GENEVA, Switzerland, September 23 /PRNewswire/ --

- PREDICT Aims to Identify Potential Genetic Markers and Additional Serum Biomarkers That Could Play a Role in Predicting the Response to Growth Hormone Treatment in Children With Growth Hormone Deficiency or Turner Syndrome

- Results Will be Used in the Development of a Novel Pharmaco-Prediction Model to Optimize Growth Hormone Therapy

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today presented the results of the PREDICT study at the 47th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) in Istanbul, Turkey. This Phase IV open-label study for predictive markers of response to treatment in pre-pubertal children with growth hormone deficiency (GHD) or Turner syndrome (TS) treated with Saizen(R), is one of the largest prospective studies conducted in endocrinology in GHD and TS, exploring the relationship between short-term biomarker changes, genotyping (DNA) and gene expression profiling (mRNA).

"The existing clinical prediction models have only explained approximately 40% to 60% of the response variability in TS and GHD, respectively, in the first year of treatment. The PREDICT results will be used to develop a novel pharmacoprediction model which will be a really useful tool for optimizing growth hormone therapy in paediatric indications", stated Prof. Peter Clayton, global coordinating investigator for the PREDICT study. "By studying the relationship between genetic variation and drug response, we can lay the foundations of a new era in growth hormone therapy, based not only on efficacy and safety, but also on genotype diversity. This is a unique opportunity for children suffering from GHD and TS to optimize their chances of reaching their target height."

Initiated in 2002, the PREDICT study was conducted in 42 sites across 15 countries. A total of 318 prepubertal GH-treatment naïve children with GHD (N= 169) or TS (N= 149) were treated with a single daily dose of Saizen(R) for four weeks. The results of the study were presented at ESPE:

- With Saizen(R) therapy, levels of all biomarkers studied significantly changed between baseline and one month in both TS and GHD children(1),(2). - Over 1500 genetic markers in 98 candidate genes involved in the control of growth and metabolism pathways, were analyzed for their association with the change in the most sensitive biomarker Insulin-like Growth Factor 1 (IGF-I) (3). - Genome-wide expression analysis was performed in GHD and TS children based on their IGF-I levels(4). Children from the PREDICT study will be treated and followed up for five years through an observational program currently in progress. First-year results of the PREDICT long-term follow-up program will be presented in 2009.

"As a leader in the field of endocrinology, Merck Serono is committed to support the PREDICT clinical program over the next decade," said Dr. Bernhard Kirschbaum, Executive Vice-President Research at Merck Serono. "If successful, the program will provide clinicians with an efficient pharmacoprediction model to assess patients' response to Saizen(R) and allow for stratified medicine: a tailored dose from the start of treatment, which is a key factor in successful growth hormone therapy."


(1) Tato L, et al., ESPE 2008; Abstract No: 1355138

(2) Chatelain P, et al., ESPE 2008; Abstract No: 1355186

(3) Clayton P, et al., ESPE 2008; Abstract No: 1355211

(4) Clayton P, et al., ESPE 2008; Abstract No: 1355251

About Saizen(R)

Saizen(R) (somatropin) is a recombinant human growth hormone (GH) and is therapeutically equivalent to the natural GH produced by the body.

Saizen(R) is currently registered for the treatment of:

- GH deficiency in children (78 countries) - GH deficiency in adult patients (54 countries) - Children born Small for Gestational Age (38 countries - not registered for this indication in the US) - Turner's syndrome (72 countries - not registered for this indication the US) - GH deficiency in children associated with chronic renal failure (51 countries - not registered for this indication in the US)

About Growth Hormone Deficiency (GHD)

Growth hormone deficiency occurs when the pituitary gland in the brain is unable to release or produce adequate amounts of growth hormone. In children, growth hormone deficiency causes slow growth, and without treatment, few will reach their full height potential as an adult.

It is estimated that the incidence of growth hormone deficiency in children is between 1 in 4,000 and 1 in 10,000.

Adult growth hormone deficiency can also be a significant problem. More than 50,000 adults in the United States are growth hormone deficient, and 6,000 new cases are reported each year. It is recognized as a specific clinical syndrome.

About Turner syndrome (TS)

Turner Syndrome is caused by a genetic defect that occurs only in girls. Most girls are born with two female X chromosomes; in girls born with TS one of the two X chromosomes is missing, incomplete or damaged. TS can cause growth disorders and short stature. Early GH therapy has been shown to increase the rate of gain in height in girls with TS and may increase final adult height.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Euthyrox(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)).

With an annual R&D expenditure of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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