The Medicines Company (MDCO) recently discontinued an ongoing study being conducted with its phase II pipeline candidate – MDCO-2010. MDCO-2010 was being developed for the reduction of blood loss during surgery.
The company decided to discontinue the study voluntarily following the emergence of serious unexpected patient safety issues during the phase IIb dose-ranging study. Although the company is yet to establish a link between the cause of the safety issues and the candidate, the development of MDCO-2010 has been discontinued due to the evidence of risk to patients.
The Medicines Company is currently analyzing all patient data from the study and information related to risk-drivers. The company intends to publish the findings once the analysis is completed and reviewed.
With The Medicines Company deciding to stop the study and discontinue the development of MDCO-2010, regulatory agencies in Germany and Switzerland have been informed. Moreover, regulatory agencies in the US and Canada have been notified. While patients in Germany and Switzerland were already enrolled in the study, future patient enrollment was scheduled to occur in the US and Canada.
MDCO-2010 became a part of The Medicines Company’s pipeline following its August 2008 acquisition of Curacyte Discovery GmbH. MDCO-2010 was considered to be a promising candidate given the positive phase IIa data reported by the company in October 2011. The discontinuation of the candidate is disappointing - The Medicines Company’s shares were down more than 5% on the news.
Meanwhile, The Medicines Company has important pipeline events lined up for later this year. We expect investor focus to remain on the announcement of data on oritavancin (treatment of acute bacterial skin and skin structure infections) and Cangrelor (prevention of platelet activation and aggregation when oral therapy is not feasible or desirable).
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