NeuroVive signs contracts with Fresenius Kabi

Today, 29 August 2008, on schedule, NeuroVive has signed contracts with Fresenius Kabi for GMP production and registration work for the company’s first product, NeuroSTAT®.

Negotiations which were underway when the NeuroVive prospectus was being written have now been completed and contracts have been signed with Fresenius Kabi, a global market leader specialising in infusion technology for pharmaceuticals. Fresenius Kabi (www.fresenius-kabi.com) has around 17,000 staff, a global network of over 50 sales organisations and around 45 plants, with annual sales of around EUR 2 bn. As the prospectus indicates, Fresenius Kabi has already produced small volumes of NeuroSTAT® for NeuroVive. Signing these contracts strengthens the partnership between NeuroVive and Fresenius Kabi as planned.

In a nutshell, the contract means that Fresenius Kabi will be CMO (Contract Manufacturing Organisation) for NeuroVive’s first product, NeuroSTAT®, which comprises an intravenous carrier medium in the form of a lipid emulsion and the active agent, cyclosporine-A. The lipid emulsions of the kind NeuroVive’s product contain have considerably less serious side-effects than cremophor-based carrier media. The serious side-effect of anaphylactic shock as published in the literature amount to approximately 1 in 60,000 patients, compared with approximately 1 in 1,000 patients for drugs containing cremophor (polyoxyethylated castor oil).

The contract as signed covers all aspects of production work through to registering the product, and includes handling the active agent, cyclosporine-A, GMP production of the product for clinical trials, drug analysis, a comprehensive stability programme to confirm the product’s stability with a view to registration and compiling the pharmaceutical documentation required for registration with the authorities. As Fresenius Kabi will be acting as CMO, it will be paid under contract for the work performed. The contract does not provide for any royalties.

MD Eskil Elmér comments:

“This is currently an eventful period for us. We signed contracts with Fresenius Kabi today, right on schedule. It’s incredibly inspiring to realise how quickly we are getting towards the stage of conducting clinical trials. The contract with Fresenius Kabi means we now have a well-established partner, which will help us in our continuing work.”

Eskil Elmér
MD and CSO, also physician and associate professor of experimental neurology at Lund University

For more information contact:

Eskil Elmér
MD and CSO, Neurovive Pharmaceutical AB (publ)

Telefon: + 46 (0)46-288 01 10
eskil(punkt)elmer(snabel-a)neurovive(punkt)se

NeuroVive is involved in research and development into cyclosporine-based drugs, also known as cyclophilin-D inhibitors. The company’s first product, NeuroSTAT®, is now ready for clinical trials in humans. NeuroVive is also involved in advanced research and development into new potential drugs that could protect nerve cells. The company holds broad patent rights to a family of drugs known as cyclosporines. NeuroVive intends to license products to major pharmaceutical companies for registration and marketing.