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Merck Serono Launches Glucophage(R) Powder (Metformin Hydrochloride) in First European Countries

Feltham, England (ots/PRNewswire)

- Innovative Powder Formulation of Metformin Designed to
Facilitate Adherence by Increasing Patient Choice in the Treatment of
Type 2 Diabetes, Now Available in France and the United Kingdom
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today
announced that Glucophage(R) Powder for Oral Solution in Sachets,
(metformin hydrochloride in 500mg, 850mg and 1000mg strengths)
indicated for the first-line treatment of type 2 diabetes mellitus,
is now licensed in France and the United Kingdom(1), the first
European countries to launch  this new formulation of Glucophage(R).
Launches in other European countries  are expected to take place in
the coming months, once individual marketing authorisations are
granted.
Bioequivalent to the existing Glucophage(R) tablets(2), the new
powder formulation is packaged in individual sachets of 500mg, 850mg
and 1000mg(1). Glucophage(R) powder can be easily dissolved in water
to produce  a clear to slightly opalescent solution.(2)
"Adherence to therapy is increasingly being recognised by
physicians as a key condition to achieve glycaemic control for
patients with diabetes," said Roberto Gradnik, Executive Vice
President Commercial Europe at Merck Serono. "We are pleased to
provide this innovative powder formulation of Glucophage(R) to
patients seeking a convenient alternative to tablets which may
facilitate their adherence to treatment."
The International Diabetes Federation (IDF) estimates that
diabetes currently affects 246 million people worldwide, representing
roughly 6% of the adult population; this number is expected to rise
to 380 million by 2025. Type 2 diabetes constitutes about 85% to 95%
of all diabetes cases in developed countries and accounts for an even
higher percentage in developing countries. The IDF recommends that,
metformin remains a drug of choice for first-line therapy of type 2
diabetes.(3)
The American Diabetes Association (ADA) and the European
Association for the Study of Diabetes (EASD) advise that metformin
therapy should be initiated concurrently with lifestyle intervention
at diagnosis of type 2 diabetes.(4) However the current therapeutic
indication for Glucophage(R) remains the treatment of type 2 diabetes
mellitus, particularly in overweight patients, when dietary
management and exercise alone does not result in adequate glycaemic
control.(5)
References
1. In the United Kingdom, Glucophage powder for Oral Solution in
Sachets is available in 500mg and 1000mg strengths only.
2. Summary of Product Characteristics (SmPC) Glucophage Powder
500mg and 1000mg 12th March 2009
3. International Diabetes Federation, Global Guideline for Type 2
Diabetes, http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf
4. Nathan DM et al., Medical Management of Hyperglycemia in Type
2 Diabetes: a Consensus Algorithm for the Initiation and Adjustment
of  Therapy, Diabetes Care 2009, 32:193-203
5. National Institute for Clinical Excellence (NICE). Type 2
diabetes. The management of type 2 diabetes (update). NICE clinical
guideline 66, corrected December 2008. Accessed via  http://www.nice.
org.uk/nicemedia/pdf/CG066NICEGuidelineCorrectedDec08.pdf
About Glucophage(R) (metformin hydrochloride)
Glucophage(R) has been approved worldwide as a first line
treatment of Type 2 diabetes. It belongs to the biguanide class of
molecules, which decrease glucose production by the liver. A primary
objective of type 2 diabetes treatments is to correct the dual
effects of tissue unresponsiveness to insulin (insulin resistance)
and insulin deficiency arising from impaired functioning of the beta
cells in the pancreas that make insulin. Metformin corrects insulin
resistance by making tissues, such as the liver and muscle,
responsive to insulin. This way, patients get less "in-house" glucose
production in the liver and better glucose uptake into muscle, where
it is stored as glycogen or burnt off to produce energy. The net
result is restoration of normal glucose levels.
The wealth of evidence documented in some 5,600 scientific
publications since 1957, the year of metformin's introduction into
clinical practice, led the International Diabetes Federation (IDF) to
recommend metformin as the 1st line therapy of choice for the
treatment of type 2 diabetes in its global guidelines, issued in
2005. A landmark study, the United Kingdom Prospective Diabetes Study
(UKPDS) has shown metformin to be effective at lowering blood glucose
and reducing the risk of long term complications (eg heart attacks
and strokes).
Merck Serono is a world market leader in oral diabetes
medications. More than six million patients in over 100 countries
around the globe currently benefit from various products of the
Glucophage(R) family.
Glucophage(R) Powder for Oral Solution in Sachet is a new
formulation manufactured under license from Dainippon Sumitomo Pharma
Co., Ltd. Osaka, Japan.
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), cetuximab), multiple sclerosis (Rebif(R), interferon
beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine and
metabolic disorders (Saizen(R) and Serostim(R), somatropin),
(Kuvan(R), sapropterin hydrochloride) as well as cardiometabolic
diseases (Glucophage(R), metformin), (Emcor(R) and Concor(R),
bisoprolol), (Euthyrox(R), levothyroxine). Not all products are
available in all markets.
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 7.6 billion in 2008, a history that began in 1668,
and a future shaped by 32,700 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.
For more information, please visit http://www.merckserono.co.uk

Contact:

Merck Serono, 9 Chemin des Mines, Media Relations, 1202 Geneva, Tel.:
+41-22-414-36-00, Switzerland

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