Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris� (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot

CHESHIRE, Conn.--(BUSINESS WIRE)--
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that it is
initiating a voluntary recall of certain lots of Soliris
(eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion
that were manufactured using a process component during vial filling
identified in the November 2013 recall to the hospital/user level. As
previously stated, Alexion believes that it has identified the process
component that resulted in the presence of the visible particles and
implemented a change to the process. Alexion does not anticipate any
interruption to patient supply. This recall has been initiated due to
the presence of visible proteinaceous particles detected in a single lot
during periodic stability testing for Soliris. This lot was distributed
only in the U.S. No safety risks to patients who have received Soliris
have been identified. There is no financial impact from the voluntary
recall announced today.

The single affected Soliris lot is #10007A. Although these lots
currently remain in specification, Alexion is including the following
remaining lots, which were produced with the same process component
during vial filling, within the scope of the U.S. recall: 10002-1,
00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. Following
this voluntary recall, there will no longer be Soliris in the U.S.
manufactured using the previously identified process component that
Alexion believes resulted in the stability failure.

The administration of particulate, if present in a parenteral drug,
poses a potential safety risk to patients in two general areas: immune
reaction and blood clots. 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
product from the affected lot was last shipped on October 29, 2013,
Alexion believes there is little, if any, inventory currently being held
at the hospital or user level.

Soliris is approved as a treatment for patients with paroxysmal
nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome
(aHUS), two ultra-rare and life-threatening 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 from the
identified lots was last shipped on October 30, 2013, there is
anticipated to be little, if any, material from these lots still
remaining in commercial distribution.

The following table lists the lots that are being recalled, which were
distributed in the U.S. to wholesalers, hospitals and pharmacies:

Healthcare professionals and pharmacists with questions regarding this
recall can contact Alexion at 1-888-765-4747, Monday-Friday from 8:30
a.m. to 5:00 p.m. ET. 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.

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

Soliris(eculizumab) is a first-in-class terminal complement
inhibitor developed from the laboratory through regulatory approval and
commercialization by Alexion. Soliris is approved in the U.S. (2007),
European Union (2007), Japan (2010) and other countries as the first and
only treatment for patients with paroxysmal nocturnal hemoglobinuria
(PNH), a debilitating, ultra-rare and life-threatening blood disorder,
characterized by complement-mediated hemolysis (destruction of red blood
cells). Soliris is indicated to reduce hemolysis in PNH patients.
Soliris is also approved in the U.S. (2011), the European Union (2011),
Japan (2013) and other countries as the first and only treatment for
patients with atypical hemolytic uremic syndrome (aHUS), a debilitating,
ultra-rare and life-threatening genetic disorder characterized by
complement-mediated thrombotic microangiopathy, or TMA (blood clots in
small vessels). The effectiveness of Soliris in aHUS is based on the
effects on TMA and renal function. Soliris is not indicated for the
treatment of patients with Shiga toxin -related hemolytic
uremic syndrome (STEC-HUS). More information, including the full
prescribing information on Soliris, is available at www.soliris.net.

The U.S. product label for Soliris includes a boxed warning:
"Life-threatening and fatal meningococcal infections have occurred in
patients treated with Soliris. Meningococcal infection may become
rapidly life-threatening or fatal if not recognized and treated early
[see Warnings and Precautions (5.1)]. Comply with the most current
Advisory Committee on Immunization Practices (ACIP) recommendations for
meningococcal vaccination in patients with complement deficiencies.
Immunize patients with a meningococcal vaccine at least 2 weeks prior to
administering the first dose of Soliris, unless the risks of delaying
Soliris therapy outweigh the risk of developing a meningococcal
infection [See Warnings and Precautions (5.1) for additional guidance on
the management of the risk of meningococcal infection]. Monitor patients
for early signs of meningococcal infections and evaluate immediately if
infection is suspected. Soliris is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS). Under
the Soliris REMS, prescribers must enroll in the program [see Warnings
and Precautions (5.2)]. Enrollment in the Soliris REMS program and
additional information are available by telephone: 1-888-SOLIRIS
(1-888-765-4747)."

In patients with PNH, the most frequently reported adverse events
observed with Soliris treatment in clinical studies were headache,
nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of
patients with PNH should not alter anticoagulant management because the
effect of withdrawal of anticoagulant therapy during Soliris treatment
has not been established. In patients with aHUS, the most frequently
reported adverse events observed with Soliris treatment in clinical
studies were headache, diarrhea, hypertension, upper respiratory
infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough,
peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is
not indicated for the treatment of patients with Shiga toxin E. coli
related hemolytic uremic syndrome (STEC-HUS). Please see full
prescribing information for Soliris, including boxed WARNING regarding
risk of serious meningococcal infection. http://soliris.net/sites/default/files/assets/soliris_pi.pdf

Alexion is a biopharmaceutical company focused on serving patients with
severe and 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
paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic
syndrome (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 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,
including asfotase alfa, across multiple therapeutic areas. This press
release and further information about Alexion can be found at: www.alexionpharma.com.

[ALXN-G]

Irving
Adler, 203-271-8210Executive Director, Corporate CommunicationsorKim
Diamond, 203-439-9600Senior Director, Corporate CommunicationsorElena
Ridloff, 203-699-7722Executive Director, Investor Relations

Source: Alexion Pharmaceuticals, Inc.