Oasmia Pharmaceutical AB ("Oasmia") announced today that its lead cancer product Paclical received market authorization in the Russian Federation by the Russian Ministry of Health. Paclical is the first water-soluble cancer drug with paclitaxel to receive a market authorization. Paclical is planned for launch in the second half of 2015.
Paclical, a novel formulation of paclitaxel based on Oasmia's XR-17 technology, was approved for treatment of (i.e., it received market authorization for) epithelial ovarian cancer in combination with carboplatin. XR-17 is non-toxic and forms water soluble nanoparticles with paclitaxel.
The Russia-based company Pharmasyntez holds the distribution rights to Paclical in Russia and will be responsible for marketing the product in Russia and the CIS countries. CIS consists of Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Ukraine, Georgia, Turkmenistan and Uzbekistan. The market for cytostatics in Russia amounts to 2.05 billion with an annual growth rate of 36 % according to DSM, the Russian equivalent of IMS Health.
Standard treatment of ovarian cancer is Taxol in combination with carboplatin. Taxol is a combination of paclitaxel, Cremophor EL (polyethoxylated castor oil) and ethanol. 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 Oasmia's pivotal Phase III study, 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.
The two leading paclitaxel-based products on the market are Taxol and Abraxane, two widely used cancer drugs. Taxol indications are breast cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer and AIDS-related Kaopsis sarcoma. In 2013, Taxol generated $92 million in sales. Abraxane, which received FDA approval in 2005 for metastatic breast cancer, followed by approvals for lung (in 2012) and pancreatic cancer (in 2013), generated $649 million in worldwide annual sales in 2013 and $848 million in 2014.