Alexion Accelerates Plans to Launch Soliris® (Eculizumab) in Japan
Increasing Numbers of Patients to Be Served in Japan in Q3 and Q4
2010 Guidance Revised Upward for Revenues and Non-GAAP Net Income;
Guidance Narrowed for SG&A
CHESHIRE, Conn. & LAUSANNE, Switzerland, Jun 02, 2010 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Alexion Pharma
International Sàrl today announced that the launch of Soliris
(eculizumab) as a treatment for patients with PNH in Japan will begin in
the third quarter of 2010, approximately three months earlier than
previously expected.
Reimbursement Process in Final Stages
Alexion's accelerated plans for the launch of Soliris in Japan are based
on recent approval of the price for Soliris(R) (eculizumab) in Japan by an
advisory committee of Japan's Ministry of Health, Labour and Welfare
(MHLW). The approval positions the MHLW to list Soliris for
reimbursement through Japan's National Health Insurance (NHI) system.
Following this listing, Alexion will begin discussions with individual
hospital treatment centers to place Soliris on their formularies, a
process expected to take an additional one to three months in individual
cases.
PNH is an ultra-rare, debilitating and life-threatening blood disorder
defined by chronic red blood cell destruction, or hemolysis. Soliris, a
first-in-class terminal complement inhibitor, is the first therapy
approved in Japan for the treatment of patients with PNH. Soliris
received orphan drug designation from the MHLW in 2009 and was approved
for marketing under the Ministry's priority review process in April 2010.
"We appreciate the rapid action of the government in Japan, where much
of the early research in PNH took place, to finalize the NHI
reimbursement and listing for Soliris," said Leonard Bell, M.D., Chief
Executive Officer of Alexion. "We expect to provide this
life-transforming therapy to increasing numbers of patients throughout
Japan in the third and fourth quarters. As we continue to diversify our
global access operations, the upcoming launch of Soliris in Japan
represents our first major expansion into the Asia-Pacific region."
2010 Guidance Revised Upward for Revenues and Non-GAAP Net Income,
and Narrowed for SG&A
In light of the earlier than anticipated commercial launch of Soliris in
Japan in the second half of this year, the Company has also announced
today that it is raising its previously issued guidance for full-year
2010 revenues and non-GAAP net income. Alexion is revising upward its
previously announced guidance for 2010 revenues, from the previous range
of $505 to $520 million, now to a higher range of $515 to $530 million.
Alexion is also revising upward its non-GAAP earnings per share (EPS)
guidance from the previous range of $1.60 to $1.65 for non-GAAP diluted
EPS now to a higher range of $1.63 to $1.68. Guidance for non-GAAP
Selling, General and Administrative (SG&A) expenses remains within the
previously announced range of $185 to $195 million, and is now narrowed
to $190 to $195 million, reflecting expenses associated with earlier
launch in Japan. Guidance for 2010 R&D expenses remains unchanged; thus,
guidance for total operating expenses remains within the previously
announced range of $280 to $295 million, but is now narrowed to $285 to
$295 million. All other items of previously announced 2010 guidance
remain unchanged. Non-GAAP results conform with U.S. GAAP in all regards
except that share based compensation and non-cash taxes are excluded in
the non-GAAP reporting.
The Company notes that 2010 guidance has been revised upward despite the
impact of recent and anticipated measures related to healthcare
reimbursement in the U.S. and some European countries, as well as recent
weakness in the Euro and the British pound.
About PNH
PNH is a rare blood disorder that strikes people of all ages, with an
average age of onset in the early 30s. (1) Approximately 10 percent of
all patients first develop symptoms at 21 years of age or younger. (2)
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 ranging from one to more than 10 years. (3) It is estimated
that approximately one-third of patients with PNH do not survive more
than five years from the time of diagnosis. (3) PNH has been identified
more commonly among patients with disorders of the bone marrow,
including aplastic anemia (AA) and myelodysplastic syndromes (MDS).
(4,5,6) In patients with thrombosis of unknown origin, PNH may be an
underlying cause. (1) More information on PNH is available at www.pnhsource.com.
About Soliris
Soliris (eculizumab) is a first-in-class terminal complement inhibitor
developed from the laboratory through regulatory approval by Alexion.
Soliris has been approved by the healthcare authorities in the U.S.,
European Union, Japan and other countries as the first treatment for
patients with PNH, a rare, debilitating and life-threatening blood
disorder defined by hemolysis, or the destruction of red blood cells.
Prior to these approvals, there was no therapy specifically available
for the treatment of PNH.
Patients with PNH in more than 20 countries now have access to Soliris
therapy through national or private healthcare providers. As the first
terminal complement inhibitor to be approved in countries around the
world, Soliris represents a long-sought breakthrough in medical
innovation. Alexion's innovative approach to complement inhibition has
received some of the pharmaceutical industry's highest honors: the 2008
Prix Galien USA Award for Best Biotechnology Product with broad
implications for future biomedical research, and the 2009 Prix Galien
France Award in the category of Drugs for Rare Diseases. More
information on Soliris is available at www.soliris.net.
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.
The U.S. product label for Soliris also includes a boxed warning:
"Soliris increases the risk of meningococcal infections. Meningococcal
infection may become rapidly life-threatening or fatal if not recognized
and treated early. Vaccinate patients with a meningococcal vaccine at
least two 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." During clinical studies, 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 are encouraged to enroll in the PNH 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.
About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to
develop and deliver life-changing drug therapies for patients with
serious and life-threatening medical conditions. Alexion is engaged in
the discovery, development and commercialization of therapeutic products
aimed at treating patients with a wide array of severe disease states,
including hematologic and kidney diseases, transplant, other
inflammatory disorders, and cancer. Soliris is Alexion's first marketed
product. Alexion is evaluating other potential indications for Soliris
as well as other formulations of eculizumab for additional clinical
indications, and is pursuing development of other antibody product
candidates in early stages of development. This press release and
further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
[ALXN-G]
Safe Harbor Statement
This news release contains forward-looking statements, including
statements related to potential health and medical benefits from
Soliris, the timing of regulatory and commercial milestones for Soliris
in Japan, and guidance regarding the anticipated financial results for
2010. Forward-looking statements are subject to factors that may cause
Alexion's results and plans to differ from those expected, including for
example, decisions of regulatory authorities regarding marketing
approval or material limitations on the marketing of Soliris, delays in
arranging satisfactory manufacturing capability and establishing
commercial infrastructure, delays in developing or adverse changes in
commercial relationships, the possibility that results of published
reports or clinical trials are not predictive of safety and efficacy
results of Soliris in broader patient populations, the risk that
clinical trials may not be completed successfully, the possibility that
initial results of commercialization are not predictive of future rates
of adoption of Soliris, the risk that third parties won't agree to
license any necessary intellectual property to Alexion on reasonable
terms or at all, the risk that third party payors will not reimburse for
the use of Soliris at acceptable rates or at all, 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-Q for the period
ended March 31, 2010, and in Alexion's 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.
(1) Socié G, Mary J Yves, de Gramont A, et al. Paroxysmal nocturnal
haemoglobinuria: long-term follow-up and prognostic factors. Lancet.
1996: 348:573-577.
(2) Parker C, Omine M, Richards S, et al. Diagnosis and management of
paroxysmal nocturnal hemoglobinuria. Blood. 2005;106 (12):3699-3709.
(3) Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural
history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;
333:1253-1258.
(4) Wang H, Chuhjo T, Yasue S, Omine M, Naka S. Clinical significance of
a minor population of paroxysmal nocturnal hemoglobinuria-type cells in
bone marrow failure syndrome. Blood. 2002;100 (12):3897-3902.
(5) Iwanga M, Furukawa K, Amenomori T, et al. Paroxysmal nocturnal
haemoglobinuria clones in patients with myelodysplastic syndromes. Br J
Haematol. 1998;102 (2):465-474.
(6) Maciejewski JP, Risitano AM, Sloand EM, et al. Relationship between
bone marrow failure syndromes and the presence of glycophosphatidyl
inositol-anchored protein-deficient clones. Br J Haematol.
2001;115:1015-1022.
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director, Corporate Communications
or
Makovsky & Company
Mark Marmur (Media), 212-508-9670
or
Rx Communications
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