RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age

RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in 
Children Greater Than or Equal to One Month of Age 
PARSIPPANY, NJ -- (Marketwired) -- 05/09/13 --  The Medicines Company
(NASDAQ: MDCO) today announced that the U.S. Food and Drug
Administration (FDA) has expanded the indication for RECOTHROM(R),
Thrombin topical (Recombinant) to include use in pediatric patients,
following completion of a post-approval pediatric clinical trial
commitment. RECOTHROM is a recombinant topical thrombin now indicated
to aid hemostasis whenever oozing blood and minor bleeding from
capillaries and small venules is accessible and control of bleeding
by standard surgical techniques (such as suture, ligature, or
cautery) is ineffective or impractical in adult and pediatric
populations greater than or equal to one month of age. RECOTHROM
provides patients greater than one month of age an alternative to
bovine or human plasma derived thrombin.  
"Pediatric patients, in various surgical settings, have an increased
chance of repeat surgeries. RECOTHROM has been studied in pediatric
patients and shown to have a low rate of immunogenicity, and offers
an important tool for use in this patient population," said Kevin N.
Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center
at Maricopa Medical Center. 
The recent FDA approval is based, in part, on data from a completed
Phase 4, open-label, single-group safety and immunogenicity study.
This study was conducted in 30 pediatric patients greater than one
month of age undergoing synchronous burn wound excision and skin
grafting. The safety of RECOTHROM in pediatric patients greater than
or equal to one month of age is supported by these data and by
extrapolation of efficacy from adequate and well-controlled studies
of RECOTHROM in adults. Safety and efficacy has not been established
in neonates. 
"Our purpose is to save lives, alleviate suffering and improve the
economic efficiency of the approximately 2,500 leading hospitals in
the world," said Brent Furse, Senior Vice President and Chief
Customer Officer of The Medicines Company. "There are several hundred
leading hospitals in the United States that conduct thousands of
surgical procedures in pediatric patients each year. We believe the
expande
d pediatric indication for RECOTHROM provides an opportunity
to make this topical hemostat available to a broader range of
surgical patients." 
About The Medicines Company
 The Medicines Company (NASDAQ: MDCO)
provides medical solutions to improve health outcomes for patients in
acute and intensive care hospitals worldwide. These solutions
comprise medicines and knowledge that directly impact the survival
and well-being of critically ill patients. The Medicines Company's
website is www.themedicinescompany.com. 
Statements contained in this press release about The Medicines
Company that are not purely historical, and all other statements that
are not purely historical, may be deemed to be forward-looking
statements for purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Without limiting
the foregoing, the words "believes," "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements involve known and
unknown risks and uncertainties that may cause the Company's actual
results, levels of activity, performance or achievements to be
materially different from those expressed or implied by these
forward-looking statements. Important factors that may cause or
contribute to such differences include the extent of the commercial
success of Recothrom, the ability of the Company to obtain regulatory
approvals of Recothrom in jurisdictions other than the United States
and Canada, risks related to the Company's dependence on
Bristol-Myers Squibb to manufacture and supply Recothrom products
during the collaboration term, the Company's ability to successfully
manufacture Recothrom products after it completes the acquisition of
the manufacturing assets, the ability of Bristol-Myers Squibb and the
Company to complete the acquisition following the collaboration term,
the ability of the Company to obtain third party consents necessary
for the transfer of the acquired assets, the ability of the Company
to successfully integrate the Recothrom business with its other
businesses, the Company's ability to develop its global operations
and penetrate foreign markets, risks associated with the
establishment of international operations, and such other factors as
are set forth in the risk factors detailed from time to time in the
Company's periodic reports and registration statements filed with the
Securities and Exchange Commission including, without limitation, the
risk factors detailed in the Company's Annual Report on Form 10-K
filed on March 1, 2013, which are incorporated herein by reference.
The Company specifically disclaims any obligation to update these
forward-looking statements.  
Contact: 
Michael Mitchell 
The Medicines Company
973-290-6000
michael.mitchell@themedco.com 
 
 
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