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Janumet XR

Merck & Co., Inc.

Drug Names(s): Janumet extended release, MK-0431A XR, Januvia (sitagliptin) with Glumetza (Metformin XR), Velmetia XR, Efficib XR

Description: Janumet extended release is a once-daily fixed-dose combination of Januvia with extended release metformin. Januvia is an inhibitor of di-peptidyl peptidase-IV (DPP-IV), an enzyme that breaks down glucagon-like peptide-1 (GLP-1). GLP-1 binds to receptors on pancreatic beta cells stimulating the release of the hormone insulin. GLP-1 also reduces the secretion of glugacon, a hormone produced by the pancreas that stimulates the liver to convert glycogen to glucose thus increasing blood sugar levels. By delaying the degradation of GLP-1, DPP-IV inhibitors extends the action of insulin while also suppressing the release of glucagon.

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Though not definitively established, recent evidence suggests its intracellular target is AMP-activated protein kinase, which regulates lipid and glucose metabolism.

Deal Structure: In June 2004, OSI acquired a portfolio of medical use patents relating to DPIV from Probiodrug. This portfolio contains a number of patent families comprising issued and pending patents and patent applications with claims relating to the use of DPIV inhibitors for the treatment of diabetes and related indications. OSI also licensed sub-licensable rights to patents and patent applications claiming combinations of DPIV inhibitors with other oral anti-diabetic drugs such as metformin. Its rights to this patent estate provide it with a source of upfront payments, and milestone and royalty revenue through the issuance of non-exclusive licenses to the patent estate. Merck has taken a license to this patent estate and OSI receives royalty payments from sales of Januvia and Janumet.

Ono and Merck
In November 2004, Merck granted Ono co-development and co-marketing rights to MK-0431, which is also to be developed and marketed by Banyu Pharmaceutical, Mercks subsidiary in Japan....See full deal structure in Biomedtracker

Partners: Ono Pharmaceutical Company, Ltd. Royalty Pharma AG Otsuka Holdings Co., Ltd. PDL BioPharma, Inc.

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