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August 15, 2001 01:00
Serono Receives European Approval for the Use of Saizen(R) In the Treatment of Adult Growth Hormone Deficiency
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GENEVA, Switzerland, Aug. 15 /PRNewswire/ -- Serono S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) announced today the positive conclusion of the Mutual Recognition Procedure for use of Saizen(R) [somatropin (rDNA origin) for injection] in the treatment of adult growth hormone deficiency. Serono is planning to launch Saizen(R) in this new indication in several European countries by the end of 2001, based on national approval procedures.
Adult growth hormone deficiency (GHD) is a condition caused by the reduced secretion of growth hormone from the pituitary gland. Adult growth hormone deficiency is associated with reduced life expectancy and impaired quality of life. Common symptoms of GHD in adults include:
* abnormal body composition (reduced lean body mass and increased
abdominal fat),
* reduced bone mineral density resulting in an increased fracture risk,
* reduced exercise capacity and vitality,
* increased cardiovascular risk,
* impaired psychological wellbeing (depression, social isolation, anxiety,
etc.).
Although, growth hormone deficiency affects approximately 50,000 adults in the US and 50,000 in Europe, it is still often regarded as a condition affecting only children. "It is important to treat adult patients suffering from growth hormone deficiency, as this condition increases the risk of cardiovascular disease and affects quality of life," said Dr. Bengt Ake Bengtsson, prominent member of the Growth Hormone Research Society.
The adult GHD population includes two types of patients: those who had growth hormone deficiency as children, and who will require treatment throughout adulthood, and patients with adult onset deficiency due to damage to the pituitary gland (arising from various causes including tumors and their treatment with radiotherapy or surgery or head injuries).
Serono has conducted one of the largest trials ever done in the field of adult growth hormone deficiency, showing the beneficial effects of Saizen(R) in the adult population (1)(2). Saizen(R) has been shown to improve cardiac performance and body composition in GH deficient adults.
"The availability of Saizen(R) for the treatment of adult growth hormone deficiency in Europe, reinforces the commitment of Serono towards growth hormone therapy," said Bharat Tewarie, Corporate Vice President, Head of Global Therapeutic Area Metabolic Endocrinology.
Saizen(R), Serono's recombinant growth hormone, was introduced by Serono in 1989, and is currently approved for the treatment of growth retardation due to growth hormone deficiency (81 countries), Turner Syndrome (68 countries) and chronic renal failure (29 countries).
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 April 23, 2001. 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, 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.
About Serono
Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Rebif(R), Serostim(R) and Saizen(R) (Rebif(R) and Luveris(R) are not approved in the USA). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are thirteen molecules in development.
In 2000, Serono achieved worldwide revenues of US$1.240 billion, and a net income of US$301 million, making it the third largest biotech company in the world based on revenues. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X65824271
SOURCE Serono S.A.
/CONTACT: Media Relations, +41-22-739 36 00, or Investor Relations,
+41-22-739 36 01, both of Serono S.A.; or Noonan/Russo Communications,
+44-207 726 4452; or Media Relations of Serono, Inc., +1-781-681-2340/
/Web site: http://www.serono.com/
(SRA)
Serono Receives European Approval for the Use of Saizen(R) In the Treatment of Adult Growth Hormone Deficiency
Jump to first matched term
GENEVA, Switzerland, Aug. 15 /PRNewswire/ -- Serono S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) announced today the positive conclusion of the Mutual Recognition Procedure for use of Saizen(R) [somatropin (rDNA origin) for injection] in the treatment of adult growth hormone deficiency. Serono is planning to launch Saizen(R) in this new indication in several European countries by the end of 2001, based on national approval procedures.
Adult growth hormone deficiency (GHD) is a condition caused by the reduced secretion of growth hormone from the pituitary gland. Adult growth hormone deficiency is associated with reduced life expectancy and impaired quality of life. Common symptoms of GHD in adults include:
* abnormal body composition (reduced lean body mass and increased
abdominal fat),
* reduced bone mineral density resulting in an increased fracture risk,
* reduced exercise capacity and vitality,
* increased cardiovascular risk,
* impaired psychological wellbeing (depression, social isolation, anxiety,
etc.).
Although, growth hormone deficiency affects approximately 50,000 adults in the US and 50,000 in Europe, it is still often regarded as a condition affecting only children. "It is important to treat adult patients suffering from growth hormone deficiency, as this condition increases the risk of cardiovascular disease and affects quality of life," said Dr. Bengt Ake Bengtsson, prominent member of the Growth Hormone Research Society.
The adult GHD population includes two types of patients: those who had growth hormone deficiency as children, and who will require treatment throughout adulthood, and patients with adult onset deficiency due to damage to the pituitary gland (arising from various causes including tumors and their treatment with radiotherapy or surgery or head injuries).
Serono has conducted one of the largest trials ever done in the field of adult growth hormone deficiency, showing the beneficial effects of Saizen(R) in the adult population (1)(2). Saizen(R) has been shown to improve cardiac performance and body composition in GH deficient adults.
"The availability of Saizen(R) for the treatment of adult growth hormone deficiency in Europe, reinforces the commitment of Serono towards growth hormone therapy," said Bharat Tewarie, Corporate Vice President, Head of Global Therapeutic Area Metabolic Endocrinology.
Saizen(R), Serono's recombinant growth hormone, was introduced by Serono in 1989, and is currently approved for the treatment of growth retardation due to growth hormone deficiency (81 countries), Turner Syndrome (68 countries) and chronic renal failure (29 countries).
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 April 23, 2001. 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, 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.
About Serono
Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Rebif(R), Serostim(R) and Saizen(R) (Rebif(R) and Luveris(R) are not approved in the USA). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are thirteen molecules in development.
In 2000, Serono achieved worldwide revenues of US$1.240 billion, and a net income of US$301 million, making it the third largest biotech company in the world based on revenues. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X65824271
SOURCE Serono S.A.
/CONTACT: Media Relations, +41-22-739 36 00, or Investor Relations,
+41-22-739 36 01, both of Serono S.A.; or Noonan/Russo Communications,
+44-207 726 4452; or Media Relations of Serono, Inc., +1-781-681-2340/
/Web site: http://www.serono.com/
(SRA)
