Hikma Pharmaceuticals gained a license to promote and distribute Astellas Pharma’s immunosuppressant, Advagraf®, in 17 countries in the Middle East and North Africa (MENA) territory. Advagraf is a prolonged-release, once-daily formulation of Prograf® (tacrolimus).
Hikma has been selling Prograf in the MENA region since 1997 and has exclusive distribution agreements for another eight Astellas products in these countries. Advagraf is marketed in 29 countries worldwide and is approved for the prophylaxis of transplant rejection in adult kidney or liver allograft patients and for treating allograft rejection in organ transplants resistant to other immunosuppressants in adults.
In Japan Prograf was also approved in ulcerative colitis in July and for all types of myasthenia gravis in October. In May FDA approved Prograf combined with mycophenolate mofetil for the prevention of organ rejection in kidney transplant recipients.
Astellas reported worldwide sales for Prograf of ¥201 billion (about $2.24 billion) in financial year 2008. Sales in North America were ¥88.8 billion (about $98.93 million) and in Europe were ¥66 billion (about $73.53 million).