration will leverage our competitiveness and enable us to enter new markets with promising growth trajectories hereby supporting our objective of a stronger regional foothold”, says Jérôme Cabannes, COO of AJ Vaccines.

Strong potential for new business
Currently AJ Vaccines supplies BCG Vaccine and Tuberculin to several countries in the region. “The GHC registration will definitely increase our market shares of both products. In addition, I see a potential to market our booster vaccines, cancer therapy and the new inactivated polio vaccine, Picovax^® in the region. This innovative dose-sparing polio vaccine is AJ Vaccines response to the growing global demand for inactivated polio vaccines that are key to the success of the Global Polio Eradication Initiative”, concludes Jérôme Cabannes, COO of AJ Vaccines.

24-30 April 2020

World Immunization Week 2020

‘World Immunization Week’ is particularly relevant this year, as we all face the many challenges brought by the new infectious disease, COVID-19.

World Immunization Week aims to promote the use of vaccines to protect people of all ages against disease and resonates completely with our AJ Vaccines vision of a world free of serious diseases, across generations, life by life.

The Value of Vaccines
Immunisation saves millions of lives every year and is widely recognised as one of the world’s most successful and cost-effective health interventions.*

Routine immunisations protect children from illness, disability and death and are available for many childhood diseases, including polio, tuberculosis, diphtheria, tetanus and pertussis.

In 2018, one in 26 children died globally before reaching the age of 5, compared to one in 11 in 1990.** More than half of these early childhood deaths are preventable with simple, affordable interventions including immunisation, adequate nutrition, safe water and food.**

Yet, there are still nearly 20 million children in the world today who are not getting the vaccines they need.*

Working together to protect children and families from infectious diseases
We are committed to continuing our work globally with partners and healthcare professionals, and exploring new approaches and partnerships, to ensure children and families around the world have access to the recommended vaccines they need and deserve.

Thus, we were particularly happy to announce the WHO prequalification of our new inactivated polio vaccine this week, which will enable us to help meet the unmet global demand for inactivated polio vaccines to support the continuing efforts towards the global eradication of polio.

In addition to this and our work to develop a new vaccine to protect people from COVID-19, we are working closely with our partners around the world to understand how this global lockdown may affect changes in overall vaccine demand, and to ensure that we are able to anticipate and plan for these changes.

Our Logistics and Supply Chain teams are collaborating both with their colleagues across AJ Vaccines, and with our logistics partners, to ensure our vaccines reach the healthcare practitioners and those people, young and old, that need them. It is vital that during this COVID-19 pandemic we must continue to do everything we can, while ensuring the safety of our valuable teams, to help prevent a potential resurgence of vaccine preventable diseases and that we continue to protect children and their families from further unnecessary suffering, disability and death.

To find out more about our products and the protection they may provide please click here.

Preventing further outbreaks
Outbreaks of vaccine preventable diseases could substantially increase sickness and fatalities and be catastrophic for communities and health systems already affected by the impact of COVID-19.

That is why the WHO has issued guidance for countries to prioritise routine immunisation of children in essential service delivery, as well as some adult vaccinations for at risk groups. If immunisation services must be suspended, the WHO recommends urgent catch-up vaccinations as soon as possible, prioritising those most at risk. To find out more about the WHO guidance please see the full paper here.

* https://www.who.int/news-room/events/detail/2020/04/24/default-calendar/world-immunization-week-2020

** https://www.who.int/news-room/fact-sheets/detail/children-reducing-mortality

PRESS RELEASE 22 April 2020

Global media contact: AJ Vaccines A/S | Denmark Mr. Christian Malling M: +45 2552 8170 E: cmal@ajvaccines.com

Breakthrough in the global battle against polio:
AJ Vaccines granted WHO prequalification for new polio vaccine 

International vaccine manufacturer, AJ Vaccines has received WHO prequalification for Picovax®, the first stand-alone dose sparing Inactivated Polio Vaccine (IPV) on 21^st April 2020. First deliveries to UN agencies such as UNICEF and PAHO are expected by mid-2020.

COPENHAGEN, 22 April 2020 – Despite ongoing concerted efforts to eradicate polio, it appears to be on the rise again with more cases registered in 2019 than 2018. Looking ahead, AJ Vaccines’ dose sparing technology provides a significant opportunity to expand supply, with the potential to deliver up to 100 million doses over the five-year period 2020-2024 to help meet the currently unmet global demand for inactivated polio vaccines.

A milestone achievement
The development of the first stand-alone dose sparing polio vaccine is a milestone for the significant investment and innovation in the Danish based vaccine production. “The WHO prequalification is an acknowledgement of our continued investment which enables AJ Vaccines to serve the growing demand for effective polio vaccines and we hereby open a new chapter in the company’s continued journey to serve the Danish population and a growing number of people globally”, says Mr. Abdulaziz Hamad Aljomaih, founding principal investor in AJ Vaccines.

A tribute to dedicated employees
The achievement of the WHO prequalification is a tribute to the employees for their dedication and contribution to a comprehensive review of production process and quality control procedures, independent laboratory testing, assessment of files and a site audit of manufacturing facilities carried out jointly between the WHO and Danish Medicines Agency in 2019. “The prequalification is a recognition of our dedicated employees’ competencies and embodies the essence of our company’s vision, striving for a world free of serious diseases across generations”, says Dr. Tabassum Khan, Chairman of AJ Vaccines.

Significant investments
The Picovax® development project was supported by the Bill & Melinda Gates Foundation. “Since our take over in 2017, we have invested significantly in the strategic expansion of our production facilities and recruitment of 200 new employees to secure AJ Vaccines’ position as a significant player in the vaccine market, contributing to the important strategic global goal for the eradication of polio”, says Jesper Helmuth Larsen, CEO of AJ Vaccines.

The new vaccine will play a key role in the Global Polio Eradication Initiative (GPEI)
The new Inactivated Polio Vaccine, Picovax®, is indicated for active immunization against poliomyelitis by primary vaccination of infants from the age of six weeks, and for revaccination of infants, children and adolescents. The dose sparing IPV is shown to provide protection comparable to that provided by other inactivated polio vaccines currently available. “The dose sparing technology secures a much-needed increase in supply, helping to meet the increasing demand for inactivated polio vaccines to support the Global Polio Eradication Initiative”, concludes Jérôme Cabannes, COO AJ Vaccines.

Mr. Abdulaziz Hamad Aljomaih, founding principal investor in AJ Vaccines.

20 March 2020

World TB Day

24^th March is World TB Day. In 2018, worldwide, an estimated 10 million people fell ill with TB and 1.5 million died as a result of TB. That is why we at AJ Vaccines are committed to working with partners around the world to reduce the death and suffering caused by this serious infectious disease.

About 3 million of those people who fall ill with TB each year suffer delays in diagnosis and treatment, which can lead to worse health and treatment outcomes, increased transmission of the disease and higher costs for patients and their families.

Early detection of TB reduces patient suffering and death from TB and shortens the duration of infectiousness, thus reducing transmission, prevalence and incidence of TB infections. That is why regular screening of high-risk groups is recommended by the World Health Organisation (WHO).

To find out more about our products click here.

PRESS RELEASE 6 March 2020

Global media contact: AJ Vaccines A/S | Artillerivej 5 DK-2300 Copenhagen S CVR 3791143 Mr. Christian Malling M: +45 2552 8170 E: cmal@ajvaccines.com

AJ Vaccines to develop vaccine for COVID-19

Danish vaccine manufacturer AJ Vaccines has initiated the development of a new vaccine, effective for protection against coronavirus COVID-19. The vaccine candidate will use technology to raise strong immune responses while being well tolerated and to meet potential global demand in 2021.

COPENHAGEN, 6 March 2020 – “This endeavor reiterates our ambition to serve the global community, not only with existing effective high-quality vaccines, but also with the development of innovative new vaccines to answer the current global challenge of coronavirus COVID-19”, says Dr Tabassum Khan, Chairman to AJ Vaccines.

Committed to prevent serious disease globally
“The impact of the COVID-19 disease globally is developing by the hour and we are committed to a world free of serious diseases across all generations. Our employees are aware of the current challenges and are dedicated to finding solutions to the COVID-19 challenge with state-of-the-art technology”, says Jesper Helmuth Larsen, CEO AJ Vaccines.

High protection, low risk of side effects
“The main principle of vaccination is to proactively induce a protective immune response by mimicking the natural interaction of infectious pathogens with our immune system. Modern antigen technology allows for the production of vaccines combining high protection with a low reactogenicity and favorable safety profile as compared to some of the more traditional vaccines. Our aim is to combine the best possibly designed antigens in such a way to mimic closely the authentic native structures of the virus. Similar technologies were previously successfully applied in US FDA-approved vaccines. In short, the use of such technology is expected to induce the relevant immune responses and therefore protect against disease with a lower risk for side effects”, concludes Jerome Cabannes, COO AJ Vaccines.

PRESS RELEASE 28 June 2019

Global media contact: Mr. Christian Malling M: +45 2552 8170 E: cmal@ajvaccines.com

AJ Vaccines will contribute to global polio eradication with its innovative vaccine Picovax®

Picovax® has been approved by the Danish Medicines Agency, and the WHO prequalification is expected by the end of 2019, enabling initial delivery of up to 100 million doses globally via UN agencies in 2020-2024.

Copenhagen, Denmark 28 June 2019 – AJ Vaccines today announced that its adjuvanted IPV vaccine Picovax® has gained marketing approval in Denmark by the Danish Medicines Agency. The approval process was initiated in 2018 following positive results from clinical trials involving almost 3,000 infants. The Danish marketing approval paves the way for WHO prequalification with a view to enable AJ Vaccines to deliver Picovax® doses to UN agencies such as UNICEF and PAHO early next year.

The marketing approval of the adjuvanted Inactivated Polio Vaccine (IPV) is a major milestone in the ongoing efforts of the Global Polio Eradication Initiative, established in 1988. Picovax® provides active immunization against poliomyelitis by primary vaccination in infants from the age of 6 weeks and for revaccination of infants, children, adolescents and adults. Picovax® vaccine is based on a proprietary formulation technology that allows a lower dose of active substances, it is a well-tolerated and non-inferior alternative to currently approved IPV vaccines.

“The approval of Picovax® underlines the world-class innovation and development capabilities of AJ Vaccines. We are proud that our dedicated employees have deployed their combined skills to develop a ground breaking vaccine, which has the potential to contribute greatly to the eradication of polio and reach millions of infants in need of affordable and effective immunization globally,” said Jesper Helmuth Larsen, CEO of AJ Vaccines.

The marketing approval in Denmark and expected WHO prequalification of Picovax®, combined with the recent investment in a state of the art WHO GAPIII compliant polio vaccine manufacturing facility, form a strong foundation for establishing AJ Vaccines as a major contender in the global market for IPV vaccines during the global eradication endgame and for routing immunizations after the eradication.

“We expect the development and approval of Picovax® to have a positive impact on the lives of millions of people, while simultaneously constituting a significant business potential and growth opportunity for AJ Vaccines. We aim to launch the product globally in early 2020 through partnerships with UNICEF and other pooled procurement programs as well as directly to the private market,” said Jesper Helmuth Larsen.

The polio vaccine development project was initiated in 2013 in cooperation with and financial support from the Bill & Melinda Gates Foundation.

21 December 2018

New CEO at AJ Vaccines A/S

Jesper Helmuth Larsen replaces Klaus Hermansen as CEO at AJ Vaccines A/S as per 20^th December 2018. Jesper Helmuth Larsen previously held the position as Chief Financial Officer in AJ Vaccines, and will continue to assume this responsibility until a new CFO has been found.

19 March 2018

AJ Vaccines successfully completes two phase III trials of its new low-dose IPV-Al vaccine

The primary objectives in both trials were met successfully and next steps towards documentation, approvals and production can commence to satisfy the global demand for sufficient and affordable IPV vaccine.

AJ Vaccines today announced the positive phase III results for its low-dose adjuvanted IPV vaccine. In two separate observer-blind, randomized and controlled clinical Phase III trials all primary objectives were met when comparing this new adjuvanted IPV vaccine to licensed IPV. The project can now enter its last phases. The product approval process, including WHO pre-qualification, will be initiated in 2018 with expected approval and initial sales in 2019.

The development project, funded by the Bill & Melinda Gates Foundation, was initiated in 2013 to develop a low-dose affordable IPV vaccine. The vaccine uses a formulation technology that allows for a smaller dose of active substances compared to a currently approved IPV vaccine. This will significantly decrease production cost, making it more affordable to use in the Global Eradication Campaign.

AJ Vaccines has worked in close cooperation with Statens Serum Institut to reach the pivotal phase III milestone and the global demand for affordable IPV vaccines is huge.

“At AJ Vaccines we are proud of having achieved today’s major milestone in the development of the vaccine. With the essential funding and support from Bill & Melinda Gates Foundation and through excellent cooperation with Statens Serum Institut we have reached this breakthrough making it realistic that before the end of 2019 we can offer affordable IPV vaccine to help reduce the gap between demand and supply for this essential vaccine and thus contribute to the global eradication of polio,” said Klaus Hermansen, CEO of AJ Vaccines.

AJ Vaccines plans to ramp up production to deliver polio vaccine to UNICEF and other pooled procurement programs and for delivery directly to the commercial market.

“We look forward to take our new IPV vaccine through the last phase and to the thousands of people who need affordable and efficient polio immunization globally. We have only come this far because of great partnerships, dedicated and skilled employees and our new ownership, making it possible to secure the necessary investments to finalize and deliver on a project of this scale,” said Klaus Hermansen.

25 January 2018

AJ Vaccines kicks off its product portfolio expansion with the development of an innovative and pioneering Meningococcal Vaccine

Only one year after the formation of AJ Vaccines, the company will play a central role in the development of a new vaccine that will reshape immunization standards, protecting against five serogroups, which cause meningococcal infections and septicemia.

AJ Vaccine Group has entered into a collaboration with Hilleman Laboratories (Hilleman Labs) for the development of a new groundbreaking meningococcal vaccine to protect against five out of the six serogroups that frequently cause invasive meningococcal infection – Meningitis and Septicemia. Current vaccines in the market offer protection against a maximum of four serogroups.

“AJ Vaccines was established with a clear strategy for generating growth and development. As part of the AJ Vaccines Group, we have been able to embark directly on this project where our strong competencies and expertise from existing quality products will contribute significantly in all development phases of an entirely new vaccine providing better coverage against diseases that cause up to 130,000 deaths per year across the globe,” said Klaus Hermansen, CEO of AJ Vaccines.

AJ Vaccines will contribute throughout the process from development to the production and future marketing of the vaccine, which will address a very wide patient base due to its improved geographical coverage.

“We are excited to have the opportunity to play an important role in such a visionary project in collaboration with Hilleman Labs, an equal joint venture between Merck & Co (known as MSD outside US and Canada) and Wellcome Trust. The new MCV-5 vaccine will contribute to the improvement of people’s life and health, which will further develop AJ Vaccines’ product portfolio, creating exciting jobs and increasing company’s revenue and earnings,” said Klaus Hermansen.

“We are very confident that AJ Vaccine Group with the co-development program of MCV-5 takes strides towards being one of the key vaccine players globally. We are further developing additional plans, which will boost our aspirations to be a leader in preventing disease and growing healthy communities around the world,” said Dr. Tabassum Khan, Chairman of AJ Vaccine Group.

“We are honored to collaborate with AJ Vaccine Group, to develop this new affordable Meningococcal conjugate vaccine for the global market. By leveraging the expertise offered by AJ Vaccines and their development capabilities, we are confident that the new vaccine will be the industry’s game-changer. Beyond the vaccine’s introduction, we also hope to increase awareness about the prevalence of the disease amongst healthcare practitioners, public health experts and communities worldwide.”, said Dr Davinder Gill, the CEO of Hilleman Laboratories.

For further information, please contact:
info@ajvaccines.com