0001113481-14-000005.txt : 20140205 0001113481-14-000005.hdr.sgml : 20140205 20140205162924 ACCESSION NUMBER: 0001113481-14-000005 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20140204 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140205 DATE AS OF CHANGE: 20140205 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICINES CO /DE CENTRAL INDEX KEY: 0001113481 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043324394 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31191 FILM NUMBER: 14576491 BUSINESS ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-290-6000 MAIL ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K 1 form8-k.htm 8-K Form 8-K BARDA




UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 5, 2014
The Medicines Company
(Exact Name of Registrant as Specified in Charter)
Delaware
 
000-31191
 
04-3324394
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

8 Sylvan Way
Parsippany, New Jersey
 
07054
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (973) 290-6000
Not Applicable.
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))






Item 1.01. Entry Into a Material Definitive Agreement.
On February 4, 2014, Rempex Pharmaceuticals, Inc. (“Rempex”), a wholly owned subsidiary of The Medicines Company (the “Company”), entered into an agreement (the “BARDA Agreement”) with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (“BARDA”), which provides up to $89.8 million in funding to support the development of Carbavance™. Carbavance is a combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor for treatment of multi-drug resistant (MDR) gram-negative infections.
The BARDA Agreement is a cost-sharing arrangement that consists of an initial base period and seven option periods that BARDA may exercise in its sole discretion pursuant to the BARDA Agreement. The BARDA Agreement provides for initial commitment by BARDA of an aggregate of $19.8 million for the initial base period and the first option period, and up to an additional $70.0 million if the remaining six option periods are exercised by BARDA. Under the cost-sharing arrangement, Rempex will be responsible for a designated portion of the costs associated with each period of work. If all option periods are exercised by BARDA, the estimated period of performance would be extended until approximately July 31, 2019. BARDA is entitled to terminate the projects under the BARDA Agreement for convenience at any time and is not obligated to provide continued funding beyond current year amounts from Congressionally approved annual appropriations.
The total award under the BARDA Agreement will support non-clinical development activities, clinical studies, manufacturing and associated regulatory activities designed to obtain marketing approval of Carbavance in the U.S. for treatment of serious gram-negative infections. The BARDA Agreement also covers studies to assess the potential usefulness of Carbavance for treatment of certain gram-negative bioterrorism agents.
As previously reported, on December 3, 2013, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Rempex, Ravioli Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company, and Fortis Advisors LLC, a Delaware limited liability company, solely in its capacity as the representative and agent of the stockholders and optionholders of Rempex (the “Representative”), and subsequently closed the transactions contemplated by the Merger Agreement and completed its acquisition of Rempex on the same day. In accordance with the terms of the Merger Agreement, Rempex’s receipt of non-refundable, non-repayable proceeds under the BARDA Agreement may result in up to $34.0 million in milestone payments becoming due, at least a portion of which would be deposited into an escrow fund, and all of which would be paid in quarterly installments in arrears based on the non-refundable, non-repayable amounts actually received by Rempex in the prior calendar quarter.
The foregoing description of the BARDA Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the BARDA Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2014.
Item 8.01. Other Events.
On February 5, 2014, the Company issued a press release announcing Rempex’s entry into the BARDA Agreement. The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d)    Exhibits
99.1
Press release issued by the Company on February 5, 2014





SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
THE MEDICINES COMPANY
Date: February 5, 2014
By: /s/ Paul M. Antinori                                           
Name: Paul M. Antinori
Title: Senior Vice President and General Counsel






EXHIBIT INDEX
Exhibit No.
Description
99.1
Press release issued by the Company on February 5, 2014





EX-99.1 2 exh99-01.htm EXHIBIT Exh 99 - 01


EXHIBIT 99.1


BARDA Awards Contract Worth up to $90 Million to The Medicines Company/Rempex for Development of Gram-Negative Antibiotic

Parsippany, NJ and San Diego, CA, February 5, 2014 --The Medicines Company (NASDAQ: MDCO) today announced that Rempex Pharmaceuticals, a wholly owned subsidiary, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) worth up to $90 million to support the development of Carbavance. Carbavance is a combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor for treatment of multi-drug resistant (MDR) gram-negative infections.

The BARDA contract is a cost-sharing arrangement that includes non-clinical development activities, clinical studies, manufacturing, and associated regulatory activities designed to gain US approval of Carbavance for treatment of serious gram-negative infections. Studies are also planned to assess the potential usefulness of Carbavance for treatment of certain gram-negative bioterrorism agents.

The contract includes an initial commitment of $19.8 million and subsequent option periods over 5 years that, if completed, would bring the total value of the award to approximately $90 million.

Michael Dudley, PharmD, Senior Vice President and Chief Scientific Officer of The Medicines Company/Rempex Pharmaceuticals, Inc. stated, “BARDA has assumed a leadership role in working to advance new antimicrobials through partnerships with the few companies that prioritize antimicrobial research and development. We are grateful that BARDA has recognized the potential usefulness of Carbavance for management of MDR gram-negative pathogens that present an urgent threat to the US healthcare system.”

Clive Meanwell, MD, PhD, Chairman and CEO of The Medicines Company, added, "With acute and intensive care hospitals in the United States facing rapid and increasing antibacterial resistance, this mutual commitment with BARDA is intended to save lives, alleviate suffering and contribute to the economics of healthcare by attacking gram-negative pathogens with Carbavance."

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 and Rempex 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, including with respect to Carbavance, 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 decisions of regulatory authorities regarding clinical trials related to, marketing approval for or material limitations on the marketing of Carbavance, and the timing of those decisions; whether results of preclinical studies and early clinical trials will be indicative of the results





generated in later clinical trials; the extent of the commercial success of Carbavance, if approved; whether all option periods are exercised by BARDA and whether BARDA provides continued funding under the contract; the ability of the Company to successfully integrate Rempex’s business with the Company’s other businesses; 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 Quarterly Report on Form 10-Q filed on November 5, 2013, 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