Sanofi lets Novozymes buy Delta Biotechnology

Delta is currently hot property as Sanofi Pasteur's measles, mumps and rubella (MMR) vaccine, the world's first and only animal-free alternative to human serum albumin (HSA), made with Delta's recombinant human albumin (Recombumin), was approved last month by the European Medicines Agency (EMEA).

US drug giant Merck has also developed an MMR vaccine with Delta's Recombumin which was approved by the US Food and Drug Administration last year.

In-PharmaTechnologist.com​ has learned that Novozymes, which already produces and develops ingredients for the biopharmaceutical industry, had been looking at Delta, which sanofi-aventis always considered a "non-core asset," for more than a year, until it was convinced it was a good fit with its biotechnology.

"We have been working to expand our access to the market with microorganisms and although we have the best expression systems around we did not have access to yeast,"​ Anders Gram, managing director of Novozymes, told In-PharmaTechnologist.com​.

"We now own Delta's high-value products which complement our global product portfolio very well."​

Apart from Merck and Sanofi Pasteur, Delta has made several deals for Recombumin, including with Vitrolife in Sweden for the supply of Recombumin for IVF media manufacture, with Novalung in Germany for the supply of Recombumin for medical device manufacture, and ConjuChem in Canada for the supply of Recombumin for clinical development.

The Nottingham-based company also claims it has approximately 30 pharma and biotech companies currently evaluating Recombumin in their products, with several in clinical development in Europe and the US.

The company's sales, which are primarily contract-based, amounted to around €13m in 2005 and have mainly been based on annual sales of Recombumin.

With an 8,000 litre fermentation capacity, Delta manufactures Recombumin using Saccharomyces cerevisiae​, which have a long track record in the production of protein therapeutics such as insulin.

The company has developed a series of S. cerevisiae​ strains with various traits such as genetic stability, high copy number expression plasmids, protease deficient mutants and strains deficient in the enzymes involved in O-linked glycosylation.

Based on a proprietary 2-micron plasmid construct, the system is optimised for the production of recombinant proteins where glycosylation does not naturally occur or can be designed out without impacting product efficacy.

Recombumin is manufactured at Delta's current good manufacturing practice (cGMP)-compliant facility in Nottingham, UK.

Delta also has in its pipeline projects for other quality grades of recombinant albumin and recombinant transferrin, which may be used as ingredients for cell culture media in the future, and has developed a platform for producing recombinant proteins based on the Albufusion technology.

The acquisition of Delta for an undisclosed amount is expected to be finalised in the next one to three months.