US drugmaker Merck & Co says that it anticipates submitting its developmental drug MK-0431A, a combination oral treatment for type 2 diabetes, later this year.
This brings the submission date for MK-0431A forward form its earlier schedule of early 2007 and offers the company to consolidate its position as the lead player in the new oral dipeptidyl peptidase-4 (DPP-4) inhibitor segment.
MK-0431A combines Merck’s already-filed DPP-4 inhibitor Januvia (sitagliptin phosphate) with mainstay oral diabetes drug metformin. The firm has said that it intends to provide additional information on the product at the upcoming annual scientific sessions of the American Diabetes Association meeting in Washington DC.
Januvia is designed to provide treatment for type 2 diabetes by enhancing the function of the incretin system, thereby lowering blood sugar levels. Merck has a roughly six-month lead over its nearest rival, Novartis, which filed its DPP-4 inhibitor Galvus (vildagliptin) in March.
Merck said studies it has carried out so far on Januvia have revealed that the agent is not associated with the excessive weight gain and hypoglycemia that often occurs during treatment for diabetes.
The market for these drugs could be in the region of $3 billion in the USA alone, according to Morgan Stanley, assuming they win a half share of the market for sulfonylureas. Both GlaxoSmithKline and Bristol-Myers Squibb are also working on drugs in this class.
