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Diosynth to make Somavert API for Pfizer


Akzo Nobel's Diosynth unit has signed a multi-year contract to manufacture and supply the active pharmaceutical ingredient for Pfizer's growth hormone receptor antagonist Somavert (pegvisomant). The value of the agreement was not disclosed, but Akzo claims it will contribute significantly to Diosynth's income in the coming years.

Somavert is the first and only growth hormone receptor antagonist to be approved for sale and is indicated for treating acromegaly, a life-threatening disorder caused by overproduction of growth hormone that is often the result of a pituitary tumor, in patients who respond inadequately to other treatments. The drug received marketing authorisation in the European Union towards the end of last year and in the USA in April.

Toon Wilderbeek, Akzo's board member with responsibiity for the group's pharma operations, said: "The contract with Pfizer is an example of exactly what we had in mind when we established our biotech bridgehead in the USA with the acquisition of Covance Biotechnology Services in 2001." Diosynth has been systematically investing in recombinant biotech manufacturing facilities, most recently unveiling a new process for peptide manufacture called DioRaSSP .

The agreement with Pfizer provides a good example of Diosynth Biotechnology's strategy, which was to develop laboratory techniques into industrial-scale processes. The company has been involved in the development of the manufacturing process for Somavert since the early clinical testing stage of the product's development. Now, the integration of Akzo's biotech facilities at Research Triangle Park in the US and Oss in the Netherlands under the Diosynth Biotechnology banner "has enhanced our product development efficiencies and increased our global manufacturing capacity to meet the needs of pharmaceutical and biotechnology companies worldwide," commented Johan Evers, general manager of Diosynth.

Pfizer's requirements will initially be supplied from the US operation, while process transfer activities are underway to supply the company's increased market needs both from Oss and North Carolina. US and European approvals for the Oss facilities are expected later next year.

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