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news.Sweden-based Oasmia Pharmaceutical has received market authorization from the Russian Ministry of Health for its lead cancer product Paclical in Russia.
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Paclical is the first water-soluble cancer drug with paclitaxel to receive a market authorization and the product is scheduled to be launched in the second half of 2015.
It is a new formulation of paclitaxel based on the company’s XR-17 technology, while the product was approved to treat epithelial ovarian cancer in combination with carboplatin.
The company said that XR-17 is non-toxic and forms water soluble nanoparticles with paclitaxel.
Pharmasyntez, a Russian firm, holds the distribution rights to Paclical and will be responsible for marketing the product in Russia and the CIS countries, which include Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Ukraine, Georgia, Turkmenistan and Uzbekistan.
Taxol, a combination of paclitaxel, Cremophor EL and ethanol, in combination with carboplatin is the standard treatment of ovarian cancer.
The company said that in order to avoid hypersensitivity reactions to Cremophor EL, treatment with Taxol requires extensive pre-medication with corticosteroids and antihistamines as well as a long infusion time.
In the recently published results from the company’s pivotal Phase III trial, Paclical showed a positive risk/benefit profile compared to treatment with Taxol; no need for pre-medication, the infusion time is one hour and possibly a reduced risk of experiencing neuropathy.