License Agreement for "Glucophage "
Sumitomo Pharmaceuticals, Co., Ltd. announces the concluding on March 6 of a license agreement with Merck Sante SAS (Lyon, France), the French subsidiary of Merck KGaA Germany, for the antihyperglycemic treatment Glucophage (generic name: metformin HCl) on the Japanese market.
Glucophage is a biguanide orally administered antidiabetic drug that can lower blood sugar levels without promoting the secretion of insulin, marketed around the world by the Merck Group.
The agreement provides Sumitomo Pharmaceuticals with the right to develop and sell Glucophage in Japan. Supplies of the product by Merck will be received once it has been approved as an ethical drug. Sumitomo has also obtained the option for related products, and Merck reserves the option to market the drugs in Japan.
In 1961, Sumitomo Pharmaceuticals became the first company in Japan to develop its own metformin HCl antidiabetic, marketing it as Melbin tablets.
However, as a result of the discovery of the serious side effect lactic acidosis in other biguanide antihyperglycemics, Melbin tablets have been under restrictions for indications/effects and dosage/administration since 1977.
Since then, knowledge of metformin HCl treatments has evolved. Progress has been made in Europe and the US since the latter half of the 1980s in understanding the drug's mechanism, and in accumulating clinical experience. There have been many reports of its high usefulness as an antihyperglycemic, including the information that occurrences of lactic acidosis are rare, except when the drug is administered in inappropriate cases, such as to renal failure patients. This has led to a widely-publicized metformin renaissance. In Japan, the view of the drug is also being re-evaluated, with 2002 guidelines for the treatment of diabetes based on scientific evidence calling it "a drug which may become the medication of first choice, particularly in cases of obesity."
Given these circumstances, Sumitomo Pharmaceuticals, as one of the earliest manufacturers of metformin HCl treatments, determined that it was important to provide treatment information which contributes to Evidence-Based Medicine with Japanese patients, and so decided to reestablish the data for metformin agents according to current approval standards for new drugs, examining the appropriate indications/effects and dosage/administration once more. In order to achieve this objective, it was judged that the best course would be to introduce Glucophage, for which a wealth of non-clinical study data and overseas clinical study data has already been accumulated. This judgment led to the license agreement that is being announced.
Sumitomo Pharmaceuticals will now begin clinical trials on the effectiveness and safety of Glucophage to gain early approval.
Until Glucophage receives approval and sales begin, Sumitomo Pharmaceuticals will actively promote more widespread use of Melbin tablets, and work to increase awareness of the usefulness of metformin treatments, including the safety aspects.