Guilford Pharmaceuticals Inc announced that Daiichi Radioisotope Laboratories (DRL), a leading Japanese radiopharmaceutical company, has filed an application for marketing approval of Dopascan Injection with the Japanese Health Authority triggering a milestone payment to Guilford of $0.55 million. Guilford granted DRL exclusive marketing, sales, and distribution rights to Dopascan Injection in Japan, Korea, and Taiwan in December 1995.
DRL is seeking approval of Dopascan Injection to detect the degeneration of dopamine nerve cells seen in Parkinson's disease, a serious, debilitating neurodegenerative disorder. In Japan, approximately 100,000 people each year undergo diagnostic testing for Parkinson's disease. The marketing application is based on a Phase III clinical trial DRL completed in Japan in July 2002.
Outside Japan, MAP Medical Technologies holds exclusive European sales, marketing and distribution rights to DOPASCAN(R) Injection. In 2002, MAP filed a regulatory submission in Finland for European approval of the product.
"Based upon information provided by our partners, if Dopascan Injection is approved for marketing in Europe and Japan, it is anticipated that Guilford would receive up to an estimated $5 million in combined milestone payments and royalty revenues over the next four years," commented Craig R. Smith, Guilford's Chairman, President and Chief Executive Officer.
While still an experimental drug in the United States, Dopascan Injection is currently being used to measure treatment effectiveness in a Phase II clinical trial of GPI 1485, an investigational product candidate for Parkinson's disease. The Phase II clinical trial, which began in December 2002 and is being sponsored by Guilford, is expected to complete enrollment in the third quarter. All two hundred patients participating in the trial will be imaged using Dopascan Injection at base and at one year and two years after treatment with either GPI 1485 or placebo. Guilford has retained all commercial rights to Dopascan Injection in the United States.