Serono Announces Final Settlement of Serostim(R) Investigation
October 17 2005 - 12:40PM
PR Newswire (US)
GENEVA, Switzerland, Oct. 17 /PRNewswire-FirstCall/ -- Serono
(virt-x: SEO and NYSE: SRA) announced today that its U.S.
affiliates have agreed to settle the government investigation led
by the U.S. Attorney's office in Massachusetts into commercial
practices related to Serostim(R). This investigation was part of an
ongoing industry-wide investigation by the states and the federal
government of commercial practices. The comprehensive settlements
with federal and state agencies will conclude all liabilities to
the government in connection with the investigation. In April 2005,
the company announced that it had taken a $725 million provision to
cover the settlement and related costs. The provision, which was
recorded as an exceptional charge in the company's earnings report
for the first quarter of 2005, will be sufficient to cover the
comprehensive settlements and related costs. The comprehensive
settlements also include a Corporate Integrity Agreement,
administered through the Office of the Inspector General. "This
settlement concludes a four-year government investigation into
commercial practices related to Serostim, and we are pleased to put
the matter behind us," said Thomas G. Gunning, Vice President and
General Counsel, Serono U.S. "The activities described in the
settlement were confined to one unit in our U.S. operations and
cover a brief period in our history. Serono takes compliance issues
very seriously and has a rigorous compliance program to ensure that
its employees meet the highest ethical standards. We now look
forward to continuing to focus and devote our energies on our core
mission of developing treatments to meet unmet medical needs."
About Serono Serono is a global biotechnology leader. The Company
has eight biotechnology products, Rebif(R), Gonal-f(R), Luveris(R),
Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology.
Currently, there are approximately 30 ongoing development projects.
In 2004, Serono achieved worldwide revenues of US$2,458.1 million,
and a net income of US$494.2 million, making it the third largest
biotech company in the world. Its products are sold in over 90
countries. Bearer shares of Serono S.A., the holding company, are
traded on the virt-x (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA). Forward-looking
statement Some of the statements in this press release are forward
looking. Such statements are inherently subject to known and
unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements of Serono S.A. and
affiliates to be materially different from those expected or
anticipated in the forward-looking statements. Forward-looking
statements are based on Serono's current expectations and
assumptions, which may be affected by a number of factors,
including those discussed in this press release and more fully
described in Serono's Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission on March 16, 2005. These
factors include any failure or delay in Serono's ability to develop
new products, any failure to receive anticipated regulatory
approvals, any problems in commercializing current products as a
result of competition or other factors, our ability to obtain
reimbursement coverage for our products, the outcome of government
investigations and litigation and government regulations limiting
our ability to sell our products. Serono has no responsibility to
update the forward-looking statements contained in this press
release to reflect events or circumstances occurring after the date
of this press release. For more information, please contact: Media
Relations, USA: Investor Relations, USA Tel: +1 781 681 2340 Tel:
+1 781 681 2552 Fax: +1 781 6812935 Fax: +1 781 681 2912
http://www.seronousa.com/ Corporate Media Relations: Corporate
Investor Relations: Tel: +41 22 739 36 00 Tel: +41 22 739 36 01
Fax: +41 22 739 30 85 Fax: +41 22 739 30 22 http://www.serono.com/
Reuters: SEO.VX / SRA.N Bloomberg: SEO VX / SRA US DATASOURCE:
Serono CONTACT: Media Relations, USA, +1-781-681-2340, or Investor
Relations, USA, +1-781-681-2552, or Corporate Media Relations, +41
22 739 36 00, or Corporate Investor Relations, +41 22 739 36 01 Web
site: http://www.serono.com/
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