Sample Record for Search: Pre-Registrations
Drug: iometopane; iometopane (123I)
Brand: DOPASCAN
Latest Information:
26 May 2003: Daiichi Radioisotopes is no longer involved in the development of Guilford's iometopane (DOPASCAN), a potential imaging agent for the diagnosis of Parkinson's disesase, to which the company had acquired rights in certain South East Asian countries including Japan.
Development History:
Commercial Summary:
Guilford is developing iometopane as a potential imaging agent for the diagnosis of Parkinson's disesase. Licensee MAP Medical Technologies has submitted the product for approval in Finland and plans submissions across the EU once Finnish registration is obtained (MAP Medical Technologies, APR 2002). Phase III trials are being conducted with the agent in Japan (Guilford, JAN 2002). Phase II studies have been completed in the USA with iometopan, for use with SPECT imaging in the diagnosis of early stage Parkinson's disease, distinguishing it from other forms of tremor, and monitoring of disease progression (Guilford, JUN 1998). MAP Medical Technologies has acquired rights to develop, manufacture and commercialize the agent in Europe and other select markets. Under the agreement, an upfront fee as well as milestones and royalties will be payable to Guilford by MAP Medical Technologies (Guilford, JAN 2002). Iometopane is licensed-in from Research Technologies Institute by Guilford. Iometopane had been licensed-out by Guilford exclusively to Daiichi Radioisotopes in Japan, South Korea and Taiwan, for marketing and development. Under the terms of the agreement with Daiichi Radioisotopes, Daiichi was to pay all development costs in these areas, and Guilford received and upfront fee and was also entitled to milestone and royalty payments. Daiichi Radioisotopes is no longer involved with this product, however (Daiichi, MAY 2003). (Daiichi reviewed, AUG 1996)(Guilford reviewed, JUN 1998)
Scientific Summary:
Following iv injection of iometopane, an image was seen within 12-24 h, with a variation of 8% and very small retest variability. Animal studies and human volunteer studies showed that iometopane selectively labels dopamine transporters. Iometopane was able to differentiate patients with a Parkinsonian disorder (Parkinson's disease or progressive supranuclear palsy) from healthy patients or patients with essential tremor, with a sensitivity of 98% and specificity of 97%. No serious adverse events were reported (Guilford, JUN 1997).
Patent Summary:
Product (Research Triangle Institute): US 5128118 1992, priority US 564755 1990. Equivalents identified in 22 countries.
Source: R&D Focus, May 26, 2003
IMS R&D Focus
© 2003 IMS Health & Affiliates. All rights reserved.
Dialog® File Number 445 Accession Number 2004895
