8-K

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)

August 8, 2014

CUBIST PHARMACEUTICALS, INC.

(Exact name of registrant as specified in charter)

Delaware	0-21379	22-3192085
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

65 Hayden Avenue, Lexington, Massachusetts 02421

(Address of Principal Executive Offices, including Zip Code)

(781) 860-8660

(Registrant’s telephone number, including area code)

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:

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

8.01 Other Events.

On August 8, 2014, Cubist Pharmaceuticals, Inc. (“Cubist” or the “Company”) issued a press release announcing a voluntary recall of nine lots of CUBICIN® (daptomycin for injection) following complaints of foreign particulate matter in reconstituted vials.  To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.  A copy of the press release has been filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Cubist does not expect that this recall will materially interfere with the ongoing supply of CUBICIN or that this recall will have a material financial impact on the Company.

By filing the information contained in this Current Report on Form 8-K, the Company makes no admission as to the materiality of any information in this report. The information contained in this report and the exhibit hereto is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report or the exhibit hereto, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosure.

Cubist Safe Harbor Language

This Current Report on Form 8-K includes forward-looking statements, including those addressing our expectations regarding the recall of certain lots of CUBICIN described in this report, the potential for adverse events, the impact on CUBICIN supply, and the financial implications to Cubist from the recall.  Each forward-looking statement contained in this report is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement.  Applicable risks and uncertainties include, among others, complexities, challenges, and unanticipated issues involved in manufacturing and supply chain management; performance and reliance on third party manufacturers; reputational implications from the recall; whether the FDA or other regulatory authorities determine to take additional corrective or disciplinary actions against Cubist; and the risks identified under the heading “Risk Factors” in Cubist’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent Quarterly Reports on Form 10-Q, each as filed with the SEC, as well as the other information we file with the SEC.  The Company cautions investors not to place considerable reliance on the forward-looking statements contained in this report.  Investors are encouraged to read Cubist’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this report speak only as of its date, and Cubist undertakes no obligation to update or revise any of these statements. The Company’s business is subject to substantial risks and uncertainties, including those referenced above.  Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Item 9.01Financial Statements and Exhibits.

(d)Exhibits

99.1Press Release dated August 8, 2014.

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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.

	Cubist Pharmaceuticals, Inc.
	By:	/s/ Thomas J. DesRosier
	Name:	Thomas J. DesRosier
	Title:	Executive Vice President, Chief Legal and Administrative Officer
Date: August 11, 2014

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EXHIBIT INDEX

99.1Press Release dated August 8, 2014.

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EX-99.1

Exhibit 99.1

Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials

Following Complaints of Foreign Particulate Matter in Reconstituted Vials

Contacts

CONSUMERS:

Cubist Medical Information

(877) 282-4786

MEDIA:

Julie DiCarlo, (781) 860-8063

Senior Director, Corporate Communications

julie.dicarlo@cubist.com

Lexington, Mass., August 8, 2014 — Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN® (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.

The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.

CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN is supplied in a single-use vial packaged in a carton (refer to www.cubicin.com). CUBICIN was distributed Nationwide to multiple consignees.

Product Description	Lot #	Expiration Date	Ship Dates(MM/DD/YY)
CUBICIN® (daptomycin for injection) 500 mg NDC 67919-011-01; UPC 3 67919-011-01 6	CDC203	DEC 2015	9/2/13 through 9/24/13
	CDC207	JAN 2016	9/16/13 through 10/15/13
	CDC213	FEB 2016	10/1/13 through 10/7/13
	CDC217	MAR 2016	12/2/13 through 12/11/13
	CDC226	APR 2016	7/29/13 through 8/26/13
	CDC234	MAY 2016	8/26/13 through 9/19/13
	CDC235	MAY 2016	9/19/13 through 10/17/13
	CDC243	JUL 2016	10/17/13 through 11/12/13
	CDC246	JUL 2016	11/12/13 through 12/2/13

Cubist is notifying customers by letter and phone.  Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of this recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.

Cubist is arranging for return of recalled product. For healthcare professionals and pharmacists with medical questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EDT, Monday through Friday.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax.

·Complete and submit the report Online: http://www.fda.gov/MedWatch/report.htm

·Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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