News Releases
Mochida Pharmaceutical and JCR Pharmaceuticals Reluctantly Abandon Attempts to Obtain Approval For Thrombomodulin — A Therapeutic Agent For Disseminated Intravascular Coagulation
(Tokyo, Novemeber 6, 2002) - Mochida Pharmaceutical Co., Ltd. (TSE: 4534, 1st Section) announced today that, as a result of consultations with JCR Pharmaceuticals Co., Ltd., a decision has been taken to abandon attempts to obtain approval to manufacture Thrombomodulin (proposed retail name: THRODULIN Inj.), a therapeutic agent for disseminated intravascular coagulation (DIC).
Although the application for approval to manufacture the drug had been submitted in September 2001, comments received in the review process regarding inadequacies in the design of the Phase III study and on the study results themselves led the companies to announce withdrawal of the joint application on 27 September.
Since the initial decision to withdraw the application, the two companies have discussed the possibility of conducting supplemental studies with many clinical physicians. However, they reached the conclusion that treatment of DIC in particular individual patients requires not only different anti-coagulant drugs, but also different basic treatments, supplementation with blood preparations, and total body management, etc. It would therefore be extremely difficult to carry out an accurate evaluation of the influence of the treatment for the underlying diseases in which these conditions remained constant, as required in the comments made by the authorities.
Also, while the authorities' comments allowed for the possibility of continued consideration of the application in the case of treating DIC in patients with a specific underlying disease, in this case, only a portion of the market originally envisaged could be secured. This led to the decision to abandon the application.