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Avexa and Novasep Sign Manufacturing Agreement

By Biotechdaily staff writers
Posted on 28 Feb 2007
Avexa (Melbourne, Australia) and Novasep (Nancy, France) announced the signing of a manufacturing agreement for the production of apricitabine (ATC), Avexa's novel nucleoside reverse transcriptase inhibitor (NRTI), which is in clinical development for the treatment of human immunodeficiency virus (HIV) infection. More...
The agreement covers the continued production, process optimization, and further scale-up of the active pharmaceutical ingredient (API) of ATC based upon the Varicol continuous chromatography system for use in phase III clinical trials and in preparation for the commercial launch of the product.

Novasep is a well established company with extensive experience in the chemical processes required for ATC production, said Dr Julian Chick, CEO of Avexa. We are delighted to be working with Novasep on the production and supply of ATC API for our phase III program. The signing of this agreement signals yet another step forward in the progression of apricitabine towards the market.

Avexa is a biotechnology company with a focus on research and development of drugs for the treatment of infectious diseases, in particular diseases which have a significant unmet medical need. Avexa has dedicated resources and funding for key projects including antiviral drugs for (HIV)/AIDS and an antibiotic alternative for antibiotic-resistant bacterial infections. The company's lead program is apricitabine which is currently in phase IIb clinical trials. Recruitment for Phase IIb was completed at the end of 2006 and the results are due in the first quarter of 2007.

Novasep Synthesis provides R&D and exclusive synthesis, from lab to industrial scale, with special expertise in hazardous chemistry, chiral technologies, highly potent APIs, and early stage services. Novasep Synthesis includes two business units: exclusive synthesis and proprietary products.

Groupe Novasep covers the special needs of the pharmaceutical, food, cosmetics, agrochemicals, and specialty chemicals industries. It combines chemical synthesis and chemical engineering expertise in order to develop new technologies. The group operates through two divisions: Novasep Synthesis and Novasep Process focusing on the synthesis and process of intermediates, advanced intermediates, and APIs.


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