A biogeneric company leads the field of next generation human growth hormone (hGH)

The global hGH market of US$ 2.2 bln in 2004 is not endangered by the only three biogeneric competitors in regulated countries, but by next generation developments of more convenient administration regimens and forms. After Genentech had to terminate commercializtion of its Nutropin Depot preparation, the field now is lead by Korea-based LG Life Science and its European licensee BioPartners with the slow release formulation of hGH (LB03002) which received FDA clearance to initiate phase III studies. Current market leaders Pfizer (33 % market share), Eli Lilly (19.4 %), Novo Nordisk (16.8 %), Genentech (16 %) and Serono (12.1 %) only have early stage R&D projects with next generation formulations. These results were found in a search conducted by La Merie Business Intelligence. The results were published in the October 24 issue of R&D Pipeline News , edited by La Merie.

The first biogeneric hGH preparation (Omnitrope) from Sandoz (Novartis) is cleared for sale in Australia and received position opinions from European and US regulators, but marketing clearance so far was not granted, although basic hGH patents already expired. LG Life Science submitted the marketing application for its yeast produced hGH already in June 2004 to the EMEA. Canadian Cangene and partners Apotex and BioGeneriX are still in phase III trials.

All first generation and biogeneric hGH preparations so far require daily parenteral administration which is inconvenient for the patient. Less frequent administration and pain-avoiding needle-free delivery systems would constitute a real advantage. Ongoing R&D projects concentrate on slow-release and long-acting hGH molecules as well as on oral and pulmonary delivery systems. Transdermal and intranasal systems are also offered by the drug delivery industry, whereas low cost production in transgenic cows or aquatic plants still is in its infancy. The number of hGH manufacturing companies in countries without patent protection and, therefore, potential biogeneric producers, is small despite a continuosly growing market due to life cycle management measures and label extensions.


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