0001113481-15-000035.txt : 20150709 0001113481-15-000035.hdr.sgml : 20150709 20150709084540 ACCESSION NUMBER: 0001113481-15-000035 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150702 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150709 DATE AS OF CHANGE: 20150709 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: 15980477 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-kxsandoz.htm 8-K Form 8-K - Sandoz


 
 
 
 
 

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): July 2, 2015


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
 
(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 July 2, 2015, The Medicines Company (the “Company”) entered into a Supply and Distribution Agreement (the "Agreement") with Sandoz Inc. (“Sandoz”). Under the Agreement, the Company has granted Sandoz the exclusive right to sell in the United States bivalirudin (250 mg/vial) under the Company’s approved New Drug Application for Angiomax but labeled and sold under the Sandoz name (the “Product”).
Under the Agreement, the Company has agreed to supply Sandoz with Product, and Sandoz has agreed to purchase Product exclusively from the Company. Sandoz has agreed to pay the Company a price per vial equal to the Company’s cost of goods.
Sandoz has agreed to use commercially reasonable efforts to market, distribute and sell the Product in the United States during the term of the Agreement. Sandoz will pay the Company on a quarterly basis a high double digit percentage of its net profits (net sales less the Company’s cost of goods and certain agreed expenses of Sandoz) on sales of the Product.
The term of the Agreement will continue until July 2, 2020 and will automatically renew for successive one-year periods thereafter unless either party provides notice of non-renewal at least six months prior to the end of the applicable term. Either party may terminate the Agreement at any time if the other party is in material breach of the Agreement and does not cure such breach within 60 days, the other party undergoes bankruptcy events, the other party is unable to perform its obligations under the Agreement for more than 120 consecutive days due to a force majeure event, compliance with the Agreement would violate law or net profits related to sales of the Product in any month fall below a low double digit percentage of net sales of the Product in such month. The Company may also terminate the Agreement at any time that no other pharmaceutical product containing bivalirudin in a lyophilized form as its sole active ingredient is being sold in the United States.

Item 8.01 Other Events.
On July 9, 2015, the Company issued a press release announcing the execution of the Agreement with Sandoz. The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.
(d)    Exhibits
99.1
Press release issued by the Company on July 9, 2015


1



SIGNATURES
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:  July 9, 2015
By:
/s/ Stephen M. Rodin
 
Stephen M. Rodin
 
Senior Vice President and General Counsel
 
 
 
 
 


2



EXHIBIT INDEX
Number
Description
 
 
 
 
99.1
Press release issued by the Company on July 9, 2015

 


3
EX-99.1 2 ex991mdcosandozpressreleas.htm EXHIBIT 99.1 Ex 99.1 (MDCOSandoz press release (7-9-2015)


Exhibit 99.1
Contacts:

Investor Relations:
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Neera.Ravindran@themedco.com


Media:
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com

FOR IMMEDIATE RELEASE
 
 
 
 
The Medicines Company Authorizes Generic Launch of ANGIOMAX® (bivalirudin)

PARSIPPANY, N.J. - (BUSINESS WIRE) - July 9, 2015 - The Medicines Company (NASDAQ:MDCO) today announced an agreement with Sandoz Inc. for the distribution of an authorized generic of ANGIOMAX® (bivalirudin) for injection in the United States.

“Bivalirudin has become a foundation anti-thrombin for patients undergoing PCI under MDCO’s fifteen-year leadership in the cath lab,” said Glenn Sblendorio, President and Chief Financial Officer, The Medicines Company. “This agreement with Sandoz, itself a leader in the generics market, helps to ensure that bivalirudin remains a high quality product in this market. With the imminent launch of KENGREAL™ (cangrelor), our intravenous P2Y12 inhibitor, we look forward to advancing patient care in the cath lab for years to come.”

About ANGIOMAX® (bivalirudin) for Injection
ANGIOMAX is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, ANGIOMAX is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous





transluminal coronary angioplasty (PTCA). ANGIOMAX is intended for use with aspirin. ANGIOMAX® is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.

Important Safety Information
An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration. ANGIOMAX should be used with caution in patients with disease states associated with an increased risk of bleeding.

In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of ANGIOMAX. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components.

In clinical trials comparing ANGIOMAX and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever.
Please see full prescribing information for ANGIOMAX, available at http://www.angiomax.com.


About KENGREAL™ (cangrelor) for Injection
KENGREAL is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.


Important Safety Information
KENGREAL is contraindicated in patients with significant active bleeding.

KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product.

Drugs that inhibit platelet P2Y12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL than with clopidogrel. Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups. Once KENGREAL is discontinued, there is no antiplatelet effect after an hour.

The most common adverse reaction is bleeding.

Please see full prescribing information for KENGREAL, available at http://www.kengreal.com.







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: serious infectious disease care, acute cardiovascular care and surgery and perioperative 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," "expects," “hopes” and “potential” 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, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, whether third parties on whom the Company relies to manufacture and support the development and commercialization of our products are able to fulfill their obligations or the Company is able to establish or maintain such arrangements; 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 with the SEC on May 5, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.



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