The company has applied a technology used in its insulin franchise to create a liquid hGH formulation available in a pen system. Norditropin NordiFlex (somatropin [rDNA] injection) is the first premixed, prefilled, multi-dose, disposable hGH pen, and has been approved in the US for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
The disposable product is prefilled - so there is no loading of cartridges - and can deliver fine dosing increments from 0.025 to 4.50 mg, depending on the capacity. The product is available in a 5 mg/1.5 mL and a 15 mg/1.5 mL pen format. Between these two delivery systems, a total of 100 different dosing options are available.
"This product eliminates the need for reconstitution and the complex loading of devices," said Michael Shalmi, vice president of biopharmaceuticals at Novo Nordisk Pharmaceuticals. This makes it easier to learn how to use the device, and to ensure that accurate and correct doses are delivered by the child or carer.
Novo Nordisk introduced its first cartridge-based hGH pen system to Europe and Japan in 1999, and followed this with a US launch in 2000.
The company, like other hGH manufacturers (e.g. Eli Lilly, Genentech and Serono) is turning to new formulations of its product to provide a competitive edge in a market that is facing the threat of generic competition.
Just last month, Novo Nordisk started an appeal against two US District Court rulings against the validity and enforceability of the firm's growth hormone patent 5,633,352,, the active ingredient in Norditropin. The August 3 decisions by Judge Susan Robinson prevent Novo Nordisk from barring Teva Pharmaceuticals and its licensor, Savient Pharmaceuticals, from marketing hGH in the USA.
This decision followed two related litigations, one in which Novo Nordisk sued Teva and Savient in April 2002, claiming the companies infringed a patent for Norditropin. In the other, Savient appealed a decision by the Board of Patent Appeals and Interferences that upheld Novo Nordisk's right to its patent covering recombinant human growth hormone. The Federal District Court reversed the decision of the Board of Patent Appeals and ruled that the Danish firm's patent is invalid and unenforceable.
Also waiting in the wings is Sandoz, which recently was stymied in its attempts to launch a generic version of hGH by the US Food and Drug Administration after the agency conceeded defeat - for the time being - on being able to work out a mechanism for approving generic versions of biologic drugs.