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