Home > Press > Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
![]() |
Abstract:
Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) 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(R). Oasmia Pharmaceutical is conducting a Phase III study comparing the use of Paclical to Taxol(R) 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(R). 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 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.
About Paclical(R)
With the retinoid based unique platform XR-17, Oasmia has managed to produce a water soluble formulation of Paclitaxel (Paclical(R)), that does not require premedication and without the severe Cremophor(R) EL related side effects. The main indication is ovarian cancer. Other planned indications are malignant melanoma and lung cancer (NSCLC).
####
About Oasmia Pharmaceutical,
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.
For more information, please click here
Contacts:
Maria Lunden
Head of Public Relations
Oasmia Pharmaceutical AB.
Phone: +46-0-18-50-54-40
Information is also available at:
www.ngm.se
Copyright © PR Newswire Association LLC.
If you have a comment, please Contact us.Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
Related News Press |
News and information
Electrifying results shed light on graphene foam as a potential material for lab grown cartilage June 6th, 2025
Quantum computers simulate fundamental physics: shedding light on the building blocks of nature June 6th, 2025
A 1960s idea inspires NBI researchers to study hitherto inaccessible quantum states June 6th, 2025
Govt.-Legislation/Regulation/Funding/Policy
Electrifying results shed light on graphene foam as a potential material for lab grown cartilage June 6th, 2025
Institute for Nanoscience hosts annual proposal planning meeting May 16th, 2025
Rice researchers harness gravity to create low-cost device for rapid cell analysis February 28th, 2025
Nanomedicine
Ben-Gurion University of the Negev researchers several steps closer to harnessing patient's own T-cells to fight off cancer June 6th, 2025
Cambridge chemists discover simple way to build bigger molecules – one carbon at a time June 6th, 2025
Electrifying results shed light on graphene foam as a potential material for lab grown cartilage June 6th, 2025
Self-propelled protein-based nanomotors for enhanced cancer therapy by inducing ferroptosis June 6th, 2025
Announcements
Electrifying results shed light on graphene foam as a potential material for lab grown cartilage June 6th, 2025
Quantum computers simulate fundamental physics: shedding light on the building blocks of nature June 6th, 2025
A 1960s idea inspires NBI researchers to study hitherto inaccessible quantum states June 6th, 2025
![]() |
||
![]() |
||
The latest news from around the world, FREE | ||
![]() |
![]() |
||
Premium Products | ||
![]() |
||
Only the news you want to read!
Learn More |
||
![]() |
||
Full-service, expert consulting
Learn More |
||
![]() |