-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Qjn7KG+tj+Wu6nZz/RgLY+AeM/+GDQn/CgBSwWHCKxBcVzlEbNQm2eaPn1K9T45Q a7mQm4H49sG9amm6eODJGg== 0000950123-09-073187.txt : 20091224 0000950123-09-073187.hdr.sgml : 20091224 20091223183629 ACCESSION NUMBER: 0000950123-09-073187 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20091218 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091224 DATE AS OF CHANGE: 20091223 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: 091259298 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 y81147e8vk.htm FORM 8-K e8vk
 
 
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): December 18, 2009
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.
Pfizer License Agreement
On December 18, 2009, The Medicines Company (the “Company”) entered into a License Agreement (the “License Agreement”) with Pfizer Inc. (“Pfizer”) with respect to the compound designated by Pfizer as ETC-216 (“ETC-216”), a variant of ApoA-I Milano, a naturally occurring variant of a protein found in human high-density lipoprotein.
Pursuant to the License Agreement, Pfizer granted the Company an exclusive, worldwide, royalty-bearing license under specified Pfizer patents, patent applications and know-how to develop, manufacture and commercialize products containing ETC-216 and improvements to ETC-216 (collectively, the “Products”). The Company may sublicense the intellectual property to third parties, provided that it has complied with Pfizer’s right of first negotiation and, in the case of sublicenses to an unaffiliated third parties in certain countries, provided that it has first obtained Pfizer’s consent. The Company, itself or through its affiliates or sublicensees, has agreed to use commercially reasonable efforts to develop at least one Product and to commercialize any approved Products.
Under the License Agreement, the Company will pay Pfizer an upfront payment of $10,000,000 and upon the achievement of clinical, regulatory and sales milestones up to an aggregate of $410,000,000. The Company has also agreed to make royalty payments to Pfizer on the sale of the Products by the Company, its affiliates or sublicensees. The royalties are payable, on a Product-by-Product and country-by-country basis, until the latest of the expiration of the last patent or patent application covering the Product, the expiration of any market exclusivity, and a specified period of time after first commercial sale of the Product. The Company has also agreed to pay Pfizer a portion of the consideration received by the Company or its affiliates in connection with sublicenses.
The Company has agreed to indemnify Pfizer against third party claims arising from (a) the development and commercialization of the Products by the Company, its affiliates, subcontractors or sublicensees, (b) the negligence or wrongful intentional acts or omissions of the Company, its affiliates, subcontractors or sublicensees, (c) a breach of the License Agreement by the Company, or (d) claims by a Brewer/Matin Party (as defined below) resulting from the License Agreement or any agreement or arrangement between the Company and a Brewer/Matin Party.
The License Agreement will expire upon expiration of the Company’s obligation to make royalty payments. Each party may terminate the License Agreement if (a) the other party breaches its material obligations under the License Agreement and fails to cure such breach during a specified period of time, (b) the other party become insolvent or bankrupt, or (c) the other party is subject to a force majeure event for a specified period of time. Pfizer may also terminate the License Agreement if the Company provides written notice to Pfizer that the Company intends to permanently abandon the development, manufacture and commercialization of the Products or if the Company otherwise ceases, for a specified period of time, to use commercially reasonable efforts to develop, manufacture and commercialize, as applicable, at least one Product. The Company may terminate the License Agreement in its entirety, or on a Product-by-Product basis, at any time and for any reason upon prior written notice.
Upon termination of the License Agreement, the licenses to the Company terminate. If Pfizer terminates the License Agreement due to the Company’s uncured breach, bankruptcy, force majeure event, abandonment of the Products or ceasing to use commercially reasonable efforts to develop and commercialize at least one Product, or if the Company terminates the License Agreement for convenience, the Company will grant Pfizer a sublicenseable, royalty-free, perpetual license under any intellectual property licenseable by the Company that arose from the Company’s development or commercialization of the terminated Products, to develop, manufacture and commercialize the terminated Products. This license will be non-exclusive with respect to trademarks and exclusive with respect to other intellectual property.

 


 

Brewer/Matin Consent Agreement
On December 18, 2009, the Company entered into a Consent and Release Agreement (“Consent Agreement”) with Washington Cardiovascular Associates, LLC, HDLT LLC, H. Bryan Brewer, Silvia Santamarina-Fojo and Michael Matin (collectively, the “Brewer/Matin Parties”) under which the Brewer/Matin Parties consented to the Company’s entry into the License Agreement.
Prior to the Company’s entry into the License Agreement, the Company and certain of the Brewer/Matin Parties had conducted discussions concerning the Brewer/Matin Parties’ potential participation in a transaction between the Company and Pfizer.
Under the Consent Agreement, the Company has agreed to pay Messrs. Brewer and Matin or their designees upfront payments of $7,500,000 in the aggregate and additional payments to Messrs. Brewer and Matin upon the achievement of specified development events consistent with some of the milestones under the License Agreement. The Company has also agreed to make continuing payments to Messrs. Brewer and Matin on the sale of the Products by the Company, its affiliates or sublicensees. These payments are payable, on a Product-by-Product and country-by-country basis, until the earlier of December 18, 2039 or the date on which the Company’s royalty obligations to Pfizer under the License Agreement end in connection with the Product in that country. Under the Consent Agreement, the Company and the Brewer/Matin Parties have released each other and specified related persons from any claims that each might have against the other.
The foregoing is a summary description of certain terms of the License Agreement and the Consent Agreement and is qualified in its entirety by reference to the full text of the License Agreement and the Consent Agreement, which the Company intends to file as exhibits to its Annual Report on Form 10-K for the fiscal year ending December 31, 2009.
Item 9.01.   Financial Statements and Exhibits.
(d) Exhibits.
See the Exhibit Index attached to this report.

 


 

SIGNATURE
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  THE MEDICINES COMPANY
 
 
Date: December 23, 2009  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 dated December 22, 2009

 

EX-99.1 2 y81147exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(GRAPHIC)
Contact:
Robyn Brown
The Medicines Company
Phone: (973) 290-6000
investor.relations@themedco.com
 
THE MEDICINES COMPANY ACQUIRES APOA-I MILANO FROM PFIZER
Product Has Potential to Reverse Plaque Buildup in Arteries
FOR U.S. AUDIENCES ONLY
PARSIPPANY, NJ, and NEW YORK, NY, DECEMBER 22, 2009 — The Medicines Company (NASDAQ: MDCO) today announced the exclusive worldwide licensing of ApoA-I Milano from Pfizer Inc. (NYSE:PFE). ApoA-I Milano is a naturally occurring variant of a protein found in human high-density lipoprotein (HDL) that has the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with acute coronary syndrome (ACS).
Under the terms of the agreement, Pfizer will receive an up-front payment of $10 million for ApoA-I Milano and will receive additional payments upon the achievement of certain clinical, regulatory and sales milestones up to a total of $410 million. Pfizer will also be eligible to receive single-digit royalty payments on worldwide net sales of ApoA-I Milano. The Medicines Company will also pay $7.5 million to third parties.
“The acquisition of ApoA-I Milano provides The Medicines Company with a significant asset that fits well within our current areas of business,” said Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. “By mimicking the actions of HDL, ApoA-I Milano has been shown in an early clinical study, published in JAMA, to rapidly reduce the size of atherosclerotic plaques. This is an area of cardiovascular medicine that is not yet served by currently available therapies — and the potential to provide disease modification for patients with high risk atheroma and associated acute coronary syndromes represents a major innovation opportunity.”
“We are very pleased to partner with The Medicines Company to advance the ApoA-I Milano program as part of our strategy of out licensing programs that Pfizer no longer pursues internally. The ApoA-I Milano program has the potential to become a valuable and innovative medicine for the treatment of cardiovascular diseases. We look forward to seeing it progress, thanks to The Medicines Company’s experience in conducting large clinical trials in
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973) 290-6000 Fax: (973)656-9898

 


 

(THE MEDICINES COMPANY LOGO)
cardiovascular patients as well as their expertise in treating critical and intensive care patients,” said David K. Rosen DVM, Head of Out Licensing for Pfizer Inc.
About ApoA-I Milano
ApoA-I Milano is a naturally occurring variant of apolipoproteinA-I (ApoA-I), the main protein component of the HDL lipoprotein particle. The variant has been found in approximately 45 individuals from Limone sul Garda, a small village in northern Italy. Carriers of this variant appear to have reduced risk of cardiovascular disease. Patented by the University of Milan and Pharmacia, ApoA-I Milano was licensed to Esperion Therapeutics. Esperion was subsequently acquired by Pfizer in 2004. Since that time, Pfizer has moved development forward with improvements to the original manufacturing process.
In multiple non-clinical models, ApoA-I Milano rapidly removed excess cholesterol from artery walls, thereby stabilizing and regressing atherosclerotic plaque. A phase I-II study in 36 patients demonstrated statistically significant reductions on coronary plaque volume by 4.2% in 6 weeks. These findings were published in the Journal of the American Medical Association and continue to be widely referenced and discussed.
The Medicines Company will host a conference call Wednesday, December 23, 2009 at 8:30 a.m. Eastern Time. The conference call will be available via phone and webcast. The dial in information is listed below:
Domestic Dial In: 866-825-1709
International Dial In: 617-213-8060
Passcode for both dial in numbers: 31802183
Replay is available from 11:30 a.m. Eastern Time following the conference call through January 4, 2010. To hear a replay of the call, dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 58773912.
The webcast and supporting slides can be accessed at The Medicines Company’s website at www.themedicinescompany.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. 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
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898

Page 2 of 3


 

(THE MEDICINES COMPANY LOGO)
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 whether physicians, patients and other key decision-makers will accept clinical trial results, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company’s products will advance in the clinical trials process on a timely basis or at all, whether the Company will be able to obtain regulatory approvals, whether we are able to obtain or maintain patent protection for the intellectual property relating to the Company’s 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 Quarterly Report on Form 10-Q filed on November 9, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898

Page 3 of 3

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-----END PRIVACY-ENHANCED MESSAGE-----