“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. …”
“Oasmia: FDA grants Paclical® Orphan Drug Designation for ovarian cancer in the USA
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.
About Ovarian Cancer
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 [European Union] 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.
With the retinoid based unique platform XR-17, Oasmia has managed to produce a water soluble formulation of Paclitaxel (Paclical®), that does not require premedication and without the severe Cremophor® EL related side effects. The main indication is ovarian cancer. Other planned indications are malignant melanoma and lung cancer (NSCLC).
Oasmia Pharmaceutical AB develops second and third generation cancer drugs based on nanotechnology for human and veterinary use. The broad portfolio is focused on oncology and contains several promising products in clinical and pre-clinical phase. Oasmia cooperates with leading universities and other biotech companies to discover and optimize substances with a favourable safety profile and better efficacy. The company was founded in 1998 and is based in Uppsala, Sweden. …”
Source: Oasmia: FDA grants Paclical® Orphan Drug Designation for ovarian cancer in the USA, Oasmia Pharmaceutical AB, April 14, 2009.