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8K12132013

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 13, 2013
    
ALEXION PHARMACEUTICALS, INC.
-----------------------------------------------------------
(Exact name of registrant as specified in its charter)

Delaware
000-27756
13-3648318
------------------
------------------
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(State or other jurisdiction of
of incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification No.)


352 Knotter Drive, Cheshire, Connecticut 06410
---------------------------------------------------------------
(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code:    (203) 272-2596
   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):

¨
Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
¨

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






Item 8.01    Other Events.

On December 13, 2013, Alexion Pharmaceuticals, Inc. issued a press release regarding the previously communicated voluntary recall and replacement of two lots of Soliris® (eculizumab) in the United States. A copy of the press release is filed as Exhibit 99.1 to this Form 8-K.

The voluntary recall of these two lots described in the press release was previously reported on November 12, 2013. In November 2013, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.

There is no change to the expense impact and non-GAAP EPS guidance reported by Alexion in its Form 8-K filed on November 12, 2013.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits
 
99.1    Press Release issued by Alexion Pharmaceuticals, Inc. on December 13, 2013.








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.

Date: December 13, 2013
 
ALEXION PHARMACEUTICALS, INC.
 
 
By:    /s/ Michael V. Greco      
Name: Michael V. Greco
Title: Vice President of Law and Corporate Secretary




pressrelease121313


Alexion Provides Update on Previously Communicated November 2013 Voluntary Nationwide Recall of Two Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion

FOR IMMEDIATE RELEASE – Cheshire, Conn., Dec. 13, 2013 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on November 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.

The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in 2 general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels which could be life threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As previously stated, Alexion does not anticipate any interruption to patient supply of Soliris.

The product is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on November 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level. 

The following table lists the 2 affected lots, which were distributed nationwide.

Product
Lot
Expiration Date
First Ship Date
Last Ship Date
Soliris®(eculizumab)
300 mg/30 mL
Concentrated solution for intravenous infusion only
NDC 25682-001-01
10010A
Oct 31, 2015
Oct 11, 2013
Nov 1, 2013
10001-1
July 31, 2014
June 4, 2012
May 8, 2013

As previously disclosed, Alexion believes that it has identified the filling process step that resulted in the presence of the visible particles and implemented the change necessary to correct the issue. To date, visible particles have not been observed in other lots of Soliris distributed in the U.S.

Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747).



Alexion will replace any recalled vials of Soliris. Unaffected lot numbers can continue to be used according to the instructions for use. 

Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
•Online: www.fda.gov/MedWatch/report.htm1
•
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
•
Fax: 1-800-FDA-0178

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

About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
Safe Harbor Statement
This news release includes forward-looking statements relating to continued adequacy of supply of Soliris, and identification and correction of the cause of the visible particles. These statements are subject to risks, uncertainties and other factors, including risks related to continuous product inventory and supply, the uncertainties involved in manufacturing of biologic products, and whether the FDA, EMA or other international regulatory authorities decide to take corrective or disciplinary actions against Alexion, as well as the risks that are described in detail in Alexion’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Alexion, and Alexion assumes no duty or obligation to update or revise any such forward-looking statements or any other statement in this report.


Contacts
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Executive Director, Corporate Communications
or

Alexion Pharmaceuticals, Inc.
Kim Diamond, 203-439-9600
Senior Director, Corporate Communications
or
Investors:
Rx Communications
Rhonda Chiger, 917-322-2569