(NGM: OASM A) Oasmia has received a final advice from the EMEA on the clinical Phase III program for Paclical®. The program is scheduled to begin immediately. The Phase III development program for Paclical® on the indication ovarian cancer has received a final advice from the European Medicines Agency (EMEA). Oasmia is now ready for the next step in the development process. The company has previously received an Orphan Drug designation on ovarian cancer. The designation protects the product from direct competition for ten years on the indication when registered. Oasmia has designed the program with assistance from the EMEA to make the future registration process as efficient as possible. The company now plans to initiate the Phase III-program immediately. The Program will be carried out at 35 different sites in Europe. - This is a major milestone for the company's clinical program and is a very important step in the development of Paclical® for all indications and not just ovarian cancer, says Oasmia CEO Julian Aleksov in a quick comment. The positive response will also significantly benefit the development of the company's other products as confidence in the Oasmia oncology portfolio continues to grow. More information is available at www.ngm.se or www.oasmia.com Media contact: Maria Lundén +46 (0) 18 50 54 40 e-mail: info@oasmia.com Oasmia Pharmaceutical is a pharmaceutical company that specialises in the treatment of severe diseases. A pharmaceutical company based on the latest concepts in bio-organic chemistry. The main idea is to improve the treatment of serious diseases. Primarily, this development is in oncology but Oasmia also in antibiotics, asthma and neurological diseases. Oasmia has in-house production capacity of pharmaceuticals for clinical trials, both company related and others. Oasmia has developed several products based on existing pharmaceuticals in a new environment leading to new solutions for cancer treatment. These products give Oasmia a solid product portfolio within oncology with several products in clinical or pre-clinical phase. Oasmia is listed on NGM Eguity.
OASMIA: EMEA FINAL ADVICE FOR START OF OASMIA´S PACLICAL® PHASE III PROGRAM
| Source: Oasmia Pharmaceutical AB