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Ceftiofur Long Acting to Reduce Antibiotics

Periodic Report Summary 1 - CLARA (Ceftiofur Long Acting to Reduce Antibiotics)

Project Context and Objectives:
The project

The Ceftiofur Long Acting to Reduce Antibiotics (CLARA) is a new technology project for large animal pharmaceutical products with one shot, long acting treatment, based on a widely recognized molecule.
It will result in a long acting antibiotic injection process (one shot / 7 to 8 days) of Ceftiofur to treat farm animals against important infectious diseases on respiratory and digestive systems, with a very short delay. This new technology for delivering antibiotics will help to:
- reduce the quantity of antibiotic delivered,
- reduce the number of injection or delivery,
- improve tolerance for animals,
- Improve food chain safety.

So-called Hydrogels, obtained through hydratation of high technologies polymers (PLA and PEG). will be the base of the technology for this innovation.

The needs in R&D of the project to obtain such an innovation will be:

-to check compatibility between the new type of vector and the different forms of the molecule,
-to test the appropriate and optimum quantities ,
-to validate the full concept both in vitro et in vivo,
-Following this first step (validation of the technology), the project will consist in following all the steps of a new treatment development, up to the registration and start of dissemination.

Dissemination and impact

Due to Coordinator internal rules and the consortium agreement proposed for this project, there will be a full property on the results for the consortium. As the project is completely SME and industry driven, there is also a unique commitment to disseminate the veterinary products resulting of the project as final products in every European country and, to diffuse them on the worldwide market with great opportunities on emerging and fast growing markets (Asia and Pacific). The project starts from pure R&D actions to pre-sales operations with the final delivery of a “ready to use” full technical dossier to obtain the official authorisation to conduct the last clinical trials before applying of the complete dossier to the authorities. This final deliverable will help the consortium to achieve the major aim of the project and reach a pan-European central registration at the European Medicines Agency (EMEA).

Key strength

A consortium of Animal Health Pharmaceutical SMEs individually recognized as references in their respective country
A 24 months project based on a recognized antibiotic molecule (Ceftiofur) and an awarded delivery technology (Medincell) based on 20 years of European research at French CNRS.
The project results will be ready to help the consortium to get registration and, as SMEs, participants have a clear commitment to deliver the new product to the animal health market. Without a funding, those SMEs won’t have the capacity to fully develop that innovative project. The risk is then to see a European technology benefiting to large multinational groups established abroad of Europe.

RTD performers are well known and recognized European R&D companies that work closely with European academic and professors.

Project Results:
the CLARA project should have achieved at this date, Work Package 2 (Feasibility) and Work Package 3 with the delivery of a Master Formulation which should have pasted In Vivo Testing confirmation Evaluations. As of today, the project should be at the middle of Work Package 4
But at the end of WP3, we have failed to achieve expected results :

• Although well implemented, the feasibility study (WP2) could not reach this negative conclusion .
- Therefore the project went from WP2 to WP3 in order to find the best formulation
• As explained during the project kick off meeting on November 19th 2008, the consortium has already launched a search for alternatives to obtain a new long acting formulation to deliver antibiotics to large animals.
- Those alternatives have to be evaluated in terms of scientific pertinence and considering both the interest for Europe and the benefit of the participating SMEs (access to the technology, endorsement of the Grant Agreement and Consortium Agreement)
• The consortium participants are strongly committed to find the alternative, execute the work plan to its end, follow up the described dissemination and marketing plan and fund the additional costs for the additional tasks to be conducted
• Medincell technology (hydrogel) doesn’t reach the objectives listed by the consortium within the DoW
- No additional work and investment could help to solve the problems the Medincell technology faces

Potential Impact: