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ProMetic techs for next generation hyperimmunes

By staff reporter, 09-Nov-2007

Related topics: Processing & QC, Processing (automation, control, separation)

Italian biopharmaceutical firm Kedrion is set to sign a deal with ProMetic BioTherapeutics to gain access to the firm's manufacturing technologies to increase yield and reduce prions in its hyperimmune products.

The preliminary agreement was announced yesterday, with Kedrion due to in-license technologies from ProMetic to enable the production of the company's hyperimmune products in Europe.

Kedrion will pay as-yet undisclosed license and service fees to ProMetic, along with royalties on sales in Europe, and will be responsible for funding the product development programme, including clinical trials to establish bioequivalence to its existing products.

ProMetic has a number of high profile pharmas on its client list, including GlaxoSmithKline and Novo Nordisk, all making use of the firm's mimetic ligand technology to purify their biological products and remove pathogens.

The deal announced with Kedrion specifically highlights removal of prions, an endeavour that ProMetic has been particularly active in through a joint venture company with the American Red Cross, Pathogen Removal and Diagnostic Technologies (PRDT).

PRDT has formed a strategic alliance with MacoPharma, focusing on the reduction of transmissible spongiform encephalopathies (TSEs) such as vCJD from blood and blood products.

ProMetic's mimetic ligand technology is used for large scale purification of biologics and removal of pathogens. The affinity chromatography technology relies on the ability of proteins to recognise and bind to other molecules (ligands) in a specific (and reversible) way.

The company has synthetically 'mimicked' and enhanced the natural molecular affinity of binding ligands to produce molecules that are highly specific and selective in binding proteins. The synthetic molecules can therefore be used to purify a target protein by binding it out of a mixture, or using the same process to target and remove a contaminant.

According to the company, its mimetic ligand products are particularly cost beneficial, being around 50 - 75 per cent cheaper than competing technologies. The technology can also produce ligands for a variety of processes and can be custom designed for specific purposes, even when detailed information on the target protein is lacking.

Kedrion will be taking care of full scale manufacturing at one of its two Italian manufacturing facilities, with ProMetic retaining the commercial rights to the fully developed hyperimmune products for the North American market. ProMetic will, in turn, pay royalties to Kedrion on North American sales.

The first product to be targeted will be Hepatitis B, which the firms believe could reach the commercial stage by 2010/2011. The market for Hepatitis B hyperimmune in the US and Europe is currently estimated at $200m and expected to double by 2015.

Integrating the ProMetic technologies into Kedrion's existing manufacturing infrastructure will increase the company's production capacity and enable both companies to increase market share in Europe and North America, according to a statement released by ProMetic.