FDA grants Oasmia Pharmaceutical Expedited Review Status (ERS) for Paclical® Vet

2009-01-14


PRESS RELEASE                                                                   
                                                                                
Oasmia has been granted Expedited Review Status (ERS) for the company's Animal  
Health product candidate. The company also changes the name of the candidate    
from Paclical® Vet to Paccal® Vet in order to use the same name world-wide.     

The center for Veterinary Medicine, Food and Drug Administration in the United  
States has granted to Oasmia Pharmaceutical, Uppsala, Sweden, the product       
Paclical® Vet Expedited Review Status (ERS).                                    

The US Food and Drug Administration Center for Veterinary Medicine grants       
Expedited Review Status (ERS) to certain products classified as important       
advances in animal health receive priority review beginning at the              
Investigational New Animal Drug (INAD) stage, but with no diminished standards  
for data quality or evaluation.                                                 

ERS is reserved only for products that FDA believes represent an important      
therapeutic gain. In most cases this is restricted to drugs that are indicated  
for a life-threatening or severely debilitating disease for which there is no   
other approved treatment available.                                             

Because of the importance of these products to animal health, the FDA review    
time is half as long as those assigned to products without ERS. Normally, the   
review time assigned to a submission is 180 days. Products under ERS will have a
review “clock” of 90 days. In theory, this should significantly shorten the time
to approval.                                                                    

- It is a very positive and important achievement for us, since it will shorten 
the time to registration significantly. It will benefit our ongoing phase III   
study in the US and EU a great deal and an earlier launch on the very important 
US market, says Julian Aleksov, CEO of Oasmia.                                  

Due to European approval of a new name, Oasmia changes the name to Paccal® Vet. 
The intention is to have same name world-wide. An application for name change is
submitted in the USA.                                                           

For more information about ERS:                                                 
http://www.fda.gov/cvm/Policy_Procedures/3135.htm                               

About Paccal® Vet                                                               
Paccal® Vet is a water soluble, solvent free nanoparticle formulation, based on 
the well-known cytotoxic substance paclitaxel. Paccal® Vet's unique properties  
are based on Oasmia's nanotechnological formulation and micellar model XR-17,   
which is protected by international patents. The new Oasmia platform means that 
paclitaxel is water-soluble, resulting in abolishing Cremophor EL related       
toxicity, that no premedication is necessary, infusion times can be shortened   
and infusion procedure can be made more effective.                              

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