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 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®                                                                 
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) and.                                           
                                                                                
About Oasmia                                                                    
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 contact: Maria Lundén, Head of Public Relations,   
Oasmia Pharmaceutical AB. E-mail: press@oasmia.com Phone: +46 (0) 18 50 54 40.  
Information is also available at www.ngm.se and www.oasmia.com