NEW HAVEN, Conn.--(BUSINESS WIRE)--
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it has
filed with the U.S. Securities and Exchange Commission (SEC) a Form
12b-25 Notification of Late Filing with regard to its Quarterly Report
on Form 10-Q for the quarter ended September 30, 2016.
The Audit and Finance Committee of the Board of Directors is conducting
an investigation into allegations that recently have been made by a
former employee with respect to the Company's sales practices of Soliris®
(eculizumab). Specifically, the Audit and Finance Committee is
investigating whether Company personnel have engaged in sales practices
that were inconsistent with Company policies and procedures and the
related disclosure and other considerations raised by such practices.
The Audit and Finance Committee has retained outside counsel to assist
it in the investigation.
At this point in time, the Audit and Finance Committee's investigation
has not identified instances where Soliris orders were not placed by
customers for patients or any facts that require the Company to update
its previously reported historical results. The Audit and Finance
Committee and its counsel are working diligently to complete the
investigation, but at this time it is uncertain when this investigation
will be complete and what the results of such investigation will be.
The delayed filing does not affect Alexion's ability to serve existing
or new patients worldwide or to progress the Company's clinical
development programs.
[ALXN-G]
About Alexion
Alexion is a global biopharmaceutical company focused on developing and
delivering life-transforming therapies for patients with devastating and
rare disorders. Alexion developed and commercializes Soliris®
(eculizumab), the first and only approved complement inhibitor to treat
patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical
hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare
disorders. As the global leader in complement inhibition, Alexion is
strengthening and broadening its portfolio of complement inhibitors,
including evaluating potential indications for eculizumab in additional
severe and ultra-rare disorders. Alexion's metabolic franchise includes
two highly innovative enzyme replacement therapies for patients with
life-threatening and ultra-rare disorders, Strensiq®
(asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma®
(sebelipase alfa) to treat patients with lysosomal acid lipase
deficiency (LAL-D). In addition, Alexion is advancing the most robust
rare disease pipeline in the biotech industry with highly innovative
product candidates in multiple therapeutic areas. This press release and
further information about Alexion can be found at: www.alexion.com.
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements often include words such as "anticipate,"
"believe," "expect," "will," or similar expressions. A number of
important factors could cause actual results of the Company to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, (i) risks relating to the
internal investigation being conducted by the Audit and Finance
Committee; (ii) legal proceedings and government investigations relating
to the subject of the Audit and Finance Committee's investigation or
related matters; (iii) the risk that these or other risk factors impact
the expected timing of the filing of the Company's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2016; (iv) the risk that
the failure by the Company to file the 10-Q in a timely manner could
lead to a default under certain of the Company's indebtedness; and (v)
the risk factors detailed in Part I, Item 1A, "Risk Factors," of the
Company's Annual Report on Form 10-K and the Company's Quarterly Reports
on Form 10-Q, and other risk factors identified herein or from time to
time in the Company's periodic filings with the SEC. The Company
therefore cautions you against relying on these forward-looking
statements. All forward-looking statements attributable to the Company
or persons acting on the Company's behalf are expressly qualified in
their entirety by the foregoing cautionary statements. All such
statements speak only as of the date made, and, except as required by
law, the Company undertakes no obligation to update or revise publicly
any forward-looking statements, whether as a result of new information,
future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161109006268/en/
Alexion Contacts:
Media
Stephanie
Fagan, 475-230-3777
Senior Vice President, Corporate Communications
or
Kim
Diamond, 475-230-3775
Executive Director, Corporate Communications
or
Investors
Elena
Ridloff, CFA, 475-230-3601
Vice President, Investor Relations
Source: Alexion Pharmaceuticals, Inc.
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