Serono Announces Formal Conclusion of Serostim Settlement
December 15 2005 - 1:19PM
PR Newswire (US)
GENEVA, and ROCKLAND, Mass., Dec. 15 /PRNewswire-FirstCall/ --
Serono (virt-x: SEO; NYSE: SRA) announced today that one of its
U.S. affiliates has voluntarily entered a guilty plea and the
company has formally concluded the previously announced settlement
of the government investigation led by the U.S. Attorney's office
in Massachusetts into commercial practices related to Serostim(R)
[somatropin (rDNA origin) for injection]. The comprehensive
settlement, announced in October, with federal and state agencies
concludes all liabilities to the government in connection with the
investigation. The company's U.S. products are Rebif(R) (interferon
beta-1a), Novantrone(R) (mitoxantrone for injection concentrate),
Gonal-f(R) (follitropin alfa for injection), Luveris(R) (lutropin
alfa for injection), Ovidrel(R) (choriogonadotropin alfa
injection), Crinone 8%(R) (progesterone gel), Cetrotide(R)
(cetrorelix acetate for injection), Serostim(R) [somatropin (rDNA
origin) for injection], Saizen(R) [somatropin (rDNA origin) for
injection] and Zorbtive(TM) [somatropin (rDNA origin) for
injection]. These products continue to be available in the U.S.
through Serono Inc., and are eligible for reimbursement under
federal and state health care programs. Settlement Background 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, is sufficient to
cover the comprehensive settlements and related costs and the
settlement amount will be paid in 2005. 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 2481 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 Website:
http://www.seronousa.com DATASOURCE: Serono CONTACT: Media
Relations, USA, +1-781-681-2481, or Investor Relations, USA,
+1-781-681- 2552, or Corporate Media Relations, +41 22 739 36 00,
Corporate Investor Relations, +41 22 739 36 01, all of Serono
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