Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International



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.

Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA

UPPSALA, Sweden | Posted on April 14th, 2009

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.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Flexible electronics integrated with paper-thin structure for use in space January 17th, 2025

‘Brand new physics’ for next generation spintronics: Physicists discover a unique quantum behavior that offers a new way to manipulate electron-spin and magnetization to push forward cutting-edge spintronic technologies, like computing that mimics the human brain January 17th, 2025

Quantum engineers ‘squeeze’ laser frequency combs to make more sensitive gas sensors January 17th, 2025

How a milk component could eliminate one of the biggest challenges in treating cancer and other disease, including rare diseases: Nebraska startup to use nanoparticles found in milk to target therapeutics to specific cells January 17th, 2025

Govt.-Legislation/Regulation/Funding/Policy

Department of Energy announces $71 million for research on quantum information science enabled discoveries in high energy physics: Projects combine theory and experiment to open new windows on the universe January 17th, 2025

Quantum engineers ‘squeeze’ laser frequency combs to make more sensitive gas sensors January 17th, 2025

Chainmail-like material could be the future of armor: First 2D mechanically interlocked polymer exhibits exceptional flexibility and strength January 17th, 2025

Researchers uncover strong light-matter interactions in quantum spin liquids: Groundbreaking experiment supported by Rice researcher reveals new insights into a mysterious phase of quantum matter December 13th, 2024

Nanomedicine

How a milk component could eliminate one of the biggest challenges in treating cancer and other disease, including rare diseases: Nebraska startup to use nanoparticles found in milk to target therapeutics to specific cells January 17th, 2025

Exosomes: A potential biomarker and therapeutic target in diabetic cardiomyopathy November 8th, 2024

NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery: NYU Abu Dhabi researchers develop novel covalent organic frameworks for precise cancer treatment delivery September 13th, 2024

Unveiling the power of hot carriers in plasmonic nanostructures August 16th, 2024

Announcements

Quantum engineers ‘squeeze’ laser frequency combs to make more sensitive gas sensors January 17th, 2025

How a milk component could eliminate one of the biggest challenges in treating cancer and other disease, including rare diseases: Nebraska startup to use nanoparticles found in milk to target therapeutics to specific cells January 17th, 2025

The National Space Society Congratulates SpaceX on Starship’s 7th Test Flight: Latest Test of the Megarocket Hoped to Demonstrate a Number of New Technologies and Systems January 17th, 2025

The National Space Society Congratulates Blue Origin on the Inaugural Flight of New Glenn: The Heavy Lift Reusable Rocket Will Open New Frontiers and Provide Healthy Competition January 17th, 2025

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project