Indian drug firm Dabur Pharma yesterday introduced Nanoxel, the first nanoparticle drug delivery system to be developed outside the US.
"Owing to its water insolubility, the widely used chemotherapy agent paclitaxel that is known to have substantial anti-tumour activity is now used with a castor oil based solvent, cremophor, which in turn is an agent for life threatening side effects," said Dabur Research Foundation R&D president Dr Rama Mukherjee.
"The anti-cancer drug nanoxel, based on principles of nanotechnology, is a cremophor free soluble formulation - and is indicated as an effective and safe therapy for advanced breast, non-small-cell lung, and ovarian carcinomas."
On of the major challenges with anti-cancer drug treatments is damage to surrounding healthy organs and tissue as many anti-cancer drugs are designed simply to destroy cells. The threat of severe side effects caused by random distribution of the drugs has meant that maximum dosages are necessarily restricted.
However, utilising nanotechnology to design new drug delivery systems is helping to tackle this problem. Nanoxel's polymeric nanoparticle drug delivery system is being touted as a 'potential super generic' due to its increased safety and pharmacokinetic profile.
"Nanoparticle drug delivery devices like Nanoxel enable therapy to take a preferential course to the cancerous cells and directly interact with the tumour causing agents thereby throwing open a larger window for anti-tumour activity," said Dr Advani, Director of Medical Oncology at the Jaslok Hospital and Research Centre.
"It also ensures that the patient receives the full measure of the therapy while limiting the adverse side effects and toxicity affected by the drug."
Dabur plans to market Nanoxel in the Indian market, although it would be more costly than other forms of paclitaxel drug delivery available, coming in at around 16,000INR (€276) per cycle of chemotherapy treatment.
The company recently received US Food and Drug Administration (FDA) approval to market its generic paclitaxel drug in the US, where it is estimated to achieve sales of around $400m (€307m). The firm expects to start clinical trials for Nanoxel in the US and Europe 'very soon', and hopes to introduce the new chemotherapy drug delivery system into the market in the next 18-36 months.
The company is currently also developing a range of other novel molecules, and currently has 16 under development. One drug currently in advanced clinical development is a peptide based product for treatment of adenocarcinomas, including cancers of the breast, pancreas, ovary, colon and lung.
The new Nanoxel system would seem to be in competition with Abraxis BioScience's paclitaxel drug, Abraxane, which gained FDA approval in January 2005. The Abraxis drug is also free of toxic solvents, being formed of only of albumin-bound paclitaxel nanoparticles, and allows administration of 50 per cent more chemotherapy than the solvent-based paclitaxel. Revenues generated through Abraxaxne for 2006 are anticipated to be in the range of $173m to $183m (€133m to €140m).
However, in July 2006 Irish drug maker Elan accused Abraxis of infringing its patents through its Abraxane formulation. The Irish firm maintain that Abraxane trespasses on two patents issued to the company during the 1990s that cover methods of formulating anti-cancer drugs. The company themselves market their own nanotechnology product, NanoCrystal, for use with poorly water-soluble compounds.
No one from Dabur was available to comment on whether the Nanoxel technology could also infringe on Elan's patents.