Genentech, Inc. and Ipsen have signed collaborative research and development (R&D) agreement to develop sustained-release formulations of Genentech's recombinant human growth hormone [somatropin (rDNA origin)].
This R&D collaboration is in addition to and supplements a previous agreement signed in 2002 whereby Ipsen gained exclusive rights to market Nutropin AQ Pen throughout Europe and the rest of the world, excluding North America and Japan. Nutropin AQ Pen for use with the Nutropin AQ Pen cartridge was cleared for marketing by the US Food and Drug Administration in April 2002 and obtained marketing authorization under the trade name NutropinAq Pen from the European Medicines Agency in March 2004. Ipsen has already launched Nutropin AQ Pen in 12 European countries, the release says.
Jean-Luc Belingard, president and chief executive officer of the Ipsen Group said, "Our common objective is to develop sustained-release formulations of recombinant human growth hormone to meet the needs of paediatric and adult growth hormone deficiency (GHD) patients."
Nutropin AQ [somatropin (rDNA origin) injection] is produced using recombinant DNA technology and has the same amino acid sequence as human growth hormone produced naturally in the human body. It is marketed as NutropinAq in Austria, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Sweden, Portugal, Spain and the United Kingdom. Other regulatory reviews are underway in Europe and worldwide, excluding North America and Japan.