The Medicines Company
) 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
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).
Other pipeline candidates at The Medicines Company include
MDCO-216, in-licensed from
), and MDCO-157 for which the company has a licensing agreement
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