- The active pharmaceutical ingredients (API) will be produced according to GMP requirements in a clean room rented from Accessia Pharma, a provider of high-quality pharmaceutical infrastructures
- The deployment of the overall quality system and associated documentation system is completed and a GMP certification request has been filed with the Belgian Regulatory Authorities
- The granting of the GMP certification, the manufacturing of the first clinical batches and their release are expected H1 2019
Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (ASIT BE0974289218), a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced that it has installed and qualified in a clean room the equipment to produce, in compliance with GMP requirements, the API for the Phase I/II studies in house dust mite and peanut allergies treatment.
The availability of a dedicated GMP manufacturing unit reduces the technology transfer duration and improves the flexibility and the agility of such transfer from the R&D to production thanks to the "real-time" fine-tuning opportunities. It also lifts the constraints related to third party CMO capacity scheduling and secures manufacturing as well as the overall development planning.
ASIT biotech expects the grant of the GMP certification by the Belgian Regulatory Authorities, as well as the release of the first clinical batch of pnt-ASIT+ for the first-in-man study in peanut allergy, in H1 2019.
Thierry Legon, CEO of ASIT biotech, commented"The establishing of our own GMP manufacturing unit is key for the development of all our allergy-immunotherapy programs, especially in food allergies where we aim to submit the first clinical trial authorization for pnt-ASIT+ in peanut allergy as early as the end of H1 2019. We then plan to immediately seek a clinical trial application for hdm ASIT+ in house dust mite allergy. Thanks to this GMP infrastructure for the manufacturing of Phase I/II clinical batches, ASIT biotech is taking a major step towards the deployment of its ASIT+ product portfolio designed to offer short course allergy immunotherapy to patients unsatisfied with current symptomatic treatments. I would like to thank our CMC teams, as well as those of our partner Accessia Pharma, for the smooth implementation of this unique site."
Benoit Verjans, CEO of Accessia Pharma, commented: "We have been extremely satisfied about our mutual collaboration with ASIT Biotech, notably in aligning our respective processes, infrastructure and quality requirements with the aim of setting up a fully validated production environment. We hope to obtain the approval of the pharmaceutical authorities shortly to produce the first clinical batches for ASIT biotech's clinical studies."
Vincent Bille, Vice-President CMC of ASIT biotech, concluded: "I am proud of our team for having quickly achieved this important milestone. We can now benefit from a state-of-the art CMC environment that will enable us to produce the API for our upcoming clinical trials in peanut and house dust mite allergies according to the required industrial standards."
About ASIT biotech
ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+ technology platform, ASIT biotech is currently the only developer of allergy immunotherapy (AIT) product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech's product pipeline contains three novel ASIT+ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+ and house dust mite: hdm-ASIT+), and food allergies (peanut allergy: pnt-ASIT+) that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies.
ASIT biotech has a headcount of 26 staff members, at its headquarters in Brussels and a laboratory in Liège, Belgium.
Further information can be found at www.asitbiotech.com
Forward-looking statements
All statements in this announcement that do not relate to historical facts and events are "forward-looking statements". In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes," "estimates," "anticipates," "expects," "intends," "may," "will," "plans," "continue," "ongoing," "potential," "predict," "project," "target," "seek" or "should" or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company's intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company's obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement.
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This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the "Company" and the "Shares"). Any purchase of, subscription for or application for, shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company's registered office and on www.asitbiotech.com
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Contacts:
Company
Thierry Legon, CEO
Tel.: +32 2 264 03 90
ASIT biotech
investors@asitbiotech.com
Media and Investor Relations France
NewCap
Dusan Oresansky Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu
Media Relations Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be