NC 100100: DD 723, NUS, Sonazoid

Author：

ISSN： 1174-5886

Source： Drugs in R&D, Vol.3, Iss.3, 2002-01, pp. : 210-211

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Adis CommentsNC 100100 [NUS], a biodegradable, polymer-coated, gas-filled microballoon, is an ultrasound contrast agent that is being developed by Nycomed Amersham Imaging (a part of Amersham, formerly Nycomed Amersham), as Sonazoid, for cardiac perfusion, peripheral vascular imaging and liver lesions. In the third quarter of 2001, Nycomed Amersham changed its name to Amersham.Nycomed Amersham Imaging and received an approvable letter from the US FDA for use of Sonazoid as an ultrasound contrast agent for cardiac function. However, the company decided not to pursue this initial indication and may focus its investigation on new indications including liver and cardiac perfusion. Phase IIb clinical trials for liver imaging were completed in Japan. Following the analysis of the data, Phase III clinical studies were initiated for both metastatic disease and hepatocellular carcinoma. In the USA and Europe, Phase IIb clinical trials with Sonazoid for detection of liver disease were also completed. Phase III clinical studies are planned for the H2 of 2002.Nycomed Amersham Imaging has submitted a regulatory application for NC 100100 (Sonazoid) for cardiology and potential radiology indications, including heart and liver imaging, with the European Medicines Evaluation Agency. Sonazoid is also being investigated for myocardial perfusion imaging. Phase IIa trials have been completed in Europe and showed promising results. Patients are being enrolled in Phase IIb dose-ranging studies to assess blood flow to the heart muscle.Daiichi Seiyaku has acquired a licence for developing NC 100100 in preference to other ultrasound agents. Phase IIb clinical trials have been completed for liver cancer imaging in Japan. Phase III for both metastatic and hepatocellular carcinoma will proceed upon analysis of the Phase IIb results. On 12 May 2000 Mallinckrodt and Nycomed Amersham Imaging settled their intellectual property disputes including ultrasound bubble composition used in the Molecular Biosystems/Mallinckrodt's Optisonœ and SONUS Pharmaceuticals/Nycomed Amersham's SONAZOID. The agreement covers a worldwide market except the Pacific Rim countries.Under the terms of the settlement, Nycomed Amersham Imaging would receive from Mallinckrodt a $US10 million up-front licence fee and also royalties for an undisclosed amount on future ultrasound contrast product sales. Mallinckrodt would also provide Nycomed Amersham Imaging with the immediate access to its agent, Optison. Both companies are to be engaged with further development and commercialisation of Optison and SONAZOID. In return, Nycomed Amersham Imaging would grant Mallinckrodt a non-exclusive licence under Nycomed Amersham Imaging and SONUS Pharmaceuticals patents and Mallinckrodt and Molecular Biosystems grant a similar licence to Nycomed Amersham Imaging and SONUS Pharmaceuticals to their patents.However, on 6 August 2001 Nycomed Amersham Imaging announced that Mallinckrodt has decided to terminate the joint agreement for ultrasound products effective from 31 December 2001. Upon termination of the agreement, Nycomed Amersham Imaging will independently proceed with worldwide development of both Optison (except for the Pacific Rim) and SONAZOID.