Alexion Reports Progress on Commissioning of Rhode Island Manufacturing Facility as Second Source of Supply
CHMP Issues Positive Opinion for European Union; FDA Review Ongoing
CHESHIRE, Conn., Dec 02, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today provided updates on
the regulatory review and approval, or commissioning, of Alexion's Rhode
Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a
second source of supply for Soliris(R) (eculizumab). The
Company reported that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency has issued a "positive opinion"
recommending final approval of the facility by the European Commission,
which is expected in early 2010. Separately, the Company expects to meet
with the U.S. Food and Drug Administration (FDA) to provide additional
available information, and to discuss their request for a limited number
of production runs in connection with their pre-approval inspection
process.
Second Source of Supply
Since 2006, Alexion has been developing ARIMF to become a second source
of supply of Soliris and to manufacture other antibody products. The
facility does not yet provide Soliris for commercial use in any market.
As a result of the Company's previously described multi-source strategy,
Alexion has existing supplies of Soliris sufficient to serve all
anticipated clinical and commercial needs, while continuing to source
product from its primary provider.
"We are pleased to receive the positive opinion from the CHMP, which
would give us the option to use ARIMF as a second source to supply
Soliris to European countries following final EU approval," said Stephen
P. Squinto, Executive Vice President and Head of Research and
Development at Alexion. "We now look forward to progressing our
discussions and satisfying the requirements of the FDA, which would give
us the additional option of using our Rhode Island facility as a second
source to serve the U.S. market as well."
Separately, the Company provided an update on a previously described
regulatory review of an external vialer previously used by Alexion.
Alexion reported today that regulatory authorities have now permitted
release to the marketplace of all batches of Soliris that were filled by
this external vialer. The previously described contingent liability
associated with these batches has now been completely resolved at no
loss to the Company.
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, cancer, and
autoimmune disorders. Soliris(R) (eculizumab), Alexion's first
marketed product, is approved in the U.S., European Union, Australia and
Canada as a treatment for patients with paroxysmal nocturnal
hemoglobinuria (PNH), a rare, debilitating and life-threatening blood
disorder. 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 the commissioning of Alexion's Rhode Island
Manufacturing Facility and supplies of Soliris.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 U.S. and European regulatory authorities regarding final approval for
ARIMF as an alternate source of Soliris and other antibodies, regulatory
compliance and production capabilities of third party suppliers the
accuracy of inventory forecasts, market conditions or clinical studies
that could accelerate the use of Soliris, 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 Quarterly Report on Form 10-Q for the period ended September
30, 2009 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.
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, Sr. Director Corporate Communications
203-271-8210
or
Makovsky & Company
Kristie Kuhl, 212-508-9642 (Media)
or
Rx Communications
Rhonda Chiger, 917-322-2569 (Investors)
Copyright Business Wire 2009