Merck Serono's Glucophage(R) Powder for Oral Solution in Sachet Receives Positive Opinion for Approval in Europe
GENEVA, Switzerland, September 10 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Glucophage® Powder for Oral Solution in Sachet (metformin hydrochloride in 500mg, 850mg and 1000mg strengths) has received a positive opinion recommending approval for the first-line treatment of type 2 diabetes through a Decentralized Procedure (DCP) with France as the Reference Member State. Applications for marketing authorizations were filed in the 15 Member States involved in the DCP.
"The new formulation of Glucophage® Powder for Oral Solution in Sachet allows for a rapid dissolution of the drug. It has been developed to offer patients a convenient alternative to tablets," said Dr Richard Douge, Executive Vice President Marketing at Merck Serono. "We are pleased to soon add Glucophage® Powder for Oral Solution to our extended range of Glucophage® products, each one addressing the different needs of individual patients."
The launch of Glucophage® Powder for Oral Solution in Sachet will be rolled out in the coming months following the delivery of the national marketing authorizations.
About Diabetes
In 2007, the International Diabetes Federation (IDF) estimated 246 million people with diabetes around the world. This figure is expected to rise to 333 million by 2025, amounting to 6.3% of the world's population. Diabetes is now the fourth-leading cause of death in most developed countries. Each year, over three million deaths worldwide are attributable to diabetes-related causes. The most common forms of diabetes are:
- Type 1 diabetes, which is the most common form in children and young adults. Patients require injections of insulin to survive.
- In type 2 diabetes, the pancreas is deficient in producing insulin and the body cannot efficiently use the insulin it produces.
Type 2 diabetes occurs primarily in adults and accounts for 85-90 percent of all cases of diabetes. The complications of type 2 diabetes include, among others, heart disease, stroke, atherosclerosis, kidney failure and blindness, and greatly reduce the quality and duration of type 2 diabetic patients' lives.
About Glucophage® (metformin hydrochloride)
Glucophage® (metformin hydrochloride) 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. Glucophage® 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 unique in being the only antidiabetic agent to lower blood glucose without weight gain, while reducing the risk of long-term complications, such as heart attacks or 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® family.
Glucophage® 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®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Euthyrox®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
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.
For more information, please visit http://www.merckserono.net or http://www.merck.de