A Biogeneric Company Leads the Field of Next Generation Human Growth Hormone (hGH)
Genentech had to terminate commercialization 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.
The global hGH market of US$ 2.2 bln in 2004 is not endangered by the only three biogeneric competitors in regulated countries.
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 continuously growing market due to life cycle management measures and label extensions.
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