MDCO » Topics » Item 8.01. Other Events.

This excerpt taken from the MDCO 8-K filed Aug 4, 2008.

Item 8.01.  Other Events.

 

On August 4, 2008, The Medicines Company (the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable.  The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

This excerpt taken from the MDCO 8-K filed Jun 24, 2008.

Item 8.01               Other Events

 

The principal U.S. patent that covers The Medicines Company’s (the “Company”) product, Angiomax® (bivalirudin), expires in 2010.  The United States Patent and Trademark Office (the “PTO”) rejected the Company’s application under the Hatch Waxman Act for an extension of the term of the patent beyond 2010 because the application was not filed on time by our counsel.

 

On June 23, 2008, the United States House of Representatives passed a bill that, if enacted, would provide the PTO with discretion to consider patent extension applications filed late unintentionally under the Hatch Waxman Act.  While the Company is hopeful that the United States Senate will consider this legislation, the Company can provide no assurance that a bill will be enacted or that, if it is enacted, the PTO will consider the Company’s application or that the Company will be successful in extending the term of the patent.

 

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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:  June 24, 2008

 

 

By:

/s/ Paul M. Antinori

 

 

 

 

Paul M. Antinori

 

 

 

 

Senior Vice President and General Counsel

 

 

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This excerpt taken from the MDCO 8-K filed May 28, 2008.

Item 8.01.  Other Events.

 

                On May 28, 2008, The Medicines Company (the “Company”) announced receipt of a not approvable letter from the U.S. Food and Drug Administration on a supplemental New Drug Application for an additional dosing regimen for Angiomax® (bivalirudin) in the treatment of acute coronary syndromes initiated in the emergency department.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

                The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

This excerpt taken from the MDCO 8-K filed Apr 27, 2007.

Item 8.01               Other Events

The principal U.S. patent that covers The Medicines Company’s (the “Company”) product, Angiomax® (bivalirudin), expires in 2010.  In 2002, the United States Patent and Trademark Office (the “PTO”) denied the Company’s application under the Hatch Waxman Act for an extension of the term of the patent beyond 2010 because the application was not filed on time by the Company’s counsel. In October 2002, the Company filed a request with the PTO for reconsideration of the denial of the application.  On April 26, 2007, the Company received a decision denying the Company’s application for patent term extension. The Company disagrees with the PTO’s decision. The Company intends to seek review of this decision and continue to pursue other actions.

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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:  April 27, 2007

By:

/s/ GLENN P SBLENDORIO

 

 

Glenn P. Sblendorio

 

 

Executive Vice President and Chief Financial Officer

 

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This excerpt taken from the MDCO 8-K filed Dec 11, 2006.

Item 8.01               Other Events

The principal U.S. patent that covers The Medicines Company’s (the “Company”) product, Angiomax® (bivalirudin), expires in 2010.  The United States Patent and Trademark Office (the “PTO”) has rejected the Company’s application under the Hatch Waxman Act for an extension of the term of the patent beyond 2010 because the application was not filed on time by our counsel.

On December 6, 2006, the United States House of Representatives passed  a bill that, if enacted, would provide the PTO with discretion to consider patent extension applications filed late unintentionally under the Hatch Waxman Act.  On December 9, 2006, the United States Senate adjourned without considering this bill.  The Company is hopeful that the new Congress will consider similar legislation in the next session. The Company can provide no assurance that a bill will be introduced or enacted or that, if it is enacted, the PTO will consider the Company’s application or that the Company will be successful in extending the term of the patent.

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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:  December 11, 2006

By:

/s/ Glenn P Sblendorio

 

 

Glenn P. Sblendorio

 

 

Executive Vice President and Chief Financial Officer

 

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