Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


android tablet pc

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

High-Performance, Low-Cost Ultracapacitors Built with Graphene and Carbon Nanotubes: Future devices based on technology could bridge gap between batteries and conventional capacitors in portable electronics and hybrid electric vehicles April 23rd, 2014

Guo Lab Shows Potential of RNA as Heat-resistant Polymer Material for Nanoarchitectures April 23rd, 2014

Vacuum Ultraviolet Lamp of the Future Created in Japan: First Solid-State Vacuum UV Phosphor, Described in APL-Materials, Promises Smaller, Safer, Longer Lasting, Low Power Lamps for Industrial Applications April 22nd, 2014

Global leader in solar cell manufacturing eyes New York for major expansion outside of Japan: CNSE and Solar Frontier Explore $700 Million Investment, Job Creation in New York State April 22nd, 2014

Govt.-Legislation/Regulation/Funding/Policy

High-Performance, Low-Cost Ultracapacitors Built with Graphene and Carbon Nanotubes: Future devices based on technology could bridge gap between batteries and conventional capacitors in portable electronics and hybrid electric vehicles April 23rd, 2014

Guo Lab Shows Potential of RNA as Heat-resistant Polymer Material for Nanoarchitectures April 23rd, 2014

Cloaked DNA nanodevices survive pilot mission: Successful foray opens door to virus-like DNA nanodevices that could diagnose diseased tissues and manufacture drugs to treat them April 22nd, 2014

Berkeley Lab Researchers Demonstrate First Size-based Chromatography Technique for the Study of Living Cells April 22nd, 2014

Nanomedicine

Cloaked DNA nanodevices survive pilot mission: Successful foray opens door to virus-like DNA nanodevices that could diagnose diseased tissues and manufacture drugs to treat them April 22nd, 2014

Berkeley Lab Researchers Demonstrate First Size-based Chromatography Technique for the Study of Living Cells April 22nd, 2014

Amino-functionalized carbon nanotubes act as a carrier for nerve growth factor April 21st, 2014

Newly-Produced Bone Cement Able to Carry Medicine April 21st, 2014

Announcements

High-Performance, Low-Cost Ultracapacitors Built with Graphene and Carbon Nanotubes: Future devices based on technology could bridge gap between batteries and conventional capacitors in portable electronics and hybrid electric vehicles April 23rd, 2014

Guo Lab Shows Potential of RNA as Heat-resistant Polymer Material for Nanoarchitectures April 23rd, 2014

Harris & Harris Group Notes the Receipt of Proceeds From the Sale of Molecular Imprints' Semiconductor Business to Canon April 22nd, 2014

National Space Society Congratulates SpaceX on the Success of CRS-3 and the First Flight of the Falcon 9R April 22nd, 2014

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







  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE