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Europe Approves Saizen (Somatropin)

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From http://www.pslgroup.com/dg/20398e.htm


ALIGN="center"><B>Europe Approves Saizen (Somatropin) for Adult Growth Hormone Deficiency</B></P>

GENEVA, SWITZERLAND -- August 15, 2001 -- Serono S.A. announced today the positive conclusion of the European Mutual Recognition Procedure for use of Saizen? [somatropin (rDNA origin) for injection] in the treatment of adult growth hormone deficiency.

Serono is planning to launch Saizen 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 United States 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 in the adult population (1)(2). Saizen has been shown to improve cardiac performance and body composition in GH deficient adults.

"The availability of Saizen 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, 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).

SOURCE: Serono S.A.


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