Oasmia presses ahead with new water-soluble paclitaxel formulation
This article was originally published in Scrip
The US FDA has granted orphan drug designation for Oasmia Pharmaceutical's Paclical (paclitaxel) for the treatment of ovarian cancer. The Swedish company hopes to achieve a 35% market share, its CEO, Julian Aleksov, told Scrip.
Oasmia is conducting a Phase III study comparing Paclical with Bristol-Myers Squibb's Taxol (paclitaxel), the standard treatment therapy for ovarian cancer, to show its superiority in terms of fewer hypersensitivity reactions, it says. Paclical does not contain the excipient Cremophor EL, which in conventional paclitaxel preparations has been associated with side-effects.
Paclical is a water-soluble formation of paclitaxel, which Oasmia has developed with its retinoid-based delivery technology, XR17. Its use does not require premedication. Mr Aleksov claims that Paclical could be a better treatment option for patients.
The FDA will decide on the technical and financial assistance it will provide as part of the orphan drug designation once the study is complete. The drug should be launched in Europe by 2011 and in the US by 2012, the CEO confirmed.
The company, which develops second- and third-generation cancer drugs based on nanotechnology for human and veterinary use, also has three products for human use in preclinical studies: Doxophos (doxorubicin), which is being developed to treat a variety of cancers including lung cancer and breast cancer; Carbomexx (carboplatin), a combination drug, with planned indications of lung, breast, ovarian and kidney cancer; and Docecal (docetaxel), which is being developed for prostate cancer.
Doxophos will enter a Phase I trial at the beginning of next year, and Docecal and Carbomexx are expected to enter into Phase I trials later in 2010, Mr Aleksov commented.
Following positive preclinical results, Oasmia has grown significantly over the past two years and now has 58 full time staff. However, the company has proceeded cautiously with a sharp focus on controlling costs, the CEO told Scrip. As a result, the company is currently operating with both limited resources and staff, he says.
Mr Aleksov hopes that, with the right partners and distributors, the company will be cash flow positive by 2012.