CHMP Adopts Positive Opinion for Alexion's Soliris(TM) in Europe

Cheshire, Connecticut (ots/PRNewswire) -

- CHMP recommends marketing authorization for Soliris(TM)
(eculizumab) to treat all patients with paroxysmal nocturnal
hemoglobinuria (PNH) -

- First medicinal product to receive positive opinion from CHMP
under Accelerated Assessment Procedure -

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that
the Committee for Human Medicinal Products (CHMP) of the European
Medicines Agency (EMEA) adopted a positive opinion recommending
marketing authorization for Soliris(TM) (eculizumab) for the
treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Based upon the CHMP's positive recommendation, marketing
authorization by the European Commission is expected in two to three
months.

Soliris, a designated orphan medicinal product, is intended to
reduce hemolysis (destruction of red blood cells) in patients with
paroxysmal nocturnal hemoglobinuria (PNH). The CHMP recommended a
broad label for Soliris covering all patients with PNH. According to
the adopted CHMP opinion, "Soliris (eculizumab) is indicated for the
treatment of patients with paroxysmal nocturnal haemoglobinuria
(PNH)." An additional sentence describing the PNH patient population
that was studied in the Phase III clinical trials states, "Evidence
of clinical benefit of Soliris in the treatment of patients with PNH
is limited to patients with history of transfusions." Soliris was
previously approved by the U.S. Food and Drug Administration on March
16, 2007 for the treatment of PNH to reduce hemolysis, and is
currently being marketed in the United States.

The CHMP evaluated Soliris under the European Accelerated
Assessment procedure, the fastest evaluation timeframe for full
approval awarded by EMEA. According to the EMEA, Soliris is the first
medicinal product to receive a positive CHMP opinion within the
Accelerated Assessment procedure.

There are no therapies specifically available for the treatment of
PNH in Europe. PNH is a rare, disabling and life-threatening blood
disorder defined by chronic red blood cell destruction, or hemolysis.
Hemolysis can cause one or more of the following symptoms in patients
with PNH: severe anemia, disabling fatigue, recurrent pain, shortness
of breath, pulmonary hypertension, intermittent episodes of dark
colored urine (hemoglobinuria), kidney disease, impaired quality of
life and blood clots (thromboses).

"Soliris brings real hope to people who live daily with the
devastating effects of PNH," said Leonard Bell, MD, chief executive
officer of Alexion Pharmaceuticals. "The positive opinion adopted by
CHMP is an important step in Alexion's mission to improve PNH
patients' lives in Europe and around the globe. Importantly, the
adopted CHMP opinion recommends marketing authorization for Soliris
to treat all patients with PNH."

CHMP based its opinion on clinical data from three multi-national
clinical studies involving 195 patients. In these studies Soliris
reduced hemolysis in every treated patient, thereby reducing
symptoms, stabilizing hemoglobin and significantly reducing
transfusions. Soliris patients reported markedly less fatigue and
improved health-related quality of life. Additionally, there were
fewer thrombotic events during Soliris treatment than during the same
period of time prior to treatment.

A summary of the CHMP opinion can be accessed at
http://www.emea.europa.eu .

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse
events observed in clinical studies were headache, nasopharyngitis (a
runny nose), back pain and nausea. Treatment with Soliris should not
alter anticoagulant management because the effect of withdrawal of
anticoagulant therapy during Soliris treatment has not been
established.

In the United States, the product label for Soliris also includes
a boxed warning: "Soliris increases the risk of meningococcal
infections. Vaccinate patients with a meningococcal vaccine at least
2 weeks prior to receiving the first dose of Soliris; revaccinate
according to current medical guidelines for vaccine use. Monitor
patients for early signs of meningococcal infections, evaluate
immediately if infection is suspected, and treat with antibiotics if
necessary." Two out of 196 vaccinated PNH patients treated with
Soliris experienced a serious meningococcal infection.

Prior to beginning Soliris therapy, all patients and their
prescribing physicians in the United States, and following approval
those in Europe as well, will be enrolled in the Soliris Safety
Registry which is part of a special risk management program that
involves initial and continuing education and long-term monitoring
for detection of new safety findings.

Please see full prescribing information for Soliris in the United
States at http://www.soliris.net.

About PNH

PNH is an acquired genetic blood disorder defined by hemolysis, in
which patients' red blood cells are destroyed by complement, a
component of the body's immune system. PNH is a rare disease that
affects an estimated 8,000 to 10,000 people in Europe and North
America. Approximately ten percent of all patients first develop
symptoms at 21 years of age or younger. PNH develops without warning
and can occur in men and women of all races, backgrounds and ages.
PNH often goes unrecognized, with delays in diagnosis often ranging
from one to more than 10 years. PNH has been identified more commonly
among patients with diseases of the bone marrow, including aplastic
anemia (AA) and myelodysplastic syndrome (MDS). In patients with
thromboses of unknown origin, PNH may be an underlying cause.

Prior to approval of Soliris, there were no therapies specifically
available for the treatment of PNH. PNH treatment was limited to
symptom management through periodic blood transfusions, non-specific
immunosuppressive therapy and, infrequently, bone marrow
transplantations - a high-risk and painful procedure used as a last
resort.

About Alexion

Alexion Pharmaceuticals is a biotechnology company working to
develop and deliver life-changing drug therapies for patients with
serious and life-threatening medical conditions. Alexion markets
Soliris(TM)(eculizumab) in the United States for the treatment of
paroxysmal nocturnal hemoglobinuria (PNH). Alexion is engaged in the
discovery and development of therapeutic products aimed at treating
patients with severe disease states, including hematologic diseases,
cancer and autoimmune disorders. Alexion applied for marketing
authorization with the European Medicines Evaluation Agency (EMEA)
for Soliris in September 2006, and in April, 2007 the Committee for
Human Medicinal Products of the EMEA adopted a positive opinion
recommending marketing authorization for Soliris for the treatment of
PNH. This press release and further information about Alexion
Pharmaceuticals, Inc. can be found at: http://www.alexionpharm.com.

This news release contains forward-looking statements, including
statements related to the timing and anticipated results of
regulatory authorities' decisions with respect to marketing
applications for Soliris, potential benefits and commercial potential
of Soliris, and estimates of the number of PNH patients.
Forward-looking statements are subject to factors that may cause
Alexion's results and plans to differ from those expected, including
requests by regulatory authorities for additional information or
data, timing and evaluation by regulatory agencies of our
applications, the need for additional research and testing, decision
of regulatory authorities not to approve (or to materially limit)
marketing of Soliris, delays in arranging satisfactory manufacturing
capability, inability to acquire funding on timely and satisfactory
terms, delays in developing or adverse changes in commercial
relationships, the possibility that results of clinical trials are
not predictive of the safety and efficacy of Soliris, the risk that
third parties won't agree to license any necessary intellectual
property to us on reasonable terms, the risk that third party payors
will not reimburse for the use of Soliris at acceptable rates or at
all, the risk that estimates regarding the number of PNH patients are
inaccurate and a variety of other risks set forth from time to time
in Alexion's filings with the Securities and Exchange Commission,
including but not limited to the risks discussed in Alexion's Annual
Report on Form 10-K for the year ended December 31, 2006, and in our
other filings with the Securities and Exchange Commission. Alexion
does not intend to update any of these forward- looking statements to
reflect events or circumstances after the date hereof, except when a
duty arises under law.

Web site: http://www.alexionpharm.com
http://www.soliris.net
http://www.emea.europa.eu

ots Originaltext: Alexion Pharmaceuticals, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Leonard Bell, M.D., Chief Executive Officer of Alexion
Pharmaceuticals, Inc., +1-203-272-2596; or Media, David Patti,
Makovsky + Company, +1-212-508-9623, or dpatti@makovsky.com; or
Investors, Rhonda Chiger of Rx Communications Group, LLC,
+1-917-322-2569, or rchiger@rxir.com


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