FDA grants Oasmia's Paclical orphan drug designation for ovarian cancer in U.S.

Apr 14 2009

Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical for the treatment of ovarian cancer.

Orphan Drug designation can entail additional assistance from FDA to expedite and optimize drug development and upon approval a seven year market exclusivity is granted.

Orphan drug designation is intended to support the clinical development of new drugs in diseases affecting less than 200,000 people. This provides Oasmia with seven year market exclusivity on the indication when the pharmaceutical is approved. There is no direct generic competition during the period and FDA often provides technical and financial assistance to expedite and optimize drug development.

The designation is based on the hypothesis that Paclitaxel is safer than Taxol. Oasmia Pharmaceutical is conducting a Phase III study comparing the use of Paclical to Taxol in patients with ovarian cancer. A safety objective is to show the superiority of hypersensitivity reactions.

This designation shows that the FDA has a great confidence in the company and our product. The United States is one of the most important markets for Paclical. This decision improves the possibilities for the product, says Julian Aleksov, CEO of Oasmia in a comment.

Ovarian cancer is a disease with few and unspecific symptoms at its early stages, and is difficult to detect. The numbers of patients that are diagnosed are increasing on a yearly basis. Ovarian cancer is most often diagnosed in women over 50 years of age, but younger women are also affected. The annual incidence of new diagnosed cases is approximately 125 000 women in EU alone. In the USA ovarian cancer accounts for 3 % of all cancer cases and is the fifth leading cause of cancer related deaths in the US.