AJ Vaccines expands capacity with a comprehensive reconstruction and renovation of its Polio vaccine production

PRESS RELEASE

14 May 2018
AJ Vaccines has initiated a total reconstruction and expansion of its existing Polio vaccine production facilities. The new facilities will increase production capacity substantially while simultaneously ensuring compliance with future WHO demands for Polio vaccine production and containment.
AJ Vaccines and the company’s owner have decided to initiate a comprehensive and needed upgrade of the production facilities in Copenhagen – not least to be able to meet the large global demand for affordable Polio vaccines.
AJ Vaccines has therefore initiated an extensive renovation of the current production facilities advised by NNE and in close coordination with Statens Serum Institut, the owner of the site that houses the production.
“Following the positive phase III results for our new and groundbreaking low-dose adjuvanted IPV vaccine we need to ramp up production, and we need state of the art production facilities, that live up to future WHO compliance standards in order to deliver the required Polio vaccines for WHO’s Global Polio Eradication Campaign. We will achieve both of these objectives when we open the new facilities during 2019,” said Klaus Hermansen, CEO of AJ Vaccines.
After the upgrade, AJ Vaccines will multiply its Polio vaccines production capacity making it possible to deliver Polio vaccine to UNICEF and other pooled procurement programs and for delivery directly to the private commercial Polio vaccines market. With only four IPV manufacturers globally, the capacity expansion will help reduce the gap between demand and supply for this essential vaccine and thus contribute to the global eradication of polio.
“We look forward to take use of our new facilities and the investment of more than DKK 300m is yet another testament to our owner’s confidence in AJ Vaccines and our efforts in Denmark. At the same time, the investment creates more new jobs and we will welcome even more new colleagues when the Polio vaccines unit is ready in 2019,” said Klaus Hermansen.
For further information, please contact:
CEO Klaus Hermansen, AJ Vaccines A/S, +45 29 49 44 35

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

19 March 2018

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.

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

25 January 2018

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:
CEO Klaus Hermansen, AJ Vaccines A/S, +45 29 49 44 35