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The Medicines Company (MDCO) Receives Complete Response Letter From FDA Requesting Additional Information For New Drug Application For Its Antiplatelet Agent Cangrelor


5/1/2014 10:08:39 AM

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PARSIPPANY, NJ--(Marketwired - April 30, 2014) - The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Company's new drug application (NDA) for its investigational intravenous antiplatelet agent cangrelor.

For the PCI indication, the Agency stated that the application cannot be approved at the present time. The Agency suggested that the Company perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials.

For the BRIDGE indication, the Agency has concluded that a prospective, adequate and well-controlled study in which outcomes such as bleeding are studied, can result in the clinical data necessary to assess the benefit-risk relationship in this indication.

The Agency provided additional comments for the Company to address, stating that the comments are not currently approvability issues, but could affect labeling.

The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor.

"We are grateful for the Agency's review, comments, and suggestions. The next steps of review will focus on additional analyses in response to the FDA," said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company. "As always, we will work closely with the Agency to accommodate their review process."

Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing PCI.

Review of the dossier is ongoing with the European Medicines Agency, in Australia, and in Switzerland.

Conference Call Information

There will be a conference call with The Medicines Company management on Thursday, May 1, 2014 at 8:30 a.m. Eastern Time to discuss the cangrelor update. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.

Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 41365745

Replay is available from 11:30 a.m. Eastern Time following the conference call through May 15, 2014. To hear a replay of the call dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial in numbers is 41365745.

About Cangrelor
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI.

The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor.

The results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013 and showed that patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours. An increase in the incidence of access site bleeding and transient dyspnea was observed with cangrelor.

In 2011, The Medicines Company also reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent that were at increased risk of thrombotic events following discontinuation of oral platelet inhibition prior to coronary artery bypass graft (CABG) surgery.

About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements
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, including the Company's preliminary revenue results, 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 whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether we are able to maintain patent protection for the intellectual property relating to our products, 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 3, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


CONTACT:
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
neera.ravindran@themedco.com

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