ANTONY, GRENOBLE France, December 13 /PRNewswire-FirstCall/ -- STALLERGENES S.A and Protein'eXpert S.A. announce they have signed a partnership agreement for developing and pharmaceutically producing mites recombinant allergens(1).
The partnership is part of the STALLERGENES "Enhanced Allergens" innovation programme for a recombinant protein treatment for sublingual desensitisation of allergy to mites. This second-generation treatment is made up of the recombinant allergens Der p 1 and Der p 2 in the form of a fusion protein, combined with an adjuvant and/or a mucoadhesive formulation for facilitating recognition of the allergen by the immune system.
Protein'eXpert will handle:
- developing processes aimed at optimising the existing production protocol;
- developing and scaling up fermentation, renaturation, and purification processes;
- producing preclinical and clinical batches.
"This partnership enables us to accelerate the development of our "Enhanced Allergens" programme, and to envisage moving rapidly on to humans in a phase I study," emphasizes Philippe Moingeon, Scientific Director of STALLERGENES. Protein'eXpert has indeed recognised know-how in the field of process development and cGMP(2) biomanufacturing."
"Protein'eXpert is very pleased to be taking part in an innovative development programme in the specific field of respiratory allergy immunotherapy," declares Nicolas Mouz, Chief Scientific Director at Protein'eXpert. "'This partnership offers us an opportunity to propose our expertise in protein engineering and therapeutic protein development, and to widen our knowledge of allergens."
About the "Enhanced Allergens" programme
The combination of molecular biology tools and of formulation/adjuvanting strategies makes it possible to target better the immune system of the sublingual mucous membrane, and to improve the efficacy of desensitisation treatments. It is on this major concept that the "Enhanced Allergens" programme is based.
The active ingredient being considered is a combination of the major allergens of Dermatophagoides pteronyssinus, Der p 1 and Der p 2, expressed as a single recombinant molecule. The use of recombinant allergens makes it possible to develop products that are fully characterised, quantifiable, and reproducible.
In January 2007, a first range of product candidates was selected and underwent pharmaceutical and preclinical development. Going on to humans is scheduled for 2009, and several product candidates will be tested in parallel so as to identify, in 2010, the final prototype. A clinical development phase is scheduled for 2011.
STALLERGENES is a biopharmaceutical company specialised in desensitisation treatments for allergy-related respiratory diseases such as allergic rhino-conjunctivitis, allergic rhinitis, and allergic asthma.
A pioneer and leader in sublingual desensitisation treatments, STALLERGENES devotes 18% of its turnover to Research and Development, and in particular development of a new therapeutic class, namely sublingual desensitisation treatment in tablet form.
In 2006, STALLERGENES recorded a turnover of 126.5 million euros, half of which on markets outside France.
STALLERGENES shares are listed on Eurolist, Compartment B of the
Euronext Paris Stock Exchange
Codes: ISIN FR0000065674, Reuters GEN.PA, Bloomberg GEN.FP
Additional information on STALLERGENES is available at:
About Protein'eXpert Funded in 2000 in Grenoble, France, Protein'eXpert is an expanding Contract Research & Manufacturing Organisation devoted to recombinant protein engineering & production for biomedical research applications.
Protein'eXpert also provides services for process development & scale-up optimisation, pre-clinical and clinical cGMP production via its integrated subsidiary PX'Pharma.
The combination of Protein'eXpert and PX'Pharma know-how and manufacturing capacities allows ensuring a seamless transfer from early research to clinical production stages for therapeutic protein and recombinant vaccine projects. Recently, Protein'eXpert has created a new subsidiary named PX'Monoclonals, which offers contract services for the development of murine and humanized monoclonal antibodies.
Leading player in France and Europe, Protein'eXpert intends to expand internationally and especially in North America. The 48-staff company expects a turnover of over EUR3.3 million in 2007 (of which 50% at export).
Protein'eXpert complies with ISO 9000:2000 international quality standards. The PX'Pharma facility and equipment have been inspected by AFSSAPS (France) and comply with the French and European (EMEA) GMP guidelines.
Additional information on Protein'eXpert is available at: http://www.proteinexpert.com
(1) Recombinant allergen: allergen produced by genetic engineering, unlike a natural allergen.
(2) cGMP: current Good Manufacturing Practices.
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