Merck Serono's ready-to-use formulation of Saizen recommended for approval in Europe

16 November 2010

Switzerland-based Merck Serono, a division of German drug major Merck KGaA (MRK: DE) says that it has successfully completed the Decentralized Procedure (DCP) allowing for approval of Saizen Solution For Injection (somatropin) in the 18 participating European Union member states. Marketing authorizations enabling commercial sales in the individual countries are expected over the next several months.

Saizen Solution For Injection is a liquid formulation of Merck Serono's recombinant growth hormone Saizen indicated in Europe for the treatment of growth hormone deficiency in children and adult patients, as well as for growth promotion in children born small for gestational age, and in children with Turner syndrome or chronic renal failure. Sales of Saizen rose 17% to 56 million euros ($76.7 million) in the third quarter of this year (The Pharma Letter October 27).

To accommodate individual patient needs, the new formulation will be available in cartridges of 6mg, 12mg and 20mg, designed for exclusive use with Merck Serono's electronic injection device easypod and needle-free auto-injector cool.click.

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