Oasmia obtains Orphan Drug designation
OASMIA OBTAINS ORPHAN DRUG DESIGNATION FOR OAS-PAC-100 (PACLITAXEL MICELLAR)
The European Medicines Agency, EMEA, has approved Oasmia's application for Orphan Drug designation for the product OAS-PAC-100 on the indication ovarian cancer. The approval entails a 10-year protection against direct competition on the indication when market authorisation is approved. The market value is about 1 billion euros. The approval is a major step for Oasmia and its oncology portfolio. The announcement was first published in a press release from EMEA Tuesday, November 14th 2006.
By the end of July 2006, Oasmia filed an application for OAS-PAC-100 (Paclitaxel micellar) to be designated as an Orphan Drug on the indication ovarian cancer with the European Medicines Agency, EMEA. The application has now been approved by EMEA. Orphan Drug designation entails a 10-year exclusivity for treatment of the disease with paclitaxel micellar, and protection against direct competition from other products.
About 100 000 women within the EU are each year affected by ovarian cancer. The market has been evaluated to exceed 1 billion Euros.
OAS-PAC-100 ( Paclitaxel micellar) is Oasmia's first product to be released on the market. It provides a more efficient treatment alternative compared to current methods. The unique formulation of OAS-PAC-100 (paclitaxel micellar) enables faster release of the active substance, no pre-medication which is the case with most current methods, higher doses and shorter infusion time compared to treatments available today.
The company is now ready to enter the next phase in development of its strong product portfolio.
